Pain
Conditions
Keywords
Pilot Study to Assess Methodologies
Brief summary
The study is designed to assess methods used in clinical research.
Interventions
DEVICEHeat Device
8-Hour Heatwrap
DEVICESham Device
Inactive wrap worn for 8 hours
DRUGmarketed analgesic
2 x 200 mg ibuprofen tablets
DRUGPlacebo
2 x placebo tablets
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Lower back pain * Male or female in generally good health, from 18 to 55 years of age (inclusive)
Exclusion criteria
* Pregnant or lactating * Subject has evidence or history of radiculopathy, i.e. sciatica extending below the knee (numbness, tingling, or shooting pain), or other neurologic deficits (abnormal straight leg raise test, patellar reflexes, and/or bowel and bladder function); * Subject has a history of previous back surgery; * Subject has back pain resulting from traumatic injury involving physical evidence of bruising, swelling, or inflammation to the abdomen or low back area which occurred less than 48 hours prior to enrollment * Has taken an investigational drug within the past 30 days prior to entering the study, or currently enrolled in another investigational study * Is a member or relative of the study site staff, CRO or Sponsor organization directly involved with the study or had a household member or relative participate concurrently or previously in this study * Has previously been enrolled in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Perceptible Relief (Confirmed by Meaningful Relief) | Baseline (time of wrap application or oral treatment administration) up to 4 hours | First perceptible relief defined as the elapsed time from wrap application or oral treatment until the participant depressed the first stopwatch labeled first perceptible relief (any pain relieving effect), provided the participant also depressed the second stopwatch labeled meaningful relief (meaningful to participant) by the end of the scheduled in-patient evaluation (4 hours / 240 minutes). If the confirmation was not achieved, the participant was censored at the time when the first stopwatch was depressed. Confidence interval (CI) calculated using the method of Simon & Lee. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8) | Baseline (time of wrap application or oral treatment administration) up to 8 hours | TOTPAR 0-8 sum of pain relief from 0 through 8 hours, weighted by the time duration between the current timepoint and the previous timepoint. Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief. Total possible score 0 to 40; higher score indicated better relief. |
| Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours | Baseline (time of wrap application or oral treatment administration) up to 8 hours | Time weighted sum of change calculated as sum of change from baseline in back stiffness scores from 0 through 8 hours, weighted by time duration between current timepoint and previous timepoint. Based on hourly (from baseline) back stiffness assessment rating from 0 (no muscle stiffness) to 100 (most possible muscle stiffness). Sum of change derived by subtracting score at post-dosing time point from baseline score. Total possible score -800 to 800; higher positive value was indicative of greater improvement. |
| Time to Treatment Failure | Baseline (time of wrap application or oral treatment administration) up to 8 hours | Time to treatment failure defined as time from dosing to the time of rescue medication within the scheduled duration of the study (8 hours); or for participants who withdrew from the study due to lack of efficacy without taking rescue medication, the time of the last assessment was considered the time to treatment failure; or if participant did not take rescue medication, or did not discontinue due to lack of efficacy, the time to treatment failure was considered censored at 8 hours (the scheduled duration of the study). |
| Individual Time-Point Pain Relief Scores | At 60, 120, 180, 240, 300, 360, 420, and 480 minutes | Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief. |
| Change From Baseline in Individual Time-point Back Stiffness Scores | At 60, 120, 180, 240, 300, 360, 420, and 480 minutes | Low back muscle stiffness rated hourly (from baseline) by the participant by placing a line on a visual analog scale (VAS) from 0 millimeters (mm) to 100 mm in length with 0=no muscle stiffness up to 100 (most possible stiffness). |
| Change From Baseline (Bsl) in Combined Flexibility Score: Extension | Baseline (time of wrap application or oral treatment administration) and 4 hours | Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees minus 5, and x degrees plus 5. Flexibility score derived using standardized value and VAS score (participant rating of pain by marking level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for extension flexibility were average of the extension flexibility data on the combined score (range -66 to 552); higher value indicated greater improvement. |
| Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | Baseline (time of wrap application or oral treatment administration) and 4 hours | Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus (+/-) 10 degrees for left, and right (L, R), movement. Angle at Bsl and 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain to 100=worst pain). Final derived data for overall flexibility was the average of side-to-side (L, R) flexibility data on the combined score (range -81 to 264); higher value=greater improvement. |
| Time to Meaningful Relief | Baseline (time of wrap application or oral treatment administration) up to 4 hours | Time to meaningful relief defined as elapsed time from start of treatment until participant depressed the second stopwatch indicating meaningful relief (meaningful to participant). Participant consider censored if participant did not depress the stopwatch by end of 4-hour in-patient evaluation, or became a treatment failure (rescue or discontinuation) during the time prior to depressing the second stopwatch. Censoring was at time of dropout if participant withdrew for non-efficacy related reasons during the 4-hour in-patient portion of the study. CI calculated using method of Simon & Lee. |
| Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension | Baseline (time of wrap application or oral treatment administration) and 4 hours | Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement of 20 degrees for extension (as if performing a sit-up) to the degree of movement at which participant perceives discomfort or pain. Higher score indicated greater improvement. |
| Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side | Baseline (time of wrap application or oral treatment administration) and 4 hours | Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement +/- 10 degrees for left, and right, side-to-side movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right side-to-side scores. Higher score indicated greater improvement. |
| Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation | Baseline (time of wrap application or oral treatment administration) and 4 hours | Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum rotation at waist of +/- 30 degrees for left, and right, movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right rotation scores. Higher score indicated greater improvement. |
| Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | Baseline (time of wrap application or oral treatment administration) and 4 hours | Flexibility assessed using Paris Plinth table with maximum extension of 20 degrees movement (as if performing a sit-up). When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher score indicated greater discomfort/pain. |
| Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | Baseline (time of wrap application or oral treatment administration) and 4 hours | Flexibility assessed using Paris Plinth table with maximum side-to-side movement of +/- 10 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain. |
| Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | Baseline (time of wrap application or oral treatment administration) and 4 hours | Flexibility assessed using Paris Plinth table with maximum rotation at waist of +/- 30 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain. |
| Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Baseline (time of wrap application or oral treatment administration) up to 8 hours | At hour 8, or at the time of rescue, if it occurred, participants performed a global assessment in their diary in response to the question: How would you rate the study treatment as a pain reliever? Very Poor=0, Poor=1, Fair=2, Good=3, Very Good=4, Excellent=5. |
| Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | Baseline (time of wrap application or oral treatment administration) and 4 hours | Flexibility assessed using Paris Plinth table with maximum rotation at waist of plus or minus (+/-) 30 degrees for left, and right (L, R), movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for overall flexibility were the average of rotation (L, R) flexibility data on combined score (range -80 to 155); higher value=greater improvement. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited who had primary muscular low back pain (in the Investigator's best judgment), which was atraumatic (no traumatic injury within 48 hours of enrollment) and not caused by, or related to, any clinically significant, medical diseases, whose onset had occurred within the past 3 months.
Pre-assignment details
Eligible participants with at least moderate pain intensity on a 6-point categorical scale were randomized (N=61) to primary efficacy (heatwrap or oral placebo) or blinding groups (sham wrap or oral Ibuprofen). May have received rescue medication (oral acetaminophen) during the 4-hour evaluation period or at discharge after assessments completed.
Participants by arm
| Arm | Count |
|---|---|
| ThermaCare® Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper. | 26 |
| Sham Wrap (Inactive) Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper. | 5 |
| Oral Ibuprofen (IBU) IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose. | 5 |
| Oral Placebo Oral Placebo matching Oral IBU. | 25 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Treated-later found eligibility not met | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | ThermaCare® | Total | Oral Placebo | Oral Ibuprofen (IBU) | Sham Wrap (Inactive) |
|---|---|---|---|---|---|
| Age Continuous | 30.0 years STANDARD_DEVIATION 6 | 29.1 years STANDARD_DEVIATION 6.8 | 28.8 years STANDARD_DEVIATION 7.7 | 30.0 years STANDARD_DEVIATION 7.2 | 25.6 years STANDARD_DEVIATION 5.4 |
| Back Stiffness Score | 45.85 millimeters STANDARD_DEVIATION 13.18 | 49.15 millimeters STANDARD_DEVIATION 16.67 | 51.24 millimeters STANDARD_DEVIATION 20.32 | 50.00 millimeters STANDARD_DEVIATION 10.61 | 55.00 millimeters STANDARD_DEVIATION 18.71 |
| Flexibility Assessment: Extension (Angle) Maximum degrees | 15.31 degree of angle STANDARD_DEVIATION 4.53 | 15.02 degree of angle STANDARD_DEVIATION 4.48 | 14.07 degree of angle STANDARD_DEVIATION 4.51 | 16.80 degree of angle STANDARD_DEVIATION 3.89 | 16.48 degree of angle STANDARD_DEVIATION 4.82 |
| Flexibility Assessment: Extension (Angle) Minus 5 degrees | 10.19 degree of angle STANDARD_DEVIATION 4.38 | 9.91 degree of angle STANDARD_DEVIATION 4.32 | 9.01 degree of angle STANDARD_DEVIATION 4.28 | 11.62 degree of angle STANDARD_DEVIATION 3.7 | 11.26 degree of angle STANDARD_DEVIATION 5.04 |
| Flexibility Assessment: Extension (Angle) Plus 5 degrees (beyond maximum) | 17.28 degree of angle STANDARD_DEVIATION 4.48 | 17.63 degree of angle STANDARD_DEVIATION 4.08 | 17.59 degree of angle STANDARD_DEVIATION 4.02 | 18.78 degree of angle STANDARD_DEVIATION 4.35 | 18.50 degree of angle STANDARD_DEVIATION 2.24 |
| Flexibility Assessment: Extension (visual analog scale ([VAS]) VAS at Maximum degrees | 48.65 millimeters STANDARD_DEVIATION 15.69 | 45.84 millimeters STANDARD_DEVIATION 19.26 | 43.40 millimeters STANDARD_DEVIATION 23.35 | 48.20 millimeters STANDARD_DEVIATION 13.52 | 41.00 millimeters STANDARD_DEVIATION 21.21 |
| Flexibility Assessment: Extension (visual analog scale ([VAS]) VAS at Minus 5 degrees | 33.54 millimeters STANDARD_DEVIATION 19.41 | 31.30 millimeters STANDARD_DEVIATION 20.11 | 29.36 millimeters STANDARD_DEVIATION 22.37 | 34.00 millimeters STANDARD_DEVIATION 11.51 | 26.60 millimeters STANDARD_DEVIATION 22 |
| Flexibility Assessment: Extension (visual analog scale ([VAS]) VAS at Plus 5 degrees (beyond maximum) | 56.92 millimeters STANDARD_DEVIATION 20.27 | 54.79 millimeters STANDARD_DEVIATION 23.78 | 52.60 millimeters STANDARD_DEVIATION 27.47 | 59.40 millimeters STANDARD_DEVIATION 14.28 | 50.00 millimeters STANDARD_DEVIATION 32.64 |
| Flexibility Assessment: Rotation (Angle) L Maximum degrees | 15.67 degree of angle STANDARD_DEVIATION 4.08 | 16.39 degree of angle STANDARD_DEVIATION 4.35 | 17.03 degree of angle STANDARD_DEVIATION 4.4 | 15.96 degree of angle STANDARD_DEVIATION 6.44 | 17.36 degree of angle STANDARD_DEVIATION 3.77 |
| Flexibility Assessment: Rotation (Angle) L Minus 5 degrees | 10.21 degree of angle STANDARD_DEVIATION 4.12 | 10.83 degree of angle STANDARD_DEVIATION 4.31 | 11.46 degree of angle STANDARD_DEVIATION 4.33 | 10.42 degree of angle STANDARD_DEVIATION 6.19 | 11.30 degree of angle STANDARD_DEVIATION 4.09 |
| Flexibility Assessment: Rotation (Angle) L Plus 5 degrees (beyond maximum) | 17.95 degree of angle STANDARD_DEVIATION 3.28 | 17.98 degree of angle STANDARD_DEVIATION 3.75 | 18.24 degree of angle STANDARD_DEVIATION 4.12 | 17.12 degree of angle STANDARD_DEVIATION 5.13 | 17.66 degree of angle STANDARD_DEVIATION 3.73 |
| Flexibility Assessment: Rotation (Angle) R Maximum degrees | 16.78 degree of angle STANDARD_DEVIATION 4.73 | 16.81 degree of angle STANDARD_DEVIATION 4.71 | 16.91 degree of angle STANDARD_DEVIATION 4.78 | 16.62 degree of angle STANDARD_DEVIATION 6.19 | 16.66 degree of angle STANDARD_DEVIATION 4.26 |
| Flexibility Assessment: Rotation (Angle) R Minus 5 degrees | 11.27 degree of angle STANDARD_DEVIATION 4.48 | 11.34 degree of angle STANDARD_DEVIATION 4.49 | 11.56 degree of angle STANDARD_DEVIATION 4.46 | 10.74 degree of angle STANDARD_DEVIATION 6.12 | 11.28 degree of angle STANDARD_DEVIATION 4.38 |
| Flexibility Assessment: Rotation (Angle) R Plus 5 degrees (beyond maximum) | 18.48 degree of angle STANDARD_DEVIATION 4.14 | 18.38 degree of angle STANDARD_DEVIATION 4.1 | 18.32 degree of angle STANDARD_DEVIATION 4.3 | 18.06 degree of angle STANDARD_DEVIATION 4.39 | 18.46 degree of angle STANDARD_DEVIATION 3.73 |
| Flexibility Assessment: Rotation (VAS) L VAS at Maximum degrees | 52.54 millimeters STANDARD_DEVIATION 23.88 | 52.28 millimeters STANDARD_DEVIATION 22.81 | 48.80 millimeters STANDARD_DEVIATION 23.41 | 60.60 millimeters STANDARD_DEVIATION 12.3 | 60.00 millimeters STANDARD_DEVIATION 23.74 |
| Flexibility Assessment: Rotation (VAS) L VAS at Minus 5 degrees | 36.92 millimeters STANDARD_DEVIATION 21.25 | 37.05 millimeters STANDARD_DEVIATION 21.77 | 33.24 millimeters STANDARD_DEVIATION 22.28 | 46.60 millimeters STANDARD_DEVIATION 21.24 | 47.20 millimeters STANDARD_DEVIATION 22.94 |
| Flexibility Assessment: Rotation (VAS) L VAS at Plus 5 degrees (beyond maximum) | 56.62 millimeters STANDARD_DEVIATION 25.62 | 54.93 millimeters STANDARD_DEVIATION 23.1 | 49.24 millimeters STANDARD_DEVIATION 22.12 | 65.80 millimeters STANDARD_DEVIATION 12.19 | 63.80 millimeters STANDARD_DEVIATION 18.79 |
| Flexibility Assessment: Rotation (VAS) R VAS at Maximum degrees | 51.65 millimeters STANDARD_DEVIATION 21.33 | 52.28 millimeters STANDARD_DEVIATION 23.56 | 49.64 millimeters STANDARD_DEVIATION 25.97 | 61.60 millimeters STANDARD_DEVIATION 15.84 | 59.40 millimeters STANDARD_DEVIATION 31.09 |
| Flexibility Assessment: Rotation (VAS) R VAS at Minus 5 degrees | 38.15 millimeters STANDARD_DEVIATION 22.26 | 38.75 millimeters STANDARD_DEVIATION 23.12 | 36.56 millimeters STANDARD_DEVIATION 25.02 | 47.40 millimeters STANDARD_DEVIATION 15.84 | 44.20 millimeters STANDARD_DEVIATION 27.47 |
| Flexibility Assessment: Rotation (VAS) R VAS at Plus 5 degrees (beyond maximum) | 59.12 millimeters STANDARD_DEVIATION 27.1 | 56.77 millimeters STANDARD_DEVIATION 26.08 | 50.92 millimeters STANDARD_DEVIATION 26.61 | 64.20 millimeters STANDARD_DEVIATION 11.5 | 66.40 millimeters STANDARD_DEVIATION 28.17 |
| Flexibility Assessment: Side-to-Side (Angle) L Maximum degrees | 6.92 degree of angle STANDARD_DEVIATION 1.69 | 7.01 degree of angle STANDARD_DEVIATION 1.65 | 7.16 degree of angle STANDARD_DEVIATION 1.5 | 6.50 degree of angle STANDARD_DEVIATION 2.4 | 7.20 degree of angle STANDARD_DEVIATION 1.79 |
| Flexibility Assessment: Side-to-Side (Angle) L Minus 5 degrees | 2.15 degree of angle STANDARD_DEVIATION 1.19 | 2.23 degree of angle STANDARD_DEVIATION 1.15 | 2.32 degree of angle STANDARD_DEVIATION 1.07 | 2.00 degree of angle STANDARD_DEVIATION 1.41 | 2.40 degree of angle STANDARD_DEVIATION 1.34 |
| Flexibility Assessment: Side-to-Side (Angle) L Plus 5 degrees (beyond maximum) | 7.22 degree of angle STANDARD_DEVIATION 1.66 | 7.26 degree of angle STANDARD_DEVIATION 1.56 | 7.42 degree of angle STANDARD_DEVIATION 1.4 | 6.60 degree of angle STANDARD_DEVIATION 2.19 | 7.40 degree of angle STANDARD_DEVIATION 1.34 |
| Flexibility Assessment: Side-to-Side (Angle) R Maximum degrees | 6.80 degree of angle STANDARD_DEVIATION 1.76 | 6.81 degree of angle STANDARD_DEVIATION 1.74 | 6.76 degree of angle STANDARD_DEVIATION 1.8 | 6.50 degree of angle STANDARD_DEVIATION 2.06 | 7.40 degree of angle STANDARD_DEVIATION 1.34 |
| Flexibility Assessment: Side-to-Side (Angle) R Minus 5 degrees | 2.05 degree of angle STANDARD_DEVIATION 1.27 | 2.00 degree of angle STANDARD_DEVIATION 1.25 | 1.92 degree of angle STANDARD_DEVIATION 1.19 | 1.80 degree of angle STANDARD_DEVIATION 1.64 | 2.40 degree of angle STANDARD_DEVIATION 1.34 |
| Flexibility Assessment: Side-to-Side (Angle) R Plus 5 degrees (beyond maximum) | 7.33 degree of angle STANDARD_DEVIATION 1.41 | 7.20 degree of angle STANDARD_DEVIATION 1.47 | 7.02 degree of angle STANDARD_DEVIATION 1.68 | 7.00 degree of angle STANDARD_DEVIATION 1.39 | 7.70 degree of angle STANDARD_DEVIATION 0.67 |
| Flexibility Assessment: Side-to-side (VAS) L VAS at Maximum degrees | 42.69 millimeters STANDARD_DEVIATION 22.61 | 38.87 millimeters STANDARD_DEVIATION 23.29 | 35.24 millimeters STANDARD_DEVIATION 25.87 | 43.60 millimeters STANDARD_DEVIATION 21.28 | 32.40 millimeters STANDARD_DEVIATION 14.64 |
| Flexibility Assessment: Side-to-side (VAS) L VAS at Minus 5 degrees | 24.85 millimeters STANDARD_DEVIATION 22.82 | 23.49 millimeters STANDARD_DEVIATION 19.66 | 22.80 millimeters STANDARD_DEVIATION 18.77 | 28.20 millimeters STANDARD_DEVIATION 14.46 | 15.20 millimeters STANDARD_DEVIATION 9.47 |
| Flexibility Assessment: Side-to-side (VAS) L VAS at Plus 5 degrees (beyond maximum) | 40.58 millimeters STANDARD_DEVIATION 26.1 | 38.95 millimeters STANDARD_DEVIATION 24.95 | 37.64 millimeters STANDARD_DEVIATION 25.93 | 48.20 millimeters STANDARD_DEVIATION 22.83 | 27.80 millimeters STANDARD_DEVIATION 15.42 |
| Flexibility Assessment: Side-to-side (VAS) R VAS at Maximum degrees | 47.38 millimeters STANDARD_DEVIATION 25.18 | 46.39 millimeters STANDARD_DEVIATION 22.03 | 45.40 millimeters STANDARD_DEVIATION 20.69 | 52.20 millimeters STANDARD_DEVIATION 14.45 | 40.40 millimeters STANDARD_DEVIATION 20.97 |
| Flexibility Assessment: Side-to-side (VAS) R VAS at Minus 5 degrees | 24.35 millimeters STANDARD_DEVIATION 19.57 | 25.02 millimeters STANDARD_DEVIATION 18.68 | 24.96 millimeters STANDARD_DEVIATION 18.75 | 34.00 millimeters STANDARD_DEVIATION 19.96 | 19.80 millimeters STANDARD_DEVIATION 13.92 |
| Flexibility Assessment: Side-to-side (VAS) R VAS at Plus 5 degrees (beyond maximum) | 48.42 millimeters STANDARD_DEVIATION 26.16 | 47.08 millimeters STANDARD_DEVIATION 23.05 | 44.92 millimeters STANDARD_DEVIATION 21.85 | 55.60 millimeters STANDARD_DEVIATION 13.63 | 42.40 millimeters STANDARD_DEVIATION 22.03 |
| Number of participants with categorical score for pain intensity Extreme=5 | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Number of participants with categorical score for pain intensity Mild=1 | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Number of participants with categorical score for pain intensity Moderate=2 | 19 participants | 44 participants | 20 participants | 2 participants | 3 participants |
| Number of participants with categorical score for pain intensity Moderately severe=3 | 7 participants | 15 participants | 4 participants | 3 participants | 1 participants |
| Number of participants with categorical score for pain intensity None=0 | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Number of participants with categorical score for pain intensity Severe=4 | 0 participants | 2 participants | 1 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 11 Participants | 29 Participants | 15 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Male | 15 Participants | 32 Participants | 10 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 26 | 0 / 5 | 0 / 5 | 0 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 5 | 0 / 5 | 0 / 25 |
Outcome results
Primary
Time to First Perceptible Relief (Confirmed by Meaningful Relief)
First perceptible relief defined as the elapsed time from wrap application or oral treatment until the participant depressed the first stopwatch labeled first perceptible relief (any pain relieving effect), provided the participant also depressed the second stopwatch labeled meaningful relief (meaningful to participant) by the end of the scheduled in-patient evaluation (4 hours / 240 minutes). If the confirmation was not achieved, the participant was censored at the time when the first stopwatch was depressed. Confidence interval (CI) calculated using the method of Simon & Lee.
Time frame: Baseline (time of wrap application or oral treatment administration) up to 4 hours
Population: Intent-to-treat population (ITT): all randomized participants who applied/dosed with study product and had a baseline assessment. Median and/or upper limit of CI reported as 240 minutes if \>240 minutes. No primary endpoint was prespecified in this Pilot study; 1 key efficacy endpoint was selected for reporting purposes only.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ThermaCare® | Time to First Perceptible Relief (Confirmed by Meaningful Relief) | 96.5 minutes |
| Sham Wrap (Inactive) | Time to First Perceptible Relief (Confirmed by Meaningful Relief) | 38.7 minutes |
| Oral Ibuprofen (IBU) | Time to First Perceptible Relief (Confirmed by Meaningful Relief) | 54.0 minutes |
| Oral Placebo | Time to First Perceptible Relief (Confirmed by Meaningful Relief) | 240 minutes |
p-value: 0.046Proportional hazards regression model
Secondary
Change From Baseline (Bsl) in Combined Flexibility Score: Extension
Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees minus 5, and x degrees plus 5. Flexibility score derived using standardized value and VAS score (participant rating of pain by marking level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for extension flexibility were average of the extension flexibility data on the combined score (range -66 to 552); higher value indicated greater improvement.
Time frame: Baseline (time of wrap application or oral treatment administration) and 4 hours
Population: ITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ThermaCare® | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | At Maximum degrees | 13.7 scores on a scale | Standard Deviation 34.8 |
| ThermaCare® | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | At Plus 5 degrees (beyond maximum) | 15.8 scores on a scale | Standard Deviation 36.4 |
| ThermaCare® | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | At Minus 5 degrees | 17.7 scores on a scale | Standard Deviation 39.1 |
| Sham Wrap (Inactive) | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | At Maximum degrees | -4.1 scores on a scale | Standard Deviation 35.6 |
| Sham Wrap (Inactive) | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | At Plus 5 degrees (beyond maximum) | -5.8 scores on a scale | Standard Deviation 31.6 |
| Sham Wrap (Inactive) | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | At Minus 5 degrees | 8.4 scores on a scale | Standard Deviation 43.2 |
| Oral Ibuprofen (IBU) | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | At Minus 5 degrees | 8.0 scores on a scale | Standard Deviation 39.7 |
| Oral Ibuprofen (IBU) | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | At Maximum degrees | 12.7 scores on a scale | Standard Deviation 23.1 |
| Oral Ibuprofen (IBU) | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | At Plus 5 degrees (beyond maximum) | 9.3 scores on a scale | Standard Deviation 30.9 |
| Oral Placebo | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | At Maximum degrees | 4.3 scores on a scale | Standard Deviation 23.3 |
| Oral Placebo | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | At Plus 5 degrees (beyond maximum) | 1.5 scores on a scale | Standard Deviation 17.7 |
| Oral Placebo | Change From Baseline (Bsl) in Combined Flexibility Score: Extension | At Minus 5 degrees | 39.0 scores on a scale | Standard Deviation 133.6 |
Comparison: At Maximum degreesp-value: 0.268ANOVA
Comparison: At Minus 5 degreesp-value: 0.419ANOVA
Comparison: At Plus 5 degrees (beyond maximum)p-value: 0.086ANOVA
Secondary
Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation
Flexibility assessed using Paris Plinth table with maximum rotation at waist of plus or minus (+/-) 30 degrees for left, and right (L, R), movement. Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain up to 100=worst pain). Final derived data for overall flexibility were the average of rotation (L, R) flexibility data on combined score (range -80 to 155); higher value=greater improvement.
Time frame: Baseline (time of wrap application or oral treatment administration) and 4 hours
Population: ITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ThermaCare® | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | At Maximum degrees | 9.9 scores on a scale | Standard Deviation 19 |
| ThermaCare® | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | At Plus 5 degrees (beyond maximum) | 10.0 scores on a scale | Standard Deviation 22.2 |
| ThermaCare® | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | At Minus 5 degrees | 13.0 scores on a scale | Standard Deviation 33.3 |
| Sham Wrap (Inactive) | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | At Maximum degrees | 24.1 scores on a scale | Standard Deviation 12.5 |
| Sham Wrap (Inactive) | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | At Plus 5 degrees (beyond maximum) | 33.4 scores on a scale | Standard Deviation 27.2 |
| Sham Wrap (Inactive) | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | At Minus 5 degrees | 35.9 scores on a scale | Standard Deviation 22 |
| Oral Ibuprofen (IBU) | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | At Minus 5 degrees | 6.8 scores on a scale | Standard Deviation 21.5 |
| Oral Ibuprofen (IBU) | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | At Maximum degrees | 12.1 scores on a scale | Standard Deviation 18.5 |
| Oral Ibuprofen (IBU) | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | At Plus 5 degrees (beyond maximum) | 14.5 scores on a scale | Standard Deviation 19.8 |
| Oral Placebo | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | At Maximum degrees | -0.2 scores on a scale | Standard Deviation 16.4 |
| Oral Placebo | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | At Plus 5 degrees (beyond maximum) | -1.4 scores on a scale | Standard Deviation 13.9 |
| Oral Placebo | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation | At Minus 5 degrees | 4.1 scores on a scale | Standard Deviation 42.9 |
Comparison: At Maximum degreesp-value: 0.043ANOVA
Comparison: At Minus 5 degreesp-value: 0.388ANOVA
Comparison: At Plus 5 degrees (beyond maximum)p-value: 0.039ANOVA
Secondary
Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side
Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus (+/-) 10 degrees for left, and right (L, R), movement. Angle at Bsl and 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain to 100=worst pain). Final derived data for overall flexibility was the average of side-to-side (L, R) flexibility data on the combined score (range -81 to 264); higher value=greater improvement.
Time frame: Baseline (time of wrap application or oral treatment administration) and 4 hours
Population: ITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ThermaCare® | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | At Maximum degrees | 13.9 scores on a scale | Standard Deviation 28.7 |
| ThermaCare® | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | At Plus 5 degrees (beyond maximum) | 11.0 scores on a scale | Standard Deviation 32.5 |
| ThermaCare® | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | At Minus 5 degrees | 9.5 scores on a scale | Standard Deviation 37.3 |
| Sham Wrap (Inactive) | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | At Maximum degrees | 14.0 scores on a scale | Standard Deviation 27.2 |
| Sham Wrap (Inactive) | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | At Plus 5 degrees (beyond maximum) | 14.8 scores on a scale | Standard Deviation 31.3 |
| Sham Wrap (Inactive) | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | At Minus 5 degrees | 2.3 scores on a scale | Standard Deviation 2.8 |
| Oral Ibuprofen (IBU) | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | At Minus 5 degrees | -18.0 scores on a scale | Standard Deviation 38 |
| Oral Ibuprofen (IBU) | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | At Maximum degrees | 3.8 scores on a scale | Standard Deviation 21.6 |
| Oral Ibuprofen (IBU) | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | At Plus 5 degrees (beyond maximum) | 10.9 scores on a scale | Standard Deviation 25.1 |
| Oral Placebo | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | At Maximum degrees | 0.7 scores on a scale | Standard Deviation 21.7 |
| Oral Placebo | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | At Plus 5 degrees (beyond maximum) | 2.0 scores on a scale | Standard Deviation 14.5 |
| Oral Placebo | Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side | At Minus 5 degrees | 14.2 scores on a scale | Standard Deviation 65.5 |
Comparison: At Maximum degreesp-value: 0.067ANOVA
Comparison: At Minus 5 degreesp-value: 0.757ANOVA
Comparison: At Plus 5 degrees (beyond maximum)p-value: 0.219ANOVA
Secondary
Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension
Flexibility assessed using Paris Plinth table with maximum extension of 20 degrees movement (as if performing a sit-up). When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher score indicated greater discomfort/pain.
Time frame: Baseline (time of wrap application or oral treatment administration) and 4 hours
Population: ITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ThermaCare® | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | At Maximum degrees | 4.7 scores on a scale | Standard Deviation 25 |
| ThermaCare® | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | At Plus 5 degrees (beyond maximum) | 9.5 scores on a scale | Standard Deviation 24.7 |
| ThermaCare® | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | At Minus 5 degrees | 2.7 scores on a scale | Standard Deviation 15.1 |
| Sham Wrap (Inactive) | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | At Maximum degrees | -0.8 scores on a scale | Standard Deviation 32.9 |
| Sham Wrap (Inactive) | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | At Plus 5 degrees (beyond maximum) | -5.6 scores on a scale | Standard Deviation 32.1 |
| Sham Wrap (Inactive) | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | At Minus 5 degrees | 7.4 scores on a scale | Standard Deviation 24.7 |
| Oral Ibuprofen (IBU) | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | At Minus 5 degrees | 7.2 scores on a scale | Standard Deviation 23.3 |
| Oral Ibuprofen (IBU) | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | At Maximum degrees | 10.4 scores on a scale | Standard Deviation 15.4 |
| Oral Ibuprofen (IBU) | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | At Plus 5 degrees (beyond maximum) | 12.6 scores on a scale | Standard Deviation 30.7 |
| Oral Placebo | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | At Maximum degrees | -0.6 scores on a scale | Standard Deviation 11 |
| Oral Placebo | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | At Plus 5 degrees (beyond maximum) | 2.0 scores on a scale | Standard Deviation 11.5 |
| Oral Placebo | Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension | At Minus 5 degrees | -1.8 scores on a scale | Standard Deviation 17.8 |
Comparison: At Maximum degreesp-value: 0.355ANOVA
Comparison: At Minus 5 degreesp-value: 0.371ANOVA
Comparison: At Plus 5 degrees (beyond maximum)p-value: 0.216ANOVA
Secondary
Change From Baseline in Individual Time-point Back Stiffness Scores
Low back muscle stiffness rated hourly (from baseline) by the participant by placing a line on a visual analog scale (VAS) from 0 millimeters (mm) to 100 mm in length with 0=no muscle stiffness up to 100 (most possible stiffness).
Time frame: At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
Population: ITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ThermaCare® | Change From Baseline in Individual Time-point Back Stiffness Scores | 60 minutes | 9.4 scores on a scale | Standard Deviation 10.8 |
| ThermaCare® | Change From Baseline in Individual Time-point Back Stiffness Scores | 120 minutes | 14.7 scores on a scale | Standard Deviation 10.4 |
| ThermaCare® | Change From Baseline in Individual Time-point Back Stiffness Scores | 180 minutes | 20.3 scores on a scale | Standard Deviation 11.8 |
| ThermaCare® | Change From Baseline in Individual Time-point Back Stiffness Scores | 240 minutes | 22.7 scores on a scale | Standard Deviation 12.2 |
| ThermaCare® | Change From Baseline in Individual Time-point Back Stiffness Scores | 300 minutes | 23.5 scores on a scale | Standard Deviation 11.8 |
| ThermaCare® | Change From Baseline in Individual Time-point Back Stiffness Scores | 360 minutes | 24.5 scores on a scale | Standard Deviation 13.1 |
| ThermaCare® | Change From Baseline in Individual Time-point Back Stiffness Scores | 420 minutes | 25.8 scores on a scale | Standard Deviation 15.7 |
| ThermaCare® | Change From Baseline in Individual Time-point Back Stiffness Scores | 480 minutes | 26.3 scores on a scale | Standard Deviation 15.8 |
| Sham Wrap (Inactive) | Change From Baseline in Individual Time-point Back Stiffness Scores | 360 minutes | 20.8 scores on a scale | Standard Deviation 10.6 |
| Sham Wrap (Inactive) | Change From Baseline in Individual Time-point Back Stiffness Scores | 300 minutes | 19.2 scores on a scale | Standard Deviation 11 |
| Sham Wrap (Inactive) | Change From Baseline in Individual Time-point Back Stiffness Scores | 120 minutes | 17.6 scores on a scale | Standard Deviation 10.3 |
| Sham Wrap (Inactive) | Change From Baseline in Individual Time-point Back Stiffness Scores | 480 minutes | 20.4 scores on a scale | Standard Deviation 10.6 |
| Sham Wrap (Inactive) | Change From Baseline in Individual Time-point Back Stiffness Scores | 420 minutes | 18.0 scores on a scale | Standard Deviation 10.4 |
| Sham Wrap (Inactive) | Change From Baseline in Individual Time-point Back Stiffness Scores | 240 minutes | 17.6 scores on a scale | Standard Deviation 12.1 |
| Sham Wrap (Inactive) | Change From Baseline in Individual Time-point Back Stiffness Scores | 180 minutes | 18.6 scores on a scale | Standard Deviation 12.8 |
| Sham Wrap (Inactive) | Change From Baseline in Individual Time-point Back Stiffness Scores | 60 minutes | 8.4 scores on a scale | Standard Deviation 10.5 |
| Oral Ibuprofen (IBU) | Change From Baseline in Individual Time-point Back Stiffness Scores | 420 minutes | 18.0 scores on a scale | Standard Deviation 28 |
| Oral Ibuprofen (IBU) | Change From Baseline in Individual Time-point Back Stiffness Scores | 180 minutes | 14.0 scores on a scale | Standard Deviation 18.5 |
| Oral Ibuprofen (IBU) | Change From Baseline in Individual Time-point Back Stiffness Scores | 240 minutes | 18.0 scores on a scale | Standard Deviation 20.2 |
| Oral Ibuprofen (IBU) | Change From Baseline in Individual Time-point Back Stiffness Scores | 300 minutes | 18.0 scores on a scale | Standard Deviation 20.2 |
| Oral Ibuprofen (IBU) | Change From Baseline in Individual Time-point Back Stiffness Scores | 360 minutes | 18.0 scores on a scale | Standard Deviation 22 |
| Oral Ibuprofen (IBU) | Change From Baseline in Individual Time-point Back Stiffness Scores | 480 minutes | 14.0 scores on a scale | Standard Deviation 26.1 |
| Oral Ibuprofen (IBU) | Change From Baseline in Individual Time-point Back Stiffness Scores | 60 minutes | -3.0 scores on a scale | Standard Deviation 8.4 |
| Oral Ibuprofen (IBU) | Change From Baseline in Individual Time-point Back Stiffness Scores | 120 minutes | 8.0 scores on a scale | Standard Deviation 12.5 |
| Oral Placebo | Change From Baseline in Individual Time-point Back Stiffness Scores | 180 minutes | 8.9 scores on a scale | Standard Deviation 24.2 |
| Oral Placebo | Change From Baseline in Individual Time-point Back Stiffness Scores | 240 minutes | 14.0 scores on a scale | Standard Deviation 23.2 |
| Oral Placebo | Change From Baseline in Individual Time-point Back Stiffness Scores | 120 minutes | 4.7 scores on a scale | Standard Deviation 11.5 |
| Oral Placebo | Change From Baseline in Individual Time-point Back Stiffness Scores | 60 minutes | 1.3 scores on a scale | Standard Deviation 11.8 |
| Oral Placebo | Change From Baseline in Individual Time-point Back Stiffness Scores | 300 minutes | 9.6 scores on a scale | Standard Deviation 17.4 |
| Oral Placebo | Change From Baseline in Individual Time-point Back Stiffness Scores | 480 minutes | 12.0 scores on a scale | Standard Deviation 17.1 |
| Oral Placebo | Change From Baseline in Individual Time-point Back Stiffness Scores | 420 minutes | 12.5 scores on a scale | Standard Deviation 17.1 |
| Oral Placebo | Change From Baseline in Individual Time-point Back Stiffness Scores | 360 minutes | 11.5 scores on a scale | Standard Deviation 17.8 |
Comparison: 60 minutes timepointp-value: 0.012ANOVA
Comparison: 120 minutes timepointp-value: 0.002ANOVA
Comparison: 180 minutes timepointp-value: 0.033ANOVA
Comparison: 240 minutes timepointp-value: 0.096ANOVA
Comparison: 300 minutes timepointp-value: 0.002ANOVA
Comparison: 360 minutes timepointp-value: 0.005ANOVA
Comparison: 420 minutes timepointp-value: 0.008ANOVA
Comparison: 480 minutes timepointp-value: 0.004ANOVA
Secondary
Change From Baseline in Pain Measurement for Flexibility Measure: Rotation
Flexibility assessed using Paris Plinth table with maximum rotation at waist of +/- 30 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain.
Time frame: Baseline (time of wrap application or oral treatment administration) and 4 hours
Population: ITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ThermaCare® | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | At Maximum degrees | 7.4 scores on a scale | Standard Deviation 15.9 |
| ThermaCare® | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | At Plus 5 degrees (beyond maximum) | 9.3 scores on a scale | Standard Deviation 21.5 |
| ThermaCare® | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | At Minus 5 degrees | 5.4 scores on a scale | Standard Deviation 17.8 |
| Sham Wrap (Inactive) | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | At Maximum degrees | 17.4 scores on a scale | Standard Deviation 9 |
| Sham Wrap (Inactive) | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | At Plus 5 degrees (beyond maximum) | 25.4 scores on a scale | Standard Deviation 14.1 |
| Sham Wrap (Inactive) | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | At Minus 5 degrees | 19.4 scores on a scale | Standard Deviation 8.4 |
| Oral Ibuprofen (IBU) | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | At Minus 5 degrees | 12.5 scores on a scale | Standard Deviation 15.6 |
| Oral Ibuprofen (IBU) | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | At Maximum degrees | 15.7 scores on a scale | Standard Deviation 18.9 |
| Oral Ibuprofen (IBU) | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | At Plus 5 degrees (beyond maximum) | 20.9 scores on a scale | Standard Deviation 18.1 |
| Oral Placebo | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | At Maximum degrees | 0.2 scores on a scale | Standard Deviation 13.5 |
| Oral Placebo | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | At Plus 5 degrees (beyond maximum) | -1.2 scores on a scale | Standard Deviation 12 |
| Oral Placebo | Change From Baseline in Pain Measurement for Flexibility Measure: Rotation | At Minus 5 degrees | 3.2 scores on a scale | Standard Deviation 13.5 |
Comparison: At Maximum degreesp-value: 0.088ANOVA
Comparison: At Minus 5 degreesp-value: 0.625ANOVA
Comparison: At Plus 5 degrees (beyond maximum)p-value: 0.034ANOVA
Secondary
Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side
Flexibility assessed using Paris Plinth table with maximum side-to-side movement of +/- 10 degrees for L, R movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain. Movement decreased 5 degrees (minus) and discomfort rated on VAS. Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS. Analyses based on the average of L, R scores. Higher score indicated greater discomfort/pain.
Time frame: Baseline (time of wrap application or oral treatment administration) and 4 hours
Population: ITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ThermaCare® | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | At Maximum degrees | 7.9 scores on a scale | Standard Deviation 13.4 |
| ThermaCare® | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | At Plus 5 degrees (beyond maximum) | 5.9 scores on a scale | Standard Deviation 18.1 |
| ThermaCare® | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | At Minus 5 degrees | 4.2 scores on a scale | Standard Deviation 10.7 |
| Sham Wrap (Inactive) | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | At Maximum degrees | 5.0 scores on a scale | Standard Deviation 10.9 |
| Sham Wrap (Inactive) | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | At Plus 5 degrees (beyond maximum) | 7.3 scores on a scale | Standard Deviation 16 |
| Sham Wrap (Inactive) | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | At Minus 5 degrees | 4.6 scores on a scale | Standard Deviation 5.8 |
| Oral Ibuprofen (IBU) | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | At Minus 5 degrees | 2.2 scores on a scale | Standard Deviation 18.3 |
| Oral Ibuprofen (IBU) | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | At Maximum degrees | 6.6 scores on a scale | Standard Deviation 21.2 |
| Oral Ibuprofen (IBU) | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | At Plus 5 degrees (beyond maximum) | 11.2 scores on a scale | Standard Deviation 25.4 |
| Oral Placebo | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | At Maximum degrees | -0.3 scores on a scale | Standard Deviation 15.4 |
| Oral Placebo | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | At Plus 5 degrees (beyond maximum) | 0.9 scores on a scale | Standard Deviation 12.7 |
| Oral Placebo | Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side | At Minus 5 degrees | 2.6 scores on a scale | Standard Deviation 10.4 |
Comparison: At Maximum degreesp-value: 0.054ANOVA
Comparison: At Minus 5 degreesp-value: 0.6ANOVA
Comparison: At Plus 5 degrees (beyond maximum)p-value: 0.294ANOVA
Secondary
Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension
Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement of 20 degrees for extension (as if performing a sit-up) to the degree of movement at which participant perceives discomfort or pain. Higher score indicated greater improvement.
Time frame: Baseline (time of wrap application or oral treatment administration) and 4 hours
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ThermaCare® | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension | 1.4 degrees | Standard Deviation 3 |
| Sham Wrap (Inactive) | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension | -1.1 degrees | Standard Deviation 3.1 |
| Oral Ibuprofen (IBU) | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension | 0.5 degrees | Standard Deviation 2.9 |
| Oral Placebo | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension | 1.2 degrees | Standard Deviation 4.6 |
p-value: 0.797ANOVA
Secondary
Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation
Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum rotation at waist of +/- 30 degrees for left, and right, movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right rotation scores. Higher score indicated greater improvement.
Time frame: Baseline (time of wrap application or oral treatment administration) and 4 hours
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ThermaCare® | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation | 0.6 degrees | Standard Deviation 2.5 |
| Sham Wrap (Inactive) | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation | 1.3 degrees | Standard Deviation 1.4 |
| Oral Ibuprofen (IBU) | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation | -0.6 degrees | Standard Deviation 0.6 |
| Oral Placebo | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation | -0.6 degrees | Standard Deviation 3.3 |
p-value: 0.122ANOVA
Secondary
Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side
Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement +/- 10 degrees for left, and right, side-to-side movement to the degree of movement at which participant perceives discomfort or pain. Maximum flexion based on the average of the left and right side-to-side scores. Higher score indicated greater improvement.
Time frame: Baseline (time of wrap application or oral treatment administration) and 4 hours
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ThermaCare® | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side | 0.1 degrees | Standard Deviation 1.2 |
| Sham Wrap (Inactive) | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side | 0.4 degrees | Standard Deviation 1 |
| Oral Ibuprofen (IBU) | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side | -0.3 degrees | Standard Deviation 0.4 |
| Oral Placebo | Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side | -0.2 degrees | Standard Deviation 1.4 |
p-value: 0.371ANOVA
Secondary
Individual Time-Point Pain Relief Scores
Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief.
Time frame: At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
Population: ITT population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ThermaCare® | Individual Time-Point Pain Relief Scores | 60 minutes | 1.4 scores on a scale | Standard Deviation 1.1 |
| ThermaCare® | Individual Time-Point Pain Relief Scores | 120 minutes | 2.1 scores on a scale | Standard Deviation 1.1 |
| ThermaCare® | Individual Time-Point Pain Relief Scores | 180 minutes | 2.9 scores on a scale | Standard Deviation 1.2 |
| ThermaCare® | Individual Time-Point Pain Relief Scores | 240 minutes | 3.0 scores on a scale | Standard Deviation 1.2 |
| ThermaCare® | Individual Time-Point Pain Relief Scores | 300 minutes | 3.1 scores on a scale | Standard Deviation 1.2 |
| ThermaCare® | Individual Time-Point Pain Relief Scores | 360 minutes | 3.2 scores on a scale | Standard Deviation 1.2 |
| ThermaCare® | Individual Time-Point Pain Relief Scores | 420 minutes | 3.1 scores on a scale | Standard Deviation 1.4 |
| ThermaCare® | Individual Time-Point Pain Relief Scores | 480 minutes | 3.2 scores on a scale | Standard Deviation 1.4 |
| Sham Wrap (Inactive) | Individual Time-Point Pain Relief Scores | 360 minutes | 2.4 scores on a scale | Standard Deviation 1.8 |
| Sham Wrap (Inactive) | Individual Time-Point Pain Relief Scores | 300 minutes | 2.0 scores on a scale | Standard Deviation 2 |
| Sham Wrap (Inactive) | Individual Time-Point Pain Relief Scores | 120 minutes | 1.6 scores on a scale | Standard Deviation 1.3 |
| Sham Wrap (Inactive) | Individual Time-Point Pain Relief Scores | 480 minutes | 2.2 scores on a scale | Standard Deviation 1.9 |
| Sham Wrap (Inactive) | Individual Time-Point Pain Relief Scores | 420 minutes | 2.0 scores on a scale | Standard Deviation 2.1 |
| Sham Wrap (Inactive) | Individual Time-Point Pain Relief Scores | 240 minutes | 2.2 scores on a scale | Standard Deviation 1.9 |
| Sham Wrap (Inactive) | Individual Time-Point Pain Relief Scores | 180 minutes | 2.2 scores on a scale | Standard Deviation 1.9 |
| Sham Wrap (Inactive) | Individual Time-Point Pain Relief Scores | 60 minutes | 1.0 scores on a scale | Standard Deviation 0.7 |
| Oral Ibuprofen (IBU) | Individual Time-Point Pain Relief Scores | 420 minutes | 2.6 scores on a scale | Standard Deviation 2.4 |
| Oral Ibuprofen (IBU) | Individual Time-Point Pain Relief Scores | 180 minutes | 2.4 scores on a scale | Standard Deviation 1.5 |
| Oral Ibuprofen (IBU) | Individual Time-Point Pain Relief Scores | 240 minutes | 2.4 scores on a scale | Standard Deviation 1.8 |
| Oral Ibuprofen (IBU) | Individual Time-Point Pain Relief Scores | 300 minutes | 2.2 scores on a scale | Standard Deviation 1.8 |
| Oral Ibuprofen (IBU) | Individual Time-Point Pain Relief Scores | 360 minutes | 2.4 scores on a scale | Standard Deviation 2.3 |
| Oral Ibuprofen (IBU) | Individual Time-Point Pain Relief Scores | 480 minutes | 2.4 scores on a scale | Standard Deviation 2.2 |
| Oral Ibuprofen (IBU) | Individual Time-Point Pain Relief Scores | 60 minutes | 1.0 scores on a scale | Standard Deviation 1.4 |
| Oral Ibuprofen (IBU) | Individual Time-Point Pain Relief Scores | 120 minutes | 1.6 scores on a scale | Standard Deviation 1.5 |
| Oral Placebo | Individual Time-Point Pain Relief Scores | 180 minutes | 1.4 scores on a scale | Standard Deviation 1.4 |
| Oral Placebo | Individual Time-Point Pain Relief Scores | 240 minutes | 1.7 scores on a scale | Standard Deviation 1.5 |
| Oral Placebo | Individual Time-Point Pain Relief Scores | 120 minutes | 1.2 scores on a scale | Standard Deviation 1.3 |
| Oral Placebo | Individual Time-Point Pain Relief Scores | 60 minutes | 0.6 scores on a scale | Standard Deviation 1.1 |
| Oral Placebo | Individual Time-Point Pain Relief Scores | 300 minutes | 1.5 scores on a scale | Standard Deviation 1.5 |
| Oral Placebo | Individual Time-Point Pain Relief Scores | 480 minutes | 1.7 scores on a scale | Standard Deviation 1.5 |
| Oral Placebo | Individual Time-Point Pain Relief Scores | 420 minutes | 1.7 scores on a scale | Standard Deviation 1.6 |
| Oral Placebo | Individual Time-Point Pain Relief Scores | 360 minutes | 1.7 scores on a scale | Standard Deviation 1.5 |
Comparison: 60 minutes timepointp-value: 0.012ANOVA
Comparison: 120 minutes timepointp-value: 0.016ANOVA
Comparison: 180 minutes timepointp-value: <0.001ANOVA
Comparison: 240 minutes timepointp-value: 0.002ANOVA
Comparison: 300 minutes timepointp-value: <0.001ANOVA
Comparison: 360 minutes timepointp-value: <0.001ANOVA
Comparison: 420 minutes timepointp-value: 0.003ANOVA
Comparison: 480 minutes timepointp-value: 0.001ANOVA
Secondary
Number of Participants Per Categorical Score for Global Assessment of Study Treatment
At hour 8, or at the time of rescue, if it occurred, participants performed a global assessment in their diary in response to the question: How would you rate the study treatment as a pain reliever? Very Poor=0, Poor=1, Fair=2, Good=3, Very Good=4, Excellent=5.
Time frame: Baseline (time of wrap application or oral treatment administration) up to 8 hours
Population: ITT population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ThermaCare® | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Very poor=0 | 0 participants |
| ThermaCare® | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Excellent=5 | 2 participants |
| ThermaCare® | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Very good=4 | 9 participants |
| ThermaCare® | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Poor=1 | 0 participants |
| ThermaCare® | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Response missing | 1 participants |
| ThermaCare® | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Fair=2 | 4 participants |
| ThermaCare® | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Good=3 | 10 participants |
| Sham Wrap (Inactive) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Excellent=5 | 0 participants |
| Sham Wrap (Inactive) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Good=3 | 2 participants |
| Sham Wrap (Inactive) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Fair=2 | 0 participants |
| Sham Wrap (Inactive) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Very good=4 | 0 participants |
| Sham Wrap (Inactive) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Response missing | 2 participants |
| Sham Wrap (Inactive) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Poor=1 | 0 participants |
| Sham Wrap (Inactive) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Very poor=0 | 1 participants |
| Oral Ibuprofen (IBU) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Good=3 | 2 participants |
| Oral Ibuprofen (IBU) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Very poor=0 | 0 participants |
| Oral Ibuprofen (IBU) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Poor=1 | 1 participants |
| Oral Ibuprofen (IBU) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Fair=2 | 1 participants |
| Oral Ibuprofen (IBU) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Very good=4 | 1 participants |
| Oral Ibuprofen (IBU) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Excellent=5 | 0 participants |
| Oral Ibuprofen (IBU) | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Response missing | 0 participants |
| Oral Placebo | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Fair=2 | 10 participants |
| Oral Placebo | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Response missing | 0 participants |
| Oral Placebo | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Excellent=5 | 2 participants |
| Oral Placebo | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Poor=1 | 5 participants |
| Oral Placebo | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Very poor=0 | 6 participants |
| Oral Placebo | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Very good=4 | 1 participants |
| Oral Placebo | Number of Participants Per Categorical Score for Global Assessment of Study Treatment | Good=3 | 1 participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Time to Meaningful Relief
Time to meaningful relief defined as elapsed time from start of treatment until participant depressed the second stopwatch indicating meaningful relief (meaningful to participant). Participant consider censored if participant did not depress the stopwatch by end of 4-hour in-patient evaluation, or became a treatment failure (rescue or discontinuation) during the time prior to depressing the second stopwatch. Censoring was at time of dropout if participant withdrew for non-efficacy related reasons during the 4-hour in-patient portion of the study. CI calculated using method of Simon & Lee.
Time frame: Baseline (time of wrap application or oral treatment administration) up to 4 hours
Population: ITT population. Median and/or upper limit of CI reported as 240 minutes if median or upper limit \>240 minutes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ThermaCare® | Time to Meaningful Relief | 215.7 minutes |
| Sham Wrap (Inactive) | Time to Meaningful Relief | 104.0 minutes |
| Oral Ibuprofen (IBU) | Time to Meaningful Relief | 135.1 minutes |
| Oral Placebo | Time to Meaningful Relief | 240 minutes |
p-value: 0.046Proportional hazards regression model
Secondary
Time to Treatment Failure
Time to treatment failure defined as time from dosing to the time of rescue medication within the scheduled duration of the study (8 hours); or for participants who withdrew from the study due to lack of efficacy without taking rescue medication, the time of the last assessment was considered the time to treatment failure; or if participant did not take rescue medication, or did not discontinue due to lack of efficacy, the time to treatment failure was considered censored at 8 hours (the scheduled duration of the study).
Time frame: Baseline (time of wrap application or oral treatment administration) up to 8 hours
Population: ITT population. Time to treatment failure not calculable as there were no treatment failures in this study. No participants required use of rescue medication or discontinued study prior to 8 hour evaluation.
Secondary
Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours
Time weighted sum of change calculated as sum of change from baseline in back stiffness scores from 0 through 8 hours, weighted by time duration between current timepoint and previous timepoint. Based on hourly (from baseline) back stiffness assessment rating from 0 (no muscle stiffness) to 100 (most possible muscle stiffness). Sum of change derived by subtracting score at post-dosing time point from baseline score. Total possible score -800 to 800; higher positive value was indicative of greater improvement.
Time frame: Baseline (time of wrap application or oral treatment administration) up to 8 hours
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ThermaCare® | Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours | 167.0 scores on a scale | Standard Deviation 83.7 |
| Sham Wrap (Inactive) | Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours | 140.6 scores on a scale | Standard Deviation 71.3 |
| Oral Ibuprofen (IBU) | Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours | 105.0 scores on a scale | Standard Deviation 143.2 |
| Oral Placebo | Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours | 74.5 scores on a scale | Standard Deviation 111.3 |
p-value: 0.002ANOVA
Secondary
Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8)
TOTPAR 0-8 sum of pain relief from 0 through 8 hours, weighted by the time duration between the current timepoint and the previous timepoint. Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief. Total possible score 0 to 40; higher score indicated better relief.
Time frame: Baseline (time of wrap application or oral treatment administration) up to 8 hours
Population: ITT population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ThermaCare® | Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8) | 22.0 scores on a scale | Standard Deviation 7.9 |
| Sham Wrap (Inactive) | Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8) | 15.6 scores on a scale | Standard Deviation 13.1 |
| Oral Ibuprofen (IBU) | Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8) | 17.0 scores on a scale | Standard Deviation 13.5 |
| Oral Placebo | Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8) | 11.5 scores on a scale | Standard Deviation 10 |
p-value: <0.001ANOVA