Upper Back Pain
Conditions
Keywords
upper back/neck/shoulder muscle spasm
Brief summary
Explore the clinical efficacy of 7-day treatment regimens of guaifenesin in order to investigate the evidence that guaifenesin is an effective treatment for upper back/neck/shoulder muscle spasm/stiffness and pain.
Interventions
DRUGGuaifenesin
high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
DRUGPlacebo
no active ingredient
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Paticipant presents with a new episode of acute upper back/neck/shoulder pain and muscle spasm that: 1. is at least 30 days from previous episode. 2. has an onset occurred within 48 hours of Visit 1. 3. has symptoms consistent with a clinical diagnosis as per the physical examination at Visit 1. 4. has a subject-rated muscle spasm score and a pain score of at least 40 out of 100 on a 100mm VAS. * Paticipant has a normal neurological examination.
Exclusion criteria
* Medical history: a) Paticipant has a known or suspected intolerance or hypersensitivity to guaifenesin or methocarbamol (or closely related compounds) or any of their stated ingredients. b) Paticipant has history of upper back pain with active hypersensitive spots - trigger point in the muscles of upper back/neck/shoulder/maxillofacial regions. c) Paticipant has a current or recent history of liver and/or kidney disease, neck/back/shoulder injuries, spinal disc disease, myocardial infarction (\<12 months from Visit 1) and osteoporosis. d) Subjects have history of other chronic pain e.g. headache, osteoarthritis, arthritis, lower back pain etc. * Medications: a) Paticipant has used a muscle relaxant or narcotic within 2 weeks of Visit 1. b) Paticipant has used monoamine oxidase inhibitors or selegiline within 2 weeks of Visit 1 c) Currently using tricyclic antidepressants, lithium, anticoagulants, or tramadol. * Paticipant is involved in a workers compensation case. * Paticipant is unlikely to refrain from using analgesics, NSAIDs, and other muscle relaxants for the duration of the study, with the exception of cardioprotective doses of aspirin (i.e., ≤ 325 mg/day). * Paticipant is unlikely to refrain from physical therapy, massage therapy, acupuncture, heat treatment, spas, etc for the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | 7 Days | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no spasm to 10 - unbearable spasm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores | 7 Days | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no tension to 10 - unbearable tension. |
| Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores | 7 Days | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no pain to 10 - unbearable pain. |
| Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores | 7 Days | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no discomfort to 10 - unbearable discomfort. |
| Muscle Relaxation Scores | 4 Days, 7 Days | The score was measured as mean of both AM and PM assessment scores at Days 4 and 7. Measurements were based on a 5 categorical scale: 0 - no relaxation, 1- a little relaxation, 2 - fair relaxation, 3 - good relaxation, 4 - complete muscle relaxation. |
| Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | 7 Days | The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no stiffness to 10 - unbearable stiffness. |
| Global Assessment of Treatment Helpfulness (GATH) | 4 Days, 7 Days | Measured as an overall qualitative score on a 5 point categorical scale: 0-poor, 1-fair, 2-good, 3-very good and 4-excellent. |
| Global Assessment of Sleep Disturbance (GASD) | 7 Days | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. |
| Global Assessment of Headache Frequency (GAHF) | 7 Days | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. |
| Global Assessment of Headache Intensity (GAHI) | 7 Days | Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'. |
| Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Before treatment, 4 Days, 7 Days | Vernon-Mior upper back/neck/shoulder components were assessed before the treatment and at Days 4 and 7. Each component (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) was assessed based on a 6-point categorical scale (1 to 6), with 1 being the most positive and 6 being the worst. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at multiple clinical sites
Pre-assignment details
Male or female participants aged 18-65 years (inclusive) with acute onset upper back/neck/shoulder muscle spasm and pain were recruited in this study
Participants by arm
| Arm | Count |
|---|---|
| Guaifenesin 600mg Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days | 25 |
| Placebo Matching Guaifenesin 600mg 1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days | 15 |
| Guaifenesin 1200mg 2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days | 24 |
| Placebo Matching Guaifenesin 1200mg 2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days | 14 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Guaifenesin 600mg | Placebo Matching Guaifenesin 600mg | Guaifenesin 1200mg | Placebo Matching Guaifenesin 1200mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 47.2 Years STANDARD_DEVIATION 11.87 | 43.8 Years STANDARD_DEVIATION 10.35 | 45.3 Years STANDARD_DEVIATION 10.62 | 47.3 Years STANDARD_DEVIATION 13.92 | 45.9 Years STANDARD_DEVIATION 11.47 |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 12 Participants | 6 Participants | 35 Participants |
| Sex: Female, Male Male | 17 Participants | 6 Participants | 12 Participants | 8 Participants | 43 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 | 7 / 25 | 1 / 15 | 6 / 24 | 3 / 14 |
| serious Total, serious adverse events | 0 / 25 | 0 / 15 | 0 / 24 | 0 / 14 |
Outcome results
Primary
Mean Change From Baseline of Both AM and PM Spasm Assessment Scores
The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no spasm to 10 - unbearable spasm.
Time frame: 7 Days
Population: Efficacy analysis was conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment. Subjects were analyzed according to the treatment to which they were randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guaifenesin 600mg | Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | 1.66 Score on a Scale | Standard Deviation 1.806 |
| Placebo Matching Guaifenesin 600mg | Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | 1.87 Score on a Scale | Standard Deviation 1.644 |
| Guaifenesin 1200mg | Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | 1.91 Score on a Scale | Standard Deviation 1.541 |
| Placebo Matching Guaifenesin 1200mg | Mean Change From Baseline of Both AM and PM Spasm Assessment Scores | 1.54 Score on a Scale | Standard Deviation 1.203 |
Comparison: Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.p-value: 0.6895% CI: [-1.23, 0.8]t-test, 2 sided
Comparison: Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.p-value: 0.5295% CI: [-0.72, 1.42]t-test, 2 sided
Comparison: Null hypotheses was tested as: H01: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 600mg and placebo. H02: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and placebo. H03: There was no difference in the mean change from baseline of muscle spasm score between Guaifenesin 1200mg and Guaifenesin 600mg.p-value: 0.5895% CI: [-0.64, 1.13]t-test, 2 sided
Secondary
Global Assessment of Headache Frequency (GAHF)
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time frame: 7 Days
Population: Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Guaifenesin 600mg | Global Assessment of Headache Frequency (GAHF) | Headache frequency-increased | 3 participants |
| Guaifenesin 600mg | Global Assessment of Headache Frequency (GAHF) | Headache frequency-decreased | 9 participants |
| Guaifenesin 600mg | Global Assessment of Headache Frequency (GAHF) | Headache frequency-stayed same | 13 participants |
| Placebo Matching Guaifenesin 600mg | Global Assessment of Headache Frequency (GAHF) | Headache frequency-increased | 0 participants |
| Placebo Matching Guaifenesin 600mg | Global Assessment of Headache Frequency (GAHF) | Headache frequency-stayed same | 6 participants |
| Placebo Matching Guaifenesin 600mg | Global Assessment of Headache Frequency (GAHF) | Headache frequency-decreased | 9 participants |
| Guaifenesin 1200mg | Global Assessment of Headache Frequency (GAHF) | Headache frequency-increased | 1 participants |
| Guaifenesin 1200mg | Global Assessment of Headache Frequency (GAHF) | Headache frequency-stayed same | 16 participants |
| Guaifenesin 1200mg | Global Assessment of Headache Frequency (GAHF) | Headache frequency-decreased | 7 participants |
| Placebo Matching Guaifenesin 1200mg | Global Assessment of Headache Frequency (GAHF) | Headache frequency-stayed same | 9 participants |
| Placebo Matching Guaifenesin 1200mg | Global Assessment of Headache Frequency (GAHF) | Headache frequency-decreased | 4 participants |
| Placebo Matching Guaifenesin 1200mg | Global Assessment of Headache Frequency (GAHF) | Headache frequency-increased | 0 participants |
Secondary
Global Assessment of Headache Intensity (GAHI)
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time frame: 7 Days
Population: Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Guaifenesin 600mg | Global Assessment of Headache Intensity (GAHI) | Headache Intensity-decreased | 10 participants |
| Guaifenesin 600mg | Global Assessment of Headache Intensity (GAHI) | Headache Intensity-stayed same | 14 participants |
| Guaifenesin 600mg | Global Assessment of Headache Intensity (GAHI) | Headache Intensity-increased | 1 participants |
| Placebo Matching Guaifenesin 600mg | Global Assessment of Headache Intensity (GAHI) | Headache Intensity-decreased | 9 participants |
| Placebo Matching Guaifenesin 600mg | Global Assessment of Headache Intensity (GAHI) | Headache Intensity-stayed same | 6 participants |
| Placebo Matching Guaifenesin 600mg | Global Assessment of Headache Intensity (GAHI) | Headache Intensity-increased | 0 participants |
| Guaifenesin 1200mg | Global Assessment of Headache Intensity (GAHI) | Headache Intensity-increased | 1 participants |
| Guaifenesin 1200mg | Global Assessment of Headache Intensity (GAHI) | Headache Intensity-decreased | 9 participants |
| Guaifenesin 1200mg | Global Assessment of Headache Intensity (GAHI) | Headache Intensity-stayed same | 14 participants |
| Placebo Matching Guaifenesin 1200mg | Global Assessment of Headache Intensity (GAHI) | Headache Intensity-decreased | 4 participants |
| Placebo Matching Guaifenesin 1200mg | Global Assessment of Headache Intensity (GAHI) | Headache Intensity-stayed same | 9 participants |
| Placebo Matching Guaifenesin 1200mg | Global Assessment of Headache Intensity (GAHI) | Headache Intensity-increased | 0 participants |
Secondary
Global Assessment of Sleep Disturbance (GASD)
Categorized after treatment as: 'decreased', 'increased' or 'stayed the same'.
Time frame: 7 Days
Population: Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Guaifenesin 600mg | Global Assessment of Sleep Disturbance (GASD) | Global Assessment of Sleep Disturbance-Decreased | 8 participants |
| Guaifenesin 600mg | Global Assessment of Sleep Disturbance (GASD) | Global Assessment of Sleep Disturbance-Stayed same | 16 participants |
| Guaifenesin 600mg | Global Assessment of Sleep Disturbance (GASD) | Global Assessment of Sleep Disturbance-Increased | 1 participants |
| Placebo Matching Guaifenesin 600mg | Global Assessment of Sleep Disturbance (GASD) | Global Assessment of Sleep Disturbance-Decreased | 8 participants |
| Placebo Matching Guaifenesin 600mg | Global Assessment of Sleep Disturbance (GASD) | Global Assessment of Sleep Disturbance-Stayed same | 7 participants |
| Placebo Matching Guaifenesin 600mg | Global Assessment of Sleep Disturbance (GASD) | Global Assessment of Sleep Disturbance-Increased | 0 participants |
| Guaifenesin 1200mg | Global Assessment of Sleep Disturbance (GASD) | Global Assessment of Sleep Disturbance-Increased | 2 participants |
| Guaifenesin 1200mg | Global Assessment of Sleep Disturbance (GASD) | Global Assessment of Sleep Disturbance-Decreased | 10 participants |
| Guaifenesin 1200mg | Global Assessment of Sleep Disturbance (GASD) | Global Assessment of Sleep Disturbance-Stayed same | 12 participants |
| Placebo Matching Guaifenesin 1200mg | Global Assessment of Sleep Disturbance (GASD) | Global Assessment of Sleep Disturbance-Decreased | 7 participants |
| Placebo Matching Guaifenesin 1200mg | Global Assessment of Sleep Disturbance (GASD) | Global Assessment of Sleep Disturbance-Stayed same | 5 participants |
| Placebo Matching Guaifenesin 1200mg | Global Assessment of Sleep Disturbance (GASD) | Global Assessment of Sleep Disturbance-Increased | 1 participants |
Secondary
Global Assessment of Treatment Helpfulness (GATH)
Measured as an overall qualitative score on a 5 point categorical scale: 0-poor, 1-fair, 2-good, 3-very good and 4-excellent.
Time frame: 4 Days, 7 Days
Population: Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Guaifenesin 600mg | Global Assessment of Treatment Helpfulness (GATH) | Global Assessment of Treatment Helpfulness- Day 4 | 1.48 Score on a scale | Standard Deviation 1.194 |
| Guaifenesin 600mg | Global Assessment of Treatment Helpfulness (GATH) | Global Assessment of Treatment Helpfulness- Day 7 | 1.56 Score on a scale | Standard Deviation 1.083 |
| Placebo Matching Guaifenesin 600mg | Global Assessment of Treatment Helpfulness (GATH) | Global Assessment of Treatment Helpfulness- Day 7 | 1.73 Score on a scale | Standard Deviation 1.163 |
| Placebo Matching Guaifenesin 600mg | Global Assessment of Treatment Helpfulness (GATH) | Global Assessment of Treatment Helpfulness- Day 4 | 1.53 Score on a scale | Standard Deviation 0.743 |
| Guaifenesin 1200mg | Global Assessment of Treatment Helpfulness (GATH) | Global Assessment of Treatment Helpfulness- Day 4 | 1.63 Score on a scale | Standard Deviation 0.824 |
| Guaifenesin 1200mg | Global Assessment of Treatment Helpfulness (GATH) | Global Assessment of Treatment Helpfulness- Day 7 | 1.71 Score on a scale | Standard Deviation 0.999 |
| Placebo Matching Guaifenesin 1200mg | Global Assessment of Treatment Helpfulness (GATH) | Global Assessment of Treatment Helpfulness- Day 4 | 0.85 Score on a scale | Standard Deviation 0.899 |
| Placebo Matching Guaifenesin 1200mg | Global Assessment of Treatment Helpfulness (GATH) | Global Assessment of Treatment Helpfulness- Day 7 | 1.38 Score on a scale | Standard Deviation 1.121 |
Secondary
Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores
The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no discomfort to 10 - unbearable discomfort.
Time frame: 7 Days
Population: Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guaifenesin 600mg | Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores | 1.95 Score on a scale | Standard Deviation 1.824 |
| Placebo Matching Guaifenesin 600mg | Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores | 2.57 Score on a scale | Standard Deviation 1.406 |
| Guaifenesin 1200mg | Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores | 2.33 Score on a scale | Standard Deviation 1.668 |
| Placebo Matching Guaifenesin 1200mg | Mean Change From Baseline of Both AM and PM NRS Discomfort Assessment Scores | 1.12 Score on a scale | Standard Deviation 1.459 |
Secondary
Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores
The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no stiffness to 10 - unbearable stiffness.
Time frame: 7 Days
Population: Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who receive at least one dose of study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guaifenesin 600mg | Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | 1.90 Score on a scale | Standard Deviation 1.684 |
| Placebo Matching Guaifenesin 600mg | Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | 2.09 Score on a scale | Standard Deviation 1.225 |
| Guaifenesin 1200mg | Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | 1.87 Score on a scale | Standard Deviation 1.63 |
| Placebo Matching Guaifenesin 1200mg | Mean Change From Baseline of Both AM and PM NRS Muscle Stiffness Assessment Scores | 1.77 Score on a scale | Standard Deviation 1.214 |
Secondary
Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores
The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no pain to 10 - unbearable pain.
Time frame: 7 Days
Population: Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guaifenesin 600mg | Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores | 1.65 Score on a scale | Standard Deviation 2.028 |
| Placebo Matching Guaifenesin 600mg | Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores | 2.41 Score on a scale | Standard Deviation 1.376 |
| Guaifenesin 1200mg | Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores | 2.14 Score on a scale | Standard Deviation 1.539 |
| Placebo Matching Guaifenesin 1200mg | Mean Change From Baseline of Both AM and PM NRS Pain Assessment Scores | 1.41 Score on a scale | Standard Deviation 0.995 |
Secondary
Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores
The score was measured as 'assessment at baseline' minus 'assessment after treatment' over 7 day period (mean of all AM and PM changes from baseline). Measurements were based on an 11 categorical Numerical Rating Scale (NRS) with a range from 0 - no tension to 10 - unbearable tension.
Time frame: 7 Days
Population: Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guaifenesin 600mg | Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores | 1.74 Score on a scale | Standard Deviation 1.721 |
| Placebo Matching Guaifenesin 600mg | Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores | 1.98 Score on a scale | Standard Deviation 1.496 |
| Guaifenesin 1200mg | Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores | 1.97 Score on a scale | Standard Deviation 1.54 |
| Placebo Matching Guaifenesin 1200mg | Mean Change From Baseline of Both AM and PM NRS Tension Assessment Scores | 1.54 Score on a scale | Standard Deviation 1.678 |
Secondary
Muscle Relaxation Scores
The score was measured as mean of both AM and PM assessment scores at Days 4 and 7. Measurements were based on a 5 categorical scale: 0 - no relaxation, 1- a little relaxation, 2 - fair relaxation, 3 - good relaxation, 4 - complete muscle relaxation.
Time frame: 4 Days, 7 Days
Population: Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Guaifenesin 600mg | Muscle Relaxation Scores | Degree of Muscle Relaxation at Day 4 | 1.80 Score on a scale | Standard Deviation 0.829 |
| Guaifenesin 600mg | Muscle Relaxation Scores | Degree of Muscle Relaxation at Day 7 | 1.86 Score on a scale | Standard Deviation 0.86 |
| Placebo Matching Guaifenesin 600mg | Muscle Relaxation Scores | Degree of Muscle Relaxation at Day 7 | 2.27 Score on a scale | Standard Deviation 0.98 |
| Placebo Matching Guaifenesin 600mg | Muscle Relaxation Scores | Degree of Muscle Relaxation at Day 4 | 1.90 Score on a scale | Standard Deviation 0.507 |
| Guaifenesin 1200mg | Muscle Relaxation Scores | Degree of Muscle Relaxation at Day 4 | 1.85 Score on a scale | Standard Deviation 0.759 |
| Guaifenesin 1200mg | Muscle Relaxation Scores | Degree of Muscle Relaxation at Day 7 | 2.17 Score on a scale | Standard Deviation 1.007 |
| Placebo Matching Guaifenesin 1200mg | Muscle Relaxation Scores | Degree of Muscle Relaxation at Day 4 | 1.35 Score on a scale | Standard Deviation 0.826 |
| Placebo Matching Guaifenesin 1200mg | Muscle Relaxation Scores | Degree of Muscle Relaxation at Day 7 | 1.69 Score on a scale | Standard Deviation 1.146 |
Secondary
Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores
Vernon-Mior upper back/neck/shoulder components were assessed before the treatment and at Days 4 and 7. Each component (pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation) was assessed based on a 6-point categorical scale (1 to 6), with 1 being the most positive and 6 being the worst.
Time frame: Before treatment, 4 Days, 7 Days
Population: Efficacy analysis were conducted on the intention-to-treat (ITT) population, defined as all subjects who received at least one dose of study medication and who had at least one post-baseline efficacy assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Concentration-Day 4 | 1.75 Score on a scale | Standard Deviation 0.737 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Concentration-before treatment | 2.12 Score on a scale | Standard Deviation 1.013 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Lifting-Day 7 | 2.56 Score on a scale | Standard Deviation 1.387 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Recreation-Day 4 | 2.44 Score on a scale | Standard Deviation 1.121 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Headache-Day 7 | 1.60 Score on a scale | Standard Deviation 0.913 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Headache-Day 4 | 1.76 Score on a scale | Standard Deviation 1.165 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Reading-before treatment | 3.00 Score on a scale | Standard Deviation 1.225 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Sleeping-Day 4 | 2.76 Score on a scale | Standard Deviation 1.363 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Headache-before treatment | 1.72 Score on a scale | Standard Deviation 0.98 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Reading-Day 7 | 2.00 Score on a scale | Standard Deviation 0.707 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Reading-Day 4 | 2.40 Score on a scale | Standard Deviation 0.913 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Sleeping-before treatment | 3.16 Score on a scale | Standard Deviation 1.179 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Personal Care-before treatment | 1.96 Score on a scale | Standard Deviation 0.735 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Pain Intensity-Day 4 | 2.72 Score on a scale | Standard Deviation 0.98 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Driving-Day 7 | 2.48 Score on a scale | Standard Deviation 1.503 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Pain Intensity-before treatment | 3.88 Score on a scale | Standard Deviation 0.781 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Personal Care-Day 4 | 1.72 Score on a scale | Standard Deviation 0.678 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Recreation-Day 7 | 2.29 Score on a scale | Standard Deviation 1.083 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Driving-Day 4 | 2.56 Score on a scale | Standard Deviation 1.53 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Driving-before treatment | 3.12 Score on a scale | Standard Deviation 1.424 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Personal Care-Day 7 | 1.60 Score on a scale | Standard Deviation 0.707 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Recreation-before treatment | 3.44 Score on a scale | Standard Deviation 1.261 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Work-Day 7 | 1.96 Score on a scale | Standard Deviation 0.841 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Work-Day 4 | 2.20 Score on a scale | Standard Deviation 0.957 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Lifting-before treatment | 3.04 Score on a scale | Standard Deviation 1.06 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Sleeping-Day 7 | 2.56 Score on a scale | Standard Deviation 1.193 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Work-before treatment | 2.64 Score on a scale | Standard Deviation 1.186 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Concentration-Day 7 | 1.76 Score on a scale | Standard Deviation 0.831 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Lifting-Day 4 | 2.80 Score on a scale | Standard Deviation 1.258 |
| Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Pain Intensity-Day 7 | 2.48 Score on a scale | Standard Deviation 0.918 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Driving-Day 4 | 2.13 Score on a scale | Standard Deviation 1.302 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Pain Intensity-before treatment | 3.67 Score on a scale | Standard Deviation 0.816 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Pain Intensity-Day 4 | 2.53 Score on a scale | Standard Deviation 0.834 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Pain Intensity-Day 7 | 2.20 Score on a scale | Standard Deviation 0.862 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Personal Care-before treatment | 2.07 Score on a scale | Standard Deviation 0.799 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Personal Care-Day 4 | 1.60 Score on a scale | Standard Deviation 0.632 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Personal Care-Day 7 | 1.33 Score on a scale | Standard Deviation 0.488 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Lifting-before treatment | 3.13 Score on a scale | Standard Deviation 1.302 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Lifting-Day 4 | 2.27 Score on a scale | Standard Deviation 1.1 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Lifting-Day 7 | 2.00 Score on a scale | Standard Deviation 1.309 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Reading-before treatment | 2.67 Score on a scale | Standard Deviation 0.976 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Reading-Day 4 | 2.20 Score on a scale | Standard Deviation 1.014 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Reading-Day 7 | 1.73 Score on a scale | Standard Deviation 0.799 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Headache-before treatment | 1.87 Score on a scale | Standard Deviation 0.743 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Headache-Day 4 | 1.67 Score on a scale | Standard Deviation 0.9 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Headache-Day 7 | 1.67 Score on a scale | Standard Deviation 0.617 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Concentration-before treatment | 2.20 Score on a scale | Standard Deviation 1.32 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Concentration-Day 4 | 1.60 Score on a scale | Standard Deviation 0.507 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Concentration-Day 7 | 1.53 Score on a scale | Standard Deviation 0.64 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Work-before treatment | 2.80 Score on a scale | Standard Deviation 1.014 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Work-Day 4 | 2.13 Score on a scale | Standard Deviation 0.915 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Work-Day 7 | 1.73 Score on a scale | Standard Deviation 0.799 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Driving-before treatment | 2.67 Score on a scale | Standard Deviation 0.816 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Driving-Day 7 | 2.00 Score on a scale | Standard Deviation 1.254 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Sleeping-before treatment | 3.47 Score on a scale | Standard Deviation 1.356 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Sleeping-Day 4 | 2.67 Score on a scale | Standard Deviation 1.291 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Sleeping-Day 7 | 2.20 Score on a scale | Standard Deviation 0.862 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Recreation-before treatment | 3.27 Score on a scale | Standard Deviation 1.1 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Recreation-Day 4 | 2.40 Score on a scale | Standard Deviation 1.121 |
| Placebo Matching Guaifenesin 600mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Recreation-Day 7 | 1.73 Score on a scale | Standard Deviation 0.594 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Driving-Day 4 | 1.79 Score on a scale | Standard Deviation 0.779 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Lifting-Day 4 | 2.58 Score on a scale | Standard Deviation 1.139 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Personal Care-before treatment | 2.00 Score on a scale | Standard Deviation 0.78 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Recreation-Day 7 | 1.88 Score on a scale | Standard Deviation 1.035 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Driving-Day 7 | 1.46 Score on a scale | Standard Deviation 0.509 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Recreation-before treatment | 2.88 Score on a scale | Standard Deviation 0.992 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Work-Day 4 | 1.92 Score on a scale | Standard Deviation 0.929 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Recreation-Day 4 | 2.17 Score on a scale | Standard Deviation 0.917 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Sleeping-before treatment | 2.96 Score on a scale | Standard Deviation 1.083 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Pain Intensity-Day 4 | 2.29 Score on a scale | Standard Deviation 0.955 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Pain Intensity-Day 7 | 1.88 Score on a scale | Standard Deviation 0.797 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Personal Care-Day 7 | 1.29 Score on a scale | Standard Deviation 0.55 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Reading-Day 4 | 1.88 Score on a scale | Standard Deviation 0.947 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Concentration-Day 7 | 1.46 Score on a scale | Standard Deviation 0.588 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Work-Day 7 | 1.75 Score on a scale | Standard Deviation 0.847 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Sleeping-Day 4 | 2.42 Score on a scale | Standard Deviation 1.139 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Reading-Day 7 | 1.58 Score on a scale | Standard Deviation 0.776 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Concentration-before treatment | 1.88 Score on a scale | Standard Deviation 0.992 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Reading-before treatment | 2.29 Score on a scale | Standard Deviation 1.042 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Lifting-before treatment | 2.92 Score on a scale | Standard Deviation 1.139 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Headache-before treatment | 1.79 Score on a scale | Standard Deviation 0.932 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Concentration-Day 4 | 1.54 Score on a scale | Standard Deviation 0.588 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Driving-before treatment | 2.21 Score on a scale | Standard Deviation 0.779 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Work-before treatment | 2.50 Score on a scale | Standard Deviation 0.834 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Headache-Day 4 | 2.04 Score on a scale | Standard Deviation 1.367 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Personal Care-Day 4 | 1.50 Score on a scale | Standard Deviation 0.511 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Lifting-Day 7 | 2.04 Score on a scale | Standard Deviation 0.999 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Pain Intensity-before treatment | 3.25 Score on a scale | Standard Deviation 0.897 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Headache-Day 7 | 1.75 Score on a scale | Standard Deviation 1.152 |
| Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Sleeping-Day 7 | 2.04 Score on a scale | Standard Deviation 1.083 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Headache-Day 7 | 2.00 Score on a scale | Standard Deviation 0.816 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Concentration-before treatment | 2.08 Score on a scale | Standard Deviation 0.494 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Sleeping-Day 7 | 1.92 Score on a scale | Standard Deviation 0.954 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Concentration-Day 4 | 2.00 Score on a scale | Standard Deviation 0.707 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Lifting-before treatment | 3.15 Score on a scale | Standard Deviation 1.144 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Concentration-Day 7 | 1.62 Score on a scale | Standard Deviation 0.506 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Recreation-Day 7 | 2.08 Score on a scale | Standard Deviation 1.32 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Work-before treatment | 3.00 Score on a scale | Standard Deviation 1.354 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Personal Care-Day 7 | 1.46 Score on a scale | Standard Deviation 0.519 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Work-Day 4 | 2.46 Score on a scale | Standard Deviation 0.877 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Recreation-before treatment | 3.23 Score on a scale | Standard Deviation 1.235 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Work-Day 7 | 2.08 Score on a scale | Standard Deviation 1.382 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Personal Care-Day 4 | 1.75 Score on a scale | Standard Deviation 0.754 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Pain Intensity-before treatment | 3.62 Score on a scale | Standard Deviation 0.65 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Driving-before treatment | 3.00 Score on a scale | Standard Deviation 1.225 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Personal Care-before treatment | 2.00 Score on a scale | Standard Deviation 0.816 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Driving-Day 4 | 2.38 Score on a scale | Standard Deviation 1.193 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Driving-Day 7 | 2.15 Score on a scale | Standard Deviation 1.345 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Pain Intensity-Day 7 | 1.92 Score on a scale | Standard Deviation 0.641 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Sleeping-before treatment | 3.23 Score on a scale | Standard Deviation 1.363 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Recreation-Day 4 | 2.54 Score on a scale | Standard Deviation 1.266 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Reading-Day 4 | 2.38 Score on a scale | Standard Deviation 0.65 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Reading-before treatment | 2.92 Score on a scale | Standard Deviation 1.038 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Reading-Day 7 | 1.85 Score on a scale | Standard Deviation 0.689 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Sleeping-Day 4 | 2.92 Score on a scale | Standard Deviation 1.188 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Headache-before treatment | 2.23 Score on a scale | Standard Deviation 0.832 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Lifting-Day 7 | 2.00 Score on a scale | Standard Deviation 1.291 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Pain Intensity-Day 4 | 2.83 Score on a scale | Standard Deviation 0.577 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Headache-Day 4 | 2.23 Score on a scale | Standard Deviation 0.832 |
| Placebo Matching Guaifenesin 1200mg | Upper Back/Neck/Shoulder Pain Disability (Vernon-Mior) Index Scores | Lifting-Day 4 | 2.42 Score on a scale | Standard Deviation 1.311 |