Neck Pain
Conditions
Keywords
neck pain, manual therapy, exercise
Brief summary
This study is comparing the effectiveness of a mechanical manual therapy device to a specific exercise to no treatment in individuals experiencing neck pain. We are interested in the effects of the interventions on neck pain, disability related to neck pain, and pain sensitivity.
Interventions
OTHERPulstar Multiple Impulse Therapy
Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
OTHERExercise
Participants perform an exercise to strengthen the deep neck flexors
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* currently experiencing neck pain which does not extend below the elbow * pain at least 4/10 over the past 24 hours * appropriate for conservative management of neck pain * english speaking
Exclusion criteria
* surgery to the neck within the past 6 months * systemic problem know to affect sensation * other chronic pain condition other than neck pain * neck pain as the result of trauma such as whiplash * neck pain as the result of a fracture
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2 Week Change in Pain Score on a Numeric Rating Scale | 2 weeks | a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable |
| 2 Week Change in Disability on the Neck Disability Index | 2 weeks | A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain. The neck disability index is a 10 item questionnaire assessing neck pain related disability. Items are scored from 0 to 5 with the total score doubled resulting in a final score from 0 to 100 with higher scores indicating higher levels of perceived disability. |
| Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale | Immediate within session change pre to post intervention | Participants rated the pain associated with a standardized (51 degrees Celsius) thermal stimulus applied to the plantar surface of their dominant foot using a 0 to 100 numeric pain rating scale with 0 indicating no pain at all and 100 indicating the most intense pain sensation imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Neck Extension Range of Motion at 2 Weeks | 2 weeks | change in neck extension range of motion over a 2 week period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pulstar Multiple Impulse Therapy Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device. | 20 |
| Exercise Participants perform an exercise to strengthen the deep neck flexors
Exercise: Participants perform an exercise to strengthen the deep neck flexors | 21 |
| No Intervention Participants receive/perform no intervention | 21 |
| Total | 62 |
Baseline characteristics
| Characteristic | Exercise | No Intervention | Total | Pulstar Multiple Impulse Therapy |
|---|---|---|---|---|
| Age, Continuous | 31.48 years STANDARD_DEVIATION 10.95 | 36.33 years STANDARD_DEVIATION 14.12 | 33.98 years STANDARD_DEVIATION 12.49 | 34.15 years STANDARD_DEVIATION 12.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 5 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 19 Participants | 56 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 5 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 15 Participants | 41 Participants | 11 Participants |
| Region of Enrollment United States | 21 participants | 21 participants | 62 participants | 20 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 47 Participants | 16 Participants |
| Sex: Female, Male Male | 6 Participants | 5 Participants | 15 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 | 0 / 21 |
Outcome results
Primary
2 Week Change in Disability on the Neck Disability Index
A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain. The neck disability index is a 10 item questionnaire assessing neck pain related disability. Items are scored from 0 to 5 with the total score doubled resulting in a final score from 0 to 100 with higher scores indicating higher levels of perceived disability.
Time frame: 2 weeks
Population: The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulstar Multiple Impulse Therapy | 2 Week Change in Disability on the Neck Disability Index | 4.44 2 week change in units a scale | Standard Deviation 8.53 |
| Exercise | 2 Week Change in Disability on the Neck Disability Index | 5.50 2 week change in units a scale | Standard Deviation 9.53 |
| No Intervention | 2 Week Change in Disability on the Neck Disability Index | 0.42 2 week change in units a scale | Standard Deviation 8.37 |
p-value: 0.18Mixed Models Analysis
Primary
2 Week Change in Pain Score on a Numeric Rating Scale
a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable
Time frame: 2 weeks
Population: The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulstar Multiple Impulse Therapy | 2 Week Change in Pain Score on a Numeric Rating Scale | 6.39 units on a scale | Standard Deviation 24.23 |
| Exercise | 2 Week Change in Pain Score on a Numeric Rating Scale | 20.37 units on a scale | Standard Deviation 23.67 |
| No Intervention | 2 Week Change in Pain Score on a Numeric Rating Scale | 6.45 units on a scale | Standard Deviation 19.88 |
p-value: 0.1Mixed Models Analysis
Primary
Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale
Participants rated the pain associated with a standardized (51 degrees Celsius) thermal stimulus applied to the plantar surface of their dominant foot using a 0 to 100 numeric pain rating scale with 0 indicating no pain at all and 100 indicating the most intense pain sensation imaginable.
Time frame: Immediate within session change pre to post intervention
Population: The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulstar Multiple Impulse Therapy | Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale | 0.58 units on a scale | Standard Deviation 15.39 |
| Exercise | Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale | -0.76 units on a scale | Standard Deviation 16.66 |
| No Intervention | Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale | 1.62 units on a scale | Standard Deviation 10.83 |
p-value: 0.87Mixed Models Analysis
Secondary
Change From Baseline in Neck Extension Range of Motion at 2 Weeks
change in neck extension range of motion over a 2 week period
Time frame: 2 weeks
Population: The numbers of participants analyzed is not consistent with number of participants enrolled in the study due to missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pulstar Multiple Impulse Therapy | Change From Baseline in Neck Extension Range of Motion at 2 Weeks | 2.50 degrees | Standard Deviation 15.46 |
| Exercise | Change From Baseline in Neck Extension Range of Motion at 2 Weeks | 1.32 degrees | Standard Deviation 9.04 |
| No Intervention | Change From Baseline in Neck Extension Range of Motion at 2 Weeks | -1.84 degrees | Standard Deviation 6.06 |
p-value: 0.45Mixed Models Analysis