Neck Pain
Conditions
Brief summary
The aim of this study is to determine which of tertiary prevention spinal manipulative therapy (SMT) or a home exercise program is the more efficient approach to reduce pain and increase functional capacity, quality of life and general health condition. To do so, 60 participants with chronic cervical pain, will be recruited and divided into 3 groups according to the intervention they will receive: control group, experimental group 1 who will receive preventive chiropractic care in the form of spinal manipulations and experimental group 2 will have to perform an individualized home exercise program on a daily basis. We hypothesize that a group of patient receiving SMT + a home exercise program will present less pain and functional disabilities over a 1 year period. The innovative value of this project is mainly related to the fact that it will generate new and potentially very useful data concerning the clinical significance of preventive chiropractic care. Moreover, such data will be beneficial to our profession as chiropractic makes a step towards prevention, wellness and public health.
Interventions
OTHERspinal manipulation
Monthly cervical spinal manipulation
OTHERSpinal manipulation + exercises
Monthly cervical spine manipulation and daily home exercises
Sponsors
Foundation for Chiropractic Education and Research (FCER)
Université du Québec à Trois-Rivières
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Adults between 18 and 60 years old from the city and the surrounding Trois-Rivières with chronic cervical pain of non-traumatic origin (chronic or recurrent cervical pain that lasted at least 6 months)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neck Pain | Up to 10 months | Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain) |
Secondary
| Measure | Time frame |
|---|---|
| Fear Avoidance Belief, Quality of Life, Range of Motion | One year |
Countries
Canada
Participant flow
Recruitment details
chripractic clinic
Pre-assignment details
117 participants were initially recruited. Following the initial clinical assessment, 98 met all inclusion criteria and were assigned to one of the three groups. 19 participants were excluded because they did not met all inclusion criteria (most common reason was that their neck pain could not be diagnosed as a common non specific neck pain).
Participants by arm
| Arm | Count |
|---|---|
| Control control group with no treatment only regular assessment appointments | 29 |
| Spinal Manipulation spinal manipulation | 36 |
| Spinal Manipulation and Exercises Spinal manipulation + exercises | 33 |
| Total | 98 |
Baseline characteristics
| Characteristic | Spinal Manipulation | Spinal Manipulation and Exercises | Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 36 Participants | 33 Participants | 29 Participants | 98 Participants |
| Age Continuous | 37 years STANDARD_DEVIATION 11 | 37 years STANDARD_DEVIATION 11 | 43 years STANDARD_DEVIATION 11 | 39 years STANDARD_DEVIATION 11 |
| Region of Enrollment Canada | 36 participants | 33 participants | 29 participants | 98 participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 23 Participants | 51 Participants |
| Sex: Female, Male Male | 22 Participants | 19 Participants | 6 Participants | 47 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 / 29 | 0 / 36 | 0 / 33 |
| serious Total, serious adverse events | 0 / 29 | 0 / 36 | 0 / 33 |
Outcome results
Primary
Neck Pain
Visual analog pain scale (score 0-10 cm; 0 being no neck pain and 10 extreme neck pain)
Time frame: Up to 10 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Neck Pain | 3.8 cm | Standard Deviation 1.9 |
| Spinal Manipulation | Neck Pain | 3.3 cm | Standard Deviation 1.7 |
| Spinal Manipulation and Exercises | Neck Pain | 3.4 cm | Standard Deviation 1.7 |
Secondary
Fear Avoidance Belief, Quality of Life, Range of Motion
Time frame: One year