Chronic Mechanical Neck Pain
Conditions
Keywords
neck, pain, chronic, manipulation, control, randomized trial
Brief summary
Eligible subjects with chronic neck pain will be randomly allocated to one of two intervention groups: real vs control spinal manipulation. They will receive three intervention sessions. H1: Chronic neck pain patients treated longitudinally over a series of three encounters in one week by random assignment to treatment group with either of the dual delivery procedures (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error rate of self-report of group allocation at exit interview. H2: Patients treated by the typical-control dual procedure over a typical sequence of encounters (3 times in one week) will show statistically significant improvement in clinical outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index (NDI), range of motion and pressure algometry; compared to those treated by the control-control dual procedure. H3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no significant difference in self-report of group allocation or clinical outcome measures. A total of 372 subjects will be recruited.
Interventions
PROCEDURESpinal manipulation
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Canadian Memorial Chiropractic College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male or Female * 21 to 60 years of age * Chronic neck pain * Neck pain duration greater than 6 weeks * Numeric Rating Scale greater than 30, less than 65 * Pain distribution between nuchal ridge and spine of the scapula * Pain aggravated by local provocation maneuvers at single motion segment * Antero-posterior glide * Paraspinal tenderness * Negative provocative maneuvers at adjacent segment * Able to tolerate neck movement to 50 percent normal in all directions
Exclusion criteria
* Worker's compensation or other medico-legal claim * Cervical spine surgery or fracture or dislocation * Uncontrolled hypertension (Blood Pressure over 140 over 90) * Stroke or Transient Ischemic Attack * Upper respiratory infection within 4 weeks * Severe degenerative disease of the cervical spine * New or significantly altered pattern of headache complaint * Connective tissue disease * Primary fibromyalgia * Metabolic or metaplastic bone disease * Whiplash injury within 12 months * High cholesterol levels not well-managed medically * Cardiovascular surgery in the past 6 months or planned * Use of narcotic analgesic, prescription anti-inflammatory, or muscle relaxants, anti-convulsants * Angina pectoris * Dizziness * Tinnitus * Blurred vision, vertigo, undiagnosed sensory and motor disturbances * Radicular symptoms and signs * Current use of anticoagulant therapy * Upper respiratory infection * Neck pain on provocation greater than 7 out of 10 * Provocation of radicular pain or sensory disturbance * Hypermobility of multiple peripheral joints, * Physical or mental impairment precluding following instructions or participating -in supine recumbent postures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Group registration | At exit assessment following the third intervention session | Participants will be asked to identify which of the two interventions they feel they received. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain severity | 1. at baseline, and 2. At exit assessment following the third intervention session | Pain scores on the PROMIS pain severity instrument. |
| Improvement | At exit assessment following the third intervention session | Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument. |
| Disability | 1. at baseline, and 2. At exit assessment following the third intervention session | Participants will score the The Neck Disability Index (score out of 50). |
| Tenderness | 1. at baseline, and 2. At exit assessment following the third intervention session | Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety | Daily over 7-10 days. | All adverse events will be described and tallied. Adverse events will be categorized in two modes: 1\] Serious vs. Not Serious, and, 2\] Attributable to the trial vs. Not Attributable. Both the absolute number of adverse events as well as the percentage of subjects experiencing an adverse event will be reported. |
| Expectations related to improvement | Baseline | Participants' expectations of the efficacy of the interventions will be obtained at baseline with the protocol of Fulda et al. |
Countries
Canada
Outcome results
None listed