Chiropractic Manual Therapy and Neck Pain
CompletedNot applicableNCT01772966
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Brief summary (from the registry)
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.
Study details
- Official title
- Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain
- Conditions
- Interventions
- Sponsor
- Canadian Memorial Chiropractic College
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2013-02
- Primary completion
- 2016-08
- Sex
- All
- Age range
- from 21 Years to 60 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Canadian sites (1)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01772966