Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
319 participants
INTERVENTIONAL
2013-02-28
2016-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Spinal manipulation
Participants will receive spinal manipulation delivered as segmental thrust to a specific site in the neck. They will receive three intervention sessions over 7-10 days.
Spinal manipulation
Control manipulation
Participants will receive spinal manipulation delivered as non-segmental thrust to the neck. They will receive three intervention sessions over 7-10 days.
Spinal manipulation
Interventions
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Spinal manipulation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
21 Years
60 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Canadian Memorial Chiropractic College
OTHER
Responsible Party
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Principal Investigators
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Howard T Vernon, DC, PhD
Role: PRINCIPAL_INVESTIGATOR
Canadian Memorial Chiropractic College
Locations
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Canadian Memorial Chiropractic College
Toronto, Ontario, Canada
Countries
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References
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Vernon H, MacAdam K, Marshall V, Pion M, Sadowska M. Validation of a sham manipulative procedure for the cervical spine for use in clinical trials. J Manipulative Physiol Ther. 2005 Nov-Dec;28(9):662-6. doi: 10.1016/j.jmpt.2005.07.020.
Other Identifiers
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122008
Identifier Type: -
Identifier Source: org_study_id