Validation of a Novel Sham Cervical Spinal Manipulation Procedure
NCT ID: NCT00978094
Last Updated: 2010-11-17
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
80 participants
OBSERVATIONAL
2009-02-28
2010-10-31
Brief Summary
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Ho1: In chronic neck pain patients, randomly treated with either a "sham" or "real" cervical manipulation procedure, the probability of perceiving a Real Manipulation Procedure is equal to the probability of obtaining a Real Manipulation Procedure, AND, Ho2: Spinal tenderness will remain unchanged following the treatment procedure for both groups.
Secondary (null) hypotheses:
1. Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will remain unchanged in both groups;
2. there will be no differences between groups with respect to 2a) neck joint cavitations and 2b) forces across the cervical spine measured during the manoeuvres.
Detailed Description
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2. Use novel modifications of both a sham a real manipulation to create "procedures" designed to optimize group equivalence in the RCT design. Then, evaluate the accuracy of 'patient post-treatment perception of treatment type' versus actual administered treatment (primary outcome #1).
3. Quantitatively evaluate group differences in local soft-tissue tenderness by algometry (primary outcome #2), as well as changes in self-reported neck pain, ranges of motion, myoelectric responses in selected neck muscles and forces imparted during the procedures.
4. Evaluate the occurrence of neck joint cavitation during the manoeuvres comprising these procedures.
Conditions
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Eligibility Criteria
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Inclusion Criteria
* Between 30-60 NRS 101 Scale
* ≥ 4 weeks mechanical neck pain
Exclusion Criteria
* Medically uncontrolled High Blood Pressure
* Past History of Stroke
* Upper Respiratory Infection within 4 weeks
* Current Symptoms of Dizziness
* Tinnitus, Blurred Vision, Vertigo, Sensory Motor Disturbance
* Current use of anticoagulant therapy
* Connective Tissue Disorder
* Primary Fibromyalgia or myofascial pain
* Metabolic/Neoplastic Bone Disease
21 Years
55 Years
ALL
No
Sponsors
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Canadian Memorial Chiropractic College
OTHER
Responsible Party
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Canadian Memorial Chiropractic College
Principal Investigators
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Howard Vernon, BA, DC, PhD, FCCS, FCCRS
Role: PRINCIPAL_INVESTIGATOR
CMCC
Locations
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Canadian Memorial Chiropractic College
Toronto, Ontario, Canada
Countries
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Other Identifiers
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072155
Identifier Type: -
Identifier Source: org_study_id