Validation of a Novel Sham Cervical Spinal Manipulation Procedure
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|ClinicalTrials.gov Identifier: NCT00978094|
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : November 17, 2010
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:
- Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will remain unchanged in both groups;
- 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.
|Condition or disease|
|Chronic Neck Pain|
- Develop a randomized controlled clinical trial design to optimize the testing of the effects of a sham vs real cervical manipulation.
- 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).
- 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.
- Evaluate the occurrence of neck joint cavitation during the manoeuvres comprising these procedures.
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Validation of a Novel Sham Cervical Spinal Manipulation Procedure.|
|Study Start Date :||February 2009|
|Primary Completion Date :||October 2010|
|Study Completion Date :||October 2010|
- The perception by subjects as to whether they received a real treatment (YES/NO) [ Time Frame: 10 mins ]
- Change scores of the pressure algometry [ Time Frame: 10 mins ]
- Current Neck Pain, Ranges of Motion, MES Response will be analysed by comparing baseline, 15-and 120-minute score [ Time Frame: approximately 1 hours + ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978094
|Canadian Memorial Chiropractic College|
|Toronto, Ontario, Canada, M2H 3J1|
|Principal Investigator:||Howard Vernon, BA, DC, PhD, FCCS, FCCRS||CMCC|