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Validation of a Novel Sham Cervical Spinal Manipulation Procedure

This study has been completed.
Sponsor:
Information provided by:
Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier:
NCT00978094
First received: September 15, 2009
Last updated: November 16, 2010
Last verified: November 2010
History of Changes
  Purpose

Primary hypotheses:

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.

Condition
Chronic Neck Pain

Study Type: Observational
Official Title: Validation of a Novel Sham Cervical Spinal Manipulation Procedure.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Canadian Memorial Chiropractic College:

Primary Outcome Measures:
  • The perception by subjects as to whether they received a real treatment (YES/NO) [ Time Frame: 10 mins ] [ Designated as safety issue: Yes ]
  • Change scores of the pressure algometry [ Time Frame: 10 mins ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Current Neck Pain, Ranges of Motion, MES Response will be analysed by comparing baseline, 15-and 120-minute score [ Time Frame: approximately 1 hours + ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Detailed Description:
  1. Develop a randomized controlled clinical trial design to optimize the testing of the effects of a sham vs real cervical manipulation.
  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.
  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants in this study will be consenting adults, 21-55 years of age, male or female who have chronic mechanical neck pain (NP) rated as between 30 and 65 on an NRS-101 scale [74]. For the purposes of this study NP is defined as;

Criteria

Inclusion Criteria:

  • 21-55 years old with chronic neck pain, Males/Females
  • Between 30-60 NRS 101 Scale
  • ≥ 4 weeks mechanical neck pain

Exclusion Criteria:

  • Cervical Spine Surgery
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978094

Locations
Canada, Ontario
Canadian Memorial Chiropractic College
Toronto, Ontario, Canada, M2H 3J1
Sponsors and Collaborators
Canadian Memorial Chiropractic College
Investigators
Principal Investigator: Howard Vernon, BA, DC, PhD, FCCS, FCCRS CMCC
  More Information

No publications provided

Responsible Party: Howard Vernon, Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier: NCT00978094     History of Changes
Other Study ID Numbers: 072155, 1R21AT004396-01A1
Study First Received: September 15, 2009
Last Updated: November 16, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013