Validation of a Novel Sham Cervical Spinal Manipulation Procedure

Validation of a Novel Sham Cervical Spinal Manipulation Procedure.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Neck Pain

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2H 3J1
      • Canadian Memorial Chiropractic College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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;

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The perception by subjects as to whether they received a real treatment (YES/NO)	10 mins
Change scores of the pressure algometry	10 mins

Secondary Outcome Measures

Outcome Measure	Time Frame
Current Neck Pain, Ranges of Motion, MES Response will be analysed by comparing baseline, 15-and 120-minute score	approximately 1 hours +

Collaborators and Investigators

• Sponsor: Canadian Memorial Chiropractic College
• Investigators: Principal Investigator: Howard Vernon, BA, DC, PhD, FCCS, FCCRS, CMCC

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: September 15, 2009
• First Submitted That Met QC Criteria: September 15, 2009
• First Posted (Estimate): September 16, 2009

Study Record Updates

• Last Update Posted (Estimate): November 17, 2010
• Last Update Submitted That Met QC Criteria: November 16, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 072155; 1R21AT004396-01A1 (U.S. NIH Grant/Contract)