Validation of a Novel Sham Cervical Spinal Manipulation Procedure

Completed

• Conditions: Chronic Neck Pain

• Registration Number: NCT00978094
• Lead Sponsor: Canadian Memorial Chiropractic College

Brief Summary

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.

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-09-15
• Study First Submitted QC: 2009-09-15
• Study First Posted: 2009-09-16
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-16
• Last Update Posted: 2010-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Canadian Memorial Chiropractic College; 🇨🇦 Toronto, Ontario, Canada