Validation of a Novel Sham Cervical Spinal Manipulation Procedure

Chronic Neck Pain Clinical Trial

Official title:

Validation of a Novel Sham Cervical Spinal Manipulation Procedure.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978094
• Other study ID #: 072155
• Secondary ID: 1R21AT004396-01A
• Status: Completed
• Phase: N/A
• First received: September 15, 2009
• Last updated: November 16, 2010
• Start date: February 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: Canadian Memorial Chiropractic College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Chronic Neck Pain

Locations

Country	Name	City	State
Canada	Canadian Memorial Chiropractic College	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Canadian Memorial Chiropractic College

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The perception by subjects as to whether they received a real treatment (YES/NO)		10 mins	Yes
Primary	Change scores of the pressure algometry		10 mins	Yes
Secondary	Current Neck Pain, Ranges of Motion, MES Response will be analysed by comparing baseline, 15-and 120-minute score		approximately 1 hours +	No