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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


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
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