Validation of a Novel Sham Cervical Spinal Manipulation Procedure
Primary Purpose
Chronic Neck Pain
Status
Completed
Phase
Locations
Canada
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Chronic Neck Pain
Eligibility 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
Sites / Locations
- Canadian Memorial Chiropractic College
Outcomes
Primary Outcome Measures
The perception by subjects as to whether they received a real treatment (YES/NO)
Change scores of the pressure algometry
Secondary Outcome Measures
Current Neck Pain, Ranges of Motion, MES Response will be analysed by comparing baseline, 15-and 120-minute score
Full Information
NCT ID
NCT00978094
First Posted
September 15, 2009
Last Updated
November 16, 2010
Sponsor
Canadian Memorial Chiropractic College
1. Study Identification
Unique Protocol Identification Number
NCT00978094
Brief Title
Validation of a Novel Sham Cervical Spinal Manipulation Procedure
Official Title
Validation of a Novel Sham Cervical Spinal Manipulation Procedure.
Study Type
Observational
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Canadian Memorial Chiropractic College
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will remain unchanged in both groups;
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
Develop a randomized controlled clinical trial design to optimize the testing of the effects of a sham vs real cervical manipulation.
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).
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.
Evaluate the occurrence of neck joint cavitation during the manoeuvres comprising these procedures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain
7. Study Design
Enrollment
80 (Anticipated)
Primary Outcome Measure Information:
Title
The perception by subjects as to whether they received a real treatment (YES/NO)
Time Frame
10 mins
Title
Change scores of the pressure algometry
Time Frame
10 mins
Secondary Outcome Measure Information:
Title
Current Neck Pain, Ranges of Motion, MES Response will be analysed by comparing baseline, 15-and 120-minute score
Time Frame
approximately 1 hours +
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Study Population Description
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;
Sampling Method
Non-Probability Sample
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Vernon, BA, DC, PhD, FCCS, FCCRS
Organizational Affiliation
CMCC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Canadian Memorial Chiropractic College
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2H 3J1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Validation of a Novel Sham Cervical Spinal Manipulation Procedure
We'll reach out to this number within 24 hrs