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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
Canadian Memorial Chiropractic College
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Chronic Neck Pain

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 15, 2009
Last Updated
November 16, 2010
Sponsor
Canadian Memorial Chiropractic College
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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

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Validation of a Novel Sham Cervical Spinal Manipulation Procedure

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