Validation of a Novel Sham Cervical Spinal Manipulation Procedure

NCT00978094 | Completed DMC

• 2 other identifiers: 0721551R21AT004396-01A1
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.Neck pain, cervical ranges of motion and paraspinal EMG responses to pressure pain will remain unchanged in both groups;
2. 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.

Conditions

Chronic Neck Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Current Neck Pain, Ranges of Motion, MES Response will be analysed by comparing baseline, 15-and 120-minute score

  approximately 1 hours +

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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;

You may qualify if:

• years old with chronic neck pain, Males/Females
• Between 30-60 NRS 101 Scale
• ≥ 4 weeks mechanical neck pain

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Memorial Chiropractic College: lead

Study Sites (1)

Canadian Memorial Chiropractic College

Toronto, Ontario, M2H 3J1, Canada

Location

Study Officials

• Howard Vernon, BA, DC, PhD, FCCS, FCCRS

  CMCC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2009
• First Posted: September 16, 2009
• Study Start: February 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: November 17, 2010

Record last verified: 2010-11

Locations

CA (1)