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Completed

NCT Number: NCT00978094

Validation of a Novel Sham Cervical Spinal Manipulation Procedure

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.

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Key information

Conditions

Chronic Neck Pain

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Canadian Memorial Chiropractic College

Toronto, Ontario, M2H 3J1, Canada

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The perception by subjects as to whether they received a real treatment (YES/NO)

    Time frame: 10 mins

  2. Change scores of the pressure algometry

    Time frame: 10 mins

Secondary outcomes

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

    Time frame: approximately 1 hours +

Sponsors and collaborators

Lead sponsor

Canadian Memorial Chiropractic College

Other

Registry information

Official study title

Validation of a Novel Sham Cervical Spinal Manipulation Procedure.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2009
Registry last updated
Nov 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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