Dose Response Effects of Cervical Spinal Manipulative Therapy (SMT) on Pressure Sensitivity of Myofascial Trigger Points

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Canadian Memorial Chiropractic College.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University of Guelph
Information provided by:
Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier:
NCT01418170
First received: August 15, 2011
Last updated: August 17, 2011
Last verified: August 2011
  Purpose

Specific Aim 1:

To determine if the effect of cervical spinal manipulation on the pressure pain thresholds in a myofascial trigger point in the infraspinatus muscle can be enhanced and/or extended after a second cervical spine manipulation is given during a single subject visit.

H1: There will be a statistically significant increase in pressure pain thresholds in the myofascial trigger point in the infraspinatus muscle after the second cervical spine manipulation, as compared to the first.

Specific Aim 2:

To determine if the effect of two cervical spinal manipulations on pressure pain thresholds in a myofascial trigger point in the infraspinatus muscle will be present at 48 hours follow-up. Data will be collected for descriptive purposes and hypothesis generation.


Condition Intervention Phase
Trigger Points, Myofascial
Myofascial Trigger Points
Myofascial Pain Syndrome
Other: cervical spinal manipulative therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Dose Response Effects of Cervical SMT on Pressure Sensitivity of Myofascial Trigger Points

Resource links provided by NLM:


Further study details as provided by Canadian Memorial Chiropractic College:

Primary Outcome Measures:
  • Change scores of the pressure algometry [ Time Frame: 5 minute intervals for 30 minutes post SMT ] [ Designated as safety issue: Yes ]
    The outcome being measured is PPTs of MTrP in the infraspinatus muscle with a digital hand-held algometer. PPT readings will be recorded in Newtons, the amount of force required to accelerate a 1-kg mass at 1m/s. MTrP with a baseline PPT of 35N or less will be included. PPT readings will be taken with a hand-held force gauge (NexGen Chatillon DFE Series, AMETEK TCI, Florida, USA) the force gauge tip will be 285mm2 (19 mm x 15 mm). PPT readings will be taken with a force gauge by applying a progressive increase in force perpendicular to the skin at the rate of 5N/s over the MTrP.


Secondary Outcome Measures:
  • Change scores of the pressure algometry [ Time Frame: 5 minutes ] [ Designated as safety issue: Yes ]
    A follow-up pressure pain score will be taken by a pressure algometer 48 hours after the initial intervention.

  • The perception by subjects as to whether they received a real treatment [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    After the intervention the subjects will be asked whether they received a real cSMT or the sham cSMT.


Estimated Enrollment: 26
Study Start Date: September 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Two rcSMT group
A rcSMT will be performed to the C5-C6 segment. A thrust maneuver will then be given to the C5-C6 segment. A rotational inferior drop thrust maneuver will be performed. Immediately after the first rcSMT the subject will turn over on the chiropractic table to lie in the prone position for a post-rcSMT PPT measurement with the same algometer performed by the research assistant. These will be taken at 5-minute intervals. A second rcSMT will be performed at 30 minutes after the first rcSMT. The invention protocol will be repeated. The subject will turn over to the prone position for repeat PPT measurements at 5-minute intervals post-rcSMT for 30 mins. Once the subject has left the treatment area the clinician will mark on the treatment card whether the rcSMT was performed with or without cavitation for quality control purposes.
Other: cervical spinal manipulative therapy
A real cervical spine manipulation will be used for the intervention vs a sham cervical spine manipulation. For the rcSMT the subject's head will be supported by the clinician's forearm. The contact hand of the clinician will contact the C5-C6 spinal segment. A thrust maneuver will be given by the contact hand of the clinician with the supportive hand resting on the subject's zygoma. A rotational inferior drop thrust maneuver will be completed. For the scSMT the subject's head will be rotated to 45 degrees and will be supported by the clinician's forearm, which will lie on top if the headpiece. A thrust maneuver will then be given by the contact hand of the treating clinician to the drop piece with the hand beside the paraspinal musculature simulating a real thrust, the supportive hand will be resting on the subject's zygoma. A inferior drop thrust will be applied to the drop piece (no thrust is made by the contact hand on the cervical spine).
Sham Comparator: One scSMT + One rcSMT Group
A scSMT will be performed with the contact hand of the clinician resting lightly on the paraspinal area of the neck of the subject. The subject's head will be rotated to 45 degrees and supported by the clinician's forearm, lying on headpiece. A inferior drop thrust will be applied to the drop piece. After the first scSMT maneuver the subject will turn over on the chiropractic table to lie in the prone position for a post-scSMT PPT measurement. PPT measurements will be taken at 5-minute intervals for 30 minutes. A rcSMT will be performed 30 minutes after the first scSMT. The subject will turn over to the prone position for repeat PPT measurements in 5-minute intervals for 30 minutes post-rcSMT. Once the subject has left the treatment area the clinician will mark on the treatment card weather the scSMT was performed adequately without cavitation and whether a cavitation occurred with the rcSMT.
Other: cervical spinal manipulative therapy
A real cervical spine manipulation will be used for the intervention vs a sham cervical spine manipulation. For the rcSMT the subject's head will be supported by the clinician's forearm. The contact hand of the clinician will contact the C5-C6 spinal segment. A thrust maneuver will be given by the contact hand of the clinician with the supportive hand resting on the subject's zygoma. A rotational inferior drop thrust maneuver will be completed. For the scSMT the subject's head will be rotated to 45 degrees and will be supported by the clinician's forearm, which will lie on top if the headpiece. A thrust maneuver will then be given by the contact hand of the treating clinician to the drop piece with the hand beside the paraspinal musculature simulating a real thrust, the supportive hand will be resting on the subject's zygoma. A inferior drop thrust will be applied to the drop piece (no thrust is made by the contact hand on the cervical spine).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female subjects between the ages of 21-40 from the Canadian Memorial Chiropractic College (CMCC) main campus and campus clinic
  • MTrPs in the infraspinatus muscle

Exclusion Criteria:

  • Received cSMT within the 72 hour*
  • Insufficient English language to complete pre-study questionnaires
  • No MTrP in the infraspinatus muscle
  • PPT in the MTrPs in the infraspinatus of greater than 35N
  • Any absolute or relative contraindications to manipulation such as; previous VBI, blood-clotting disorders, hypertension, or cardiovascular disorders
  • Any current or prior history of neurological signs and symptoms including facial or extremity weakness, abnormal sensation to the face, body, upper, or lower extremities, uncontrolled bodily movements, gait disturbances, unexplained dizziness, unexplained nausea or vomiting, difficulty with speaking or swallowing
  • Previous history of a whiplash associated disorder
  • Previous cervical spine surgery
  • Any current or recent cervical or thoracic injury including cervical disc herniation with or without radiculopathy, facet irritation, fracture to the cervical spine, fracture to the thoracic spine, or fracture to the scapula
  • Concomitant injuries and/or co-morbidities affecting the cervical, thoracic, upper limb musculoskeletal system and systemic diseases affecting the musculoskeletal system such as diabetes, muscular dystrophies, or chronic pain disorders
  • Current nerve entrapments in the upper extremities
  • Myositis ossificans in the infraspinatus muscle
  • Seronegative spondyloarthropathies
  • Current use of medications such as NSAIDS, antidepressants, or opioids *A wash out period of no cSMT is needed because people accommodate to treatment. A 72-hour time period was chosen as it allows sufficient time for any effects of cSMT on MTrPs to disappear
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01418170

Contacts
Contact: Michelle A Laframboise, BKin (Hons), DC 416-482-2340 ext 242 mlaframboise@cmcc.ca
Contact: John Z Srbely, BSc, DC, PhD 905-495-2999 jsrbely@rogers.com

Locations
Canada, Ontario
Canadian Memorial Chiropractic College Not yet recruiting
Toronto, Ontario, Canada, M2H 3J1
Principal Investigator: Michelle A Laframboise, BKin (Hons), DC         
Sponsors and Collaborators
Canadian Memorial Chiropractic College
University of Guelph
Investigators
Principal Investigator: Michelle A Laframboise, BKin (Hons), DC Canadian Memorial Chiropractic College
  More Information

Publications:

Responsible Party: Dr. Michelle Laframboise, Canadian Memorial Chiropractic College
ClinicalTrials.gov Identifier: NCT01418170     History of Changes
Other Study ID Numbers: 112027
Study First Received: August 15, 2011
Last Updated: August 17, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Canadian Memorial Chiropractic College:
myofascial pain syndrome
myofascial trigger points
spinal manipulative therapy
algometer
pressure pain thresholds

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Somatoform Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014