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

NCT01418170 | Completed Phase 2

• 1 other identifier: 112027
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trigger Points, Myofascial; Myofascial Trigger Points; Myofascial Pain Syndrome

Keywords

myofascial pain syndrome; myofascial trigger points; spinal manipulative therapy; algometer; pressure pain thresholds

Outcome Measures

Primary Outcomes (1)

• Change scores of the pressure algometry

  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.

  5 minute intervals for 30 minutes post SMT

Secondary Outcomes (2)

• Change scores of the pressure algometry

  5 minutes

• The perception by subjects as to whether they received a real treatment

  5 minutes

Study Arms (2)

Two rcSMT group

EXPERIMENTAL

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

One scSMT + One rcSMT Group

SHAM COMPARATOR

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

Interventions

cervical spinal manipulative therapy OTHER

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).

One scSMT + One rcSMT Group; Two rcSMT group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Canadian Memorial Chiropractic College: lead
• University of Guelph: collaborator

Study Sites (1)

Canadian Memorial Chiropractic College

Toronto, Ontario, M2H 3J1, Canada

Location

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MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Michelle A Laframboise, BKin (Hons), DC

  Canadian Memorial Chiropractic College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 17, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: January 25, 2018

Record last verified: 2011-08

Locations

CA (1)