Dose Response Effects of Cervical SMT on Pressure Sensitivity of Myofascial Trigger Points
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Change scores of the pressure algometry
Study Overview
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.
Detailed Description
Fibromyalgia syndrome (FMS) is one of the most common manifestations of myofascial pain syndromes. The total annual cost of FMS is $2298 per patient in Canada. A Canadian study suggests that FMS-related productivity loss costs per year are $10,068 per patient. The average cost of health resources in Canada is 30% higher in FMS patients compared to non-FMS patients and the prevalence of FMS in Canada is 1.1%, leading to a total of over 340 thousand Canadians suffering from FMS. As a result, the annual economic burden of FMS to the Canadian healthcare system is more than $425 million.
Typically, FMS patients have widespread musculoskeletal pain with associated non-specific tender points. There is an increase in prevalence in active myofascial trigger points (MTrPs) contributing to the widespread musculoskeletal pain associated with FMS patients. MTrPs are identified as hyperirritable muscular nodules located within taut bands of skeletal muscle and can be classified as latent or active. Studies have shown that active and latent MTrPs can play a determinant role in the not yet fully understood pathogenesis of FMS.
There are many common pathophysiological theories that exist for MTrP formation including metabolic, biochemical, motor endplate dysfunction, and the neurogenic phenomenon. MTrPs may be initiated by a sensitization within the common neurologic segment of the specific tissue containing the MTrP. The physiological changes that occur at the MTrP are secondary to an increased responsiveness of the neurons within the central nervous system leading to increased nociception and increased perception of pain.
Currently there are a variety of therapeutic techniques established to treat MTrPs including spinal manipulative therapy (SMT). SMT may attenuate the nociceptive component of spinal pain and MTrPs. SMT increases pressure pain thresholds (PPTs) leading to mechanical hypoalgesia of MTrPs in paraspinal muscles. Preliminary data collected by Srbely et al. has shown that there is a significant increase in PPTs in infraspinatus MTrPs after cSMT to the C5-C6 spinal segments compared to a sham procedure. The measure of PPT is a method of quantifying a patient's perception of pain in a MTrP. PPTs can be defined as the least amount of pressure stimulus at which a subject perceives pain upon the application of pressure in the form of force.
The appropriate dosage (frequency of application) of SMT needed to achieve optimal pain relief for patients with MTrPs has not been established. Haas et al. performed a pilot randomized controlled trial to examine the dose response relationship between SMT and cervicogenic headaches. The results showed there is a dose-response relationship, increasing the dose of SMT leads to a decreased frequency and intensity of headaches. Additionally, Haas and colleagues conducted a pilot study to make a preliminary identification of the number of chiropractic manipulations required to decrease chronic low back pain and disability. The results showed a positive dose-response relationship between SMT and low back pain. Dose-response for MTrPs has yet to be established in the current literature. This preliminary work will determine the proper dose-response for cSMT in the treatment of MTrPs in one single visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 21 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: cervical spinal manipulative therapy (Other)
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.
Intervention: cervical spinal manipulative therapy (Other)
Outcomes
Primary Outcomes
Change scores of the pressure algometry
Time Frame: 5 minute intervals for 30 minutes post SMT
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 Outcomes
- The perception by subjects as to whether they received a real treatment(5 minutes)
- Change scores of the pressure algometry(5 minutes)