Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001175965
Ethics application status
Approved
Date submitted
9/11/2011
Date registered
10/11/2011
Date last updated
11/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Spinal Manipulation Reduces Pain in Organized Patterns within Myofascial (Musculoskeletal) Tissues
Scientific title
Spinal Manipulative Therapy Evokes Reduction of Pain Pressure Threshold in Myofascial Trigger Points that are Segmentally Linked to the Manipulated Segment(s).
Secondary ID [1] 273353 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myofascial pain 279126 0
Condition category
Condition code
Musculoskeletal 279318 279318 0 0
Other muscular and skeletal disorders
Anaesthesiology 279325 279325 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention performed was spinal manipulative therapy (SMT). SMT was performed on one occasion (duration 1 hour) by a chiropractic physician with over 17 years of experience in the procedure. Participants were instructed to lay supine during the manipulation procedure(s) with the head resting on a mechanical ‘drop headpiece’, which is designed to increase the acceleration of the manual thrust. Participants assigned to the “manipulation” group received a bilateral rotary manipulation targeting the C5-C6 segment. This procedure initially involves preloading the target tissues by inducing mild flexion, lateral flexion and rotation (<40 degrees) of the cervical spine. A high velocity low amplitude rotary thrust (< 10 degrees) was then manually applied through the C5-C6 spinal segment with the contact hand. The head and neck was then returned to the neutral position. A palpable cavitation confirmed successful administration of the procedure.
Intervention code [1] 283697 0
Rehabilitation
Comparator / control treatment
Control participants received a sham manipulation procedure also targeting the C5-C6 segment. This manoeuvre involves identical preloading of the cervical tissues as in the real manipulation protocol. In the sham procedure, however, the participant’s head is supported by the clinician’s forearm which rests directly on the headpiece. The quick release and rapid acceleration of the headpiece during the sham manoeuvre evokes the sensation of a real manipulation in participants. During this procedure, the clinician thrusts downward into the headpiece with the supporting arm to produce the sensation of a rapid manual thrust to the neck; however, no real thrust is made by the contact hand and no intersegmental manipulation is achieved at the C5-C6 segment.
Control group
Placebo

Outcomes
Primary outcome [1] 279926 0
pain pressure threshold as measured with a pressure algometer
Timepoint [1] 279926 0
0 (baseline pre-treatment), 1, 5, 10 and 15 minutes post intervention
Secondary outcome [1] 294796 0
Nil
Timepoint [1] 294796 0
Nil

Eligibility
Key inclusion criteria
clinically identifiable myofascial trigger point (active or latent) within the right infraspinatus and right gluteus medius muscles.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Conditions that could affect normal somatosensory processing within the cervical spine segments. Including serious medical conditions (eg cancer), central or peripheral neurologic conditions, recent acute injury to cervical spine (eg whiplash), medication use.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation for treatment was performed by a research assistant who was not involved in the intake assessment. The presiding clinician involved in the intake assessment procedure was unaware of participant allocation at the time of allocation, however, became aware of group allocation at the time of intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random draw technique using labelled slips of paper (test, control) drawn from a bin.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
n/a
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment outside Australia
Country [1] 3944 0
Canada
State/province [1] 3944 0
Ontario

Funding & Sponsors
Funding source category [1] 284179 0
Self funded/Unfunded
Name [1] 284179 0
Country [1] 284179 0
Primary sponsor type
University
Name
University of Guelph
Address
50 Stone Road East
Guelph, Ontario
N1G2W1
Country
Canada
Secondary sponsor category [1] 269134 0
None
Name [1] 269134 0
Address [1] 269134 0
Country [1] 269134 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286138 0
University of Guelph REB
Ethics committee address [1] 286138 0
University of Guelph
50 Stone Road East
Guelph, Ontario
N1G2W1
Ethics committee country [1] 286138 0
Canada
Date submitted for ethics approval [1] 286138 0
Approval date [1] 286138 0
06/04/2009
Ethics approval number [1] 286138 0
08OC024

Summary
Brief summary
Chronic widespread pain (CWP), such as fibromyalgia and myofascial pain syndrome, is a significant and growing challenge to our health delivery system. Cost-effective approaches to management are imperative to the sustainability of our future health care system. Spinal manipulative therapy (SMT) is a cost-effective and widely employed manual intervention in the treatment of a variety of musculoskeletal pain conditions; however, its physiologic mechanisms and clinical application in the management of CWP are still unclear. Our aim in this study is to investigate the effect of SMT on musculoskeletal (myofascial) pain. Specifically, we are investigating whether SMT will evoke decreased pain in systematic patterns within myofascial tissues.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33368 0
Address 33368 0
Country 33368 0
Phone 33368 0
Fax 33368 0
Email 33368 0
Contact person for public queries
Name 16615 0
John Z Srbely
Address 16615 0
Department of Human Health and Nutritional Science
University of Guelph
50 Stone Road East
Guelph, Ontario
N1G2W1
Country 16615 0
Canada
Phone 16615 0
+011-1-519-824-4120 ext 52058
Fax 16615 0
Email 16615 0
[email protected]
Contact person for scientific queries
Name 7543 0
John Z Srbely
Address 7543 0
Department of Human Health and Nutritional Science
University of Guelph
50 Stone Road East
Guelph, Ontario
N1G2W1
Country 7543 0
Canada
Phone 7543 0
+011-1-519-824-4120 ext 52058
Fax 7543 0
Email 7543 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.