- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03949010
Investigation of the Effectiveness of Muscle Inhibition and Space Correction Techniques of Kinesiotaping Method in Female Patients With Myofascial Pain Syndrome Related to Upper Trapezius Active Trigger Points
May 14, 2019 updated by: Dilşad Sindel
To investigate the effectiveness of muscle inhibition and space correction techniques of kinesiotaping (KT) method; on pain, functional status and quality of life in female patients with myofascial pain syndrome (MPS) related to upper trapezius active trigger points (TP) in comparison to control group and to determine the advantage of each technique over another.
Study Overview
Status
Completed
Detailed Description
The investigators conducted a prospective, randomized, controlled trial involving 93 female patients with MPS related to upper trapezius TPs and randomized the patients to KT treatment group with space correction technique and home exercise program (KSCT, n=20), KT treatment group with muscle inhibition technique and home exercise program (KMIT, n=24) and control group (CG, n=27) which received home exercise program only.
Patients were evaluated by numerical rating scale (NRS) for their average and maximum pain intensity, Turkish version of neck disability index (NDI), and short form-36 (SF-36) scales.
Statistical tests were conducted at the 0.05 significance level for all outcome measures.
Study Type
Interventional
Enrollment (Actual)
93
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- being female
- being aged between 18 and 45 years old
- not being in menopausal period
- having pain in upper trapezius region
- determining a taut band in examination
- having at least one active TP in this taut band
- the pain produced by palpation of this TP is the pain that the patient complains
- painfull restriction of cervical lateral flexion
- having pain score 4 or more according to NRS
- signing informed consent.
Exclusion Criteria:
- having major surgery or trauma related to the musculoskeletal system (primarily including the spine and upper extremity)
- having any operative history including the head and neck region
- having a neuromuscular disease
- having an active rheumatic disease
- having a systemic disease (diabetes, hypothyroidism, infection, malignancy...)
- having any pathology related to musculoskeletal diseases -especially including the cervical region- (cervical discopathy, cervical spondylosis, pathologies related to shoulder joint and surrounding soft tissues, scoliosis, kyphosis, limb length discrepancy, polio sequelae, developmental hip dysplasia...)
- having serious psychological problems (having score of 30 or more from Beck Depression Inventory)
- being obese (Body Mass Index≥30 kg/m2)
- having allergy to kinesiotapes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Kinesiotaping with space correction technique
|
Kinesiotaping with space correction technique twice per week for two weeks along with home exercise program
Home exercise program which consists of stretching exercises towards neck area
|
|
Experimental: Kinesiotaping with muscle inhibition technique
|
Home exercise program which consists of stretching exercises towards neck area
Kinesiotaping with muscle inhibition technique twice per week for two weeks along with home exercise program
|
|
Active Comparator: Home exercise program
|
Home exercise program which consists of stretching exercises towards neck area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to first, second and six weeks
Time Frame: Initial assessment, First week, second week, sixth week
|
Pain intensity mesaurement via Numerical Rating Scale, range between 0 to 10, higher scores indicating more pain intensity
|
Initial assessment, First week, second week, sixth week
|
|
Change in disability related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks
Time Frame: Initial assessment, second week, sixth week
|
Functional status measurement via Neck Disability Index
|
Initial assessment, second week, sixth week
|
|
Change in quality of life affected by myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks
Time Frame: Initial assessment, second week, sixth week
|
Quality of life measurement via Short Form-36
|
Initial assessment, second week, sixth week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
May 10, 2019
First Submitted That Met QC Criteria
May 10, 2019
First Posted (Actual)
May 14, 2019
Study Record Updates
Last Update Posted (Actual)
May 16, 2019
Last Update Submitted That Met QC Criteria
May 14, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KSCT&KMIT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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