- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05925205
Muscle Energy Technique Versus Strain Counterstrain for Upper Trapezius Myofascial Pain Syndrome
June 21, 2023 updated by: Mona Mohamed Ibrahim, Cairo University
Muscle Energy Technique Versus Strain Counterstrain in Treatment of Upper Trapezius Myofascial Pain Syndrome: A Double-Blinded Randomized Controlled Trial
This study will be conducted to examine the superiority of effectiveness between muscle energy technique combined with physical therapy, strain counterstrain combined with physical therapy, and physical therapy alone in terms of pain intensity, pain pressure threshold, cervical lateral flexion and rotation range of motion, and neck function for patients with upper trapezius myofascial trigger points.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Myofascial pain syndrome represents a common, overlooked, and under-diagnosed disorder that have very critical negative effects on people's lives.
In addition, it overloads the societies and causes several burdens on healthcare systems.
However, this disorder is usually dismissed by many clinicians keeping the patients in pain for long periods.
The central feature of myofascial pain syndrome is the myofascial trigger points that when managed properly, the painful symptoms disappear.
Muscle energy technique and strain counterstrain immediate effects were compared in a recent comparative study for patients with upper trapezius myofascial trigger points in terms of pain intensity, pain pressure threshold, and neck mobility.
The results showed that there were improvements of both techniques with no significant differences between them.
Regarding the evidence of the two techniques; muscle energy technique and strain counterstrain in the management of patients with upper trapezius myofascial trigger points, there is lack of high-quality evidence investigating the effectiveness and safety of both techniques for this population and there is a need for well-developed randomized controlled trial to take a step in the pyramid of levels of evidence for the use and applicability of them.
After reviewing the available literature, it was found that there is no study directly combined both techniques with physical therapy protocol in a randomized clinical trial for patients with upper trapezius myofascial trigger points; this will enable us to compare the effects of them in a controlled design to examine and find out the differences between the three treatment protocols.
Study Type
Interventional
Enrollment (Estimated)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Haytham Morsi, M.Sc.
- Phone Number: +201013657738
- Email: 10722019485962@pg.cu.edu.eg
Study Locations
-
-
-
Kafr Ash Shaykh, Egypt
- Recruiting
- The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University
-
Contact:
- Ibrahim Morsi, PhD
- Phone Number: 01554552868
-
-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
Patients will be included in the study if they fulfil the following criteria:
- They have active myofascial trigger points in the upper trapezius muscle bilaterally according to the established criteria for myofascial trigger points examination.
- They have neck pain less than three months.
- Their age ranges from 18 to 40 years old. Exclusion Criteria
Patients will be excluded from the study if they fulfil the following criteria:
- Patients with chronic pain syndrome.
- Patients having myofascial trigger points in other neck muscles.
- Patients having a history of an injury or surgery or instability or deformity including both; cervical spine and shoulder.
- Patients diagnosed with a neurological disorder including altered sensation, migraine, cervical spondylosis, radiculopathy, or myelopathy, and tumour.
- Patients with a systemic disease including rheumatoid arthritis, Reiter's syndrome, diabetes, fibromyalgia syndrome, and severe medical or psychiatric disorders.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Experimental group 1.
|
A manual therapy technique
|
|
Experimental: Group B
Experimental group 2.
|
A manual therapy technique
|
|
Experimental: Group C
Experimental group 3.
|
Electrotherapy and exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain intensity.
Time Frame: Change from Baseline pain intensity at one month.
|
Measurement of pain intensity using the visual analogue scale.
|
Change from Baseline pain intensity at one month.
|
|
Change in the right side pain pressure threshold.
Time Frame: Change from Baseline right side pain pressure threshold at one month.
|
Measurement of right side pain pressure threshold using the pressure algometer.
|
Change from Baseline right side pain pressure threshold at one month.
|
|
Change in the left side pain pressure threshold.
Time Frame: Change from Baseline left side pain pressure threshold at one month.
|
Measurement of left side pain pressure threshold using the pressure algometer.
|
Change from Baseline left side pain pressure threshold at one month.
|
|
Change in cervical flexion range of motion.
Time Frame: Change from Baseline cervical flexion range of motion at one month.
|
Measurement of cervical flexion range of motion using the cervical range of motion device.
|
Change from Baseline cervical flexion range of motion at one month.
|
|
Change in cervical extension range of motion.
Time Frame: Change from Baseline cervical extension range of motion at one month.
|
Measurement of cervical extension range of motion using the cervical range of motion device.
|
Change from Baseline cervical extension range of motion at one month.
|
|
Change in cervical right lateral flexion range of motion.
Time Frame: Change from Baseline cervical right lateral flexion range of motion at one month.
|
Measurement of cervical right lateral flexion range of motion using the cervical range of motion device.
|
Change from Baseline cervical right lateral flexion range of motion at one month.
|
|
Change in cervical left lateral flexion range of motion.
Time Frame: Change from Baseline cervical left lateral flexion range of motion at one month.
|
Measurement of cervical left lateral flexion range of motion using the cervical range of motion device.
|
Change from Baseline cervical left lateral flexion range of motion at one month.
|
|
Change in cervical right rotation range of motion.
Time Frame: Change from Baseline cervical right rotation range of motion at one month.
|
Measurement of cervical right rotation range of motion using the cervical range of motion device.
|
Change from Baseline cervical right rotation range of motion at one month.
|
|
Change in cervical left rotation range of motion.
Time Frame: Change from Baseline cervical left rotation range of motion at one month.
|
Measurement of cervical left rotation range of motion using the cervical range of motion device.
|
Change from Baseline cervical left rotation range of motion at one month.
|
|
Change in neck function.
Time Frame: Change from Baseline neck function at one month.
|
Measurement of neck function using the neck disability index-Arabic version.
|
Change from Baseline neck function at one month.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bassem El Nahass, PhD, Professor of Orthopaedic Physical Therapy, Faculty of Physical Therapy, Cairo University
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)
May 7, 2023
Primary Completion (Estimated)
May 7, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
June 21, 2023
First Submitted That Met QC Criteria
June 21, 2023
First Posted (Actual)
June 29, 2023
Study Record Updates
Last Update Posted (Actual)
June 29, 2023
Last Update Submitted That Met QC Criteria
June 21, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T. 2023-2025
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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