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Muscle Energy Technique Versus Strain Counterstrain for Upper Trapezius Myofascial Pain Syndrome

Primary Purpose

Physical Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Muscle energy technique combined with the physical therapy program.
Strain counterstrain technique combined with the physical therapy program
The physical therapy program
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Physical Therapy focused on measuring Muscle energy technique, strain counterstrain, trapezius.

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

Experimental group 1.

Experimental group 2.

Experimental group 3.

Outcomes

Primary Outcome Measures

Change in pain intensity.
Measurement of pain intensity using the visual analogue scale.
Change in the right side pain pressure threshold.
Measurement of right side pain pressure threshold using the pressure algometer.
Change in the left side pain pressure threshold.
Measurement of left side pain pressure threshold using the pressure algometer.
Change in cervical flexion range of motion.
Measurement of cervical flexion range of motion using the cervical range of motion device.
Change in cervical extension range of motion.
Measurement of cervical extension range of motion using the cervical range of motion device.
Change in cervical right lateral flexion range of motion.
Measurement of cervical right lateral flexion range of motion using the cervical range of motion device.
Change in cervical left lateral flexion range of motion.
Measurement of cervical left lateral flexion range of motion using the cervical range of motion device.
Change in cervical right rotation range of motion.
Measurement of cervical right rotation range of motion using the cervical range of motion device.
Change in cervical left rotation range of motion.
Measurement of cervical left rotation range of motion using the cervical range of motion device.
Change in neck function.
Measurement of neck function using the neck disability index-Arabic version.

Secondary Outcome Measures

Full Information

First Posted
June 21, 2023
Last Updated
June 21, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05925205
Brief Title
Muscle Energy Technique Versus Strain Counterstrain for Upper Trapezius Myofascial Pain Syndrome
Official Title
Muscle Energy Technique Versus Strain Counterstrain in Treatment of Upper Trapezius Myofascial Pain Syndrome: A Double-Blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2023 (Actual)
Primary Completion Date
May 7, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Therapy
Keywords
Muscle energy technique, strain counterstrain, trapezius.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
ParticipantInvestigator
Masking Description
Firstly, the research assistant, another qualified physical therapist, performing the assessment process, pre and post-treatment, will be blinded regarding the patients allocation into the three treatment groups. Secondly, the patients themselves will be blinded regarding which treatment group they will be allocated into. So the research assistant won't know the randomization results, and the main investigator won't know the assessment results which will make it a double-blinded study.
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Experimental group 1.
Arm Title
Group B
Arm Type
Experimental
Arm Description
Experimental group 2.
Arm Title
Group C
Arm Type
Experimental
Arm Description
Experimental group 3.
Intervention Type
Procedure
Intervention Name(s)
Muscle energy technique combined with the physical therapy program.
Intervention Description
A manual therapy technique
Intervention Type
Procedure
Intervention Name(s)
Strain counterstrain technique combined with the physical therapy program
Intervention Description
A manual therapy technique
Intervention Type
Procedure
Intervention Name(s)
The physical therapy program
Intervention Description
Electrotherapy and exercise.
Primary Outcome Measure Information:
Title
Change in pain intensity.
Description
Measurement of pain intensity using the visual analogue scale.
Time Frame
Change from Baseline pain intensity at one month.
Title
Change in the right side pain pressure threshold.
Description
Measurement of right side pain pressure threshold using the pressure algometer.
Time Frame
Change from Baseline right side pain pressure threshold at one month.
Title
Change in the left side pain pressure threshold.
Description
Measurement of left side pain pressure threshold using the pressure algometer.
Time Frame
Change from Baseline left side pain pressure threshold at one month.
Title
Change in cervical flexion range of motion.
Description
Measurement of cervical flexion range of motion using the cervical range of motion device.
Time Frame
Change from Baseline cervical flexion range of motion at one month.
Title
Change in cervical extension range of motion.
Description
Measurement of cervical extension range of motion using the cervical range of motion device.
Time Frame
Change from Baseline cervical extension range of motion at one month.
Title
Change in cervical right lateral flexion range of motion.
Description
Measurement of cervical right lateral flexion range of motion using the cervical range of motion device.
Time Frame
Change from Baseline cervical right lateral flexion range of motion at one month.
Title
Change in cervical left lateral flexion range of motion.
Description
Measurement of cervical left lateral flexion range of motion using the cervical range of motion device.
Time Frame
Change from Baseline cervical left lateral flexion range of motion at one month.
Title
Change in cervical right rotation range of motion.
Description
Measurement of cervical right rotation range of motion using the cervical range of motion device.
Time Frame
Change from Baseline cervical right rotation range of motion at one month.
Title
Change in cervical left rotation range of motion.
Description
Measurement of cervical left rotation range of motion using the cervical range of motion device.
Time Frame
Change from Baseline cervical left rotation range of motion at one month.
Title
Change in neck function.
Description
Measurement of neck function using the neck disability index-Arabic version.
Time Frame
Change from Baseline neck function at one month.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haytham Morsi, M.Sc.
Phone
+201013657738
Email
10722019485962@pg.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bassem El Nahass, PhD
Organizational Affiliation
Professor of Orthopaedic Physical Therapy, Faculty of Physical Therapy, Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University
City
Kafr Ash Shaykh
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ibrahim Morsi, PhD
Phone
01554552868

12. IPD Sharing Statement

Plan to Share IPD
No

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Muscle Energy Technique Versus Strain Counterstrain for Upper Trapezius Myofascial Pain Syndrome

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