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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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:

  1. They have active myofascial trigger points in the upper trapezius muscle bilaterally according to the established criteria for myofascial trigger points examination.
  2. They have neck pain less than three months.
  3. Their age ranges from 18 to 40 years old. Exclusion Criteria

Patients will be excluded from the study if they fulfil the following criteria:

  1. Patients with chronic pain syndrome.
  2. Patients having myofascial trigger points in other neck muscles.
  3. Patients having a history of an injury or surgery or instability or deformity including both; cervical spine and shoulder.
  4. Patients diagnosed with a neurological disorder including altered sensation, migraine, cervical spondylosis, radiculopathy, or myelopathy, and tumour.
  5. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A
Experimental group 1.
Procedure: Muscle energy technique combined with the physical therapy program.
A manual therapy technique
Experimental: Group B
Experimental group 2.
Procedure: Strain counterstrain technique combined with the physical therapy program
A manual therapy technique
Experimental: Group C
Experimental group 3.
Procedure: The physical therapy program
Electrotherapy and exercise.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 7, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 7, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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