Physical TherapyNCT05925205
Muscle Energy Technique Versus Strain Counterstrain for Upper Trapezius Myofascial Pain Syndrome
A study testing Muscle energy technique combined with the physical therapy program., Strain counterstrain technique combined with the physical therapy program and The physical therapy program in people with Physical Therapy, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Physical Therapy
- What is being tested?
- Muscle energy technique combined with the physical therapy program., Strain counterstrain technique combined with the physical therapy program and The physical therapy program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 7 May 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University
Kafr ash Shaykh
Ibrahim Morsi, PhD, 01554552868
About this study
Official title: 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.
Read the 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.
- Conditions
- Physical Therapy
- Being tested
- Muscle energy technique combined with the physical therapy program., Strain counterstrain technique combined with the physical therapy program, The physical therapy program
- Keywords
- Muscle energy technique, strain counterstrain, trapezius.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle energy technique combined with the physical therapy program.Procedure or surgery
A manual therapy technique
Strain counterstrain technique combined with the physical therapy programProcedure or surgery
A manual therapy technique
The physical therapy programProcedure or surgery
Electrotherapy and exercise.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Experimental group 1. Receives: Procedure: Muscle energy technique combined with the physical therapy program. |
| Group B | Experimental | Experimental group 2. Receives: Procedure: Strain counterstrain technique combined with the physical therapy program |
| Group C | Experimental | Experimental group 3. Receives: Procedure: The physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity.
Measurement of pain intensity using the visual analogue scale.
Measured: Change from Baseline pain intensity at one month.
Change in the right side pain pressure threshold.
Measurement of right side pain pressure threshold using the pressure algometer.
Measured: Change from Baseline right side pain pressure threshold at one month.
Change in the left side pain pressure threshold.
Measurement of left side pain pressure threshold using the pressure algometer.
Measured: Change from Baseline left side pain pressure threshold at one month.
Change in cervical flexion range of motion.
Measurement of cervical flexion range of motion using the cervical range of motion device.
Measured: Change from Baseline cervical flexion range of motion at one month.
Change in cervical extension range of motion.
Measurement of cervical extension range of motion using the cervical range of motion device.
Measured: Change from Baseline cervical extension range of motion at one month.
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.
Measured: Change from Baseline cervical right lateral flexion range of motion at one month.
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.
Measured: Change from Baseline cervical left lateral flexion range of motion at one month.
Change in cervical right rotation range of motion.
Measurement of cervical right rotation range of motion using the cervical range of motion device.
Measured: Change from Baseline cervical right rotation range of motion at one month.
Change in cervical left rotation range of motion.
Measurement of cervical left rotation range of motion using the cervical range of motion device.
Measured: Change from Baseline cervical left rotation range of motion at one month.
Change in neck function.
Measurement of neck function using the neck disability index-Arabic version.
Measured: Change from Baseline neck function at one month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start7 May 2023
- Primary completion7 May 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical TherapyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Mohamed Ibrahim, Cairo University
- Investigators
- Bassem El Nahass, PhD, Study director, Professor of Orthopaedic Physical Therapy, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925205
- Sponsor's protocol ID
- P.T. 2023-2025
- Status last verified
- Jun 2023
- First submitted
- 21 Jun 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Energy Technique Versus Strain Counterstrain in Treatment of Upper Trapezius Myofascial Pain Syndrome: A Double-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05925205
- Acronym / sponsor ID
- P.T. 2023-2025
- Conditions
- Physical Therapy
- Keywords
- Muscle energy technique, strain counterstrain, trapezius.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 May 2023 (actual)
- Primary completion
- 7 May 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Muscle energy technique combined with the physical therapy program.Experimental group 1. |
| Group B | Experimental | Procedure: Strain counterstrain technique combined with the physical therapy programExperimental group 2. |
| Group C | Experimental | Procedure: The physical therapy programExperimental group 3. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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 with chronic pain syndrome.
- Patients having myofascial trigger points in other neck muscles.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle energy technique combined with the physical therapy program.A manual therapy technique | Procedure or surgery | Group A |
| Strain counterstrain technique combined with the physical therapy programA manual therapy technique | Procedure or surgery | Group B |
| The physical therapy programElectrotherapy and exercise. | Procedure or surgery | Group C |
Primary outcome
Change in pain intensity.
Time frame: Change from Baseline pain intensity at one month.
Measurement of pain intensity using the visual analogue scale.
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 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 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 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 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 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 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 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 in neck function.
Time frame: Change from Baseline neck function at one month.
Measurement of neck function using the neck disability index-Arabic version.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bassem El Nahass, PhD study director
Professor of Orthopaedic Physical Therapy, Faculty of Physical Therapy, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle energy technique combined with the physical therapy program., Strain counterstrain technique combined with the physical therapy program and The physical therapy program in people with Physical Therapy, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haytham Morsi, M.Sc. (+201013657738, 10722019485962@pg.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity. (time frame: Change from Baseline pain intensity at one month.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.