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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05925205
Other study ID # P.T. 2023-2025
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 7, 2023
Est. completion date December 31, 2024

Study information

Verified date June 2023
Source Cairo University
Contact Haytham Morsi, M.Sc.
Phone +201013657738
Email 10722019485962@pg.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 motion, and neck function for patients with upper trapezius myofascial trigger points.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 54
Est. completion date December 31, 2024
Est. primary completion date May 7, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
Muscle energy technique combined with the physical therapy program.
A manual therapy technique
Strain counterstrain technique combined with the physical therapy program
A manual therapy technique
The physical therapy program
Electrotherapy and exercise.

Locations

Country Name City State
Egypt The Outpatient Clinics, Faculty of Physical Therapy Kafrelsheikh University Kafr Ash Shaykh

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in pain intensity. Measurement of pain intensity using the visual analogue scale. Change from Baseline pain intensity at one month.
Primary Change in the right side pain pressure threshold. Measurement of right side pain pressure threshold using the pressure algometer. Change from Baseline right side pain pressure threshold at one month.
Primary Change in the left side pain pressure threshold. Measurement of left side pain pressure threshold using the pressure algometer. Change from Baseline left side pain pressure threshold at one month.
Primary Change in cervical flexion range of motion. 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.
Primary Change in cervical extension range of motion. 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.
Primary 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 from Baseline cervical right lateral flexion range of motion at one month.
Primary 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 from Baseline cervical left lateral flexion range of motion at one month.
Primary Change in cervical right rotation range of motion. 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.
Primary Change in cervical left rotation range of motion. 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.
Primary Change in neck function. Measurement of neck function using the neck disability index-Arabic version. Change from Baseline neck function at one month.
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