- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04597112
Effect of Myofascial Release Technique In Patients With Unilateral Cervical Radiculopathy
July 31, 2023 updated by: fatih bali, Istanbul Medipol University Hospital
The aim of the study is to investigate the effectiveness of myofascial release technique on pain, range of motion, muscle strength, functionality and quality of life in individuals diagnosed with cervical radiculopathy with unilateral arm involvement and compare this with exercise.
The individuals included in the study will be randomized into two groups, 17 control and 17 study groups.
Sessions will be 3 days a week for 4 weeks.
Conventional physiotherapy and exercise program will be applied to the control group, conventional physiotherapy and myofascial release technique will be applied in the intervention group.
Conventional physiotherapy methods; It will include Transcutaneous Electrical Nerve Stimulation (TENS), Ultrasound (US), hotpack agents.
Exercise program; extension, right and left lateral flexion, right and left rotation exercises, chin-tuck, right and left upper trapezius muscle group stretching, neck extensor muscle group isometric strengthening exercises.
Myofascial release will be applied to the fingers, wrist flexor-extensor muscle groups, elbow flexor-extensor muscle groups, pectoral muscles and rotator cuff muscle groups.
Patients will be evaluated before and after treatment with Visual Analogue Scale (VAS), Goniometric measurements, algometer, myometer, Neck Disability Scale, "Disability of Arm, Shoulder and Hand" Questionnaire (DASH).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
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 Locations
-
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Kucukcekmece
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Istanbul, Kucukcekmece, Turkey, 34173
- Fatih Bali
-
-
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
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Getting a diagnosis of cervical radiculopathy
- Unilateral upper extremity symptoms at least for a month
- The diagnosis is confirmed by the medical board report
- Being between the ages of 30-65
- Voluntary acceptance to participate in the study
Exclusion Criteria:
- Previous cervical surgery
- Previous cervical trauma
- Have had myofascial therapy or conventional therapy for cervical radiculopathy
- Long-term use of corticosteroids
- Congenital torticollis history
- Using nonsteroidal anti-inflammatory drugs for long time
- Migraine
- Cancer
- Tumor
- Osteoporosis
- Pregnancy
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Myofascial Release Group
Intervention group, who received conventional therapy and myofascial release therapy.All participants will be given conventional treatment 3 days a week for 4 weeks.
Conventional treatment will include 20 minutes hotpack, 5 minutes ultrasound, 20 minutes Transcutaneous Electrical Stimulation.
In the intervention group, the myofascial release technique will be applied to the wrist flexors and extensors, elbow flexors and extensors, pectoralis, supraspinatus, infraspinatus, trapezius muscles, starting from the fingers after the conventional treatment, 3 days a week for 4 weeks.
|
Myofascial release focuses on reducing pain by easing the tension and tightness in the trigger points.
Therapist will gently massage the myofascia and feel for stiff or tightened areas.
Normal myofascia should feel pliable and elastic.
The therapist will begin massaging and stretching the areas that feel rigid with light manual pressure.
The therapist then aids the tissue and supportive sheath in releasing pressure and tightness.
The process is repeated multiple times on the same trigger point and on other trigger points until the therapist feels the tension is fully released.
|
Active Comparator: Exercise Group
The control group will consist of patients who received conventional therapy and exercise therapy.
All participants will be given conventional treatment 3 days a week for 4 weeks.
Conventional treatment will include 20 minutes hotpack, 5 minutes ultrasound, 20 minutes Transcutaneous Electrical Stimulation.
After conventional treatment, a program consisting of neck extension, lateral flexion and rotation range of motion, stretching of the trapezius muscles and strengthening of the neck extensor muscles will be applied to the control group in the presence of a physiotherapist 3 days a week for 4 weeks.
|
Exercise is recommended by physical therapists for most cervical radiculopathy patients. In this study, a customized exercise program will be applied for patients with cervical radiculopathy. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Algometer
Time Frame: 10 minutes
|
It is a device used to evaluate the sensitivity to pain and to determine the perception of pressure.
The pressure algometer has proven useful in evaluating fibrositis and hypersensitive spots, trigger points, arthritis activation, and visceral pain-pressure sensitivity.
|
10 minutes
|
Myometer
Time Frame: 10 minutes
|
Hand myometer is a means of expressing force quantitatively.
It is preferred over other dynamometers because of its ease of use and portability.
|
10 minutes
|
Electrogoniometer
Time Frame: 10 minutes
|
It is an evaluation tool used to record the objective measurement of joint range of motion.
|
10 minutes
|
Visual Analog Scale
Time Frame: 1 minutes
|
Visual Analog Scale (VAS) is used to convert some values that cannot be measured numerically into digital.
Two end definitions of the parameter to be evaluated are written on both ends of a 100 mm line and the patient is asked to indicate where his / her condition is appropriate by drawing a line or by placing a dot or marking.
|
1 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index
Time Frame: 10 minutes
|
It is a test consisting of ten parts that determines to what extent neck pain affects daily life activities.
The questions are of a nature that includes the intensity of pain and the effect of pain on occupational and social activity and its relationship with emotional factors.
10 cm visual analogue scale (VAS) is used for each question.
High scores indicate the severity of the disease.
|
10 minutes
|
Disability of Arm Shoulder and Hand Test
Time Frame: 10 minutes
|
This questionnaire evaluates the disability and activity limitations resulting from upper extremity injury, as well as the restriction of leisure activities and work participation.
The DASH questionnaire consists of three parts.
According to the survey results; A result of 0-100 is obtained from each section.
(0 = no apology, 100 = maximum apology).
|
10 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
October 13, 2020
Primary Completion (Actual)
May 10, 2021
Study Completion (Actual)
June 1, 2021
Study Registration Dates
First Submitted
October 15, 2020
First Submitted That Met QC Criteria
October 15, 2020
First Posted (Actual)
October 22, 2020
Study Record Updates
Last Update Posted (Actual)
August 2, 2023
Last Update Submitted That Met QC Criteria
July 31, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10840098-604.01.01-E.1062
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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