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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04597112
Other study ID # 10840098-604.01.01-E.1062
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 13, 2020
Est. completion date June 1, 2021

Study information

Verified date July 2023
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 1, 2021
Est. primary completion date May 10, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Myofascial Release Technique
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.
Exercise
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.

Locations

Country Name City State
Turkey Fatih Bali Istanbul Kucukcekmece

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Algometer 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
Primary Myometer 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
Primary Electrogoniometer It is an evaluation tool used to record the objective measurement of joint range of motion. 10 minutes
Primary Visual Analog Scale 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 Neck Disability Index 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
Secondary Disability of Arm Shoulder and Hand Test 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
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