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Effect of Myofascial Release Technique In Patients With Unilateral Cervical Radiculopathy

Primary Purpose

Cervical Radiculopathy, Cervical Radicular Pain, Cervical; Hernia

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Myofascial Release Technique
Exercise
Sponsored by
Istanbul Medipol University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Cervical Radiculopathy, Pain, Radiculopathy, Cervical, Hernia, Myofascial Release, Exercise

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Getting a diagnosis of cervical radiculopathy
  • Unilateral upper extremity symptoms
  • The diagnosis is confirmed by the medical board report
  • Being between the ages of 18-70
  • Voluntary acceptance to participate in the study

Exclusion Criteria:

  • Previous cervical operation
  • Previous cervical trauma
  • Have had myofascial therapy for cervical radiculopathy
  • Long-term use of corticosteroids
  • Congenital torticollis history
  • Migraine
  • Cancer
  • Pregnancy
  • Systemic disease

Sites / Locations

  • Fatih Bali

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Myofascial Release Group

Exercise Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Myometer
Hand myometer is a means of expressing force quantitatively. It is preferred over other dynamometers because of its ease of use and portability.
Electrogoniometer
It is an evaluation tool used to record the objective measurement of joint range of motion.
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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
October 15, 2020
Last Updated
July 31, 2023
Sponsor
Istanbul Medipol University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04597112
Brief Title
Effect of Myofascial Release Technique In Patients With Unilateral Cervical Radiculopathy
Official Title
Effect of Myofascial Release Technique In Patients With Unilateral Cervical Radiculopathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
June 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medipol University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy, Cervical Radicular Pain, Cervical; Hernia, Cervical Disc Disease, Cervical Disc Herniation, Pain
Keywords
Cervical Radiculopathy, Pain, Radiculopathy, Cervical, Hernia, Myofascial Release, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myofascial Release Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial Release Technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Algometer
Description
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.
Time Frame
10 minutes
Title
Myometer
Description
Hand myometer is a means of expressing force quantitatively. It is preferred over other dynamometers because of its ease of use and portability.
Time Frame
10 minutes
Title
Electrogoniometer
Description
It is an evaluation tool used to record the objective measurement of joint range of motion.
Time Frame
10 minutes
Title
Visual Analog Scale
Description
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.
Time Frame
1 minutes
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
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.
Time Frame
10 minutes
Title
Disability of Arm Shoulder and Hand Test
Description
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).
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fatih Bali
City
Istanbul
State/Province
Kucukcekmece
ZIP/Postal Code
34173
Country
Turkey

12. IPD Sharing Statement

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Effect of Myofascial Release Technique In Patients With Unilateral Cervical Radiculopathy

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