The Effectiveness of Myofascial Release Technique in Patients With Cervical Radiculopathy With Unilateral Arm Affection

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04597112
Collaborator
(none)
40
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2
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5.3

Study Details

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 divided into two groups, 17 control and 17 study groups, in accordance with the randomization table made on www.e-picos.com. The study will be implemented every other day, 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 study 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).

Condition or Disease Intervention/Treatment Phase
  • Other: Myofascial Release Technique
  • Other: Exercise
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of Myofascial Release Technique in Patients With Cervical Radiculopathy With Unilateral Arm Affection
Actual Study Start Date :
Oct 13, 2020
Actual Primary Completion Date :
May 10, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

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.

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.

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Algometer [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.

  2. Myometer [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.

  3. Electrogoniometer [10 minutes]

    It is an evaluation tool used to record the objective measurement of joint range of motion.

  4. Visual Analog Scale [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.

Secondary Outcome Measures

  1. Neck Disability Index [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.

  2. Disability of Arm Shoulder and Hand Test [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fatih Bali Istanbul Kucukcekmece Turkey 34173

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT04597112
Other Study ID Numbers:
  • 10840098-604.01.01-E.1062
First Posted:
Oct 22, 2020
Last Update Posted:
Sep 1, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istanbul Medipol University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2021