NCT04597112

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

November 15, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

October 15, 2020

Last Update Submit

November 13, 2024

Conditions

Keywords

Cervical RadiculopathyPainRadiculopathyCervicalHerniaMyofascial ReleaseExercise

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • Electrogoniometer

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

    10 minutes

  • 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 Outcomes (2)

  • Neck Disability Index

    10 minutes

  • Disability of Arm Shoulder and Hand Test

    10 minutes

Study Arms (2)

Myofascial Release Group

EXPERIMENTAL

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

Exercise Group

ACTIVE COMPARATOR

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

Interventions

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.

Myofascial Release Group

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.

Exercise Group

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Bali

Istanbul, Kucukcekmece, 34173, Turkey (Türkiye)

Location

MeSH Terms

Conditions

RadiculopathyHerniaPainMotor Activity

Interventions

Myofascial Release TherapyExercise

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsBehavior

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

October 15, 2020

First Posted

October 22, 2020

Study Start

October 13, 2020

Primary Completion

May 10, 2021

Study Completion

June 1, 2021

Last Updated

November 15, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations