Effect of Myofascial Release Technique in Patients with Unilateral Cervical Radiculopathy

November 13, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
    • Kucukcekmece
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 15, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10840098-604.01.01-E.1062

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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