Gross Myofascial Release in Cervical Radiculopathy Pat

August 5, 2021 updated by: Lama Saad El-Din Mahmoud, October 6 University

Effect of Gross Myofascial Release on Pain and Function in Cervical Radiculopathy Patients: A Randomized Controlled Study

To investigate the Effect of gross Myofascial Release on pain and function in cervical radiculopathy patients. BACKGROUND: cervical radiculopathy is considered serious problems causing neck pain & radiating pain which affect physical inactivity and function of a patient, thus gross Myofascial Release is a form of manual therapy technique that has a profound effect upon the musculoskeletal system.

HYPOTHESES:

This study hypothesized that:

gross Myofascial Release on pain and function in cervical radiculopathy patients RESEARCH QUESTION: Is there an effect of gross Myofascial Release on pain and function in cervical radiculopathy patients?

Study Overview

Detailed Description

Forty patients with cervical radiculopathy will participate in this study. The patients will randomly be divided into two equal groups; the control group which received the conventional selected exercise program and the study group received the same exercise training program in addition to gross Myofascial Release, three times per week for four weeks. The evaluation methods are visual analogue scale (VAS), Electro-goniometer, Quick DASH scale, and Neck disability index

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • 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

    • Giza
      • Al Jīzah, Giza, Egypt, 0020
        • October 6 University
    • Select State
      • Al Jīzah, Select State, Egypt, 0020
        • October 6 University

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

Ages Eligible for Study

30 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40 cervical radiculopathy patients,
  • Age will range as (30:45) years old
  • Cervical radiculopathy due to cervical spondylosis
  • body mass index (25:29)

Exclusion Criteria:

  • difficulty to communicate or to understand program instructions
  • any other neurological deficits or orthopaedic abnormalities,
  • secondary musculoskeletal complication
  • Cervical disc prolapses
  • Any other cervical problem
  • Spinal stenosis
  • Previous spinal surgery

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: study group
received the conventional selected exercise program in addition to gross Myofascial Release
Gross Myofascial Release : is amanual technique in form of Stretch of the Posterior Cervical Musculature and Gross stretch of gross Myofascial Release upper quarter: Arm Pull for duration of 10-15 min per session each stretch position was healed for 90sec
stretching exercises for cervical muscles and pectoralis major and source of heat in form of hot packs for 15 minutes
Transcutaneous electrical nerve stimulation (TENS) is a method of pain relief involving the use of electrical current, the electrode placement on the course of pain for 15 minutes
Other Names:
  • TENS
EXPERIMENTAL: control group
the control group which received the conventional selected exercise program
stretching exercises for cervical muscles and pectoralis major and source of heat in form of hot packs for 15 minutes
Transcutaneous electrical nerve stimulation (TENS) is a method of pain relief involving the use of electrical current, the electrode placement on the course of pain for 15 minutes
Other Names:
  • TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electro-goniometer
Time Frame: 4 weeks
Measurement of cervical range of motion in four direction flexion, extension side bending and rotation
4 weeks
Quick Disabilities of the Arm, Shoulder and Handscale
Time Frame: 4 weeks
The Quick Disabilities of the Arm, Shoulder and Hand (DASH) scale only contains 11 items, It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The Quick Disabilities of the Arm, Shoulder and Hand tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level, as the higher scores indicate a greater level of disability and severity, whereas, lower scores indicate a lower level of disability, and The score ranges from 0 (no disability) to 100 (most severe disability)
4 weeks
Neck Disability Index
Time Frame: 4 weeks

The Neck Disability Index is designed to measure neck-specific disability. The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. The measure is designed to be given to the patient to complete, and can provide useful information for management and prognosis of those with neck pain.The test maximum score of 50, or as a percentage. as 0 points or 0% means : no activity limitations , and 50 points or 100% means complete activity limitation.

A higher score indicates more patient-rated disability.

4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analogue scale
Time Frame: four weeks
for the assessment of the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. The most simple visual analogue scale is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the degree of pain to be measured, as the higher scores (100mm) indicate a greater intensity of pain.
four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hosam M Metwally, PHD, lecturer , department of Neuromuscular Disorders and its surgery, faculty of physical therapy O6U physical therapy
  • Study Chair: Lama Saad ED Mahmoud, PHD, October 6 University
  • Principal Investigator: Sobhy M Aly, PHD, Cairo University

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)

May 1, 2021

Primary Completion (ACTUAL)

July 1, 2021

Study Completion (ACTUAL)

July 30, 2021

Study Registration Dates

First Submitted

June 22, 2021

First Submitted That Met QC Criteria

June 22, 2021

First Posted (ACTUAL)

June 30, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • P.T. REC/012/003223

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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