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Gross Myofascial Release in Cervical Radiculopathy Pat

Primary Purpose

Cervical Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
gross Myofascial Release
conventional selected exercise program
Transcutaneous electrical nerve stimulation (TENS)
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy

Eligibility Criteria

30 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • October 6 university
  • October 6 university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

study group

control group

Arm Description

received the conventional selected exercise program in addition to gross Myofascial Release

the control group which received the conventional selected exercise program

Outcomes

Primary Outcome Measures

Electro-goniometer
Measurement of cervical range of motion in four direction flexion, extension side bending and rotation
Quick Disabilities of the Arm, Shoulder and Handscale
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)
Neck Disability Index
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.

Secondary Outcome Measures

visual analogue scale
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.

Full Information

First Posted
June 22, 2021
Last Updated
August 5, 2021
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT04946097
Brief Title
Gross Myofascial Release in Cervical Radiculopathy Pat
Official Title
Effect of Gross Myofascial Release on Pain and Function in Cervical Radiculopathy Patients: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University

4. Oversight

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

5. Study Description

Brief Summary
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?
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
received the conventional selected exercise program in addition to gross Myofascial Release
Arm Title
control group
Arm Type
Experimental
Arm Description
the control group which received the conventional selected exercise program
Intervention Type
Other
Intervention Name(s)
gross Myofascial Release
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
conventional selected exercise program
Intervention Description
stretching exercises for cervical muscles and pectoralis major and source of heat in form of hot packs for 15 minutes
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation (TENS)
Other Intervention Name(s)
TENS
Intervention Description
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
Primary Outcome Measure Information:
Title
Electro-goniometer
Description
Measurement of cervical range of motion in four direction flexion, extension side bending and rotation
Time Frame
4 weeks
Title
Quick Disabilities of the Arm, Shoulder and Handscale
Description
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)
Time Frame
4 weeks
Title
Neck Disability Index
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
visual analogue scale
Description
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.
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hosam M Metwally, PHD
Organizational Affiliation
lecturer , department of Neuromuscular Disorders and its surgery, faculty of physical therapy O6U physical therapy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lama Saad ED Mahmoud, PHD
Organizational Affiliation
October 6 University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sobhy M Aly, PHD
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
October 6 university
City
Al Jīzah
State/Province
Giza
ZIP/Postal Code
0020
Country
Egypt
Facility Name
October 6 university
City
Al Jīzah
State/Province
Select State
ZIP/Postal Code
0020
Country
Egypt

12. IPD Sharing Statement

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Gross Myofascial Release in Cervical Radiculopathy Pat

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