NCT04946097

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?

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 May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

May 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 22, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

August 9, 2021

Status Verified

August 1, 2021

Enrollment Period

2 months

First QC Date

June 22, 2021

Last Update Submit

August 5, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Electro-goniometer

    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

    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

    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 Outcomes (1)

  • visual analogue scale

    four weeks

Study Arms (2)

study group

EXPERIMENTAL

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

Other: gross Myofascial ReleaseOther: conventional selected exercise programDevice: Transcutaneous electrical nerve stimulation (TENS)

control group

EXPERIMENTAL

the control group which received the conventional selected exercise program

Other: conventional selected exercise programDevice: Transcutaneous electrical nerve stimulation (TENS)

Interventions

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

study group

stretching exercises for cervical muscles and pectoralis major and source of heat in form of hot packs for 15 minutes

control groupstudy group

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

Also known as: TENS
control groupstudy group

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

October 6 university

Giza, Giza Governorate, 0020, Egypt

Location

October 6 university

Al Jīzah, Select State, 0020, Egypt

Location

MeSH Terms

Conditions

Radiculopathy

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Hosam M Metwally, PHD

    lecturer , department of Neuromuscular Disorders and its surgery, faculty of physical therapy O6U physical therapy

    PRINCIPAL INVESTIGATOR
  • Lama Saad ED Mahmoud, PHD

    October 6 University

    STUDY CHAIR
  • Sobhy M Aly, PHD

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of physical therapy, Department of Neuromuscular disorders and its surgery, faculty of physical therapy, october 6 univerisity

Study Record Dates

First Submitted

June 22, 2021

First Posted

June 30, 2021

Study Start

May 1, 2021

Primary Completion

July 1, 2021

Study Completion

July 30, 2021

Last Updated

August 9, 2021

Record last verified: 2021-08

Locations