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Cervical RadiculopathyNCT04946097

Gross Myofascial Release in Cervical Radiculopathy Pat

A study testing gross Myofascial Release, conventional selected exercise program and Transcutaneous electrical nerve stimulation (TENS) in people with Cervical Radiculopathy, run by October 6 University at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 45 years
Conditions the study is for
Cervical Radiculopathy
What is being tested?
gross Myofascial Release, conventional selected exercise program and Transcutaneous electrical nerve stimulation (TENS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesEgypt
Study dates
1 May 2021to 30 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • October 6 university

    Al Jīzah, Select State, 0020

  • October 6 university

    Giza, Giza Governorate, 0020

Other trials in Egypt

About this study

Official title: 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?

Read the 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

Being tested
gross Myofascial Release, conventional selected exercise program, Transcutaneous electrical nerve stimulation (TENS)
Medical subject headings
Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • gross Myofascial ReleaseOther

    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

  • conventional selected exercise programOther

    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)Device

    Also called TENS

    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

Study groups in NCT04946097
Study groupRoleWhat they receive
study groupExperimentalreceived the conventional selected exercise program in addition to gross Myofascial Release
Receives: Other: gross Myofascial Release; Other: conventional selected exercise program; Device: Transcutaneous electrical nerve stimulation (TENS)
control groupExperimentalthe control group which received the conventional selected exercise program
Receives: Other: conventional selected exercise program; Device: Transcutaneous electrical nerve stimulation (TENS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Electro-goniometer

    Measurement of cervical range of motion in four direction flexion, extension side bending and rotation

    Measured: 4 weeks

  2. 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)

    Measured: 4 weeks

  3. 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.

    Measured: 4 weeks

Secondary outcomes (1)

  1. 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.

    Measured: four weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2021
  2. Study start1 May 2021
  3. Primary completion1 Jul 2021
  4. Study completion30 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04946097
Sponsor's protocol ID
P.T. REC/012/003223
Status last verified
Aug 2021
First submitted
22 Jun 2021
Last updated
9 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing gross Myofascial Release, conventional selected exercise program and Transcutaneous electrical nerve stimulation (TENS) in people with Cervical Radiculopathy, run by October 6 University at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Electro-goniometer (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04946097.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.

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