- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05213871
Effect of Instrument-assisted Soft Tissue Mobilization Versus Myofascial Release in Treatment of Mechanical Neck Pain
March 24, 2022 updated by: Fatma Abdelfattah Hanafy shewail, Cairo University
Mechanical neck pain has become a major health problem recently, affecting around one-year prevalence ranging from 42 to 67% in young adults aged 20-24 years causing pain and functional deficits.
No study has been conducted before to investigate the effect of Instrument assisted soft tissue mobilization (IASTM) with mechanical neck pain on university students involved in distance learning.
Study Overview
Status
Completed
Conditions
Detailed Description
Mechanical neck pain is a major social and economic burden.
It showed a one-year prevalence ranging from 42 to 67% in young adults aged 20-24 years.
Treatment of neck pain is costly in terms of utilization of health care services, disability, compensation payments and lost work productivity.
With the increasing prevalence of pain and disability associated with musculoskeletal impairments, it is essential to identify the most efficacious interventions to maximize patient outcomes and decrease the societal burden.
Study Type
Interventional
Enrollment (Actual)
35
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
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Cairo, Egypt, 34518
- Outpatient clinic, Faculty of Physical Therapy, Misr university for scientific and technology, Egypt
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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
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient's age will be between 18-25 years old.
- Subjects with mechanical neck pain localized to cervical and periscapular region.
- Subjects with at least one trigger point in the upper trapezius and/or levator scapulae muscles
- Subjects should report mechanical neck pain of at least 30 mm on a visual analogue scale (VAS). The scale is ranged from 0 mm (no pain) to 100 mm (worst imaginable pain).
- Subjects who use computers daily for at least two hours and are involved in distance learning for at least three months.
Exclusion Criteria:
- Any specific neck pathology as radiculopathy, rheumatoid arthritis, and systemic diseases.
- Sensory problems at mid or upper back
- A tendency to hemorrhage or anticoagulation treatment. And nonsteroidal pain medication
- History of head and upper trunk trauma or surgery.
- Signs of severe pathology such as malignancy, fractures of the cervical spine, cervical radiculopathy or myelopathy, or vascular syndromes such as vertebrobasilar insufficiency.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IASTM group
Group (A) will receive IASTM on the right upper trapezius and levator scapulae twice a week for four weeks in addition to a postural correction program.
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For IASTM, the subject will be seated in a comfortable position.
The subject's forehead will be rested on his/her forearm on a table in front of him/her.
A lubricant (Vaseline) will be applied to the skin around the neck area prior to treatment and the M2T blade will be cleaned with an alcohol pad.
The M2T blade will be used, at an angle of 45 without causing discomfort or pain, from the muscle origin to its insertion (sweeping technique), for approximately 3 min.
Subjects will be instructed to put an ice pack on the area if they feel any burning sensations after the session.
This procedure will be repeated twice a week for four weeks.
Postural correction exercises will be applied for patients in groups A and B. This program will be conducted according to the protocols of exercise will be performed as 3 sets of 10 repetitions each for 2 times/ week for 4 weeks.
The patients will be instructed to continue the exercises as a daily home program to influence the self-correction kinesthetic awareness.
Exercises will be performed while the patients in a neutral sitting posture
|
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Experimental: myofascial release group
Group (B) will receive a myofascial release on the right upper trapezius and levator scapulae twice a week for four weeks in addition to the postural correction program.
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Postural correction exercises will be applied for patients in groups A and B. This program will be conducted according to the protocols of exercise will be performed as 3 sets of 10 repetitions each for 2 times/ week for 4 weeks.
The patients will be instructed to continue the exercises as a daily home program to influence the self-correction kinesthetic awareness.
Exercises will be performed while the patients in a neutral sitting posture
Firstly, the subject will lay supine with no pillow under his/ her head then the subject will rotate his/her head and neck away from the side which will be treated.
Therapist will sit or stand at the corner, edge or top of the treatment table and therapist will place one hand proximal to the shoulder with skin on skin and therapist's fingers pointing towards the subject's elbow on the same side.
Other hand of the therapist will be placed inferior to the subject's jaw (body of the mandible), using it as a handle, with fingers pointing towards the top of the subject's head.
Then therapist will lean into the subject to the tissue depth barrier, wait and follow each subtle release three-dimensionally.
Therapist should avoid forcing the tissue or slipping or gliding over the skin.
The technique should be applied for at least five minutes for optimal results.
This procedure will be repeated twice a week for four weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain intensity assessment
Time Frame: at baseline and after 4 weeks of intervention
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Assessing the change in pain intensity via using visual analogue scale which will be used to examine pain intensity.
It consists of a continuous 10 cm line.
The patient will be instructed to place a vertical mark on the line to indicate his/her pain, ranging from no pain or discomfort (0), to the worst pain he/she could possibly feel .
Using the visual analogue scale allows the patient freedom to record and not restricting him by numbers.
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at baseline and after 4 weeks of intervention
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Neck disability index
Time Frame: at baseline and after 4 weeks of intervention
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Assessing the change in neck disability via using Neck disability index which is is a self-reported outcome measure which is commonly used to determine the perceived disability in patients with neck pain.
It consists of 10 items; 7 related to activities of daily living, (ADL), 2 related to pain, and 1 related to concentration.
Each item is scored from 0-5 and the total score is expressed as percentage, with higher scores corresponding to greater disability.
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at baseline and after 4 weeks of intervention
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Muscle pressure intensity
Time Frame: at baseline and after 4 weeks of intervention
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Assessing the change in Muscle pressure intensity via using Pressure Algometer which is a handheld device that applies a manual pressure stimulus to assess pressure intensity.
It has been broadly used and validated.
A pressure threshold algometer will be used to measure the pressure pain threshold of a Trigger points of the upper trapezius and levator scapulae muscle before and aftertreatment.
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at baseline and after 4 weeks of intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Fatma Hanafy, 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)
February 1, 2022
Primary Completion (Actual)
March 15, 2022
Study Completion (Actual)
March 22, 2022
Study Registration Dates
First Submitted
January 16, 2022
First Submitted That Met QC Criteria
January 16, 2022
First Posted (Actual)
January 28, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2022
Last Update Submitted That Met QC Criteria
March 24, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fatma_phd_2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
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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