- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07692126
Core Stability vs Scapular Stabilization on Hand Grip Strength in Chronic Myofascial Neck Pain
Core Stability Exercises Versus Scapular Stabilization Exercises on Hand Grip Strength in Patients With Chronic Myofascial Neck Pain
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adnan AA Gharib, PHD
- Phone Number: +201065798861
- Email: dradnanpts@gmail.com
Study Contact Backup
- Name: Magda Ramadan Zahran, Assistant Professor
- Phone Number: 01065798861
- Email: dradnanpts@gmail.com
Study Locations
-
-
Giza Governorate
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Giza, Giza Governorate, Egypt, 11432
- Recruiting
- Cairo University
-
Contact:
- Magda Ramadan Zahran, Assistant Professor
- Phone Number: 01065798861
- Email: dradnanpts@gmail.com
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Contact:
- Adnan AA Gharib, PHD
- Phone Number: 01065798861
- Email: dradnanpts@gmail.com
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Principal Investigator:
- Adnan AA Gharib, PHD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients diagnosed with chronic myofascial neck pain depending on referral, and physical examination.
- Sixty patients diagnosed with chronic myofascial neck pain for more than six months.
- Patients age range will 25-45 years
- Patients body mass index (BMI) will be 18.5-24.9 kg/m2
- Each patient suffering from all active MTrPs in the upper trapezius muscle with painful/ tender nodule.
- Patients have a constant neck pain with positive jump sign when palpating the upper trapezius muscle.
- Patients have referred pain, and symptoms of ipsilateral hand muscle weakness.
- No history of undergoing physiotherapy modalities or corticosteroid injection therapies in the past six months before the study
Exclusion Criteria:
- Presence of signs of severe pathology such as malignancies, mainly of the cervical region.
- Fracture of the cervical spine.
- Cervical radiculopathy or myelopathy.
- Diabetes mellitus.
- Trauma, cognitive anomalies, and surgery around neck, shoulders, or hand.
- Fibromyalgia or vascular syndromes such as vertebral basilar insufficiency.
- Pregnancy.
- Having undergone physical therapy within the past three months before the study.
- Having corticosteroid injection therapies in the past 3 months before the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group A (Core Stability)
consists of 20 participants who receive core stability exercises, plus the traditional physical therapy program in the form of ischemic compression of upper trapezius muscle, strain-counter strain of upper trapezius muscle, and muscle energy technique of upper trapezius muscle, three sessions per week for 6 weeks.
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The core stability exercise protocol will be conducted to experimental group (A), only. The core stability exercise protocol will be conducted for 40-45 minutes (10 minutes worm-up 'stretch exercises', 25 minutes core stabilization exercises, and 5-10 minutes cool down exercises 'stretch exercises') 3 sections/ week for six weeks 1. Diaphragm Core '';360 degree expansion breathing, weighted breathing 2. Transverse abdominis 'Abdominal drawing in maneuver, supine vacuum, pelvic tilt'; 3. Multifidus 'quadruped altered leg/arm, bridge with leg extension'; 4. Pelvic Floor muscles/Kegel, bridging, and bridging dog, and squat Core stability exercise.
|
|
Experimental: Experimental Group B (Scapular Stabilization)
consists of 20 participants who receive scapular stabilization exercise, plus the traditional physical therapy program, three sessions per week for 6 weeks.
|
The scapular stabilization exercise protocol will be conducted to experimental group (B), only. The core scapular stabilization exercise protocol will be conducted for 40-45 minutes (10 minutes worm-up 'stretch exercises', 25 minutes scapular stabilization exercises, and 5-10 minutes cool down exercises 'stretch exercises') 3 sections/ week for six weeks a. Open chain stabilization exercises 'scapular elevation/depression, upward/downward rotation', b. Static closed chain stabilization exercises 'Protected weight bearing through both hands leaning against wall', c. Dynamic closed chain stabilization exercises 'scapular retraction' |
|
Active Comparator: Control Group C (Traditional Physical Therapy Program)
consists of 20 participants who receive the traditional physical therapy program, three sessions per week for 6 weeks, only
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hand Grip Strength
Time Frame: 1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
|
Hand-held Dynamometer (SAMMONS PRESTON, INC.
Bolingbrook, IL604404989) will be used to measure it.
The patient will sit on a standard height chair with no armrest with his/ her forearm in a neutral position, and shoulder in adducted and neutral rotation, with elbow flexed 90 degrees (°).
The patient will be requested to squeeze the ipsilateral hand on the hand grip dynamometer handle accordingly to the ordered verbs 'i.e., one, two, three, squeeze…harder, harder'.
Three measures will be conducted with one minute a break in between, then the average will be recorded in value score.
|
1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
|
|
Pinch Grip Strength
Time Frame: 1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
|
The pinch gauge (FEI, White plains, NY 10602, USA) will be used to measure the pinch grip strength, it is a valid and reliable tool.
The patient will sit on a standard height chair with no armrest with his/ her shoulder, elbow, forearm, and wrist in a neutral position.
The patient will be requested to squeeze the thumb pad as firm as possible against the lateral aspect of index fingers' middle phalanx, while the examiner will hold the distal end of the pinch gauge.
Three measures will be conducted with one minute a break in between, then the average will be recorded in a score value.
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1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chronic Myofascial Neck Pain Intensity assessment using Numerical Pain Rating Scale:
Time Frame: 1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
|
Numerical Pain Rating Scale will be used to assess chronic myofascial neck pain intensity, The patient will be in a relaxed position then will be given the appendix which contains numerical pain rating scale.
It involves a 0-10 scale, where 0 represents "no pain" and 10 represents "the worst pain imaginable" The patient will be instructed to place a vertical mark on the line to indicate his/her pain.
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1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
|
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Pressure Pain Threshold using electronic pressure algometer
Time Frame: 1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
|
The electronic pressure algometer 'force one gauge model FDI' (Wagner instruments, Greenwash, CT, USA) will be used to measure it, it is a valid and reliable tool.
Over trigger point recognized via jump sign clinically, a dial-style pressure algometry will be installed while a steady vertical pressure will be applied.
When the patient reported only mild pain, the patient will be asked to raise hand to indicate it.
Three measures will be conducted with one minute a break in between, then average will be recorded in value.
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1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
|
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Whole Upper Extremity Functional Level using Arabic-Q-DASH scale
Time Frame: 1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
|
The whole upper extremity functional level will be evaluated using Arabic-Q-DASH it is a valid and reliable tool.
The Arabic-Q-DASH is like the original questionnaire.
Items have a rating scale ranged from 1 to 5. The patient will be instructed to place a score that the examiner will transform it into a value between 0 and 100.
The high score indicates better hand function outcomes with exception of pain, where high value indicates more intense pain score.
|
1. At Baseline (Pre-procedure), 2. Post-treatment (Post 6 weeks of treatment program).
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sohair Shehata Rezkallah, Professor, Cairo University; Faculty of Physical Therapy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Hand Grip Strength
- Trigger Points
- Pressure Pain Threshold
- Upper Trapezius
- Pinch Grip Strength
- Core Stability Exercise
- Hand Held Dynamometer
- Scapular Stabilization Exercises
- Chronic Myofascial neck syndrome
- Pressure Algometer
- Diability of the Arm, Shoulder, and Hand Questionnaire (Arabic version), (Arabic-Q-DASH)
Other Study ID Numbers
- P.T.REC/012/006550
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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