- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07591259
Effect of Integrated Neuromuscular Inhibition Technique on Hand Grip Strength in Upper Trapezius Myofascial Trigger Points
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Myofascial pain syndrome (MPS) is one of the most common musculoskeletal disorders. Approximately, 30% to 85% of the population with musculoskeletal disorders would experience Myofascial trigger points (MTrPs) in their life. Also, the prevalence of MTrP has been reported as 21%, 30%, and 93% in the patients of a general orthopedic clinic.
Myofascial trigger points (MTrPs) are hypersensitive, cord-like or nodular tender spots found in a skeletal muscle. They are painful on palpation, compression or stretch. The prevalence of affection of these trigger points have found to be more in postural muscles such as the trapezius. It has been found that 85% of people who come to pain clinics show presence of trigger points in the neck, and that occurs more commonly in women than men.
The trigger point sites in the upper trapezius commonly refer pain along the posterolateral aspect of the neck, behind the ear to the temple. MTrP in the upper trapezius is known to usually present with complains of neck pain, headache, muscle stiffness, restricted range of motion (ROM) of the cervical joint, and insomnia by the patient. It is frequently caused by poor posture, acute trauma, muscle stress, and psychological stress.
The trapezius muscle has a supporting and stabilizing function on the movement of the upper extremities, such as in many everyday work tasks (computer work, cleaning, eating). The trapezius muscle is involved in many activities related to the high prevalence of neck pain. This muscle participates in long-term low-level activity, which is typically appreciated by office workers. Tightness of the upper trapezius lead to muscle imbalance in the scapulothoracic region, leading to neck pain and cervicogenic headaches.
The most important functions of the upper extremity for independent and smooth activities of daily living are the functions of the hand. A representative function of the hand is to hold something. The strength of the fingers when holding something is known as grip strength and it is an important index in the evaluation of motor function of the hand.
It is widely accepted that grip strength provides an objective index of the functional integrity of the upper extremity. Physical and occupational therapists commonly measure grip strength to monitor the success or failure of their treatment programs, besides, grip strength serves to be an important contributor to quality of life, functional ability, and independence.
A previous study has revealed the effectiveness of conventional treatment in reducing neck pain in patients with upper trapezius trigger points. Stretching techniques, Myofascial release, proprioceptive neuromuscular facilitation, and ischemic compression are a few types of manual therapy. Applying massage therapy to the sensitive region is one of the treatment modalities that patients choose in addition to their therapies for greater relaxation.
Integrated neuromuscular inhibition (INI) has also been proposed to alleviate neck pain, improve cervical range of motion, and eliminate neck dysfunction. INI has been approved as an efficient treatment for MTrPs, allowing the use of the three techniques in a single and coordinated manner. It was suggested that combination of Muscle energy technique (MET), ischemic compression and Strain Counter-strain (SCS) producing a most effective, targeted approach to TrP release. This method is termed as integrated neuromuscular inhibition technique (INIT). The benefit of the technique lies in its multifaceted approach allowing delivery of the techniques in a single coordinated manner.
Neuromuscular Inhibition Technique (INIT) has gained attention for its potential efficacy in deactivating MTrPs and enhancing musculoskeletal function. It was revealed that results with INIT in reducing pain and improving function in patients with upper trapezius MTrPs. For instance, a previous study has demonstrated that a single session of INIT significantly lowered pain intensity and pressure pain threshold in individuals with chronic neck pain.
There is a gap in the literature regarding the effect of integrated neuromuscular inhibition technique on hand grip strength in upper trapezius trigger points.
So, this study will conduct to discuss the effect of integrated neuromuscular inhibition technique on neck pain intensity level, pressure pain threshold (PPT), hand grip strength, pinch grip strength, wrist joint range of motion, and upper extremity function in upper trapezius myofascial trigger points.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Rania Reda Mohamed, PhD
Study Contact Backup
- Name: Nouran Ali El-Metwally Ali El-Agamy, B.Sc
- Phone Number: +20 10 19835158
- Email: nouranelagamy01@gmail.com
Study Locations
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Gamasa, Egypt
- out patient clinic of Delta University hospital
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Contact:
- Nouran Ali El-Metwally Ali El-Agamy, B.Sc
- Phone Number: +20 10 19835158
- Email: nouranelagamy01@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects will be selected from out patient clinic of Delta University hospital, Dakahlia, Egypt.
- Subjects aged between 18 and 55 years.
- Their body mass index (BMI) were ranged from 18-30 kg/m2.
- Subjects diagnosed as myofascial pain syndrome with a unilateral upper trapezius myofascial trigger point on the dominant side by a physician.
- Subjects must have characteristics of trigger points: hardened, thickened taut bands in MPS patients. Contraction knots within taut muscle bands are pathognomonic features of MTrPs. Common features of the trigger point include the tender bands of muscles, taut band which could produce pain while pressing it directly or sometimes spontaneous, with this there was weak muscles, sensory motor dysfunctions, changes in motor control function and disruption of normal patterns of motor recruitments are seen.
- Subjects from both genders.
- The severity of pain on the visual analogue scale should be higher than two out of ten.
- Patients will receive all standard medical treatment.
Exclusion Criteria:
- A history of any major neurological or musculoskeletal disorders, cardiovascular or respiratory diseases.
- Neck pain due to cervical spine pathology.
- Any history of cervical trauma, fractures or dislocations, carcinoma.
- Uncooperative behavior, and unwillingness to participate.
- Wrist problems (stiffness, fracture, operation or carpal tunnel syndrome).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Integrated Neuromuscular Inhibition Technique + Conventional Physical Therapy
It will consist of 30 participants who will receive the integrated neuromuscular inhibition technique, including muscle energy techniques (MET), ischemic compression (IC), and strain-counterstrain (SCS), in addition to conventional physical therapy consisting of deep friction massage, passive stretching, and isometric strengthening exercises for the neck muscles.
All participants will receive 12 treatment sessions, conducted three times weekly over a period of four weeks.
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Participants in the experimental group will receive the integrated neuromuscular inhibition technique three times per week for four consecutive weeks.
The integrated neuromuscular inhibition technique protocol will include ischemic compression, strain-counterstrain (SCS), and muscle energy technique (MET).
Participants in the two groups will receive conventional physical therapy three times per week for four consecutive weeks.
It consists of deep transverse friction massage (DTFM), passive stretching, and isometric strengthening exercises for the neck muscles.
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Active Comparator: Conventional Physical Therapy
It will consist of 30 participants who will receive conventional physical therapy only, including deep friction massage, passive stretching, and isometric strengthening exercises for the neck muscles.
All participants will receive 12 treatment sessions, conducted three times weekly over a period of four weeks.
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Participants in the two groups will receive conventional physical therapy three times per week for four consecutive weeks.
It consists of deep transverse friction massage (DTFM), passive stretching, and isometric strengthening exercises for the neck muscles.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Hand Grip Strength assessment
Time Frame: 4 weeks
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Hand grip strength will be assessed using a Baseline Digital Hand Dynamometer following the standardized guidelines of the American Society of Hand Therapists (ASHT).
Participants will be seated comfortably with back support, shoulders abducted, elbows flexed to 90°, and forearms and wrists maintained in a neutral position.
The contralateral hand will rest on the thigh during testing.
Participants will be instructed to grip the dynamometer maximally for approximately 3 seconds after one practice trial for each hand.
Grip strength values will be recorded in kilograms using the same device throughout the study.
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4 weeks
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Pinch Grip Strength assessment
Time Frame: 4 weeks
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Pinch grip strength will be assessed using a Baseline Digital Pinch Dynamometer according to the standardized posture recommended by the American Society of Hand Therapists (ASHT).
Participants will be seated comfortably with the back straight and feet fully supported on the floor.
The shoulders will remain stable without rotation, the elbow will be flexed to 90°, and the forearm will be maintained in a neutral position.
The wrist will be positioned between 0-30° of extension and 15° of ulnar deviation, with the arm unsupported by the chair handle during testing.
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4 weeks
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Wrist Range of Motion assessment
Time Frame: 4 weeks
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It will be assessed by using Digital Goniometer.
A goniometer was placed at the ulnar styloid next to the little finger and set the initial state as the zero-degree position for wrist flexion and extension measurements.
The radial deviation and ulnar deviation were measured by placing the goniometer at the center of the hand and in the middle of the middle finger.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Intensity Level assessment
Time Frame: 4 weeks
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Pain intensity level will be assessed using the Visual Analog Scale (VAS).
Participants will be asked to mark a point on a 100 mm horizontal line that best represents their pain intensity.
The examiner will measure the distance in millimeters from the "no pain" anchor to the marked point using a ruler, yielding a score ranging from 0 to 100.
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4 weeks
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Pressure Pain Threshold assessment
Time Frame: 4 weeks
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Pressure pain threshold will be assessed using a pressure algometer.
Participants will be positioned comfortably, and the upper trapezius trigger point will be identified by palpation.
Gradual vertical pressure will be applied at a rate of 1 kg/sec until slight discomfort is reported by the participant.
The procedure will be repeated three times with 30-second rest intervals, and the mean value will be calculated as the pressure pain threshold.
The pressure algometer is considered a reliable assessment tool for pressure pain threshold measurement.
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4 weeks
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Upper Extremity Function assessment
Time Frame: 4 weeks
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Upper extremity function will be assessed using the Quick Disabilities of the Arm, Shoulder, and Hand questionnaire (QuickDASH).
The questionnaire consists of 11 items scored on a five-point Likert scale, with total scores ranging from 0 to 100, where higher scores indicate greater disability.
Item scores will be summed, averaged, and transformed into the final score according to the standardized scoring method.
Scores below 15 will indicate minimal symptoms, whereas scores above 40 will reflect marked functional limitation and reduced work ability due to upper limb dysfunction.
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4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Rania Reda Mohamed, PhD, Ass. Prof, Cairo university
- Study Director: Hoda Ibrahim Abbas, PhD, Lecturer, Cairo university
- Study Director: Amr Abdalla Azzam, PhD, Consultant, National Institute of Neuromotor System
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006407
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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