- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07571655
Comparative Effect of Active Release Technique and Myofascial Release in Cervical Myofascial Syndrome
Comparative Effect of Active Release Technique and Myofascial Release to Improve Asthenopia, Sleep and Stress in Patients With Cervical Myofascial Pain Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A musculoskeletal condition known as myofascial pain is characterized by discomfort in the region of a muscle and the fascia, the connective tissue that surrounds it. In addition to having several trigger sites, the pain may be local or widespread. Trigger points are very sensitive muscle foci that radiate pain to the surrounding area and hurts to touch. In particular, the rhomboids, trapezius, levator scapulae, supraspinatus, and infraspinatus often affected muscles in the cervical area. Acute or chronic pain is possible, and it is most likely brought on by overuse, altered posture, or muscular injury. Cervical myofascial pain is highly prevalent globally. A 2021 study by Kamran Ezzati found that 88.9% of Iranian participants had at least one neck trigger point. Similarly, a 2024 study by Sahib Rehman et al in Pakistan reported high prevalence of Myofascial Trigger Points in cervical radiculopathy patients, with mean scores of MTrPs.
Cervical myofascial pain or neck muscle pain is often caused by poor posture or prolonged use of electronic devices, leading to muscle knots or trigger points. A component of myofascial pain is the emotional stress we carry which contributes to muscle tension (in the form of, increased activation of the "fight or flight" response) releasing stress hormones like cortisol that increase muscle tension. As a health care profession, we know that physical injuries like whiplash cause damage to the structures of the neck and may also alter how certain structures respond post injury (inflammation and stiffness). There are many other conditions, such as degenerative disc disease, osteoarthritis, and fibromyalgia, both predispose the patient to altered spinal posture. As a result, muscle may function differently resulting in myofascial pain Cervical myofascial pain can be managed with orthopedic manual techniques like Active Tissue Release (ATR) and Myofascial Release (MFR). ATR, developed by Dr. Michael Leahy, combines pressure with movement to break down adhesions, improve circulation, and reduce trigger point activity. It helps restore muscle balance and relieve postural strain. MFR, popularized by John F. Barnes, uses gentle sustained pressure to release fascial restrictions, improve blood flow, and reduce nervous system overactivity. Both techniques enhance mobility, reduce pain, and promote better posture and function in the neck.
Combining these interventions with eye exercises targets both neuromuscular and visual dysfunction, offering a holistic approach to improving sleep quality, reducing stress, and alleviating cervical pain. The study addresses a gap in evidence by directly comparing ART and MFR with integrated eye exercises, potentially guiding physiotherapists and clinicians toward the most effective treatment strategy for CMPS.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: KINZA ANWAR, MS-OMPT
- Phone Number: +92-3239735427
- Email: kinza.anwar@riphah.edu.pk
Study Locations
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Punjab Province
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Rawalpindi, Punjab Province, Pakistan, 46600
- Railway General Hospital, Rawalpindi
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Contact:
- KINZA ANWAR, MS-OMPT
- Phone Number: +92-3239735427
- Email: kinza.anwar@riphah.edu.pk
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Contact:
- IQRA, MS-OMPT*
- Phone Number: IFTIKHAR
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Sub-Investigator:
- IQRA iFTIKHAR, MS-OMPT*
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Both genders
- Age between 18 and 40 years
- Neck pain since last month with NPRS >3
- Cervical Myofascial pain (Presence of one or more trigger point in neck/ shoulder muscles particularly (upper trapezius, SCM and levator)
- PSQI score > 5
- Subjects with ASQ-17 score > 13
Exclusion Criteria:
• Subjects with a history of cervical trauma or surgery
- Subjects with a history of substance abuse
- Subjects with use of sleep medications
- Subjects with psychological disturbance (stress, depression or anxiety)
- Visual impairment or ophthalmologic disease other than asthenopia
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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Other: Active Release Technique + Eye exercises
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ART applied to cervical region (upper trapezius, Levator scapula and SCM) deep tension stretch with thumb over the tender areas , repeated 3-5 times. Frequency: 3 days/week for 4 weeks Followed by Eye exercises (3 days/week for 4 weeks)
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Other: Myofascial Release + Eye exercises
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|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
: Neck Disability Index (NDI)
Time Frame: Baseline, 2 weeks and 4 weeks (one-month follow-up)
|
The Neck impairment Index (NDI) is a self-report questionnaire designed to measure the self-rated impairment of patients with neck pain and to establish how neck pain impacts a patient's everyday life.
A vertical scale from 0 to 5 is used to rate the questions; After scoring, 0-4 points (0-8%) indicate no disability, 5-14 points (10-28%) indicate mild disability, 15-24 points (30-48%) indicate moderate disability, 25-34 points (50-64%) indicate severe disability, and 35-50 points (70-100%) indicate complete disability
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Baseline, 2 weeks and 4 weeks (one-month follow-up)
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Numeric Pain Rating Scale NPRS
Time Frame: Baseline, 2 weeks and 4 weeks (one-month follow-up)
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The numeric pain rating scale (NPRS) is a tool used to assess pain intensity, where patients rate their pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst possible pain.
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Baseline, 2 weeks and 4 weeks (one-month follow-up)
|
|
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, 2 weeks and 4 weeks (one-month follow-up)
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The Pittsburgh Sleep Quality Index (PSQI) is a standardized questionnaire used to assess sleep quality and disturbances over a one-month period.
It consists of 19 self-rated questions grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
a global score ranging from 0 to 21.
A global PSQI score greater than 5 indicates poor sleep quality, while a score of 5 or below reflects good sleep quality.
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Baseline, 2 weeks and 4 weeks (one-month follow-up)
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ASQ-17 (Asthenopia Survey Questionnaire)
Time Frame: Baseline, 2 weeks and 4 weeks (one-month follow-up)
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The ASQ-17 (Asthenopia Survey Questionnaire) is a self-administered questionnaire that measures asthenopia (or eye strain) and associated symptoms.
The ASQ-17 covers 7 items of eye strain symptoms, 6 items of visual symptoms and 4 items of systemic and psychological symptoms with a maximum total score of 51 and an optimal cut-off threshold value of 12.5, indicating the presence of asthenopia.
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Baseline, 2 weeks and 4 weeks (one-month follow-up)
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Perceived Stress Scale (PSS)
Time Frame: Baseline, 2 weeks and 4 weeks (one-month follow-up)
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The Perceived Stress Scale (PSS) is a widely used psychological instrument designed to measure the degree to which individuals perceive their lives as stressful.
The scale typically includes 10 items (PSS-10), yielding a total score ranging from 0 to 40.
Scoring involves reversing the scores for positively worded items (items 4, 5, 7, and 8), then summing all item scores.
Interpretation of scores is generally categorized as follows: 0-13 indicates low stress, 14-26 suggests moderate stress, and 27-40 reflects high perceived stress.
Higher scores indicate greater levels of perceived stress.
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Baseline, 2 weeks and 4 weeks (one-month follow-up)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: KINZA ANWAR, MS-OMPT, Riphah International University
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Iqra Iftikhar
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
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