- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05684809
Efficacy of Mobilization With Post- Isometric Relaxation in Neck Pain Associated With Myofascial Trigger Points
Efficacy of Cervical Mobilization With Post Isometric Relaxation in Managing Mechanical Neck Pain Associated With Myofascial Trigger Points: a Randomized Comparative Study
Study Overview
Status
Conditions
Detailed Description
This study will be based on a randomized controlled design which will be comparative in nature. Participants will be recruited using the convenience sampling method and will be randomly divided into two groups A and B respectively. Thirty participants of mechanical neck pain associated with upper Trapezius trigger point pain will be recruited from the Physiotherapy department, at the Najran University, Saudi Arabia. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly assigned into two equal groups A and B.
Group A will be receiving the hot pack, active Stretching, isometric exercise intervention, and PIR technique while group B will receive the hot pack, active Stretching, isometric exercise intervention, and cervical Mobilization.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Najran
-
Najrān, Najran, Saudi Arabia, 1988
- Hashim Ahmed
-
Najrān, Najran, Saudi Arabia, 66262
- Hashim Ahmed
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 20-40 years,
- having mechanical neck pain located in the neck or scapular regions along with 1-2 MTrPs which,
- on palpation replicated their chief complaints in the upper Trapezius muscle (unilateral).
Exclusion Criteria:
- known cases of fibromyalgia syndrome,
- cervical radiculopathy or myelopathy,
- history of cervical spine surgery,
- congenital or acquired postural deformity, presence of MTrPs in bilateral upper Trapezius muscles,
- patients who received any treatment for their pain one month prior to the study.
Study Plan
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: Group A
in addition to Conventional treatment, PIR and cervical mobilization were given
|
In PIR intervention, the patients were requested to lie down in a supine position and their neck was in a lateral flexion to the opposite side so that the target upper Trapezius muscle fibers would be in a lengthened position.
The therapist performed a moderate isometric contraction (approximately 75% of maximal) of upper Trapezius muscles, held it for 5 seconds, then relaxed for 3 seconds before moving the cervical spine into the new barrier.
In each session, this technique was repeated for four times, on alternate days for three weeks.
Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10-second relaxation) were given, and isometric exercise of the neck((10 repetitions of two sets with 10 seconds hold) alternate days for three weeks.
Cervical Mobilization was delivered in prone lying with their foreheads resting comfortably on his hands, and the chin was tucked in.The treatment session was done on alternate days (3 days a week) for 3 weeks, hence the total number of sessions were 9.
|
Active Comparator: Group B
in addition to Conventional treatment, PIR were given
|
In PIR intervention, the patients were requested to lie down in a supine position and their neck was in a lateral flexion to the opposite side so that the target upper Trapezius muscle fibers would be in a lengthened position.
The therapist performed a moderate isometric contraction (approximately 75% of maximal) of upper Trapezius muscles, held it for 5 seconds, then relaxed for 3 seconds before moving the cervical spine into the new barrier.
In each session, this technique was repeated for four times, on alternate days for three weeks.
Hot Pack was given for twenty minutes, slow sustained stretching exercises ( 20 second hold, 10-second relaxation) were given, and isometric exercise of the neck((10 repetitions of two sets with 10 seconds hold) alternate days for three weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity
Time Frame: 3 Weeks
|
The pain intensity was assessed Using a numeric pain rating scale (NPRS), Its a 11 point scale, where zero indicates no pain and 10 indicates severe pain
|
3 Weeks
|
Range of Motion
Time Frame: 3 Weeks
|
The Neck Side Flexion range of motion was assessed using cervical range of motion(CROM) device
|
3 Weeks
|
Neck Disability Index
Time Frame: 3 Weeks
|
The Neck Disability was assessed using a neck disability index (NDI) questionnaire, the minimum value 0- and the maximum value is 50
|
3 Weeks
|
Pain Pressure Threshold
Time Frame: 3 Weeks
|
The Pain Pressure Threshold (PPT) was assessed using an algometer algometer
|
3 Weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 444-42-20993-DS
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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