- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05415813
Effects of IC With and Without MET on Upper Trapezius Trigger Points
April 6, 2023 updated by: University of Lahore
Effects of Ischemic Compression With and Without Muscle Energy Technique on Pain, Range of Motion and Functional Disability in Patients With Trigger Points in Upper Trapezius; A Randomized Clinical Trial
the aim of the study is to check the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius.
In previous studies, Muscle Energy Technique and Ischemic Compression are compared with different conventional and combined therapy approaches, including most of the techniques used to treat Trigger Points in the upper trapezius.
No study has evaluated the effects of ischemic compression with and without muscle energy technique on Pain, Range of motion, and Functional Disability on myofascial trigger points in the upper trapezius.
The outcome measures are a Numeric pain rating scale, universal goniometer and neck disability index questionnaire.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
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 Contact
- Name: Syed Asadullah Arslan, Ph D.PT
- Phone Number: 00923321483575
- Email: asadshahgilani@gmail.com
Study Contact Backup
- Name: Muhammad Haider Ullah Khan, MSPT(neuro)
- Phone Number: 00923314127210
- Email: haiderullah@live.com
Study Locations
-
-
Punjab
-
Sialkot, Punjab, Pakistan
- University of Sialkot
-
-
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 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Both gender Aged 18 to 50 years (40)
- Participants with active myofascial trigger points in the upper trapezius diagnosed by a senior physiotherapist on the basis of Travel and Simon criteria will be randomly allocated into two clinical groups.
- Taut band having palpable nodule within upper trapezius muscle
- Pain produced in a specific pattern which is radiating in character when firm pressure is applied on trigger points
Exclusion Criteria:
- Trauma (whiplash injury)
- Injury to Cervical Spine
- Cervical Spine surgery
- Cervical Myelopathy and Radiculopathy
- Osteoporosis of the cervical spine
- Cervical myeloma
- Complex regional pain syndrome
- Patients with the H/O any Neurological, Rheumatology and other serious medical illnesses.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Ischemic Compression
Ischemic Compression will be applied to the upper trapezius trigger points in patients recruited in group 1.
|
It includes conventional Physical therapy, hot packs (75°C) for 20 minutes, and active stretching exercises for the upper trapezius muscle (slow, 5 repetitions per session, 10-second hold, and 10-second relaxation between two repetitions) as a baseline treatment.
For the Ischemic compression, the patient will be in the supine position with the cervical spine in opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were kept in a lengthened position physiotherapist will apply gradually increasing pressure to the Trigger points until the subject perceived the first noticeable pain.
At that moment, the pressure will be maintained until the discomfort and/or pain eased by around 50% as perceived by the patient, at which time the pressure will be increased until the discomfort appears again.
This process will be maintained for 90 seconds.
|
Experimental: Ischemic compression and Muscle Energy Technique
ischemic compression along with muscle energy technique will be applied to the upper trapezius trigger points in patients allocated to group 2.
|
The Participants will receive all the treatments given to the active comparator group and they will also receive the Muscle Energy Technique treatment in supine position and the practitioner will stabilize the shoulder of the affected side with one hand, while the ear/mastoid area of the affected side will be held by the opposite hand.
The head and neck were then bent towards the contralateral side, flexed, and ipsilaterally rotated.
The subjects will then shrug the stabilized shoulder towards the ear at a sub-maximal pain-free effort (20% of the available strength).
The isometric contraction will be held for 7-10s.
This position will be maintained for 30 seconds and repeated three to five times per treatment session.
Treatment sessions will be given on alternate days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in pain on Numeric Pain Rating Scale at week 4
Time Frame: Baseline and week 4
|
on a scale of 1 to 10, o means no pain while 10 means worst pain
|
Baseline and week 4
|
Change from Baseline in Goniometer readings at week 4
Time Frame: Baseline and week 4
|
for flexion any value less than 90 degrees indicates limited range of motion, for extension any value less than 70 indicates limited range of motion, for lateral flexion values less than 20 and greater than 45 considered limited, for rotation value less than 90 is considered limited
|
Baseline and week 4
|
Change from baseline in Neck disability index questionnaire scores at week 4
Time Frame: Baseline and week 4
|
on a scale of 0 to 50, 0 indicates no disability and 50 indicates completely disabled
|
Baseline and week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain on Numeric Pain Rating Scale at week 2
Time Frame: week 2
|
on a scale of 1 to 10, o means no pain while 10 means worst pain
|
week 2
|
Goniometer readings at week 2
Time Frame: week 2
|
Using goniometer, neck ranges of motion will be measured.
for flexion any value less than 90 degrees indicates limited range of motion, for extension any value less than 70 indicates limited range of motion, for lateral flexion values less than 20 and greater than 45 considered limited, for rotation value less than 90 is considered limited
|
week 2
|
Neck disability index questionnaire scores at week 2
Time Frame: week 2
|
on a scale of 0 to 50, 0 indicates no disability and 50 indicates completely disabled
|
week 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Syeda Khadija Kazmi, DPT, The University of Lahore
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)
August 17, 2021
Primary Completion (Actual)
June 17, 2022
Study Completion (Actual)
June 23, 2022
Study Registration Dates
First Submitted
June 8, 2022
First Submitted That Met QC Criteria
June 8, 2022
First Posted (Actual)
June 13, 2022
Study Record Updates
Last Update Posted (Actual)
April 7, 2023
Last Update Submitted That Met QC Criteria
April 6, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- IRB-UOL-FAHS/890-II/2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Upper Trapezius Trigger Points
-
Cairo UniversityCompleted
-
European University CyprusCompletedMyofascial Pain Syndrome | Myofascial Trigger Point Pain | Upper Trapezius Trigger PointsCyprus
-
Escola Superior de Tecnologia da Saúde do PortoCompletedLatent Myofascial Trigger Point of Upper Trapezius MusclePortugal
-
Riphah International UniversityCompleted
-
Institute of Technology, CarlowCompleted
-
Taif UniversityNot yet recruiting
-
Dilşad SindelCompletedFemale Patients With Myofascial Pain Syndrome (MPS) Related to Upper Trapezius Active Trigger Points (TP)
-
Pamukkale UniversityCompleted
-
University of Castilla-La ManchaCompleted
-
Goethe UniversityCompletedTrigger PointsGermany
Clinical Trials on Ischemic Compression
-
Guy Hains ChiropractorCompletedShoulder PainCanada
-
Riphah International UniversityRecruiting
-
Riphah International UniversityCompletedScalenus SyndromePakistan
-
Universidad Católica de ÁvilaCompletedLow Back Pain | Physiotherapy SpecialtySpain
-
Mae Fah Luang University HospitalUnknownMyofascial Pain Syndrome
-
Tokat Gaziosmanpasa UniversityNot yet recruiting
-
Health Education Research Foundation (HERF)CompletedNeck Pain | Trigger Point Pain, Myofascial | Muscle Tightness | Neck Muscle Issue | NeckachePakistan
-
Universidad de LeónUniversidad Complutense de MadridCompletedMyofascial Pain Syndrome | Trigger Point Pain, MyofascialSpain
-
Universidad Rey Juan CarlosCompleted
-
Baskent UniversityCompleted