- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06302829
Comparison of IMES Versus DN on ATrPs of AC
January 28, 2025 updated by: Riphah International University
Comparison of Intramuscular Electrical Stimulation Versus Dry Needling on Active Trigger Points of Adhesive Capsulitis
The aim of our study to compare DN and IMES for pressure pain threshold, ROM and the shoulder function in active trigger points with adhesive capsulitis.
This study will add to the growing body of knowledge that if these two techniques yield comparable outcomes and if one technique is superior to the other, which should be the alternative of therapy.
Moreover, it would add to the society as there are very limited researches done in Pakistan using needling for trigger points in adhesive capsulitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
In literature review 2021, they were see the short-term effect of dry needling of myofascial trigger point in patient with adhesive capsulitis.
They conclude MTrPs with DN technique were improve pain, ROM, disability, and PPT along with conventional physiotherapy management among patient with adhesive capsulitis In another study 2021, in their study they were see the effect of dry needling and muscle energy technique separately in patient suffering shoulder impingement syndrome on active trigger point of infraspinatus.
In their study they conclude dry needling is an effective treatment to treat the active trigger point in patient suffering from shoulder impingement syndrome In another study 2023, in their study they see impact of dry needling with electrical stimulation on pain and disability in patient with musculoskeletal shoulder pain.
They do the systemic review of 5 studies to see the beneficial effect of dry needling and IMES.
They conclude that the significant improvement in pain, ROM, and functional disability in patient with musculoskeletal shoulder pain In 2021 study, in their study they were see the effect of Dry Needling with percutaneous electrical nerve stimulation in patient with Myofascial neck pain.
They were applying the dry needling on myofascial trigger point present in upper trapezius in patient with Myofascial neck pain They conclude that electric nerve stimulation will improve disability and pain intensity in patient with myofascial neck pain In another study 2021, in their study they see the effect of intramuscular stimulation along with dry needling in patient with adhesive capsulitis.
They target the shoulder girdle muscle and paraspinal muscle (C3 to C7).
They conclude that IMES and dry needling were improve pain, ROM and functional disability in patient with adhesive capsulitis In another study 2021, in their study they were target the deltoid myofascial trigger point to improve pain they conclude that dry needling and IMES were enhance blood circulation and cervical and shoulder ROM in MTrPs patient IMES and dry needling according to literature review is an effective treatment to treat the trigger points present at various points in different musculoskeletal conditions.
It reduces the shoulder pain severity and upper limb disability by deactivating the active MTrPs and improve the shoulder ROM in patient with adhesive capsulitis.
Hence there is lack of evidence to allow conclusions to be drawn about the effectiveness of Dry needling when compared with intramuscular electrical stimulation for adhesive capsulitis in term of pressure pain threshold and shoulder function in active trigger points
Study Type
Interventional
Enrollment (Actual)
44
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 Locations
-
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Punjab
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Rawalpindi, Punjab, Pakistan, 46000
- Railway general hopsital
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-
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
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 40 to 60 year of both genders
- Diagnosed patients of stage 3 Adhesive capsulitis with type I and II diabetes
- Involvement of at least 3 shoulder girdle muscles in Active MTrPs (subscapularis, latissimus dorsi, deltoid (anterior, middle, posterior)
- Active MTrPs in shoulder girdle muscles (subscapularis, supraspinatus, deltoid (anterior, middle, posterior), teres minor, latissimus dorsi)
- Reproduction of the patient's symptoms at active trigger point, Taut band, Hypersensitive spot, Referred pain pattern, local twitch response
- Minimum 60 degrees of active/passive shoulder abduction range of movement.
Exclusion Criteria:
- Systemic inflammatory joint disease of shoulder joint (RA, OA polymyalgia rheumatic)
- Cerebral Vascular Accident
- Fibromyalgia, neurological deficits of upper limb (Nerve root entrapment, Cervical radiculopathy, Thoracic outlet syndrome)
- History of Fracture, Dislocation, Acute soft tissue injury, Acute bursitis
- Avascular necrosis of humeral head or visceral referred pain to shoulder
- Pregnancy, Hypothyroidism, skin infection
- Patients who are using Antiplatelet Therapy with in past 3 days of study
- Extreme fear of needles
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intramuscular Electrical stimulation
Myofascial trigger point would be targeted by direct intramuscular electrical stimulation by using direct electrode placement method, where anode pole and the cathode pole of the stimulator connected to the needles of the MTrPs of the shoulder girdle muscles using the alligator clip connector in which both electrodes are on the muscle belly in which anode pole at proximal end and cathode pole at the distal end along the musculotendinous junction.
The special programmed comfy stim (a double channeled multipurpose electrical stimulator) was used to deliver electrical impulses with following parameters; pulse duration 80µs, frequency 100HZ, and time duration for 10 min
|
Myofascial trigger point would be targeted by direct intramuscular electrical stimulation by using direct electrode placement method, where anode pole and the cathode pole of the stimulator connected to the needles of the MTrPs of the shoulder girdle muscles .AROM 10 repetitions ×2 set×30 sec ,6days\week, Shoulder strengthening exercises: Isometric pain free (elastic Thera-band) 10 repetitions ×2 set×30 sec ,6days\week, Maitland mobilization grade 3 and 4 10 repetitions ×2 set×30 sec ,6days\week Total of 6 session were given each consisting of 30 min
Other Names:
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Active Comparator: Dry Needling
DN for the MTrPs will be performed over the identified trigger points locations at a suitable angle.
The needles of suitable length and thickness (30-mm), depending on the depth of the MTrPs location inserted into the shoulder girdle muscles to deactivate the active MTrPs.
Subsequently, the inserted needles moved to-and-fro direction to elicit the local twitch responses, which further reaffirms the ideal placement of needle into the MTrPs.
After the twitch response obtained, the dry needles were kept within the muscles approximately for 10 minutes.
Dry needling was performed subscapularis, latissimus dorsi, supraspinatus, deltoid, teres minor.
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AROM 10 repetitions ×2 set×30 sec ,6days\week, Shoulder strengthening exercises: Isometric pain free (elastic Thera-band) 10 repetitions ×2 set×30 sec ,6days\week, Maitland mobilization grade 3 and 4 10 repetitions ×2 set×30 sec ,6days\week Total of 6 session were given each consisting of 30min
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Algometer (pressure pain threshold)
Time Frame: 3rd week
|
This tool can be used to assess the participant pressure pain at baseline ,2nd week,3rd week post assessment.
Pressure pain threshold is measured at active trigger point at subscapularis, deltoid (ant, middle, post), latissimus dorsi, teres minor, supraspinatus.
The PPT are measured by mean and standard deviation kg\cm2
|
3rd week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ROM Shoulder (Flexion)
Time Frame: 3rd week
|
Changes from baseline,2nd week,3rd week ROM range of motion of shoulder flexion was taken
|
3rd week
|
|
ROM Shoulder (Abduction)
Time Frame: 3rd week
|
Changes from baseline,2nd week,3rd week ROM range of motion of shoulder abduction was taken
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3rd week
|
|
ROM Shoulder (External rotation)
Time Frame: 3rd week
|
Changes from baseline,2nd week,3rd week ROM range of motion of shoulder External rotation was taken with the help of Digital Goniometer
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3rd week
|
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ROM Shoulder (Internal Rotation)
Time Frame: 3rd week
|
Changes from baseline,2nd week,3rd week ROM range of motion of shoulder Internal rotation was taken with the help of Digital Goniometer
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3rd week
|
|
American shoulder and elbow surgeons scale
Time Frame: 3rd week
|
Changes from baseline,2nd week,3rd week, American shoulder and elbow surgeons scale (ASES) Scale scoring was done at 2 level, pain questionnaire 5× (10-Q7 value), ADL Questionnaire (5× (raw score) divided by 3, final scoring is done by adding pain score and ADL score.
A total 100-point scale Minimum score 0 which mean worst shoulder function and maximum score 100 which mean better shoulder function.
|
3rd week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aneela zia, MS-OMPT, Riphah International University
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)
January 21, 2024
Primary Completion (Actual)
July 30, 2024
Study Completion (Actual)
July 30, 2024
Study Registration Dates
First Submitted
March 4, 2024
First Submitted That Met QC Criteria
March 4, 2024
First Posted (Actual)
March 12, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
January 28, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RiphahIU Shafia Anjum
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
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