Shoulder PainNCT06302829
Comparison of IMES Versus DN on ATrPs of AC
A study testing Dry needling and intramusuar electrical stimulation in people with Shoulder Pain, run by Riphah International University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Dry needling and intramusuar electrical stimulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Jan 2024to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Shoulder Pain
- Being tested
- Dry needling, intramusuar electrical stimulation
- Keywords
- trigger points, range of motion, dry needling, disability
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
Also called conventional treatment
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
intramusuar electrical stimulationOther
Also called conventional treatment
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
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular Electrical stimulation | Experimental | 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 Receives: Other: intramusuar electrical stimulation |
| Dry Needling | Active comparator | 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. Receives: Other: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algometer (pressure pain threshold)
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
Measured: 3rd week
Secondary outcomes (5)
ROM Shoulder (Flexion)
Changes from baseline,2nd week,3rd week ROM range of motion of shoulder flexion was taken
Measured: 3rd week
ROM Shoulder (Abduction)
Changes from baseline,2nd week,3rd week ROM range of motion of shoulder abduction was taken
Measured: 3rd week
ROM Shoulder (External rotation)
Changes from baseline,2nd week,3rd week ROM range of motion of shoulder External rotation was taken with the help of Digital Goniometer
Measured: 3rd week
ROM Shoulder (Internal Rotation)
Changes from baseline,2nd week,3rd week ROM range of motion of shoulder Internal rotation was taken with the help of Digital Goniometer
Measured: 3rd week
American shoulder and elbow surgeons scale
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.
Measured: 3rd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start21 Jan 2024
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aneela zia, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302829
- Sponsor's protocol ID
- RiphahIU Shafia Anjum
- Status last verified
- Jan 2025
- First submitted
- 4 Mar 2024
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intramuscular Electrical Stimulation Versus Dry Needling on Active Trigger Points of Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06302829
- Acronym / sponsor ID
- RiphahIU Shafia Anjum
- Conditions
- Shoulder Pain
- Keywords
- trigger points, range of motion, dry needling, disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 21 Jan 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intramuscular Electrical stimulation | Experimental | Other: intramusuar electrical stimulationMyofascial 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 |
| Dry Needling | Active comparator | Other: Dry needlingDN 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needlingAlso: conventional treatmentAROM 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 | Dry Needling |
| intramusuar electrical stimulationAlso: conventional treatmentMyofascial 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 | Intramuscular Electrical stimulation |
Primary outcome
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
5 secondary outcomes
ROM Shoulder (Flexion)
Time frame: 3rd week
ROM Shoulder (Abduction)
Time frame: 3rd week
ROM Shoulder (External rotation)
Time frame: 3rd week
ROM Shoulder (Internal Rotation)
Time frame: 3rd week
American shoulder and elbow surgeons scale
Time frame: 3rd week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Shoulder Pain
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aneela zia, MS-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and intramusuar electrical stimulation in people with Shoulder Pain, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algometer (pressure pain threshold) (time frame: 3rd week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.