Comparison of IMES Versus DN on ATrPs of AC

Shoulder Pain Clinical Trial

Official title:

Comparison of Intramuscular Electrical Stimulation Versus Dry Needling on Active Trigger Points of Adhesive Capsulitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302829
• Other study ID #: RiphahIU Shafia Anjum
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2024
• Source: Riphah International University
• Contact: imran amjad, PHD
• Phone: +923324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• Dry needling
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 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 .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

Locations

Country	Name	City	State
Pakistan	Railway general hopsital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3rd week
Secondary	ROM Shoulder (Flexion)	Changes from baseline,2nd week,3rd week ROM range of motion of shoulder flexion was taken	3rd week
Secondary	ROM Shoulder (Abduction)	Changes from baseline,2nd week,3rd week ROM range of motion of shoulder abduction was taken	3rd week
Secondary	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	3rd week
Secondary	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	3rd week
Secondary	ASES Questionnaire; (American shoulder and elbow surgeons scale)	Changes from baseline,2nd week,3rd week, 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