NCT06302829

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

March 4, 2024

Last Update Submit

January 28, 2025

Conditions

Keywords

trigger pointsrange of motiondry needlingdisability

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • ROM Shoulder (Flexion)

    3rd week

  • ROM Shoulder (Abduction)

    3rd week

  • ROM Shoulder (External rotation)

    3rd week

  • ROM Shoulder (Internal Rotation)

    3rd week

  • American shoulder and elbow surgeons scale

    3rd week

Study Arms (2)

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

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.

Other: Dry needling

Interventions

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

Also known as: conventional treatment
Dry Needling

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

Also known as: conventional treatment
Intramuscular Electrical stimulation

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Railway general hopsital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Aneela zia, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
randomized
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

January 21, 2024

Primary Completion

July 30, 2024

Study Completion

July 30, 2024

Last Updated

January 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations