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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: zia

Study Locations

  • Pakistan
    • Punjab
      • Rawalpindi, Punjab, Pakistan, 46000
        • Railway general hopsital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: 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
Other Names:
  • conventional treatment
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.
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
Other Names:
  • conventional treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
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
3rd week
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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