Effect of Transfer Energy Capacitive Resistive Therapy on Shoulder Pain and Function in Shoulder Impingement Syndrome

NCT ID: NCT06595641

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-03-01

Brief Summary

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This study investigates the efficacy of combining Transfer Energy Capacitive and Resistive (TECAR) therapy with standard strengthening exercises in treating Shoulder Impingement Syndrome (SIS). A double-blinded randomized controlled trial will compare outcomes between patients receiving only strengthening exercises and those receiving both TECAR therapy and exercises. Key outcomes include improvements in pain, muscle strength, joint position sense, and shoulder function. The study aims to determine if TECAR therapy enhances treatment benefits beyond those achieved with exercises alone.

Detailed Description

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Background: Shoulder Impingement Syndrome (SIS) is a prevalent musculoskeletal condition characterized by pain and functional impairment due to the compression of rotator cuff tendons beneath the coracoacromial arch. Despite the effectiveness of conservative treatments such as strengthening exercises, there is emerging interest in additional modalities, including Transfer Energy Capacitive and Resistive (TECAR) therapy. TECAR therapy utilizes high-frequency electromagnetic waves to provide deep thermal energy, potentially enhancing tissue repair and pain relief.

Objective: This study aims to evaluate the effectiveness of combining TECAR therapy with a standard strengthening exercise regimen compared to strengthening exercises alone in patients with SIS.

Methods: A double-blinded randomized controlled trial will be conducted with 30 participants diagnosed with Neer's Stage I SIS. Participants will be randomly assigned to either a control group receiving only strengthening exercises or an experimental group receiving both TECAR therapy and strengthening exercises. The study will assess pain, shoulder muscle strength, joint position sense, and shoulder function using a range of validated instruments including the Visual Analogue Scale (VAS), Hand-Held Dynamometer (HHD), Digital Inclinometer, and the Shoulder Pain and Disability Index (SPADI).

Conditions

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Impingement Syndrome, Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blinded randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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strength training program group

In Group I, fifteen patients will undergo a 3-week exercise program, with sessions lasting 35-45 minutes, three times a week. Each session includes five exercises, each performed for three sets of 10 repetitions:

Shoulder Retraction - Strengthens muscles between shoulder blades. Shoulder Scaption - Improves stability and range of motion. Shoulder External Rotation from Side Lying - Targets rotator cuff muscles. Shoulder Protraction - Enhances shoulder blade function. Shoulder Extension - Strengthens posterior shoulder muscles.

Group Type ACTIVE_COMPARATOR

strength training program

Intervention Type OTHER

Each session includes five exercises, each performed for three sets of 10 repetitions:

Shoulder Retraction - Strengthens muscles between shoulder blades. Shoulder Scaption - Improves stability and range of motion. Shoulder External Rotation from Side Lying - Targets rotator cuff muscles. Shoulder Protraction - Enhances shoulder blade function. Shoulder Extension - Strengthens posterior shoulder muscles

Experimental TECAR Group

In the experimental group, fifteen patients will follow a three-week program that combines targeted exercises with Transfer Energy Capacitive and Resistive (TECAR) therapy. Each session of the exercise program, conducted three times a week, will include a series of five shoulder exercises: retraction, scaption, external rotation from a side-lying position, protraction, and extension.

Alongside these exercises, patients will receive TECAR therapy, which involves applying high-frequency electromagnetic energy to the affected shoulder. During the therapy, a capacitive electrode will first be used for ten minutes to target the soft tissues near the biceps. Following this, the therapy will switch to the resistive mode for another ten minutes, focusing on the deeper tissues around the T1-T9 vertebrae. Each TECAR session will last for a total of twenty minutes, and patients will undergo this treatment nine times over the course of the study, with three sessions each week.

Group Type EXPERIMENTAL

Transfer Energy Capacitive Resistive Therapy

Intervention Type DEVICE

It's a physical treatment modality commonly used to treat musculoskeletal pain. It normally uses a longwave radiofrequency of \~0.5 MHz. The system consists of a neutral plate and two different electrodes that can transfer energy in two modalities: capacitive and resistive

strength training program

Intervention Type OTHER

Each session includes five exercises, each performed for three sets of 10 repetitions:

Shoulder Retraction - Strengthens muscles between shoulder blades. Shoulder Scaption - Improves stability and range of motion. Shoulder External Rotation from Side Lying - Targets rotator cuff muscles. Shoulder Protraction - Enhances shoulder blade function. Shoulder Extension - Strengthens posterior shoulder muscles

Interventions

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Transfer Energy Capacitive Resistive Therapy

It's a physical treatment modality commonly used to treat musculoskeletal pain. It normally uses a longwave radiofrequency of \~0.5 MHz. The system consists of a neutral plate and two different electrodes that can transfer energy in two modalities: capacitive and resistive

Intervention Type DEVICE

strength training program

Each session includes five exercises, each performed for three sets of 10 repetitions:

Shoulder Retraction - Strengthens muscles between shoulder blades. Shoulder Scaption - Improves stability and range of motion. Shoulder External Rotation from Side Lying - Targets rotator cuff muscles. Shoulder Protraction - Enhances shoulder blade function. Shoulder Extension - Strengthens posterior shoulder muscles

Intervention Type OTHER

Other Intervention Names

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TECAR

Eligibility Criteria

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Inclusion Criteria

* Both gender age from 25-40 with a clinical diagnosis of Neer's stage II SIS and body mass index (18.5-29.9)

* Shoulder pain for at least three months
* Painful arc of movement during flexion or abduction
* Positive Neer's or kennedy- hawkins test or empty can test
* Pain on resisted external rotation, abduction

Exclusion Criteria

* Symptoms of cervical radiculopathy.

* Diagnosed inflammatory disorder.
* Neurological disorder.
* Widespread pain condition.
* Evidence of complete rotator cuff tear (positive drop arm test).
* Previous surgery to the affected shoulder.
* Noncompliance patient.
* Pacemaker.
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Mahmoud Abdelaziz Khalil

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Enas Fawzy Youssif, Professor

Role: STUDY_CHAIR

Cairo University

ahmed mohamed khalil, PhD

Role: STUDY_DIRECTOR

Pharos University in Alexandria

Sherif Hamdy Zawam, PhD

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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Mostafa Mohamed Abdelkhalek, B.Sc

Role: CONTACT

929-435-8403

ahmed mohamed khalil, PhD

Role: CONTACT

929-435-8403

References

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Davies H, Wells F, Czarkowski M. Standards for research ethics committees: purpose, problems and the possibilities of other approaches. J Med Ethics. 2009 Jun;35(6):382-3. doi: 10.1136/jme.2008.027722.

Reference Type RESULT
PMID: 19482984 (View on PubMed)

Yi SD, Baek SK. Interrupted coarsening in the zero-temperature kinetic Ising chain driven by a periodic external field. Phys Rev E Stat Nonlin Soft Matter Phys. 2015 Jun;91(6):062107. doi: 10.1103/PhysRevE.91.062107. Epub 2015 Jun 5.

Reference Type RESULT
PMID: 26172661 (View on PubMed)

Braun BJ, Osche D, Rollmann M, Orth M, Morsdorf P, Histing T, Pohlemann T, Herath SC. Increased therapy demand and impending loss of previous residence status after proximal femur fractures can be determined by continuous gait analysis - A clinical feasibility study. Injury. 2019 Jul;50(7):1329-1332. doi: 10.1016/j.injury.2019.05.007. Epub 2019 May 18.

Reference Type RESULT
PMID: 31178148 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/31178148

The Effectiveness of an Upper Extremity Neuromuscular Training Program on the Shoulder Function of Military Members With a Rotator Cuff Tendinopathy: A Pilot Randomized Controlled Trial

https://pubmed.ncbi.nlm.nih.gov/26172661

Effectiveness of microwave diathermy on pain, functional capacity, muscle strength, quality of life, and depression in patients with subacromial impingement syndrome: a randomized placebo-controlled clinical study

https://pubmed.ncbi.nlm.nih.gov/19482984

Restricted scapular mobility during arm abduction: implications for impingement syndrome

Other Identifiers

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P.T.REC/012/005345

Identifier Type: -

Identifier Source: org_study_id

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