NCT06595641

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

September 10, 2024

Last Update Submit

September 12, 2024

Conditions

Keywords

Strengthening ExercisesShoulder Impingement SyndromeTransfer energy capacitive and resistive

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale

    which rates pain intensity from 0 (no pain) to 10 (worst possible pain)

    3 weeks

Secondary Outcomes (3)

  • Manual Muscle Test System (MMT)

    3 weeks

  • Joint Position Sense of the Shoulder joint

    3 weeks

  • shoulder Function Using the Arabic SPADI Questionnaire

    3 weeks

Study Arms (2)

strength training program group

ACTIVE COMPARATOR

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.

Other: strength training program

Experimental TECAR Group

EXPERIMENTAL

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.

Device: Transfer Energy Capacitive Resistive TherapyOther: strength training program

Interventions

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

Also known as: TECAR
Experimental TECAR Group

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 Groupstrength training program group

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Enas Fawzy Youssif, Professor

    Cairo University

    STUDY CHAIR
  • ahmed mohamed khalil, PhD

    Pharos University in Alexandria

    STUDY DIRECTOR
  • Sherif Hamdy Zawam, PhD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Mostafa Mohamed Abdelkhalek, B.Sc

CONTACT

ahmed mohamed khalil, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blinded randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 10, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion

February 1, 2025

Study Completion

March 1, 2025

Last Updated

September 19, 2024

Record last verified: 2024-09