Impingement Syndrome, ShoulderNCT06595641
Effect of Transfer Energy Capacitive Resistive Therapy on Shoulder Pain and Function in Shoulder Impingement Syndrome
A study testing Transfer Energy Capacitive Resistive Therapy and strength training program in people with Impingement Syndrome, Shoulder, run by Cairo University.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 40 years
- Conditions the study is for
- Impingement Syndrome, Shoulder
- What is being tested?
- Transfer Energy Capacitive Resistive Therapy and strength training program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
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
- Impingement Syndrome, Shoulder
- Being tested
- Transfer Energy Capacitive Resistive Therapy, strength training program
- Keywords
- Strengthening Exercises, Shoulder Impingement Syndrome, Transfer energy capacitive and resistive
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transfer Energy Capacitive Resistive TherapyDevice
Also called TECAR
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 programOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transfer Energy Capacitive Resistive Therapy; Other: strength training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
which rates pain intensity from 0 (no pain) to 10 (worst possible pain)
Measured: 3 weeks
Secondary outcomes (3)
Manual Muscle Test System (MMT)
will be used to obtain normative strength values for both external and internal shoulder rotators .
Measured: 3 weeks
Joint Position Sense of the Shoulder joint
All participants will be submitted to the evaluation of the JPS at 30° and 120° of shoulder forward flexion, using a digital inclinometer
Measured: 3 weeks
shoulder Function Using the Arabic SPADI Questionnaire
The Arabic SPADI is recommended for the evaluation of Arabic-speaking patients with shoulder dysfunction . To answer the questions, patients will be asked to place a mark on a 10 cm visual analogue scale for each question. Verbal anchors for the pain dimension are 'no pain at all' and 'worst pain imaginable', and those for the functional activities are 'no difficulty' and 'so difficult, it required help'. The scores from both dimensions are averaged to derive a total score
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Impingement Syndrome, ShoulderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mahmoud Abdelaziz Khalil, Cairo University
- Investigators
- Enas Fawzy Youssif, Professor, Study chair, Cairo Universityahmed mohamed khalil, PhD, Study director, Pharos University in AlexandriaSherif Hamdy Zawam, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595641
- Sponsor's protocol ID
- P.T.REC/012/005345
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 19482984Yi 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.
PubMed 26172661Braun 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.
PubMed 31178148
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transfer Energy Capacitive Resistive Therapy on Shoulder Pain and Function in Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT06595641
- Acronym / sponsor ID
- P.T.REC/012/005345
- Conditions
- Impingement Syndrome, Shoulder
- Keywords
- Strengthening Exercises, Shoulder Impingement Syndrome, Transfer energy capacitive and resistive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| strength training program group | Active comparator | Other: strength training programIn 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. |
| Experimental TECAR Group | Experimental | Device: Transfer Energy Capacitive Resistive Therapy, Other: strength training programIn 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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Both gender age from 25-40 with a clinical diagnosis of Neer's stage II SIS and body mass index (18.5-29.9)
Key exclusion criteria (8 listed)
- Symptoms of cervical radiculopathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transfer Energy Capacitive Resistive TherapyAlso: TECARIt'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 | Device | Experimental TECAR Group |
| strength training programEach 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 | Experimental TECAR Group, strength training program group |
Primary outcome
Visual Analog Scale
Time frame: 3 weeks
which rates pain intensity from 0 (no pain) to 10 (worst possible pain)
3 secondary outcomes
Manual Muscle Test System (MMT)
Time frame: 3 weeks
Joint Position Sense of the Shoulder joint
Time frame: 3 weeks
shoulder Function Using the Arabic SPADI Questionnaire
Time frame: 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Results publication: PubMed 19482984Davies 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.
- Results publication: PubMed 26172661Yi 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.
- Results publication: PubMed 31178148Braun 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.
- 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 TrialLink provided by the sponsor.
- 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 studyLink provided by the sponsor.
- Restricted scapular mobility during arm abduction: implications for impingement syndromeLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enas Fawzy Youssif, Professor study chair
Cairo University
ahmed mohamed khalil, PhD study director
Pharos University in Alexandria
Sherif Hamdy Zawam, PhD study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Transfer Energy Capacitive Resistive Therapy and strength training program in people with Impingement Syndrome, Shoulder, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Mohamed Abdelkhalek, B.Sc (929-435-8403, drmostafamohamedgalal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06595641, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.