- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07788287
Transfer of Energy Capacitive and Resistive Therapy on Shoulder Range of Motion In Idiopathic Adhesive Capsulitis
Effect of Transfer of Energy Capacitive and Resistive (TECAR) Therapy on Shoulder Range of Motion In Idiopathic Adhesive Capsulitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adhesive capsulitis or frozen shoulder is often defined as insidious shoulder pain and range of motion (ROM) loss of more than 25% in at least 2 planes. Furthermore, there was passive external rotation loss of more than 50% of the unaffected shoulder, or less than 30° of available external rotation. The specific cause of the rotator interval contracting and the capsule thickening, which results in shoulder pain and a decrease in capsular volume, is still a mystery One of the alternate methods used for the treatment of musculoskeletal diseases is transfer energy capacitive and resistive or TECAR therapy, which is a deep heat-generating modality delivering radiofrequency energy ranging from 300 kHz to 1 MHz. TECAR therapy enhances the physiological tissue metabolism by transferring energy and increasing electrolytic motions within tissues, causing increased deep temperature, microcirculation, vasodilatation, and muscle flexibility Considering the importance of proper adhesive capsulitis treatment and the lack of rigorous studies, especially randomized controlled studies, on the effects of TECAR Therapy in adhesive capsulitis management and capsular extensibility.
Besides, application of TECAR therapy may show added benefit, like decreasing the time needed to gain ROM when compared to stretching only and pain and function. Results could provide more insight into the directional preference of modalities during treatment. Therefore, the results of the current study might help to improve practice, helping clinicians to consider using TECAR therapy as an effective treatment for primary frozen.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed H Nasser, Master
- Phone Number: 01007966818
- Email: Mohamed.hemiednasser@gmail.com
Study Contact Backup
- Name: Nesrin F Mahmoud, PHD
- Phone Number: 01127283925
- Email: Dr-nesreenfawzy@cu.edu.eg
Study Locations
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Cairo, Egypt
- Cairo University
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Contact:
- Mohamed H Nasser, Master
- Phone Number: 01007966818
- Email: Mohamed.hemiednasser@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients of both genders with primary adhesive capsulitis.
- Patients aged between 40-65.
- Pain duration of three months or more.
- Range of motion loss of greater than 25% in at least 2 planes and passive external rotation loss that is greater than 50% of the uninvolved shoulder or less than 30° of external rotation.
Exclusion Criteria:
- Bilateral adhesive capsulitis,
- Systemic diseases such as rheumatoid arthritis,
- Malignancies,
- Heart diseases
- Infections
- Coagulation disorders
- Full rotator cuff tear
- History of recent shoulder surgery
- Neurological problems involving the upper extremity
- Shoulder joint osteoarthritis
- Upper extremity fractures
- Cervical radiculopathy
- Impaired sensation
- Having a heart pacemaker
- Pregnancy
- Physiotherapy treatment in the previous 6 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Transfer of Energy Capacitive and Resistive (TECAR) Therapy and stretching exercise group
The participants will receive transfer of energy capacitive and resistive (TECAR) therapy with stretching for limited ROM (Flexion, abduction, internal rotation, and external rotation).
Patients will receive three sessions per week for 1 month.
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To apply TECAR therapy, the patient will lie supine, with the passive electrode, a flexible rectangular stainless steel plate measuring 150 £ 200 mm, placed under the affected side's scapula.
A rigid circular metallic electrode with a 60-mm diameter will be used as the active electrode.
Using the resistive mode with the power of 8 to 10 mA, the active electrode will be circularly moved continuously for 10 minutes on the anterior-inferior shoulder capsule while the patient's arm will be held at the end existing range of abduction and external rotation.
As well, a conductive cream will be used as a coupling medium between the electrodes and the skin.
Based on the manufacturer's recommendation for safe performance, the TECAR intensity will be set as the most effective method, causing no pain based on each patient's feedback.
While the patients were lying on the bed, they would receive cyclic (intermittent) stretching.
Cyclic stretching is the application, release, and reapplication of a relatively short-duration stretch force repeatedly but progressively.
Twenty seconds of stretching and 10 seconds of rest will be used 10 times in each of the following directions (flexion, scapular plane abduction, external rotation, and internal rotation) and stretch to target rotator cuff interval.
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Active Comparator: Stretching exercise group
The participants will receive stretching alone for limited ROM (Flexion, abduction, internal rotation and external rotation).
Patients will receive three sessions per week for 1 month.
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While the patients were lying on the bed, they would receive cyclic (intermittent) stretching.
Cyclic stretching is the application, release, and reapplication of a relatively short-duration stretch force repeatedly but progressively.
Twenty seconds of stretching and 10 seconds of rest will be used 10 times in each of the following directions (flexion, scapular plane abduction, external rotation, and internal rotation) and stretch to target rotator cuff interval.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Glenohumeral External Rotation range of motion (ROM) in Adducted shoulder
Time Frame: 1 month
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To measure external rotation range of motion (ROM) with the shoulder adducted, the patient will be positioned in supine with the upper arm positioned at the side and the elbow flexed to 90°.
The examiner will passively externally rotate the glenohumeral joint until end range is reached.
Range of motion will be measured by placing the axis of the goniometer on the olecranon process.
The stationary arm will be aligned with the vertical position.
The movable arm will be aligned with the ulnar styloid process.
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1 month
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Glenohumeral External Rotation range of motion (ROM) in Abducted shoulder
Time Frame: 1 month
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External rotation range of motion (ROM) may also be measured with the shoulder abducted to 45° or to 90° in the frontal plane (if the patient has the available abduction ROM).
The stationary arm of goniometer will be aligned with the vertical position.
The movable arm will be aligned with the ulnar styloid process.
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1 month
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Glenohumeral Internal Rotation range of motion (ROM) in Abducted shoulder
Time Frame: 1 month
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Internal rotation range of motion (ROM) will be measured while the patient is positioned in supine, the shoulder abducted to 90°, and the elbow flexed to 90°.
If glenohumeral abduction is less than 90°, a 45° abduction angle can be used.
The examiner passively internally rotates the glenohumeral joint until end range is reached, ensuring that there is no scapular compensation.
Range of motion will be measured by placing the axis of the goniometer on the olecranon process.
The stationary arm will be aligned with the vertical position.
The movable arm will be aligned with the ulnar styloid process
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1 month
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Shoulder Flexion range of motion (ROM)
Time Frame: 1 month
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To measure flexion range of motion (ROM), the patient will be positioned in supine with the arm rest at the side.
The examiner will passively flex the shoulder until end range is reached (with no compensatory movements from the thorax and the lumbar spine).
Range of motion will be measured by placing the axis of the goniometer on the greater tuberosity.
The stationary arm will be aligned with the midline of the trunk.
The movable arm will be aligned with the lateral epicondyle.
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1 month
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Shoulder Abduction range of motion (ROM)
Time Frame: 1 month
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To measure abduction range of motion (ROM), the patient will be positioned in supine with the arm comfortably by the side.
The examiner passively abducts the shoulder until end range is reached (shoulder must remain in the same plane).
Range of motion will be measured by placing the axis of the goniometer on the head of the humerus.
The stationary arm will be aligned parallel with the midline of the sternum.
The movable arm will be aligned with the midshaft of the humerus.
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1 month
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Shoulder extension range of motion (ROM)
Time Frame: 1 month
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To measure extension range of motion (ROM), the patient is positioned in prone position with the arm rest at the side.
The examiner passively extends the shoulder until the end range is reached.
Range of motion will be measured by placing the axis of the goniometer on the greater tuberosity.
The stationary arm will be aligned with the midline of the trunk.
The movable arm will be aligned with the lateral epicondyle.
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of shoulder pain
Time Frame: 1 month
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The Arabic version of the shoulder pain and disability index (SPADI) will be used.
The 13-item SPADI consists of two primary components, five pain items, and eight disability items.
The five pain items will be recorded to determine pain level.
The weighting of each domain score for the overall score is equal.
The total score for pain is 50.
The overall score is between 0 and 100, with 0 denoting no pain or difficulty.
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1 month
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Assessment of shoulder function
Time Frame: 1 month
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The Arabic version of the shoulder pain and disability index (SPADI) will be used.
The 13-item SPADI consists of two primary components, five pain items, and eight disability items.
The eight disability items will be recorded to determine shoulder function.
The weighting of each domain score for the overall score is equal.
The total score for the disability scale is 80.
A percentage is used to represent the overall SPADI score.
The overall score is between 0 and 100 ; 0 for best and 100 for worst.
More disability is indicated by a higher score.
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Mohamed A Mohamed, As.professor, Cairo University
- Study Chair: Mona M Ibrahim, As.Professor, Cairo University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Musculoskeletal Diseases
- Joint Diseases
- Bursitis
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Physical Therapy Modalities
- Patient Care
- Exercise Therapy
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Exercise
- Therapeutics
- Muscle Stretching Exercises
Other Study ID Numbers
- P.T.REC/012/006279
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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