Effect of Capacitive Resistive Energy Transfer Therapy on Postmenopausal Women With Frozen Shoulder
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Frozen shoulder is more commonly seen in women, particularly during and after menopause, due to hormonal changes that affect joint health. Previous research has indicated a significant association between menopause and the increased risk of developing adhesive capsulitis.
Despite the known benefits of capacitive resistive energy transfer therapy in managing musculoskeletal disorders, its specific effectiveness in treating adhesive capsulitis remains underexplored. Existing studies have not focused on postmenopausal women, a population particularly vulnerable to this condition.
Moreover, previous studies have often been limited by short intervention durations, providing only preliminary insights without conclusive evidence. This highlights the need for further research to evaluate the long-term effects of capacitive resistive energy transfer therapy in this population. Therefore, this study aims to fill a gap in the literature by providing baseline data on the effectiveness, safety, and potential complications of capacitive resistive energy transfer therapy in postmenopausal women with frozen shoulder. The findings may also contribute to the development of more targeted and effective treatment protocols for this specific group.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Kholoud N Mohamed, Master
- Telefonnummer: 01003327521
- E-post: kholoudnour@gmail.com
Studera Kontakt Backup
- Namn: Doaa A Osman, As.professor
- Telefonnummer: 01115792245
- E-post: Doaa.osman@cu.edu.eg
Studieorter
-
-
-
Giza, Egypten
- Cairo University
-
Kontakt:
- Kholoud N Mohamed, Master
- Telefonnummer: 01003327521
- E-post: kholoudnour@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Sedentary, ambulatory, non-smoking women.
- Postmenopausal women with at least one-year amenorrhea.
- Having natural menopause at least one year prior to participating in the study.
- No history of bilateral surgical removal of the ovaries and/or the uterus.
- Women with age of 50-60 years.
- Their body mass index (BMI) will be ≤ 30 kg/m2.
- The parity number will be 2-4 times.
- Diagnosed with unilateral frozen shoulder (adhesive capsulitis) - Stage II (frozen stage).
- Patients with moderate to severe shoulder pain (Pain score ≥ 4 on the visual analogue scale).
Exclusion Criteria:
- Diabetes.
- Osteoporosis.
- Previous shoulder surgeries.
- History of tumor.
- Bilateral frozen shoulder.
- Upper extremity fractures or cervical radiculopathy.
- Impaired sensation or heart pacemaker.
- Any autoimmune disease.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Conventional physical therapy group
The participants will receive conventional physical therapy only three times per week for a total duration of six weeks.
|
The treatment will involve stretching exercises for the levator scapulae, upper trapezius, pectoralis minor, and pectoralis major muscles.
It will also include strengthening exercises for the middle and lower trapezius and the rotator cuff muscles, along with manual therapy techniques such as anteroposterior, posteroanterior, and inferior glides of the shoulder joint.
|
|
Experimentell: conventional physical therapy plus Capacitive Resistive Energy Transfer (TECAR) therapy
The participants will receive conventional physical therapy program, in addition to Capacitive Resistive Energy Transfer (TECAR) therapy, three times per week for a total duration of six weeks.
|
The treatment will involve stretching exercises for the levator scapulae, upper trapezius, pectoralis minor, and pectoralis major muscles.
It will also include strengthening exercises for the middle and lower trapezius and the rotator cuff muscles, along with manual therapy techniques such as anteroposterior, posteroanterior, and inferior glides of the shoulder joint.
This equipment contains a mobile electrode handled by the therapist, which treats the part affected by the pathology, and a fixed electrode that is in contact with the patient's skin, serving as a conductor. Each patient will be seated in a comfortable position with the affected shoulder exposed, ensuring adequate support and stability throughout the treatment session. The affected shoulder was prepared with a conductive gel to enhance energy transfer. During the session, the capacitive electrode was initially applied, targeting the superficial muscles and tendons around the shoulder joint using circular or linear movements for 5 min. Following this, the resistive electrode was employed to target deeper structures, focusing on the joint capsule and rotator cuff muscles for 10 min. The output power was adjusted based on the patient's tolerance, ensuring a comfortable warm sensation without causing discomfort or burning feeling or pain |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Assessment of shoulder pain intensity
Tidsram: 6 weeks
|
It will be evaluated before and after treatment program by using visual analogue scale (VAS), which is a linear scale that measures the magnitude of pain severity.
It encompasses a horizontal line scaled as a spectrum from mild pain beginning from the left to increasing severity to the right end of the horizontal line.
The line is 10 cm in length, with each side of the line ending in extremes either no pain or intense pain.
In terms of utilization, each participant will mark her pain on the line of the spectrum of the scale.
|
6 weeks
|
|
Assessment of pressure pain threshold
Tidsram: 6 weeks
|
It will be measured with an algometer on the sub-occipitalis, levator scapulae, subscapularis, and pectoralis minor.
These four muscle groups were evaluated on the painful side of the body in particular, the suboccipital muscles were evaluated in their insertional component at the level of the occiput, the levator scapulae muscle in its distal portion at the level of the insertion of the superomedial angle of the scapula, the subscapularis muscle on its muscle belly, and the pectoralis minor muscle near its insertion on the coracoid process.
The algometer was placed with the probe against the muscle belly
|
6 weeks
|
|
Measurement of shoulder external rotation range of motion (ROM)
Tidsram: 6 weeks
|
It will be measured before and after treatment program by using goniometer.
place the patient supine or seated with the shoulder abducted to 90° and elbow flexed to 90°.
Align the goniometer axis over the olecranon process, keep the stationary arm parallel or perpendicular to the floor/trunk, and align the moving arm with the ulnar styloid process as the arm rotates back.
Normal range is approximately 90 degrees.
|
6 weeks
|
|
Shoulder abduction range of motion
Tidsram: 6 weeks
|
It will be measured before and after treatment program by using goniometer.
place the patient supine, align the fulcrum at the anterior acromion, set the stationary arm parallel to the sternum, and align the moving arm with the anterior humerus as the arm moves outward up to a normal range of 0-180
|
6 weeks
|
|
Shoulder flexion range of motion
Tidsram: 6 weeks
|
It will be measured before and after treatment program by using goniometer.
place the patient supine with the arm in neutral rotation.
Align the goniometer axis over the lateral aspect of the greater tubercle of the humerus, the stationary arm parallel to the mid-axillary line of the trunk, and the moving arm along the lateral midline of the humerus.
The normal range is 0 to 180 degrees
|
6 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Disability assessment
Tidsram: 6 weeks
|
The level of disability caused by the shoulder joint pain will be assessed, through shoulder pain and disability index (SPADI).
The SPADI consists of 13 items that evaluate two domains; one is a 5-item subscale that assesses pain and the other is an 8-item subscale that measures disability on a Likert scale.
The results of each subscale will be added up and converted into a score out of 100: the closer the score is to 100, the greater the pain and disability.
|
6 weeks
|
|
Assessment of Health-Related Quality of Life
Tidsram: 6 weeks
|
It will be assessed before and after treatment program using Free online short form 36- health survey questionnaire (SF-36) score calculator.
The SF-36 measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health.
Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).
|
6 weeks
|
|
Serum C-reactive protein level
Tidsram: 6 weeks
|
It is a pentameric protein synthesized by the liver, whose level rises in response to inflammation.
|
6 weeks
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Hossam Hussein, professor, Al-Azhar University
- Studiestol: Khadega AbdulAziz, Professor, Cairo University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P.T.REC/012/006451
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .