An interventional study of High energy density pulse electromagnetic field and physiotherapy in Frozen Shoulder, sponsored by Tri-Service General Hospital. Terminated at 1 site in Taiwan. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by Tri-Service General Hospital · Not applicable, Interventional, and Treatment
The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with frozen shoulder
Frozen shoulder causes shoulder pain and limited range of motion(ROM). It is thought to afflict between 2 and 5% of the general population. Individuals of middle age are most often affected, typically during the 5th to 7th decades of life. Typical symptoms include gradual onset of shoulder pain, limited shoulder ROM at least in two or more directions (especially in external rotation). In the case of primary adhesive capsulitis, the disease is usually self-limiting, and typically lasts 18-24 months. However, persistent symptoms and movement restriction beyond 3 years have been reported in up to 40% of patients, with up to 15% of patients suffering permanent disability. Therefore, an effective treatment is necessary to treat the shoulder pain and disability caused by frozen shoulder. High energy density pulse electromagnetic field (High-PEMF), different from traditional PEMF, includes characteristics as following:
It has been applied in chronic tendinopathy with positive outcomes. However, few studies support its application in the setting of frozen shoulder. Hence, the aim of our study is to investigate the efficacy and the underlying possible mechanism of High-PEMF for patients with frozen shoulder.
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This study's enrollment of 17 is below the median of 45 across 371 interventional studies indexed under Bursitis.
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Exclusion Criteria:
The patient undergoes physiotherapy and high-PEMF therapy twice a week, for a duration of three weeks.
Device: High energy density pulse electromagnetic field · Other: physiotherapy
The patient undergoes physiotherapy and sham high-PEMF therapy twice a week, for a duration of three weeks.
Other: physiotherapy · Device: sham High energy density pulse electromagnetic field
The treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. A high energy of high-PEMF with a rate of 3 pulse per second is applied to the patient.
Physiotherapy such as shoulder passive and active-assisted range of motion (ROM) exercises, Pendulum exercises, Codman's exercises and Cross-body reach exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time.
The sham treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. The setting is the same as the experimental group(high energy, a rate of 3 pulse per second) with the difference that the energy output doesn't export to the patient.
Change in pain Visual Analogue Scale(VAS)
The visual analogue scale (VAS) is a scale used to determine the pain intensity experienced by individuals. "0" means painless and "10" means extremely painful.
Time frame: the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
Change in Shoulder Pain and Disability Index (SPADI)
Shoulder function and disability were evaluated using the Chinese version of the Shoulder Pain and Disability Index (SPADI), a self-report questionnaire that yields pain and disability domain and total scores. The SPADI includes five questions on pain and eight questions on disability, referring to various problems with the shoulder encountered over the preceding week. Each item's score ranges from 0 (no pain/normal) to 10 (maximal pain/disability), with total scores of pain from 0-50 and disability from to 0-80. A higher score shows more disability.
Time frame: the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
This study is terminated, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Tri-Service General Hospital