Clinical trial NCT06000254: High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis
Official title: Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Adhensive Capsulitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: adhesive capsulitis
high energy density pulse electromagnetic field
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with adhesive capsulitis

Detailed description: Adhesive capsulitis, a condition causing shoulder pain and limited range of motion (ROM), is estimated to affect 2-5% of the general population. Typically occurring in middle-aged individuals during their 50s to 70s, it presents with gradually developing shoulder pain and restricted ROM, particularly in external rotation.

In cases of primary adhesive capsulitis, the condition often resolves on its own, lasting around 18-24 months. However, some individuals experience persistent symptoms beyond 3 years, with up to 40% of patients and 15% facing lasting disability. Therefore, effective treatment is essential to alleviate the pain and disability associated with frozen shoulder.

High energy density pulse electromagnetic field (High-PEMF) differs from traditional PEMF and possesses the following characteristics:

Brief pulse duration (50μs) with a damped oscillation. Wide bandwidth (200kHz\~300MHz) centered around 240kHz. High voltages (up to 40 kV) and peak currents (up to 10 kA) in the applicator spool.

Delivery of around 96Ws (Joule) of energy per pulse with a magnetic flux density of 50\~100mT.

Tissue and organ penetration up to 20 cm. Although High-PEMF has shown positive results in chronic tendinopathy, there is limited evidence of its effectiveness in treating adhesive capsulitis. Therefore, our study aims to explore the efficacy and potential mechanisms underlying the use of High-PEMF in treating adhesive capsulitis patients.

Eligibility criteria: Inclusion Criteria:

1. Physicians diagnose frozen shoulder by considering the patient's medical background, conducting a physical assessment, and reviewing X-ray and ultrasound findings.
2. The symptoms endure for a duration exceeding 3 months.
3. There exists a decrease of no less than 30 degrees in a minimum of two joint angles of the affected shoulder, namely flexion, abduction, and external rotation, in comparison to the corresponding angles of the unaffected side.

Exclusion Criteria:

1. Musculoskeletal ultrasound of the shoulder identifies a full-thickness tear or substantial tear in the rotator cuff tendons or presents calcific tendinitis.
2. Presence of systemic rheumatic disease.
3. Prior history of shoulder fracture or surgical intervention involving the shoulder joint.
4. Acute compression of cervical nerve root.
5. Patients displaying instability (e.g., those with signs of internal bleeding) or individuals with cancer.
6. Recent receipt of shoulder injections for treatment within the last 3 months.
7. Impaired cognitive function that hinders the patient's ability to provide informed consent or engage in rehabilitation therapy.
8. Expectant or breastfeeding women.
9. Meets any of the contraindications for high-energy electromagnetic pulse therapy: individuals with organ transplants, implanted cardiac pacemakers, defibrillators, metal implants (such as stents), cochlear implants, and those requiring insulin supplementation.

Primary outcomes:
measure: Change in pain Visual Analogue Scale(VAS)
timeFrame: the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
Secondary outcomes:
measure: Change in Shoulder Pain and Disability Index (SPADI)
timeFrame: the change from baseline, post-intervention immediately, post-intervention 1, 3, 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-service general hospital
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General
name: Liang cheng Chen, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: