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NCT Number: NCT05483517

High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy

The aim of our study is to investigate the efficacy of high energy density pulse electromagnetic field for patients with rotator cuff tendinopathy

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Key information

Conditions

Rotator Cuff Tendinosis Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tri-service general hospital

Taipei, Neihu, 11490, Taiwan

About this study

Traditional pulse electromagnetic field (PEMF) devices have been approved by the U.S. Food and Drug Administration (FDA) to treat nonunion fractures and cleared to treat post-operative pain and edema, osteoarthritis, and plantar fasciitis. However, high level of evidence indicated that the lack of beneficial effects of PEMF on pain, function or range of motion in the treatment of shoulder pain.

High energy density pulse electromagnetic field(High-PEMF) which builds up a voltage up to 30 kilovolt (kV) with shorter impulse time(50us) and broad band-width(200kHz~300MHz) is very different from traditional PEMF. Magnetic field about 50~150 millitesla (mT) is created and it can penetrate the body up to 20 cm. The aim of our study is to investigate the efficacy of High-PEMF for patients with rotator cuff tendinopathy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age between 20 to 75 years old
  • persistent shoulder pain for at least 3 months and pain VAS score >=5
  • positive result in any of the following physical examinations: Hawkins-Kennedy, Neer or Jobe tests
  • confirmed rotator cuff tendinopathy by ultrasonography or MRI

Exclusion criteria

  • complete or full-thickness tear of rotator cuff found by ultrasonography or MRI
  • previous shoulder surgery
  • previous history of severe trauma in shoulder
  • cervical radiculopathy related shoulder pain or referred pain
  • other shoulder diseases: adhesive capsulitis, calcifying tendinopathy, radiology-confirmed acromion type III, shoulder instability, degenerative osteoarthritis, labral tear
  • present with any of the following systemic diseases: active infection, sever and uncontrolled medical condition, cancer, immune-related or rheumatoid arthritis, hyperuricemia and gout
  • previous treatment with articular or subacromial steroid injections within the last 3 months
  • cognitive impairment with loss of ability to sign the agreement and receive rehabilitation
  • pregnancy or lactating women
  • has any of the following contraindications: Carriers of pacemakers, internal defibrillators,internal metal implants (locally dependent), Cochlea implants, metallic stents, insulin pumps

Treatment and study plan

High energy density pulse electromagnetic field

Device

The treatment coil is placed over the shoulder region at the maximum pain point for 9 minutes. A normal energy of high-PEMF with a rate of 2 pulse per second is applied to the patient.

sham High energy density pulse electromagnetic field

Device

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(normal energy, a rate of 2 pulse per second) with the difference that the energy output doesn't export to the patient.

Physiotherapy

Behavioral

Physiotherapy includes shoulder range of motion (ROM), stretching and muscle strengthening exercises. Under the physiotherapist's guidance, the patient receives the training session about 30 minutes every time.

Primary outcomes

  1. Change in Pain Visual Analogue Scale(VAS)

    Time frame: baseline, immediate after treatment, 4 weeks, 12 weeks

    The Visual Analog Scale (VAS) was used to measure pain intensity. The scale ranges from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain. Higher scores indicate worse outcomes.

Secondary outcomes

  1. Change in Total Score of Shoulder Pain and Disability Index (SPADI)

    Time frame: baseline, immediate after treatment, 4 weeks, 12 weeks

    The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with activity of daily livings (ADLs) requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. The patient is instructed to choose the number that best describes their level of pain and extent of difficulty using the involved shoulder. The pain scale is summed up to a total of 50 while the disability scale sums up to 80.

    The total SPADI score is calculated by adding the scores of the Pain and Disability subscales, with a range from 0 to 130. A higher total score indicates greater pain and disability.

  2. Changes of Shoulder Range of Motion in Active Flexion

    Time frame: baseline, immediate after treatment, 4 weeks, 12 weeks

    Shoulder ROM during flexion, abduction in the sitting position, internal rotation (IR) at 90° of abduction of the affected shoulder were measured using a digital goniometer, and the mean of three values was used for analysis

  3. Changes of Shoulder Range of Motion in Active Abduction

    Time frame: baseline, immediately after treatment, 4 weeks, 12 weeks

    Shoulder ROM during flexion, abduction in the sitting position, internal rotation (IR) at 90° of abduction of the affected shoulder were measured using a digital goniometer, and the mean of three values was used for analysis

  4. Changes of Shoulder Range of Motion in Active Internal Rotation

    Time frame: baseline, immediately after treatment, 4 weeks, 12 weeks

    Shoulder ROM during flexion, abduction in the sitting position, internal rotation (IR) at 90° of abduction of the affected shoulder were measured using a digital goniometer, and the mean of three values was used for analysis

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

Efficacy of High Energy Density Pulse Electromagnetic Field for Patients With Rotator Cuff Tendinopathy: A Double-blinded, Randomized Controlled Trail

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2022
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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