Clinical Effectiveness of PEMF as a Treatment Adjunct to Eccentric Exercise for Achilles Tendinopathy

NCT ID: NCT05316961

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-08-01

Brief Summary

This study aims to investigate the clinical effectiveness of PEMF as an adjunct to a program of eccentric exercise for the treatment of Achilles tendinopathy. The study objective is to establish whether PEMF plus eccentric exercise in people with Achilles tendinopathy will improve rehabilitation outcomes compared to eccentric exercise only. This study also investigates the effects of PEMF on pain, functional outcomes, mechanical and morphological properties of tendon among patients with Achilles tendinopathy. Investigators hypothesize that pulsed electromagnetic field therapy is effective in reducing pain, improving functional outcomes, and restoring mechanical and morphological properties of tendons in patients with Achilles tendinopathy.

This study is a double-blinded, randomized controlled trial to investigate the clinical effects of pulsed electromagnetic field therapy (PEMF) for Achilles tendinopathy. Participants will be recruited from the outpatient clinic of the orthopedic and traumatology department at Prince of Wales Hospital. Fifty-four patients aged between 18 and 70 with Achilles tendinopathy will be invited to join this trial after informed consent. Participants will be randomized to any of the 2 groups: the intervention group (n=27; PEMF (Quantum Tx) treatment), and the control group (n=27; sham treatment with dummy exposure to PEMF).

Baseline measurements of all self-reported outcomes, functional outcomes, and ultrasound imaging assessments, such as ankle range of motion, jumping ability, pain level, calf muscle strength, calf muscle endurance, physical activity level, quality of life by SF-36 will be measured.

Detailed Description

Randomization and blinding Participants will be randomized into 1:1 allocation, blocked randomization with 27 participants in the PEMF group and 27 participants in the sham group. Each allocation will be assigned with a unique RFID (generated during block randomization by the PEMF supplier service) recognizable by the PEMF machine. The participants will be assigned an RFID by which the PEMF or sham treatment will be randomly assigned to the RFID. A biostatistician who does not participate in the recruitment of patients will oversee the randomization. Hence, both participants and the research personnel are blinded, and participants will use the RFID to complete the assigned treatment without knowing which treatment they are receiving.

Intervention The intervention will be held at the Chinese University of Hong Kong. Participants in the intervention group will be exposed to PEMF treatment by a PEMF device (Quantum Tx, Singapore). The active PEMF device does not produce heat or cause any sensation to the tissue which allows the participants to be blinded to the treatment. Participants in the control group will receive a sham exposure with the same PEMF device. The diseased leg will be exposed to PEMF or sham treatment for 10 minutes per session, and the treatment regime will run twice a week for 8 weeks, summing up 16 sessions of PEMF or sham exposure in total.

The procedure of PEMF treatment is shown as follows:

The subject will be seated at a 90 degrees position on a chair. The solenoids of the PEMF device will be adjusted to be over the foot and ankle (Achilles tendon and lower calf muscle).

The options of the appliance will be adjusted to 1.5mT, 10Hz on the diseased leg for 10 minutes.

In addition to PEMF, all participants will also perform eccentric calf muscle exercise. The first step is stretching exercises for the calf muscles. The stretching is a static stretch of the gastrocnemius (knee in extension) and soleus (knee in flexion). The participants are instructed to hold these at least for 30s and repeat each exercise three times. There is a 1-min rest between each stretch. 3 sets of 10 repetitions of the eccentric exercises are carried out once daily for 6 weeks and after 6 weeks, the participants are instructed to carry out 3 sets of 10 repetitions, 3 times per week for 6 more weeks. The intensity of the exercise should be such that pain, or discomfort, is experienced in the last set of 10 repetitions. Every session ended with the same static stretch exercise as in step 1. If a participant is unable to complete 3 sets of 15 repetitions, the participant is instructed to start with a lower number of repetitions and/or sets (a minimum of 2 sets of 10) and progress to the full amount as able.

Conditions

Achilles Tendinopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PEMF group

Participants will receive active pulsed electromagnetic field therapy two times a week for eight weeks. The options of the appliance will be adjusted to 1.5 mT, 10Hz on one leg for 10 minutes. A total of 16 sessions will be given to each participant. Each session will last for 10 minutes. Participants will be positioned in sitting on a chair comfortably. They will receive intervention at Prince of Wales hospital.

3 sets of 10 repetitions of the eccentric exercises are carried out once daily for 6 weeks and after 6 weeks, the patients are instructed to carry out 3 sets of 10 repetitions, 3 times per week for 6 more weeks. The intensity of the exercise should be such that pain, or discomfort, is experienced in the last set of 10 repetitions.

Group Type: EXPERIMENTAL

Active PEMF

Intervention Type: DEVICE

PEMF 1.5mT, 10Hz, 10 minutes

Eccentric exercise

Intervention Type: OTHER

Eccentric exercise, 10 repetitions, 3 sets

Sham group

Participants will receive sham pulsed electromagnetic field therapy two times a week for eight weeks. The options of the appliance will be adjusted to 0 mT, 0Hz on one leg for 10 minutes. A total of 16 sessions will be given to each participant. Each session will last for 10 minutes. Participants will be positioned in sitting on a chair comfortably. They will receive intervention at Prince of Wales hospital.

3 sets of 10 repetitions of the eccentric exercises are carried out once daily for 6 weeks and after 6 weeks, the patients are instructed to carry out 3 sets of 10 repetitions, 3 times per week for 6 more weeks. The intensity of the exercise should be such that pain, or discomfort, is experienced in the last set of 10 repetitions.

Group Type: SHAM_COMPARATOR

Sham PEMF

Intervention Type: DEVICE

PEMF 0mT, 0Hz, 10 minutes

Eccentric exercise

Intervention Type: OTHER

Eccentric exercise, 10 repetitions, 3 sets

Interventions

Active PEMF

PEMF 1.5mT, 10Hz, 10 minutes

Intervention Type: DEVICE

Sham PEMF

PEMF 0mT, 0Hz, 10 minutes

Intervention Type: DEVICE

Eccentric exercise

Eccentric exercise, 10 repetitions, 3 sets

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age between 18 and 70
• Tenderness with palpation 2-6 cm above the Achilles tendon insertion on the calcaneus (midportion Achilles tendinopathy)
• Recurrent complaints in 1 or both Achilles' tendons at rest and/or during exercise for the preceding 3 month
• Structural changes of the tendon were confirmed via sonographic examination during the initial physical exam
• Achilles tendinopathy affecting the insertional and mid-portion of the Achilles tendon
• Clinical symptoms associated with Achilles tendinopathy that do not respond well to conventional conservative treatments before entering the study
• Informed consent

Exclusion Criteria

• History of surgery on the affected lower limb in the past year
• Mental/physical limitation rendering participant to follow instructions
• With medical or musculoskeletal problems that could affect the ability to complete assessments (i.e. with walking aids or wheel-chaired)
• Severe cognitive impairments and neurological disorders that will affect data collection by questionnaires
• Fractures of the trained body parts within the past 12 months

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Samuel KK Ling

Assistant Professor (Clinical) of Orthopaedics & Traumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ka-Kin Samuel Ling, MSc

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

KO Man Chi

Hong Kong, , Hong Kong

Countries

Hong Kong

References

Ko VM, Chen SC, He X, Fu SC, Franco-Obregon A, Yung PS, Ling SK. Short-term Effects of Pulsed Electromagnetic Field Therapy for Achilles Tendinopathy: A Randomized Controlled Trial. Orthop J Sports Med. 2024 Nov 12;12(11):23259671241284772. doi: 10.1177/23259671241284772. eCollection 2024 Nov.

Reference Type: DERIVED

PMID: 39534390 (View on PubMed)

Ko VM, He X, Fu SC, Yung PS, Ling SK. Clinical effectiveness of pulsed electromagnetic field therapy as an adjunct treatment to eccentric exercise for Achilles tendinopathy: a randomised controlled trial. Trials. 2023 Jun 12;24(1):394. doi: 10.1186/s13063-023-07434-6.

Reference Type: DERIVED

PMID: 37308969 (View on PubMed)

Other Identifiers

2021.150-T

Identifier Type: -

Identifier Source: org_study_id