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

NCT05316961 | Unknown DMC

• 1 other identifier: 2021.150-T
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendinopathy

Keywords

Pulsed electromagnetic field therapy; Eccentric exercise; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Visual Analogue Scale (VAS)

  The Visual Analogue Scale (VAS) requires participants to rate their pain on a defined scale from 0-10. 0 refers to no pain while 10 refers to severe pain. Lower scores mean a better outcome.

  Change from baseline to 6 months

• Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A)

  The Victorian Institute of Sport Assessment - Achilles questionnaire (VISA-A) is used to evaluate the clinical severity of patients, monitor the change in symptoms and function following interventions provided for Achilles tendinopathy. The questionnaire contains eight questions, covering three necessary domains: 1) pain, 2) functional status, and 3) activity. The first seven questions have a score out of 10, and question 8 scores a maximum of 30. The minimum value is 0 and the maximum value is 100. Higher scores mean a better outcome. Asymptomatic individuals may score 100 points in VISA-A.

  Change from baseline to 6 months

Secondary Outcomes (6)

• Ankle range of motion

  Change from baseline to 6 months

• Calf muscle endurance

  Change from baseline to 6 months

• Tendon thickness

  Change from baseline to 6 months

• Neovascularity

  Change from baseline to 6 months

• Tendon elasticity

  Change from baseline to 6 months

Study Arms (2)

PEMF group

EXPERIMENTAL

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.

Device: Active PEMF; Other: Eccentric exercise

Sham group

SHAM COMPARATOR

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.

Device: Sham PEMF; Other: Eccentric exercise

Interventions

Active PEMF DEVICE

PEMF 1.5mT, 10Hz, 10 minutes

PEMF group

Sham PEMF DEVICE

PEMF 0mT, 0Hz, 10 minutes

Sham group

Eccentric exercise OTHER

Eccentric exercise, 10 repetitions, 3 sets

PEMF group; Sham group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

KO Man Chi

Hong Kong, 999077, Hong Kong

Location

Related Publications (2)

• 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.

  PMID: 39534390 DERIVED

• 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.

  PMID: 37308969 DERIVED

Study Officials

• Ka-Kin Samuel Ling, MSc

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor (Clinical) of Orthopaedics & Traumatology

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: April 7, 2022
• Study Start: July 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: September 25, 2023

Record last verified: 2023-09

Locations

HK (1)