Pulsed Electromagnetic Field Therapy on Muscle Strength and Function in Patients With End-stage of Knee Osteoarthritis

NCT06196567 | Recruiting DMC

• 1 other identifier: 2023.210
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

End-stage OA knee is one of the most common musculoskeletal complaints, with over 34,000 patients waiting for joint replacement in Hong Kong and is expected to increase as the population continues to age constantly. The nominal waiting time for joint replacement in Hong Kong is long compared with many developed countries, averaging at 122 months, resulting in many elderly patients living with severe pain, limiting their daily activities. We are, therefore, in dire need to improve the well-being of this large and increasing group of patients as the capacity for operations remains limited. It is important to maintain preoperative knee-extensor strength in the end-stage of knee OA awaiting TKR because the improvement of knee-extensor strength may postpone the need for surgery and increase the ability to perform functional activities after TKR at the same time. PEMF exposure, on top of regular exercise training, may promote the secretion of myokine and in turn, promote muscle regeneration. These findings laid grounds for implementing PEMF treatment for end-stage knee OA patients to enhance muscle regeneration in periods with limited physical activity. The novelty of this study is that this is the first RCT to examine if pulsed electromagnetic field therapy (PEMF), in addition to a standard rehabilitation, produces better muscle strength and functional performance before and after TKR in people with knee OA than either intervention alone. The impact of this study is particularly strong given end-stage patients waiting for knee replacement surgeries in Hong Kong.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; PEMF; Knee muscle strength; total knee replacement; knee pain and function

Outcome Measures

Primary Outcomes (1)

• Changes of knee muscle strength

  The peak torque in kgf will be recorded with in 2 trials in the 5 seconds isometric muscle strength test.

  Day 0, 4th week, 8th week after the commencement the intervention and 6th week, 3 months, and 12 months after the TKR surgery

Secondary Outcomes (16)

• Appendicular muscle mass

  Day 0, 4th week, 8th week after the commencement the intervention and 6th week, 3 months, and 12 months after the TKR surgery

• myokine evaluation-Brain-derived neurotrophic factor (BDNF)

  Day 0, 8th week after the commencement the intervention and 6th week, 3 months, and 12th month after the TKR surgery

• myokine evaluation-Fibroblast growth factor-21 (FGF-21)

  Day 0, 8th week after the commencement the intervention and 6th week, 3 months, and 12th month after the TKR surgery

• myokine evaluation-Interleukin-6 (IL-6)

  Day 0, 8th week after the commencement the intervention and 6th week, 3 months, and 12th month after the TKR surgery

• myokine evaluation-Interleukin-15 (IL-15)

  Day 0, 8th week after the commencement the intervention and 6th week, 3 months, and 12th month after the TKR surgery

Study Arms (3)

active control group

ACTIVE COMPARATOR

will receive the standard prehabilitation a physio-based exercise program designed to increase quadriceps muscle strength for 2 sessions per week for 8 weeks. Sessions will be performed at the same time (i.e., in the morning). The main programme comprised 5 sets of 10 repetitions for each exercise, with 60 rest between sets.

Other: exercise

Pulsed Electromagnetic Field (PEMF)

EXPERIMENTAL

will receive the active PEMF treatment provided by a PEMF device (Quantum Tx, Singapore). Alternating leg will be exposed to PEMF for 10 minutes per session for 2 sessions per week for 8 weeks.

Device: PEMF

standard prehabilitation plus PEMF intervention

EXPERIMENTAL

This group will have both the standard prehabilitation and PEMF intervention for 2 sessions a week for eight weeks.

Device: PEMF; Other: exercise

Interventions

PEMF DEVICE

Subjects will receive PEMF treatment with the duration of 8 weeks, twice a week with total 16 treatment sessions

Pulsed Electromagnetic Field (PEMF); standard prehabilitation plus PEMF intervention

exercise OTHER

do the exercise aimed at improving knee muscle strength,twice a week for 8 weeks before surgery

active control group; standard prehabilitation plus PEMF intervention

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients end-stage knee OA over 50 waiting for TKR
• Patient has been scheduled for TKR at Prince of Wales Hospital
• Able to comply with the assessments and has given oral and written consent

You may not qualify if:

• Patients with connective tissue disorders or myositis condition
• History of any Hip \& Knee joint replacement
• Patients with acute immobility (i.e., post hip fracture or post-acute hospital admission)
• Previous cases of any substances abuse
• Patients already had TKR for one knee before
• Patients are unable to transport themselves for intervention
• Patients have any neuromuscular or neurodegenerative conditions
• Patients have the history of inflammatory arthritis

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Michael.Ong@Cuhk.Edu.Hk

Hong Kong, NEW Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael Tim-Yun Ong

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Tim-Yun Ong

CONTACT

26364171; michael.ong@cuhk.edu.hk

Qianwen WANG

CONTACT

26364171; alicia157@link.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: It is single-blinded, the investigators don't know the group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: Participants will be randomly assigned to one of three intervention groups, which will have treatment for 8 weeks prior to the surgery.

Study Record Dates

• First Submitted: December 8, 2023
• First Posted: January 9, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: starting 12 months after publication
• Access Criteria: Journal reviewers

Locations

HK (1)