The Effects of Pulsed Electromagnetic Field Therapy on Patients With End-stage of Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

The Effects of Pulsed Electromagnetic Field Therapy on Patients With End-stage of Knee Osteoarthritis: A Double-blinded Randomized Control Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05550428
• Other study ID #: 2022.185
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A double-blinded, randomizepd controlled trial to investigate the treatment effects of pulsed electromagnetic field (PEMF) on end stage of knee osteoarthritis patients with sarcopenia will be carried out. Subjects will be recruited from the Prince of Wales Hospital. Sixty participants age ≥ 60 will be invited to join this trial after informed consent. They will be randomised to any of the 2 groups: intervention group (n=30; PEMF (Quantum Tx) treatment), and control group (n=30; sham treatment with dummy exposure to PEMF). Both group will receive home-based exercise. Baseline measurements include appendicular muscle mass by DXA, bone microarchitecture (XtremeCT II), knee flexion and extension strength by handheld dynamometer, knee flexion and extension range of motion by goniometer, self-reported knee pain (VAS) and function by The Knee Injury and Osteoarthritis Outcome Score (KOOS), International Physical Activity Questionnaire (IPAQ) for assessment of physical activity level, quality of life by SF-36, hand grip test, bioelectrical impedance analysis （BIA）of body composition, postural stability, chair stand test, 30s arm curl test and 6-meter walking test. These measurements will be performed again at middle and end of treatment, 3, 6, and 12 months after commencement of treatment, except DXA, which will not be performed at the midpoint. In addition, blood samples will be taken at baseline, middle, and end of treatment, 3, 6, and 12 months after commencement of treatment, for determing of serum myokines which are reported to be sensitive to PEMF treatment and contribute to myogenesis. The aim of this study is to conduct a double-blinded, randomized controlled trial to investigate the effects of PEMF treatment on muscle gain and pain relief in knee osteoarthritis with sarcopenia elderly in Hong Kong. We hypothesize that PEMF treatment is effective to promote a gain in muscle mass and function and pain relief in knee osteoarthritis with sarcopenia elderlies.

Description:

PEMF therapy is the use of electromagnetic fields in a pulsating pattern directed towards the body. The clinical use of PEMF therapies in orthopedics has been approved for over 40 years and commonly entail analgesic benefits. When specifically targeting the knee, however, evidence that the technology improves pain, physical function, and quality of life has been inconclusive, probably due to the unaddressed muscle weakness. Therefore, the approach employed in the present study was to target the leg musculature for its delivery of regenerative agents that naturally promote healing. The therapy entails a muscle-targeted, low-energy PEMF therapy previously used in human trials. Notably, this same PEMF paradigm was shown to improve functional mobility, increase lean muscle mass, and reduce pain in a community cohort containing frail elderly subjects. This PEMF paradigm has been demonstrated effective in promoting human muscle regeneration by inducing mitochondrial adaptations, similar to those invoked during oxidative muscle development in response to exercise

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

Inclusion Criteria:

• subjects with knee osteoarthritis will be included:

1. radiographic Kellgren/Lawrence scale knee OA grade =3

2. enlistment on a TKR surgical waiting list; ability to comply with the trial assessments and fully comprehend questionnaires;

3. be over 50 years of age and

4. ability to walk unaided over 6 meters.

Exclusion Criteria:

• 1. With medical or musculoskeletal problems that could affect the ability to complete assessments (i.e. with walking aids or wheel-chaired).

2. Severe cognitive impairments and neurological disorders that will affect data collection by questionnaires.

3. Any medical conditions which are contraindicated to do exercise by PARQ restricting any physical activity.

4. history of knee or hip surgeries 5. body mass index over 30 kg/m2 and 6. history of cancer.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Sarcopenia

Intervention

Other:
• home-based-exercise
All the participants were instructed on the proper performance of the exercise regimen by a senior physiotherapist before the commencement of the intervention. Subjects were then instructed to perform the home-based exercises on their own twice a week for eight weeks. One dedicated research assistant kept a weekly record of the participants' physical activity. sessions.

Device:
• active pulsed electromagnetic field(PEMF)therapy
Alternating legs on consecutive visits were exposed to either PEMF or sham therapy for eight weeks for a total of 16 PEMF sessions per participant, each leg receiving 8 exposures.
• shame pulsed electromagnetic field(PEMF)therapy
Alternating legs on consecutive visits were exposed to either PEMF or sham therapy for eight weeks for a total of 16 sham PEMF sessions per participant, each leg receiving 8 exposures.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of knee extensor and flexor strength	The peak torque will be recorded in 2 trials in the 5 seconds isometric muscle strength test.	pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
Secondary	the change of Muscle mass	Skeletal muscle mass will be measured by a Dual-energy X ray absorptiometry (DXA) scan or BIA according to standardized procedure The muscle mass in kg m^2 will be recorded in different time points.	pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
Secondary	the change of self-report knee pain and function	Self-reported pain and physical function will be measured using the the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire. This 42-item questionnaire is divided into five sub-scales, which address pain, other disease symptoms, function in activities of daily living, function in sport and recreation, and quality of life.	pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
Secondary	the change of 30s Arm curl	The participants receive a weight on the dominant hand. The weight is 2.27 kg [5 lb] for women and 3.63 kg [8 lb] for men. The task is to perform a 30s Arm Curl test. The number of the arm curl will be recorded.	pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
Secondary	the change of bone image	High-Resolution Peripheral Quantitative Computed Tomography Scans (HR-pQCT) High-resolution peripheral quantitative computed tomography scans (HR-pQCT) using XtremeCT II (Scanco Medical AG?, Brüttisellen, Switzerland) provides an analysis of bone microarchitecture at human peripheral sites with high spatial resolution and low exposure to radiation. Bone mineral density (BMD, calibrated with hydroxyapatite standards) and finite element analysis of subchondral bone over the knee joint will be performed using the Scanco software. Scans will be performed on both legs before the start of the PEMF treatment, in the middle of 8weeks, and after the completion of the PEMF treatment (3, 6- and 12-months).	pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
Secondary	the change of chair stand test	The rate of force development will be determined as the mean slope of the rising force of the first force peak of each of the 2nd to the 6th repetition in the interval of 30-70% exerted peak force. Results are reported as the mean of the two fastest approved trials in body weight per second (BW/s).	pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
Secondary	the change of postural stability	A force platform (Tekscan, U.S.) will be utilized to evaluate static postural control using the COP measures in static and dynamic postural control conditions. Sway path length (cm) of center of pressure (COP), velocity of COP (cm/s), ellipse area (cm^2)of COP (will be recorded.These static postural conditions include stand on double leg with open (DO) and close eyes (DC) for 30s, tandem stance for 30s, squat for 15s and stand on one leg with open eyes (SO) for 10s.Dynamic postural control will be evaluated using the task of transitioning from double-leg to single-leg standing.	pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
Secondary	the change of Serum myokine evaluation	Blood taking (5 ml) will be performed before PEMF treatment, and at 3, 6, and 12 months after the commencement of treatment. Serum will be prepared by centrifugation and kept in -80º freezer until use. Quantitative analysis for myokines and proteins related to muscle metabolism will be performed by Human Myokine Magnetic Bead Panel (Millipore) with Bioplex-200 bead-based suspension assay system (LKSIHS core facilities), or enzyme linked immunosorbent assay (ELISA). These include Brain-derived neurotrophic factor (BDNF), Fibroblast growth factor-21 (FGF-21), Interleukin-6 (IL-6), IL-15, Irisin, Myostatin (MSTN)/GDF8, Insulin-like growth factor 1 (IGF-1), FGF-2, IL-8, Follistatin, Musclin, Myonectin, Decorin, Meteorinlike, Osteopontin, Secreted protein acidic and rich in cysteine (SPARC), Klotho, Procollagen type III N-terminal peptide (P3NP), and C-terminal of troponin T1 (TNNT1)	pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
Secondary	the change of self-report pain	The Visual Analogue Scale (VAS) requires participants to rate participants' pain on a defined scale from 0-10 after each ending session of the PEMF therapy.	pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
Secondary	the change of self-report quality of life	Short Form-36 questionnaires (SF-36) will be used to evaluate Health-Related Quality of Life.	pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]
Secondary	the change of physical activity	Physical Activity Readiness Questionnaire (PAR-Q) and International Physical Activity Questionnaire (IPAQ) will be used to determine whether participants should complete medical evaluation before participating in the exercise program in this study.	pre, mid, end of PEMF treatment , 2-months, 3-months, 6-months, and 12-months after the commencement of PEMF]