Clinical trial NCT06196567: Pulsed Electromagnetic Field Therapy on Muscle Strength and Function in Patients With End-stage of Knee Osteoarthritis
Official title: The Effectiveness of Pulsed Electromagnetic Field Therapy on Muscle Strength and Function in Patients With End-stage of Knee Osteoarthritis Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
PEMF
Knee muscle strength
total knee replacement
knee pain and function
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 43
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three intervention groups, which will have treatment for 8 weeks prior to the surgery.
Primary purpose: TREATMENT

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.

Detailed description: Knee osteoarthritis (OA) is one of the most common chronic degenerative joint conditions affecting our ageing population. It is widely stated that OA is the leading cause of disability in elders due to discordant symptoms, such as pain and stiffness. Radiographic evidence of OA increased with age, from 8% in subjects younger than age 50, to over 60% in subjects aged 60 or above. Typically, conservative therapies that target symptoms are recommended as first- and second-line treatments for knee OA to reduce pain, stiffness, and activity limitations. However, when conservative therapies fail, they would then require total knee replacement (TKR). In 2022 to 2023, there were over 34,000 patients on the Hospital Authority (HA) waiting list for TKR. With only 3389 TKRs being performed, the nominal waiting time for TKR was outrageously long, 122 months in Hong Kong, as compared to an average of 9 months in Canada. Despite the efforts from the government to establish more joint replacement centres, the number of patients suffering from end-stage OA knees and requiring surgery will increase significantly as the population ages. Toward those requiring TKR, the excruciating pain would further cause significant functional impairment and lower health-related quality of life, which could eventually affect post-surgery outcomes. Although TKR appears to be an effective treatment in most people with end-stage Knee OA, 20%-40% of individuals remain dissatisfied. This is due to reduced leg strength occurring years after surgery, impaired functional capacity like poorer walking performance, greater deficits in physically demanding tasks such as stair climbing and poor performance of domestic duties .

The role of knee-extensor strength in the end-stage of Knee OA Knee-extensor muscle weakness has been regarded as a risk factor for knee OA. As shown, end-stage knee OA patients awaiting TKR had 35% reduced knee-extensor strength compared to healthy, age-matched individuals. In addition, pre-operative knee-extensor strength has also been found to be a predictor of postoperative functional ability up to a year following surgery. On average, patients would lose an additional 80% of their pre-operative knee-extensor strength shortly after TKA. Collectively, these data highlight the importance of maintaining preoperative knee-extensor strength in the end-stage of knee OA awaiting TKR and suggest that 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.

The role and limitation of prehabilitation before TKR The concept of preparing the body for a stressful event, such as surgery, has been named "prehabilitation". Prehabilitation was reported to positively affect knee OA symptoms and support patients' self-management of their knee OA condition, potentially postponing the need for surgery. As supported by the latest systematic review, it is important to focus on knee extensor muscle strength when evaluating the effects of prehabilitation before surgery in patients eligible for TKR. The review found that prehabilitation exercise could help to moderately increase knee extensor muscle strength and physical function and reduce pain. Moreover, a 30-40% increase in knee-extensor strength has been suggested to improve knee pain and disability. In conclusion, current prehabilitation has limited effects on improving sufficient knee extensor muscle strength.

Potential role of PEMF PEMF treatment utilizes a pulsed electromagnetic field to stimulate mitochondrial activity in skeletal muscle. Our group (Prof. Alfredo Franco-Obregon) showed that brief 10-minute exposure of 1 mT amplitude of PEMF (Quantum Tx) on myoblast in vitro could activate myogenesis. This can lead to a boost in repair and muscle regeneration via the release of myokines. Additionally, it plays an important role in regulating the production and secretion of myokine. Therefore, it is hypothesized that PEMF exposure, on top of regular exercise training, may promote the secretion of myokine and in turn promote muscle regeneration. These findings laid grounds to implement PEMF treatment for end-stage knee OA patients to enhance muscle regeneration in periods where limited physical activity is occurred. Also, this may help to set up a treatment regime for the PEMF device to impose myogenic effects, including exposure time per session, the number of treatment sessions and the duration of treatment.

Aims

The proposed project aims to set up a single-blinded randomized control trial to examine if pulsed electromagnetic field therapy (PEMF) in addition to a standard prehabilitation produces better muscle strength and functional performance before and after TKR in people with knee OA than either intervention alone.

To investigate the effect of PEMF in addition to a standard prehabilitation for muscle strength in end-stage OA knee patients.

To investigate the effect of PEMF in addition to a standard prehabilitation for knee symptoms and functional performance of OA knees in end-stage OA knee patients.

To investigate the effect of PEMF in addition to a standard prehabilitation for improving pain, function, and quality of life of OA knees in end-stage OA knee patients after surgery.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Changes of knee muscle strength
timeFrame: 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:
measure: Appendicular muscle mass
timeFrame: Day 0, 4th week, 8th week after the commencement the intervention and 6th week, 3 months, and 12 months after the TKR surgery
measure: myokine evaluation-Brain-derived neurotrophic factor (BDNF)
timeFrame: Day 0, 8th week after the commencement the intervention and 6th week, 3 months, and 12th month after the TKR surgery
measure: myokine evaluation-Fibroblast growth factor-21 (FGF-21)
timeFrame: Day 0, 8th week after the commencement the intervention and 6th week, 3 months, and 12th month after the TKR surgery
measure: myokine evaluation-Interleukin-6 (IL-6)
timeFrame: Day 0, 8th week after the commencement the intervention and 6th week, 3 months, and 12th month after the TKR surgery
measure: myokine evaluation-Interleukin-15 (IL-15)
timeFrame: Day 0, 8th week after the commencement the intervention and 6th week, 3 months, and 12th month after the TKR surgery
measure: myokine evaluation-Irisin
timeFrame: Day 0, 8th week after the commencement the intervention and 6th week, 3 months, and 12th month after the TKR surgery
measure: myokine evaluation-Insulin-like growth factor 1 (IGF-1)
timeFrame: Day 0, 8th week after the commencement the intervention and 6th week, 3 months, and 12th month after the TKR surgery
measure: myokine evaluation-Insulin-Follistatin
timeFrame: Day 0, 8th week after the commencement the intervention and 6th week, 3 months, and 12th month after the TKR surgery
measure: myokine evaluation-Insulin-C- terminal of troponin T1 (TNNT1)
timeFrame: Day 0, 8th week after the commencement the intervention and 6th week, 3 months, and 12th month after the TKR surgery
measure: Stair Ascent-Descent Assessment
timeFrame: Day 0, 4th week, 8th week after the commencement the intervention and 6th week, 3 months, and 12 months after the TKR surgery
measure: Chair Stand Test
timeFrame: Day 0, 4th week, 8th week after the commencement the intervention and 6th week, 3 months, and 12 months after the TKR surgery
measure: Postural Stability Assessment
timeFrame: Day 0, 4th week, 8th week after the commencement the intervention and 6th week, 3 months, and 12 months after the TKR surgery
measure: Short-Form 36 (SF-36)
timeFrame: Day 0, 4th week, 8th week after the commencement the intervention and 6th week, 3 months, and 12 months after the TKR surgery
measure: Knee injury and Osteoarthritis Outcome Score
timeFrame: Day 0, 4th week, 8th week after the commencement the intervention and 6th week, 3 months, and 12 months after the TKR surgery
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: Day 0, 4th week, 8th week after the commencement the intervention and 6th week, 3 months, and 12 months after the TKR surgery
measure: Visual Analogue Scale
timeFrame: Day 0, 4th week, 8th week after the commencement the intervention and 6th week, 3 months, and 12 months after the TKR surgery
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Michael.Ong@Cuhk.Edu.Hk
state: NEW Territories
Study officials:
affiliation: Chinese University of Hong Kong
name: Michael Tim-Yun Ong
role: PRINCIPAL_INVESTIGATOR
References: