Pilot Study On Pulsed Electromagnetic Field Therapy For Osteosarcopenia

Louis Tee

Status: Unknown

Conditions: Osteopenia or Osteoporosis; Sarcopenia

Treatments: Device: PEMF

Study type: Interventional

Funder types: Other

Identifiers

NCT05043480

2020/01181

Details and patient eligibility

About

This prospective, single-site, single arm pilot study aims to assess the efficacy of Pulsed Electromagnetic Field (PEMF) exposure in the reduction of the decline in muscle strength, function and bone mineral density (BMD) in osteosarcopenia.

Full description

This prospective, single-site, single-arm pilot study aims to assess the efficacy of Pulsed Electromagnetic Field (PEMF) exposure in the reduction of the decline in muscle strength, function and bone mineral density (BMD) in osteo-sarcopenia. For this pilot study, we will recruit 80 participants aged 65 years old and greater with osteo-sarcopenia, to receive PEMF therapy, at 1.5mT, once a week for 10 min to alternate lower limb (10 mins each week) weekly for 16 weeks. Participants will be followed up at baseline, 4, 8 and 12 and 17 weeks. At each follow-up, falls risk will be assessed by Short Physical Performance Battery (SPPB), including 6-minute walk and 5 sit-to-stand tests, Falls Efficacy Scale International (FESI), 3min-NS (3 minute Nutritional Screening) and SARC-F (Strength, Assistance with Walking, Rise from Chair, Climb Stairs and Falls) questionnaires. Muscle strength (hand grip and leg extension) and calf diameter are measured. Blood tests, saliva tests, and DEXA scans will be done at baseline, immediately after first PEMF exposure and week 17 to determine changes in biomarkers for senescence, bone/fat/muscle composition and skeletal muscle mass.

Enrollment: 80 estimated patients

Sex: All

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 65 years old and above, which corresponds to the geriatric patient population seen at the Healthy Ageing clinics and wards
2. Diagnosed with primary osteopenia, including primary osteoporosis, by BMD measurements on DEXA scans
3. Diagnosed with sarcopenia by SARC-F
4. Willing and able to give written informed consent

Exclusion criteria

1. Presence of metallic implants, pacemakers or insulin pumps
2. Presence of rheumatological disease (such as osteoarthritis or rheumatoid arthritis)
3. Presence of secondary osteoporosis (such as hyperparathyroidism, steroid-induced osteoporosis)
4. Presence of end-stage organ failure, including severe dementia or cancer
5. Pregnant women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

PEMF arm

Experimental group

Description:

In this single-arm study, all participants will be assigned to the intervention arm.

Treatment:

Device: PEMF