Laser or pulsed electromagnetic field: which treatment is more effective for knee osteoarthritis?
| ISRCTN | ISRCTN17001174 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17001174 |
| Secondary identifying numbers | 08051928 |
- Submission date
- 06/04/2022
- Registration date
- 20/04/2022
- Last edited
- 17/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aim
Knee osteoarthritis (KOA) causes the cartilage in the knee joint to thin and the surfaces of the joint to become rougher so the knee doesn’t move as smoothly as it should and might feel painful and stiff. Low-level laser therapy (LLLT) and pulsed electromagnetic field laser therapy (PEMF) are effective and non-invasive treatments for KOA. In this study, patients with KOA will receive either PEMF or LLLT to see which treatment is more effective for KOA in terms of pain relief and improved function.
Who can participate?
Men and women older than 50 years old and up to 75 years old with symptomatic knee pain lasting for 6 months or longer. Patients must be able to walk for at least 30 meters.
What does the study involve?
Participants will be randomly allocated to one of two groups. One group will receive PEMF treatment and the other will receive LLLT treatment sessions. The treatment modalities will be delivered by trained physiotherapists. The treatment will be performed lying face upwards with the headrest raised according to the patient's comfort, and the knee supported on a pillow at about 15-30 degrees flexion (bending), depending on the comfort and pain reported by the patient. Each treatment is composed of six sessions, twice a week.
What are the possible benefits and risks of participating?
The possible benefits are decreased pain and increased ability to walk and function. There are no known risks to participants.
Where is the study run from?
Nedica Physical Therapy Clinic (Israel)
When is the study starting and how long is it expected to run for?
February 2021 to October 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Michal Elboim-Gabyzon
michal.elboim@gmail.com
moelboum-@staff.haifa.ac.il
Contact information
Principal Investigator
199 Aba Khoushy Ave., Mt. Carmel
Haifa
3498838
Israel
 ORCID ID |
0000-0002-7278-9421 |
|---|---|
| Phone | +972 (0)545968943 |
| moelboum-@staff.haifa.ac.il |
Study information
| Study design | Single-center double-blind randomized control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Laser or pulsed electromagnetic field: which modality is more effective in the treatment of knee osteoarthritis? A randomized controlled trial |
| Study objectives | It is hypothesized that both therapies modalities would cause a decrease in pain intensity and an increase in the level of function in subjects with knee osteoarthritis (KOA). Yet, it is not possible to determine whether a difference would be found between the modalities |
| Ethics approval(s) | Approved 26/01/2022, Ethical Review Board, Faculty of Social Welfare and Health Sciences at the University of Haifa (199 Aba Khoushy Ave. Mount Carmel, Haifa, Israel; +972 (0)4 8249948 (internal: 53948); pfientu1@univ.haifa.ac.il), ref: 069/21 |
| Health condition(s) or problem(s) studied | Primary knee osteoarthritis |
| Intervention | Participants are randomly assigned to one of the two intervention groups by using a computer-generated random software sequence of allocation. Participants are randomized by the clinic secretary, who was not involved in the study, prior to the pre-intervention assessment once the eligibility criteria are confirmed. The low-level laser therapy (LLLT) intervention is carried out while wearing goggles, which are one of the system's accessories. LLLT is applied in a six-session format twice a week. The treatment parameters are: power 100%, dose 8 J/cm², frequency 2 Hz, duty factor 75%, treatment area 20 cm² applied over five points over the anterior part of the articular space, for 3 minutes for each point for a total time of 15 minutes. The pulsed electromagnetic field laser therapy (PEMF) applicator is applied over the medial and lateral side of the knee. The parameters are field shape rectangular, frequency 30 Hz, intensity 10 mT, treatment time 15 minutes. Each treatment modality is composed of six sessions, twice a week. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Pain intensity during rest, walking, and while standing up measured using the visual analog scale (VAS) at baseline and post the six sessions (week 3) |
| Secondary outcome measures | 1. Pain intensity, stiffness, and level of physical functioning measured using the Hebrew version of the Western Ontario and McMaster Universities Osteoarthritis questionnaire (WOMAC) at baseline and post the six sessions (week 3) 2. Functional mobility measured using the Timed Up and Go (TUG) test at baseline and post the six sessions (week 3) 3. Walking ability measured using the 10-Meter Walk (10MW) at baseline and post the six sessions (week 3) |
| Overall study start date | 01/02/2021 |
| Completion date | 15/10/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 46 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Primary KOA 2. Age 50-75 years old 3. Both genders 4. Symptomatic knee pain lasting for 6 months or longer 5. Pain level ≥4 out of 10 according to the Visual Analog Scale (VAS scale) 6. Independent walking ability of at least 30 meters 7. KOA level of 2-3 according to the Kellgren–Lawrence classification scale |
| Key exclusion criteria | 1. Participants with secondary KOA 2. Significant sensory disturbances in the lower extremities 3. Uncontrolled diabetes or uncontrolled heart disease 4. Body Mass Index (BMI) >40 kg/m² 5. Presence of pacemaker 6. Previous surgeries in lower limbs 7. Metal or implants in the body 8. Inability to understand simple instructions |
| Date of first enrolment | 15/05/2021 |
| Date of final enrolment | 15/09/2021 |
Locations
Countries of recruitment
- Israel
Study participating centre
Shefar'am
2020000
Israel
Sponsor information
University/education
199 Aba Khoushy Ave.
Mt. Carmel
Haifa
3498838
Israel
| Phone | +972 (0)4 8249278 (internal: 53278) |
|---|---|
| szalka@univ.haifa.ac.il | |
| Website | http://www.haifa.ac.il/index.php/en/ |
"ROR" |
https://ror.org/02f009v59 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Michal Elboim-Gabyzon (michal.elboim@gmail.com, moelboum-@staff.haifa.ac.il). Each request will be discussed specifically considering ethical or legal restrictions. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | outcome results | 16/03/2023 | 17/03/2023 | Yes | No |
Editorial Notes
17/03/2023: Publication reference added.
20/04/2022: Trial's existence confirmed by the Ethical Review Board, Faculty of Social Welfare and Health Sciences at the University of Haifa.
