Low Level Laser Therapy in meniscal pathology
| ISRCTN | ISRCTN24203769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24203769 |
| Protocol serial number | N/A |
| Sponsor | Thessaoliniki Sports Medicine Clinic (Greece) |
| Funder | Investigator initiated and funded |
- Submission date
- 25/03/2012
- Registration date
- 25/04/2012
- Last edited
- 23/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims:
At present, Low Level Laser Therapy (LLLT) is used to improve wound healing, reduce pain and swelling, and increase the general rate of recovery after a musculoskeletal injury. LLLT has not yet been used to manage knee injuries. The aim of the study was to see how effective LLLT is when used in patients with knee pain.
Who can participate?
Patients with knee injuries and have experienced knee pain for more than 6 weeks.
What does the study involve?
Using LLLT twice per week for the first three weeks, and once per week for the next three weeks (a total of 9 sessions).
What are the possible benefits and risks of participating?
Improvement of symptoms. There are no known risks of participating in the study
Where is the study run from?
Thessaloniki Sports Medicine Clinic, Greece
When is study starting and how long is it expected to run for?
The study started on 1st January 2009 and finished on 28th February 2011
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Malliaropoulos Nikolaos
contact@sportsmed.gr
Contact information
Scientific
Thessaoliniki Sports Medicine Clinic
Asklipiou 17
Thessaloniki
56639
Greece
| contact@sportsmed.gr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind randomised placebo controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Low Level Laser Therapy in meniscal pathology: a double-blinded placebo controlled trial |
| Study objectives | Is the application of low level laser therapy (LLLT) effective in patients with knee pain related to meniscal pathology |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Patients with knee pain related to meniscal pathology |
| Intervention | Patients were randomly assigned to receive LLLT (n=32) twice per week for the first three weeks, and once per week for the next three weeks (giving a total of 9 sessions), or identical placebo therapy (n=32). LLLT was administered using a GaAs laser with an infrared wave length of 904 nm (Irradia Medical Laser, M/D Laser Professional,Stockholm, Sweden) with four infrared diodes by the same blinded experienced physiotherapist. On the laser probe, an A/B switch determined whether active (A) or sham irradiation (B) was given. During the procedure, the laser appeared identical for both active and sham irradiation, since there was no visible aiming beam. Treatment was standard, and continuous irradiation was applied over the anatomic area of the medial meniscus (stationary mode procedure). According to our protocol, the medial meniscus was divided into 2 rows of 10 segments of equal size [spots] each, and each spot was irradiated once per session. The output of the laser averaged 240 mW (Irradia Medical Laser has a built in sensor for auto-calibration of the optical output before each application); the frequency of the pulse was 2400 Ηz [anti-inflammatory frequency) and 700Hz (Healing frequency). The spot area was almost 1 cm2 over the meniscal area, with a power density of 0.24W/cm2. Each patient was treated for 420 seconds per knee and per session [210 seconds using 2400Hz and 210 seconds using 700Hz]. The dose of active treatment was 100.8 J per knee, for a total of 907.2 J per knee. The knee to treat with the laser probe in switch position A or B was decided by opening an opaque envelope containing patients badge number and a written character A or B. The A/B switch on the laser was switched by a technician, and the medial side was treated every time. Thus the allocation of patients to groups was concealed to patients, physiotherapist, and observer. The code of the A/B switch positions on the laser probe was only known to the technician who was responsible to open envelopes, and to the physiotherapist administered the treatment Follow up was performed at 6 months and after 1 year. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. The subjective knee pain of the 64 symptomatic patients was assessed at baseline and after therapy using a subjective-based 100 mm visual analogue scale (VAS) ranging from 0 (no pain) to 100 (maximal pain) [17]. The pain decreased approximately by 65% four weeks after LLLT |
| Key secondary outcome measure(s) |
All the participants were also asked to complete: |
| Completion date | 28/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 64 |
| Key inclusion criteria | 1. We included patients with unilateral medial knee pain for more than six weeks. 2. Magnetic resonance imaging (MRI) inclusion criteria: 2.1. Tiny tears seen only on 0.7 thickness sequences. 2.2. Intrasubstance tears (with spot of Grade 3 SI approaching the articular surface) osteochondral lesions |
| Key exclusion criteria | 1. Patients with bilateral or lateral knee pain 2. History of major knee trauma or knee surgery 3. Diagnosis of rheumatoid arthritis 4. Hemophilia 5. Amyloidosis 6. Seronegative arthritis 7. Psoriasis or gout 8. MRI Exclusion criteria 8.1 Meniscal tears seen on classic protocols 8.2. Chondromalacia 8.3. SONK Lesions/insufficiency fractures 8.4. Stress fractures |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 28/02/2011 |
Locations
Countries of recruitment
- Greece
Study participating centre
56639
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2013 | 23/10/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/10/2020: added pub.
