Low Level Laser Therapy in meniscal pathology
| ISRCTN | ISRCTN24203769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24203769 |
| Secondary identifying numbers | N/A |
- 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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
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
Dr Nikos Malliaropoulos
Scientific
Scientific
Thessaoliniki Sports Medicine Clinic
Asklipiou 17
Thessaloniki
56639
Greece
| contact@sportsmed.gr |
Study information
| Study design | Double blind randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 2. Participants were also asked to complete the Lysholm Knee Scoring System (LKS) [18], a knee specific questionnaire evaluating pain, function, and swelling of the knee at baseline and after therapy. Four weeks after LLLT the laser group reported an an increase (improvement) in Lysholm score of [82.5 ± 4.6; range, 77-94) |
| Secondary outcome measures | All the participants were also asked to complete: 1. The Lysholm Knee Scoring System 2. Quantify their pain using VAS at 6 months and after 1 year At 6 months only a small percentage of patient [2 of 32 patients (6.25%)] had reported a recurrence of the pain. After 1 year, 5 of 2 patients (15.6%) had reported a recurrence of the pain. |
| Overall study start date | 01/01/2009 |
| Completion date | 28/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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
Thessaoliniki Sports Medicine Clinic
Thessaloniki
56639
Greece
56639
Greece
Sponsor information
Thessaoliniki Sports Medicine Clinic (Greece)
Hospital/treatment centre
Hospital/treatment centre
Aasklipiou 17
Thessaloniki
54639
Greece
| Website | http://www.sportsmed.gr |
|---|
Funders
Funder type
Other
Investigator initiated and funded
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
23/10/2020: added pub.
