Trials / Completed
CompletedNCT04889885
Short Term Efficacy of High-intensity Laser Therapy in Patients With Knee Osteoarthritis
Short Term Efficacy of High-intensity Laser Therapy to Alleviate Pain in Patients With Knee Osteoarthritis: a Double-blinded Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Mahidol University · Academic / Other
- Sex
- All
- Age
- 50 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Knee osteoarthritis (KOA) is one of the most common health problems around the world. According to this, several interventions have been used to treat this group of patients including pharmacological and non-pharmacological management such as weight reduction, behavior modification, and physical therapy. Recently, high-intensity laser therapy (HILT) has been used to treat patients with KOA. The results of previous studies showed that HILT could help to reduce pain as well as improved function in patients with mild to moderate KOA. However, there were still no standardized guidelines for HILT treatment in KOA. Also, no previous studies evaluated the efficacy of HILT in patients with severe KOA. The present study, therefore, recruited not only mild to a moderate degree but also severe degree. The study aim was to determine the efficacy of HILT in terms of pain relief in patients with mild, moderate, and severe KOA. The hypothesis was HILT would effectively reduce pain in patients with KOA compared to sham laser plus conservative treatment.
Detailed description
* This study is a double-blinded randomized control trial that compared the efficacy of HPLT to sham laser in patients with KOA. * 42 patients who had KOA diagnosed by the American college of rheumatology (ACR) 2016 guidelines were recruited including a drop out of 20%. * The participants were then randomly allocated into two groups (21 participants per group), mainly HILT and sham laser. Also, both groups received conservative treatment such as disease education, exercise, and advice for weight reduction. * The intervention group received HILT which was applied on the medial, lateral, and posterior part of the knee joint. The total energy was 562.5 J per session which was done 2-3 sessions a week, for a total of 10 sessions. * The control group received sham laser by the same device for 10 sessions plus conservative treatment as in the intervention group. * The outcome measures, VAS and T-WOMAC score were recorded before and at the end of the study. * Statistical analysis was performed using SPSS 18.0 version to evaluate the statistically significant change within the same group and the difference between groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | High-intensity laser therapy (HILT) | HILT was done by Multiwave Locked System (MLS) laser therapy combining 2 laser wavelengths (808 and 905 nm) in order to strengthen the effects of HILT. The laser was applied on medial, lateral and posterior parts around the knee joint. The total energy per session was 562.5 Joules (J) which was done 2-3 times a week for a total of 10 sessions. Additionally, the participants received conservative treatment for knee OA such as education about the disease, proper activities, and exercise. |
| DEVICE | Sham laser | The control group received a sham laser (2-3 times a week for a total of 10 sessions) plus conservative treatment as in the intervention group. The laser machine was the same as in the intervention group; however, the laser was applied without releasing laser energy to the knee joint. |
Timeline
- Start date
- 2016-06-01
- Primary completion
- 2016-08-31
- Completion
- 2016-08-31
- First posted
- 2021-05-17
- Last updated
- 2021-05-17
Source: ClinicalTrials.gov record NCT04889885. Inclusion in this directory is not an endorsement.