Short Term Efficacy of High-intensity Laser Therapy in Patients With Knee Osteoarthritis

NCT ID: NCT04889885

Last Updated: 2021-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-01
• Study Completion Date: 2016-08-31

Brief 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

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High-intensity laser therapy (HILT)

The participants in the intervention group were treated by HILT which was applied to the knee joint (2-3 sessions a week for a total of 10 sessions) plus conservative treatment.

Group Type: EXPERIMENTAL

High-intensity laser therapy (HILT)

Intervention Type: DEVICE

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.

Sham laser

The control group received a sham laser by the same laser machine (2-3 sessions a week for a total of 10 sessions) plus conservative treatment.

Group Type: SHAM_COMPARATOR

Sham laser

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

High-power laser therapy (HPLT)

Eligibility Criteria

Inclusion Criteria

• Patients with primary knee OA diagnosed based on the American college of rheumatology (ACR) guidelines for early diagnosis of knee osteoarthritis 2016.
• Patients who had knee pain for at least 6 months and had VAS score greater than 4 out of 10 points
• Patients with knee OA who have Kellgren And Lawrence (KL) classification stages 2-4.

Exclusion Criteria

• Patients who have secondary knee OA caused by other pathologies
• Patients who have a history of corticosteroid or hyaluronate injecting into the knee joint within the past 6 months
• Patients who were treated by physical therapy equipment within 1 month before the study
• History of stroke, bleeding disorders, cancer, deep vein thrombosis, cognitive impairment, or mental disorders
• Contraindicate to laser therapy

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Siriratna P, Ratanasutiranont C, Manissorn T, Santiniyom N, Chira-Adisai W. Short-Term Efficacy of High-Intensity Laser Therapy in Alleviating Pain in Patients with Knee Osteoarthritis: A Single-Blind Randomised Controlled Trial. Pain Res Manag. 2022 Oct 21;2022:1319165. doi: 10.1155/2022/1319165. eCollection 2022.

Reference Type: DERIVED

PMID: 36313402 (View on PubMed)

Other Identifiers

MURA2016/242

Identifier Type: -

Identifier Source: org_study_id