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

NCT04889885 | Completed

• 1 other identifier: MURA2016/242
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Keywords

High-intensity, pain, knee osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  VAS is the standardized pain measurement which allows subjects to rate pain score by using the ruler scale. This pain scale starts from 0 which means no pain to 10 which means maximum pain.

  VAS was recorded in the two time points. The first time point was at the baseline or before starting the treatment. After that, VAS was recorded post-intervention (at 4 weeks from baseline) as the second time point.

Secondary Outcomes (1)

• Thai version of the Western Ontario and McMaster (WOMAC) Osteoarthritis Index for knee osteoarthritis (T-WOMAC)

  T-WOMAC was recorded in the two time points. First, T-WOMAC was recorded at the baseline and was then recorded post-intervention (at 4 weeks from baseline) as the second time point.

Study Arms (2)

High-intensity laser therapy (HILT)

EXPERIMENTAL

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.

Device: High-intensity laser therapy (HILT)

Sham laser

SHAM COMPARATOR

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.

Device: Sham laser

Interventions

High-intensity laser therapy (HILT) 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.

Also known as: High-power laser therapy (HPLT)

High-intensity laser therapy (HILT)

Sham laser 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.

Sham laser

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Related Publications (1)

• 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.

  PMID: 36313402 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 17, 2021
• Study Start: June 1, 2016
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: May 17, 2021

Record last verified: 2021-05