NCT07423182

Effects of Carbon Dioxide Infrared Laser Moxibustion on Pain and Function in Knee Osteoarthritis

Effects of Carbon Dioxide Infrared Laser Moxibustion in Patients With Knee Osteoarthritis: A Double-Blind Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University of Lahore · Academic / Other
• Sex: All
• Age: 55 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Knee osteoarthritis is a prevalent degenerative joint disorder characterized by chronic knee pain, stiffness, reduced range of motion, and limitations in daily functional activities. Exercise therapy is widely recommended as a first-line conservative approach to reduce symptoms and improve physical performance; however, a substantial proportion of patients continue to experience persistent pain and functional impairment despite adherence to exercise-based rehabilitation. Carbon dioxide (CO2) infrared laser moxibustion is a non-invasive far-infrared thermal stimulation modality intended to reproduce the localized heating effects of traditional moxibustion without smoke or odor. It is hypothesized to enhance local microcirculation, support tissue oxygenation, and modulate inflammatory activity, thereby contributing to symptom relief and improved joint function. This double-blind, parallel-group randomized controlled trial will evaluate whether adding carbon dioxide (CO2) infrared laser moxibustion to a standardized knee osteoarthritis exercise program provides greater improvement than exercise alone. Eligible participants with radiographic knee osteoarthritis will be randomly allocated to either (1) an exercise-only program or (2) the same exercise program plus carbon dioxide (CO2) infrared laser moxibustion delivered over an 8-week treatment phase (24 sessions). Outcomes will be measured at baseline and at follow-up visits at Month 3 and Month 6 to determine changes in pain intensity measured by the Numerical Pain Rating Scale (NPRS), knee range of motion measured by goniometry, articular cartilage thickness measured by magnetic resonance imaging (MRI), and biochemical markers including bone alkaline phosphatase (BAP) and serum calcium.

Detailed description

This study is a double-blind, parallel-group randomized controlled trial examining the effectiveness of carbon dioxide (CO2) infrared laser moxibustion as an adjunct to exercise therapy in individuals with knee osteoarthritis. Knee osteoarthritis is a multifactorial degenerative condition involving mechanical stress, low-grade inflammation, and progressive joint tissue changes that contribute to pain, restricted movement, and functional limitations. Exercise therapy represents a core component of conservative management; however, residual symptoms are frequently reported, supporting the evaluation of additional non-pharmacological approaches. Carbon dioxide (CO2) infrared laser moxibustion is a non-invasive modality that delivers far-infrared thermal stimulation to predefined knee-related treatment points, intended to reproduce the therapeutic effects of traditional moxibustion without smoke exposure. Proposed mechanisms include enhancement of local microcirculation, modulation of inflammatory activity, neuromodulatory analgesic effects, and potential support of local tissue metabolism. Participants with radiographic knee osteoarthritis will be allocated to either a standardized exercise program alone or the same exercise program combined with carbon dioxide (CO2) infrared laser moxibustion delivered during an 8-week treatment period. Participants will be assessed at baseline, at the end of the 8-week intervention period, and during follow-up visits at Month 3 and Month 6 to evaluate short-term and medium-term changes in pain and knee-related outcomes. The findings of this study will contribute to the evidence base for rehabilitation strategies in knee osteoarthritis and inform the potential role of carbon dioxide (CO2) infrared laser moxibustion as an adjunct conservative intervention.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
OTHER	Exercise Program for Knee Osteoarthritis	Participants receive a standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total), with each session lasting approximately 40 minutes. The program includes warm-up activities followed by progressive strengthening and mobility exercises targeting the knee and surrounding musculature, including step-ups, chair sit-to-stand exercises, quadriceps strengthening, isometric thigh activation, and balance or coordination exercises.
DEVICE	CO2 Infrared Laser Moxibustion (CILM)	CO₂ infrared laser moxibustion is administered using a 10.6 μm CO₂ infrared laser device with an output power range of 160-180 mW. The defocused probe is positioned approximately 2 cm from the skin, producing a light spot with a diameter of approximately 2 cm. Irradiation is applied to predefined knee-related points (ST35, Ex-LE4, and Ashi points) bilaterally, with each point treated for approximately 5 minutes per knee. The total irradiation time per session is approximately 30 minutes, including bilateral point application, with additional time allocated for positioning and safety checks, resulting in a total session duration of approximately 40 minutes. Treatment is delivered three sessions per week for eight weeks (24 sessions total) according to a standardized protocol.

Timeline

• Start date: 2025-10-26
• Primary completion: 2026-03-30
• Completion: 2026-07-30
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: Pakistan