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

NCT07423182 | Active Not Recruiting

• 1 other identifier: UOL-IREB-25-12-0037-70137698
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Keywords

Carbon dioxide infrared laser moxibustion; Laser moxibustion; Exercise therapy; Physical therapy; Knee rehabilitation; Pain intensity; Numerical Pain Rating Scale; Western Ontario and McMaster Universities Osteoarthritis Index; Range of motion; Cartilage thickness; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Pain intensity measured by the Numerical Pain Rating Scale (0 to 10)

  Change in knee pain intensity measured using the 0 to 10 Numerical Pain Rating Scale (0 = no pain, 10 = worst possible pain).

  Baseline and Week 8

Secondary Outcomes (4)

• Knee range of motion in flexion and extension

  Baseline, Week 8, Month 3, and Month 6

• Articular cartilage thickness measured by magnetic resonance imaging (MRI)

  Baseline and Month 6

• Serum bone alkaline phosphatase (BAP)

  Baseline, Month 3, and Month 6

• Serum calcium concentration

  Baseline, Month 3, and Month 6

Study Arms (2)

Exercise Program Only (Control)

ACTIVE COMPARATOR

Participants receive a standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total). Each session lasts approximately 40 minutes and 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. Clinical outcomes are measured at baseline, at the end of the 8-week intervention period, and at follow-up visits at Month 3 and Month 6 according to the study protocol.

Other: Exercise Program for Knee Osteoarthritis; Device: CO2 Infrared Laser Moxibustion (CILM)

Exercise Program Plus Carbon Dioxide (CO2) Infrared Laser Moxibustion (CILM)

EXPERIMENTAL

Participants receive the same standardized knee osteoarthritis exercise program delivered over an 8-week intervention period, with three supervised sessions per week (24 sessions total; approximately 40 minutes per session), in combination with carbon dioxide (CO2) infrared laser moxibustion. Carbon dioxide (CO2) infrared laser moxibustion is administered using a 10.6 micrometer CO2 infrared laser device with an output power range of 160 to 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 treatment points including ST35 (Dubi), Ex-LE4 (Neixiyan), and Ashi (tender points), applied bilaterally, with each point treated for approximately 5 minutes per knee. The total irradiation time per session is approximately 30 minutes, with additional time allocated for positioning and safety checks, resulting in a total session duration of approximately 40 minute

Other: Exercise Program for Knee Osteoarthritis; Device: CO2 Infrared Laser Moxibustion (CILM)

Interventions

Exercise Program for Knee Osteoarthritis OTHER

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.

Exercise Program Only (Control); Exercise Program Plus Carbon Dioxide (CO2) Infrared Laser Moxibustion (CILM)

CO2 Infrared Laser Moxibustion (CILM) DEVICE

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.

Also known as: 10.6 μm Infrared Laser Moxibustion, 10.6 μm CO₂ Laser Moxibustion

Exercise Program Only (Control); Exercise Program Plus Carbon Dioxide (CO2) Infrared Laser Moxibustion (CILM)

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 55 to 65 years, male or female. Diagnosis of knee osteoarthritis with radiographic evidence (Kellgren-Lawrence grade 2 or higher).
• Knee osteoarthritis grade II or III according to the American Rheumatism Association (ARA) classification criteria.
• History of moderate to severe knee pain on most days during the past month. Able and willing to provide written informed consent and comply with study procedures.

You may not qualify if:

• Other diseases affecting the knee, such as rheumatoid arthritis, ankylosing spondylitis, fibromyalgia syndrome, or chronic fatigue syndrome.
• Use of steroid medication or acupuncture or moxibustion treatment within the previous 3 months.
• Intra-articular hyaluronate injection within the previous 6 months. Arthrocentesis or arthroscopy within the previous 1 year. Knee or hip replacement surgery, or planned joint replacement surgery during the trial period.
• Use of other external treatments during the trial (e.g., topical medication for knee pain).
• Body mass index (BMI) greater than 30 kg/m². Lower-limb fracture or injury affecting function. Neurological disorders or nerve root compression affecting the lower limb.

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

Rashid Latif Medical College, Lahore, Pakistan

Lahore, 54000, Pakistan

Location

Related Publications (1)

• Zhao L, Cheng K, Wu F, Du J, Chen Y, Tan MT, Lao L, Shen X. Effect of Laser Moxibustion for Knee Osteoarthritis: A Multisite, Double-blind Randomized Controlled Trial. J Rheumatol. 2021 Jun;48(6):924-932. doi: 10.3899/jrheum.200217. Epub 2020 Jul 1.

  PMID: 32611673 RESULT

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 Officials

• Ashfaq Ahmed

  University Institute of Physical Therapy Univesity of Lahore Pakistan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be blinded to group assignment throughout the study. Allocation will be concealed from the assessor responsible for baseline and follow-up measurements. Due to the nature of the intervention, the treating personnel delivering carbon dioxide (CO2) infrared laser moxibustion cannot be blinded. Data entry and statistical analysis will be performed using coded group labels to minimize bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-arm, parallel-group randomized controlled trial comparing a standardized exercise-only program versus the same exercise program combined with carbon dioxide (CO2) infrared laser moxibustion administered over an 8-week treatment period, with follow-up assessments conducted at Month 3 and Month 6.

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 20, 2026
• Study Start: October 26, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)