Effects of Carbon Dioxide Infrared Laser Moxibustion on Pain and Function in Knee Osteoarthritis (NCT07423182) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of Carbon Dioxide Infrared Laser Moxibustion on Pain and Function in Knee Osteoarthritis
Pakistan68 participantsStarted 2025-10-26
Plain-language 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.
Who can participate
Age range
55 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
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.
Exclusion Criteria
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity measured by the Numerical Pain Rating Scale (0 to 10)