Effects of Carbon Dioxide Infrared Laser Moxibustion in Patients With Knee Osteoarthritis: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Pain intensity measured by the Numerical Pain Rating Scale (0 to 10)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Exercise Program Only (Control)
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.
干预措施: Exercise Program for Knee Osteoarthritis (Other)
Exercise Program Only (Control)
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.
干预措施: CO2 Infrared Laser Moxibustion (CILM) (Device)
Exercise Program Plus Carbon Dioxide (CO2) Infrared Laser Moxibustion (CILM)
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
干预措施: Exercise Program for Knee Osteoarthritis (Other)
Exercise Program Plus Carbon Dioxide (CO2) Infrared Laser Moxibustion (CILM)
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
干预措施: CO2 Infrared Laser Moxibustion (CILM) (Device)
结局指标
主要结局
Pain intensity measured by the Numerical Pain Rating Scale (0 to 10)
时间窗: Baseline and Week 8
Change in knee pain intensity measured using the 0 to 10 Numerical Pain Rating Scale (0 = no pain, 10 = worst possible pain).
次要结局
- 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)
研究者
Rehana Yasmeen Niazi
Principal Investigator
University of Lahore