Knee Osteoarthritis
Conditions
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
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.
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.
Interventions
OTHERExercise 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.
DEVICECO2 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.
Sponsors
University of Lahore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measured by the Numerical Pain Rating Scale (0 to 10) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee range of motion in flexion and extension | Baseline, Week 8, Month 3, and Month 6 | Change in knee joint range of motion in degrees measured using a goniometer. |
| Articular cartilage thickness measured by magnetic resonance imaging (MRI) | Baseline and Month 6 | Change in knee articular cartilage thickness measured using magnetic resonance imaging. |
| Serum bone alkaline phosphatase (BAP) | Baseline, Month 3, and Month 6 | Change in serum bone alkaline phosphatase concentration measured from venous blood samples. |
| Serum calcium concentration | Baseline, Month 3, and Month 6 | Change in serum calcium concentration measured from venous blood samples. |
Countries
Pakistan
Contacts
STUDY_DIRECTORAshfaq Ahmed
University Institute of Physical Therapy Univesity of Lahore Pakistan
Outcome results
None listed