Knee osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
Patients with knee osteoarthritis are randomly allocated into either verum or sham CO2 laser moxibustion groups. Patients receive verum or sham laser moxibustion treatment on Dubi (ST-35) and an Ashi
Sponsors
Shanghai University of Traditional Chinese Medicine (China)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with idiopathic knee OA according to the American Rheumatism Association (ARA) classification criteria as follows: knee pain with three of the following or knee joint osteophyte with one of the following conditions: 1.1. Age over 50 years 1.2. Morning stiffness within 30 minutes of waking 1.3. Crepitus 1.4. Bony tenderness 1.5. Bony enlargement 1.6. No palpable warmth 2. Kellgren-Lawrence grade = 1 (Kellgren Lawrence Grading Scale: Grade 1: doubtful narrowing of joint space and possible osteophytic lipping; Grade 2: definite osteophytes, definite narrowing of joint space, Grade 3: moderate multiple osteophytes, definite narrowing of joints space, some sclerosis and possible deformity of bone contour; Grade 4: large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone contour) 3. Moderate or greater clinically significant knee pain on most days during the past month. A minimum score of 40 of 100 on a visual analogue scale VAS at baseline is an inclusion requirement 4. Willingness to be randomly assigned, understanding and signing the informed consent
Exclusion criteria
Exclusion criteria: 1. Patients are screened by blood tests (rheumatoid factor (RF), erythrocyte sedimentation rate (ESR), etc) to rule out the possibilities of rheumatoid arthritis 2. Patients with fibromyalgia syndrome, and chronic fatigue syndrome, and ankylosing spondylitis are excluded to rule out their impact on outcome assessment 3. Use of steroid medication in the past 3 months 4. Acupuncture or moxibustion treatment received in the previous 3 months 5. Intra-articular hyaluronate injection during the past 6 months 6. Arthrocentesis or arthroscopy in the past 1 year 7. Previous history of knee/hip replacement surgery, and plan to have such surgery during the trial 8. Use of other external treatment like topical use of medication 9. Presence of serious medical conditions, including heart diseases, pulmonary diseases, kidney diseases, liver diseases or malignant tumors, systemic infection or contagious diseases and psychopathy 10. Use of trial drug in the past 30 days 11. Previous participation in other sham-controlled laser therapy 12. Recruited in other clinical trial simultaneously 13. Unable to fill measurement questionnaires
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee pain, measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain scores from baseline to 4 weeks. The most painful joint reported by participants at baseline is assessed during the whole study. Change of WOMAC pain is also assessed at week 2, 8, 12, and 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Knee function, measured using the WOMAC function scores at week 4. It is also assessed at week 2, 8, 12, and 24 2. Knee stiffness, measured using the WOMAC stiffness score, and WOMAC overall score at baseline, week 2, 4, 8, 12 and 24 3. Pain, measured using the visual analog scale (VAS) at baseline, week 2, 4, 8, 12 and 24 4. Health-related quality of life, measured using the Short Form 36 (SF-36) component scales at baseline, week 4, 12 and 24 5. Walking ability, measured using the 50-feet (i.e., 15.24 meters) walking time at baseline, week 4 and 12 6. Patients’ global assessment of OA, evaluated on a five point Likert scale at week 4 7. Guess of the group assignment to assess the masking effectiveness of the trial: 7.1. Guess from the treatment providers at week 4 7.2. Guess from the participants of their allocation at week 1 after the first treatment and at week 4 8. Assessment of safety: any adverse event, whether related to treatment or not, reported by the participants and practitioners at every visit. During the 20-week follow-up period (from week 5 to week 24), each participant is telephoned every week to follow any adverse event or side effect that occurs. Serious adverse effects are reported to DSMB and Medical Ethics Committee. The participants are asked to assess the safety of the treatment after 4 weeks’ treatment, in terms of four grades: safe, relatively safe, unsafe, and very unsafe 9. Participants' sensations, asked during the treatment at every visit 10. Usage of medication, measured using a Medication Usage Log to record their daily intake of pain medications prescribed on a symptom-contingent (i.e., as per necessary, prn) basis Exploratory outcome: Serum levels of IL-1ß, COX-2, COMP, TNF-a, IL-6, IL-17, IL-8, IL-4, IL-10 and IL-13 (considered as important cytokines involved in the progress of OA), measured using blood tests at baseline and week 4 | — |
Countries
China
Contacts
Public ContactKe Cheng
Outcome results
None listed