Effects of laser moxibustion on patients with knee osteoarthritis

Not Applicable

Completed

• Conditions: Knee osteoarthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN15030019
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine (China)

Brief Summary

2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31974753 results (added 28/01/2020) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31974753/ protocol (added 26/11/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37993959/ (added 08/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-16
• Study Completion: 2018-12-31
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 392

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified