Different Kinds of Acupuncture Treatment for Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Knee Osteoarthritis
• Interventions: Other: treatment2; Other: treatment4; Other: treatment1; Other: treatment3; Other: treatment5; Drug: Celebrex

• Registration Number: NCT03563690
• Lead Sponsor: Zhejiang Chinese Medical University

Brief Summary

Knee osteoarthritis (KOA) a chronic disease with symptoms of persistent pain or rest pain , joint stiffness, numbness, limitation of activity and even disability, with significant associated costs and effects on individuals' life quality. Acupuncture as an approach for the management of chronic pain, is receiving increasing recognition from both the public and professionals. The aim of this study is to indicate the effects of three commonly used acupuncture treatments for KOA.

Detailed Description

360 subjects with KOA recruited from six centers will be randomized to six groups ,and receive four-week acupuncture, Electro-acupuncture, Moxibustion ,Warm-needling ,sham-needle, celebrex treatment. The primary outcomes are Visual Analogue Scale (VAS) and WOMAC function score.The Secondary outcomes are WOMAC pain score, WOMAC stiffness score,the Physical Activity Scale of the Elderly (PASE),knee joint swelling measurement and WHO-BREF life quality scale.The follow-up period is six months. This study will be a rigorous,randomized, sham and drug controlled trial focusing on using different kinds of acupuncture treatment for treating KOA.

Study Timeline

• Study First Submitted: 2018-05-17
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-20
• Study Start: 2018-07-03
• Primary Completion: 2021-10-28
• Study Completion: 2022-12-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-06
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. Meet the Clinical Classification Criteria for Osteoarthritis of the Knee, diagnosed by specialist.
2. Aged 40-75 years old;
3. History of chronic knee pain for more than 3 months, and complain of knee pain on most days of the past month;
4. Kellgren and Lawrence Grades 1-3;
5. With related knee pain in one or both knees rated > 4 cm on a 10 cm Visual Analog Scale(VAS) (VAS:0 to 10)
6. Who volunteer to participate and sign the consent form .

Exclusion Criteria

1. Knee osteoarthritis patients with gout, infection, tumor, autoimmune diseases, trauma or other causes of knee pain or knee deformities;
2. Patients who have local skin damage, poor skin conditions or coagulant dysfunction and patients who are not suitable for acupuncture;
3. Patients who are accompanied with serious medical problems or mental disorders, cognitive dysfunction，disorders of shallow sensation or who cannot cooperate with the treatment;
4. Patients who have received acupuncture or needle knife in the past month;
5. Other patients who are not suitable for acupuncture treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electro-acupuncture group	treatment2	When recruited from six centers,the participant will be randomized to six groups. In this group participant receive four-week electro-acupuncture treatment(three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Warm-needling group	treatment4	When recruited from six centers,the participant will be randomized to six groups. In this group participant receive four-week warm-needling treatment (three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Acupuncture group	treatment1	When recruited from six centers,the participant will be randomized to six groups .In acupuncture group participant will receive four-week acupuncture treatment(three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Moxibustion group	treatment3	When recruited from six centers,the participant will be randomized to six groups. In this group participant receive four-week moxibustion treatment (three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Sham-needle group	treatment5	When recruited from six centers,the participant will be randomized to six groups.In this group participant receive four-week sham acupuncture treatment (three times a week )continuously for 4 weeks,12 treatments in total. The follow-up period is six months.
Celebrex group	Celebrex	When recruited from six centers,the participant will be randomized to six groups . In this group participant will receive Celebrex (Celebrex, Capsules, Pfizer Pharmaceuticals Ltd)treatment, which will be applied 1 time daily(one time oral 0.2g) for 4 weeks. The follow-up period is six months.

Primary Outcome Measures

Name	Time	Method
Visual Analog Score change	baseline,2 weeks, 4 weeks ,3 months,6months	Intensity of pain range (lately 3 days' average): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain.
WOMAC function change	baseline,2 weeks,4 weeks ,3 months,6months	The WOMAC function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.

Secondary Outcome Measures

Name	Time	Method
PASE change	baseline,2 weeks,4 weeks ,3 months,6months	Physical Activity Scale for the Elderly was comprised of 36 questions regarding physical activity of elderly's house hold,leisure,work performance with different score weight.The higher scores indicating better physical activity.
WOMAC pain change	baseline,2 weeks,4weeks ,3 months,6months	The WOMAC pain subscale referred to the patient's pain. It was comprised of 5 items, with each item scored from 0 (minimum) to 4 (maximum), where 4 indicated worst pain condition. An overall score range of 0 (minimum) to 20 (maximum), with higher scores indicating worse physical function.
Quality of life change	baseline,2 weeks,4 weeks ,3 months,6months	WHO-BREF 36-Item Form assessing quality of life was comprised of 26 items which measured the following broad domains: physical health, psychological health, social relationships, and environment.With higher scores indicating better quality of life.
Expectancy questionnaires	baseline	Expectancy questionnaires were comprised of two brief items assessing the expectancy of the patients about acupuncture(or/and)moxibustion.
WOMAC stiffness change	baseline,2 weeks,4 weeks ,3 months,6months	The WOMAC stiffness subscale was comprised of 2 questions regarding the degree of stiffness experienced in the study knee. The WOMAC stiffness subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse stiffness. An overall score range of 0 (minimum) to 8 (maximum), with higher scores indicating more stiffness.
Knee swelling measurement change	baseline,2 weeks, 4 weeks ,3 months,6months	0-3 score indicating swelling and average Knee circumference of three times.

Trial Locations

Locations (1)

The third affiliated hospital of Zhejiang CMU; 🇨🇳 Hangzhou, Zhejiang, China