Knee Osteoarthritis Clinical Trial
Official title:
Electro-acupuncture of Different Treatment Frequency in Knee Osteoarthritis: a Pilot Randomized Clinical Trial
Knee osteoarthritis (KOA) is one of the most common musculoskeletal diseases in clinic. It usually occurs in middle-aged people, especially women. An estimated lifetime risk for KOA is approximately 40% in men and 47% in women. KOA is a chronic disease which can lead to obvious pain, joint stiffness, limitation of activity and even disability, with significant associated costs and effects on society, health systems, and individuals. The use of acupuncture as an approach for the management of chronic pain, is receiving increasing recognition from both the public and professionals. However, there are no universally accepted treatment frequency criteria in previous studies. The number of acupuncture treatments is no more than twice per week in most previous studies, while it is usually 3-5 sessions per week in clinical practice in China. The aim of this study is to compare the effects of different EA sessions (3 sessions per week versus once per week) in a pilot randomized controlled trial of KOA.
Patients will be randomly allocated to one of two groups. In the 24-session treatments group
(group A), patients will receive EA 3 sessions per week for 8 weeks. The EA stimulation
lasted for 30 minutes with a dilatational wave of 2/100 Hz and a current intensity depending
on the participant's comfort level (preferably with skin around the acupoints shivering
mildly without pain). It involves having needles inserted into acupoints which are stimulated
manually for 10 seconds to create "De Qi" sensation and paired alligator clips will be
attached to the needle holders at LR8-GB33 and two other customized acupoints. Disposable
needles (Huatuo) and the HANS-200A acupoint nerve stimulator (Nanjing Jisheng Medical Co.,
Ltd. production) will be used.
Patients in the 8-session treatments group (group B) will receive EA once per week for 8
weeks. Other interventions are the same as group A. Assessments will be conducted at baseline
and 4, 6, 8, 12 and 16 weeks after randomization.
It is expected that the interventions will alleviate the sufferings of the patient. The risks
of participation are minimal. Occasionally, acupuncture can make people feel nauseous or
experience a temporary increase in pain either during or after treatment. Rare side effects
during acupuncture treatment include fainting, infection and subcutaneous hematoma (pooling
of blood under the skin). Participants will be warned of these potential side-effects before
consenting to have acupuncture.
Patients will be allowed, or required, to back out of the trial based on the following:
1. A major protocol violation;
2. Development of a serious disease;
3. Adverse events related to electro-acupuncture;
4. Request to be back out of the trial. The purpose of the study is to accumulate clinical
data, obtain the outcome data of the intervention method and prove the feasibility of
the study protocol.
Sixty patients will be selected as the sample size according to clinical experience.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04651673 -
Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
|
||
Completed |
NCT05677399 -
Knee Osteoarthritis Treatment With Peloidotherapy and Aquatic Exercise.
|
N/A | |
Active, not recruiting |
NCT04043819 -
Evaluation of Safety and Exploratory Efficacy of an Autologous Adipose-derived Cell Therapy Product for Treatment of Single Knee Osteoarthritis
|
Phase 1 | |
Recruiting |
NCT06000410 -
A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
|
Phase 3 | |
Completed |
NCT05014542 -
Needling Techniques for Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05892133 -
Prehabilitation Effect on Function and Patient Satisfaction Following Total Knee Arthroplasty
|
N/A | |
Recruiting |
NCT05528965 -
Parallel Versus Perpendicular Technique for Genicular Radiofrequency
|
N/A | |
Active, not recruiting |
NCT03472300 -
Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
|
||
Active, not recruiting |
NCT02003976 -
A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone
|
N/A | |
Active, not recruiting |
NCT04017533 -
Stability of Uncemented Medially Stabilized TKA
|
N/A | |
Completed |
NCT04779164 -
The Relation Between Abdominal Obesity, Type 2 Diabetes Mellitus and Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT04006314 -
Platelet Rich Plasma and Neural Prolotherapy Injections in Treating Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05423587 -
Genicular Artery Embolisation for Knee Osteoarthritis II
|
N/A | |
Enrolling by invitation |
NCT04145401 -
Post Market Clinical Follow-Up Study- EVOLUTION® Revision CCK
|
||
Active, not recruiting |
NCT03781843 -
Effects of Genicular Nerve Block in Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05974501 -
Pre vs Post Block in Total Knee Arthroplasty (TKA)
|
Phase 4 | |
Completed |
NCT05324163 -
Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
|
Phase 3 | |
Completed |
NCT05529914 -
Effects of Myofascial Release and Neuromuscular Training for Pes Anserine Syndrome Associated With Knee Osteoarthritis
|
N/A | |
Recruiting |
NCT05693493 -
Can Proprioceptive Knee Brace Improve Functional Outcome Following TKA?
|
N/A | |
Not yet recruiting |
NCT05510648 -
Evaluation of the Effect of High-intensity Laser Therapy in Knee Osteoarthritis
|
N/A |