Combined Effect of Laser Acupuncture and Electroacupuncture in Knee Osteoarthritis Patients
NCT ID: NCT04188925
Last Updated: 2021-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
50 participants
INTERVENTIONAL
2019-12-03
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Knee osteoarthritis (KOA) is a common degenerative joint disorder affected 250 million people globally. It can not only result in disability, but also associated with cardiovascular disease and mortality. The most common treatment for KOA is non-steroidal anti-inflammatory drug. However, the effect of analgesic is limited and may complicate with side effect. Hence, many patients search for complementary and alternative medicine. Acupuncture is one of the most popular complementary treatment with good analgesic effect and less side effect. Electroacupuncture (EA) or laser acupuncture (LA) was reported effective in pain control in knee osteoarthritis patients. However, there is no study about combination effect of EA and LA.
Methods:
This protocol is a randomized controlled trial investigating the combination effect of EA and LA on KOA. Fifty participants diagnosed KOA with aged more than 50 years old and knee pain more than 3 months were recruited and randomly assigned to the experimental group (EA plus LA) or sham group (EA plus LA without laser output) in clinical research center. The subjects will undergo EA plus LA treatment thrice a weeks for 4 weeks. The experimental group will receive acupuncture at GB33, GB34, SP9, SP10, and ST36 with transcutaneous electrical nerve stimulator on the GB34+33 and SP9+10., and the LA deliver 6 Joule of energy at EX-LE5, ST35, and BL40. The subjects in sham group will receive the same way but the LA is without any laser output. Outcome measurement will include visual analogue scale (VAS), Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and osteoarthritis outcome (KOOS), body composition analysis, knee range of motion test, muscle stiffness test, standing on one foot test, and the 30-second chair stand test before intervention and after 4 weeks intervention. The result will be analyze and compared between the experimental group and sham group using the paired t test and one-way analysis of variance.
Objectives:
The aim of this protocol is to investigate the combination effect of EA and LA in KOA patients.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Study of the Efficacy of Laser Acupuncture on Osteoarthritis Knees by Using Magnetic Resonance Imaging, Clinical Evaluation, and Movement Analysis
NCT04275427
Multi-center Clinical Research of Acupuncture Treatment of Knee Osteoarthritis
NCT02948218
The Effect of Laser Acupuncture Intervention to the Prognosis After TKR Surgery
NCT05263856
Low-level Laser Acupuncture Reduces Postoperative Pain and Morphine-related Side Effects in Patients With Total Knee Arthroplasty:
NCT03995446
Efficacy of Electro-acupuncture Versus Manual Acupuncture on Knee Osteoarthritis
NCT03274713
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
True LA with EA
Laser Acupuncture
The LA is using a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810nm; area of probe, 0.03cm2; power density, 5W/cm2; pulsed wave; RJ-Laser, Reimers \& Janssen GmbH, Waldkirch, Germany). The LA treatment will be applied to EX-LE5, ST35, and BL40 for 80 seconds, under power 150mW, to deliver a total treatment dose of 6 Joule/ cm2.
The EA is the combination of acupuncture and transcutaneous electrical nerve stimulator. The transcutaneous electrical nerve stimulator is produced by Ching Ming Medical Device Company. This machine is verified by Department of Health in Taiwan, with the ID number 001147. We perform acupuncture on GB33, GB34, SP9, SP10, and ST36.
Group B
Sham LA with EA
Sham Laser Acupuncture
Sham LA is using the same appearance of LaserPen without energy output to perform the same acupoint as above description. Both of the LaserPen in two groups are labeled with A and B, one of them is revised by the company to become the sham LA. The outward of both LaserPen are the same and our physician does not know which one is the real.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laser Acupuncture
The LA is using a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810nm; area of probe, 0.03cm2; power density, 5W/cm2; pulsed wave; RJ-Laser, Reimers \& Janssen GmbH, Waldkirch, Germany). The LA treatment will be applied to EX-LE5, ST35, and BL40 for 80 seconds, under power 150mW, to deliver a total treatment dose of 6 Joule/ cm2.
The EA is the combination of acupuncture and transcutaneous electrical nerve stimulator. The transcutaneous electrical nerve stimulator is produced by Ching Ming Medical Device Company. This machine is verified by Department of Health in Taiwan, with the ID number 001147. We perform acupuncture on GB33, GB34, SP9, SP10, and ST36.
Sham Laser Acupuncture
Sham LA is using the same appearance of LaserPen without energy output to perform the same acupoint as above description. Both of the LaserPen in two groups are labeled with A and B, one of them is revised by the company to become the sham LA. The outward of both LaserPen are the same and our physician does not know which one is the real.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Kellgren-Lawrence Grading Scale grade 1 to 3 on knee X-ray
* Provided informed consent
Exclusion Criteria
* Body mass index more than 35
* pacemaker insertion, photosensitivity
* who had undergone intra-articular injection or acupuncture in recent one month
* other factors that may affect the evaluation of the outcome, such as psychiatric disorder or moderate mental retardation etc.
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chang Gung Memorial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
201901018A3C501
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.