Combined Effect of Laser Acupuncture and Electroacupuncture in Knee Osteoarthritis Patients

NCT04188925 | Completed

• 1 other identifier: 201901018A3C501
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: 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.

Conditions

Knee Osteoarthritis

Keywords

Electroacupuncture; Laser acupuncture; Low-level laser therapy; Photobiomodulation; Complementary medicine

Outcome Measures

Primary Outcomes (2)

• Change of Visual Analog Score

  Visual Analog Score for pain during activity; change from baseline at 4 weeks; scoring from 0 to 10, and the higher scores indicate the worse condition

  Through study completion, an average of 4 weeks

• Use of analgesics

  Frequency of analgesics

  Through study completion, an average of 4 weeks

Secondary Outcomes (6)

• Change of the score of Western Ontario and McMaster Universities Arthritis Index

  Through study completion, an average of 4 weeks

• Change of the percentage of Knee Injury and Osteoarthritis Outcome Score

  Through study completion, an average of 4 weeks

• Change of the muscle stiffness of quadriceps

  Through study completion, an average of 4 weeks

• Change of the angle of knee range of motion

  Through study completion, an average of 4 weeks

• Change of the minutes of standing on one foot test

  Through study completion, an average of 4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

True LA with EA

Device: Laser Acupuncture

Group B

SHAM COMPARATOR

Sham LA with EA

Device: Sham Laser Acupuncture

Interventions

Laser Acupuncture DEVICE

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 A

Sham Laser Acupuncture DEVICE

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.

Group B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• VAS more than 3 point when daily activity
• Kellgren-Lawrence Grading Scale grade 1 to 3 on knee X-ray
• Provided informed consent

You may not qualify if:

• History of knee arthroplasty, traumatic injury related joint deformity,
• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sham LA is using the same appearance of LaserPen without energy output to perform the same acupoint as above description
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 6, 2019
• Study Start: December 3, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 28, 2021

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)