Knee OsteoarthritisNCT04188925
Combined Effect of Laser Acupuncture and Electroacupuncture in Knee Osteoarthritis Patients
A study testing Laser Acupuncture in people with Knee Osteoarthritis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Laser Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Dec 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- VAS more than 3 point when daily activity
- Kellgren-Lawrence Grading Scale grade 1 to 3 on knee X-ray
- Provided informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Effect of Laser Acupuncture and Electroacupuncture in Knee Osteoarthritis Patients: a Protocol for a Randomized Controlled Trial
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.
Read more
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
- Being tested
- Laser Acupuncture, Sham Laser Acupuncture
- Keywords
- Electroacupuncture, Laser acupuncture, Low-level laser therapy, Photobiomodulation, Complementary medicine
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser AcupunctureDevice
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 AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | True LA with EA Receives: Device: Laser Acupuncture |
| Group B | Sham comparator | Sham LA with EA Receives: Device: Sham Laser Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 4 weeks
Use of analgesics
Frequency of analgesics
Measured: Through study completion, an average of 4 weeks
Secondary outcomes (6)
Change of the score of Western Ontario and McMaster Universities Arthritis Index
Questionnaires for the function in patients with OA knee; change from baseline at 4 weeks; scoring from 0 to 68, and the higher scores indicate the worse condition
Measured: Through study completion, an average of 4 weeks
Change of the percentage of Knee Injury and Osteoarthritis Outcome Score
Questionnaires for the function in patients with OA knee; change from baseline at 4 weeks; scoring from 0 to 100 percentage, and the higher percentage indicates the better condition
Measured: Through study completion, an average of 4 weeks
Change of the muscle stiffness of quadriceps
The value is measured by Myoton Digital Palpation Device; change from baseline at 4 weeks
Measured: Through study completion, an average of 4 weeks
Change of the angle of knee range of motion
The range between flexion and extension of the knee; change from baseline at 4 weeks
Measured: Through study completion, an average of 4 weeks
Change of the minutes of standing on one foot test
The patient stands on one foot with hands on hips and eye opening. The time that the patient can stand on one foot was recorded; change from baseline at 4 weeks
Measured: Through study completion, an average of 4 weeks
Change of the times of 30-second chair stand test
The patient sits on the chair with bilateral feet stepping on the ground and hands cross beyond chest. Then he/she stands up and then sits down. The definition of once is completing one standing up and then sitting down. The number of times that the patient could stand up and then sit down within 30 seconds; change from baseline at 4 weeks.
Measured: Through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start3 Dec 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04188925
- Sponsor's protocol ID
- 201901018A3C501
- Status last verified
- Aug 2019
- First submitted
- 1 Dec 2019
- Last updated
- 28 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Effect of Laser Acupuncture and Electroacupuncture in Knee Osteoarthritis Patients: a Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04188925
- Acronym / sponsor ID
- 201901018A3C501
- Conditions
- Knee Osteoarthritis
- Keywords
- Electroacupuncture, Laser acupuncture, Low-level laser therapy, Photobiomodulation, Complementary medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Laser AcupunctureTrue LA with EA |
| Group B | Sham comparator | Device: Sham Laser AcupunctureSham LA with EA |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- VAS more than 3 point when daily activity
- Kellgren-Lawrence Grading Scale grade 1 to 3 on knee X-ray
- Provided informed consent
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser AcupunctureThe 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. | Device | Group A |
| Sham Laser AcupunctureSham 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. | Device | Group B |
Primary outcome
Change of Visual Analog Score
Time frame: Through study completion, an average of 4 weeks
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
Use of analgesics
Time frame: Through study completion, an average of 4 weeks
Frequency of analgesics
6 secondary outcomes
Change of the score of Western Ontario and McMaster Universities Arthritis Index
Time frame: Through study completion, an average of 4 weeks
Change of the percentage of Knee Injury and Osteoarthritis Outcome Score
Time frame: Through study completion, an average of 4 weeks
Change of the muscle stiffness of quadriceps
Time frame: Through study completion, an average of 4 weeks
Change of the angle of knee range of motion
Time frame: Through study completion, an average of 4 weeks
Change of the minutes of standing on one foot test
Time frame: Through study completion, an average of 4 weeks
Change of the times of 30-second chair stand test
Time frame: Through study completion, an average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Acupuncture in people with Knee Osteoarthritis, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Visual Analog Score (time frame: Through study completion, an average of 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.