Knee OsteoarthritisNCT04889885
Short Term Efficacy of High-intensity Laser Therapy in Patients With Knee Osteoarthritis
A study testing High-intensity laser therapy (HILT) in people with Knee Osteoarthritis, run by Mahidol University.
Trial summary
Knee osteoarthritis (KOA) is one of the most common health problems around the world. According to this, several interventions have been used to treat this group of patients including pharmacological and non-pharmacological management such as weight reduction, behavior modification, and physical therapy. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- High-intensity laser therapy (HILT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 31 Aug 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary knee OA diagnosed based on the American college of rheumatology (ACR) guidelines for early diagnosis of knee osteoarthritis 2016.
- Patients who had knee pain for at least 6 months and had VAS score greater than 4 out of 10 points
- Patients with knee OA who have Kellgren And Lawrence (KL) classification stages 2-4.
Who cannot join
- Patients who have secondary knee OA caused by other pathologies
- Patients who have a history of corticosteroid or hyaluronate injecting into the knee joint within the past 6 months
- Patients who were treated by physical therapy equipment within 1 month before the study
- History of stroke, bleeding disorders, cancer, deep vein thrombosis, cognitive impairment, or mental disorders
- Contraindicate to laser therapy
About this study
Official title: Short Term Efficacy of High-intensity Laser Therapy to Alleviate Pain in Patients With Knee Osteoarthritis: a Double-blinded Randomized Controlled Trial
Knee osteoarthritis (KOA) is one of the most common health problems around the world. According to this, several interventions have been used to treat this group of patients including pharmacological and non-pharmacological management such as weight reduction, behavior modification, and physical therapy. Recently, high-intensity laser therapy (HILT) has been used to treat patients with KOA. The results of previous studies showed that HILT could help to reduce pain as well as improved function in patients with mild to moderate KOA. However, there were still no standardized guidelines for HILT treatment in KOA. Also, no previous studies evaluated the efficacy of HILT in patients with severe KOA. The present study, therefore, recruited not only mild to a moderate degree but also severe degree. The study aim was to determine the efficacy of HILT in terms of pain relief in patients with mild, moderate, and severe KOA. The hypothesis was HILT would effectively reduce pain in patients with KOA compared to sham laser plus conservative treatment.
Read the detailed description
- This study is a double-blinded randomized control trial that compared the efficacy of HPLT to sham laser in patients with KOA.
- 42 patients who had KOA diagnosed by the American college of rheumatology (ACR) 2016 guidelines were recruited including a drop out of 20%.
- The participants were then randomly allocated into two groups (21 participants per group), mainly HILT and sham laser. Also, both groups received conservative treatment such as disease education, exercise, and advice for weight reduction.
- The intervention group received HILT which was applied on the medial, lateral, and posterior part of the knee joint. The total energy was 562.5 J per session which was done 2-3 sessions a week, for a total of 10 sessions.
- The control group received sham laser by the same device for 10 sessions plus conservative treatment as in the intervention group.
- The outcome measures, VAS and T-WOMAC score were recorded before and at the end of the study.
- Statistical analysis was performed using SPSS 18.0 version to evaluate the statistically significant change within the same group and the difference between groups.
- Conditions
- Knee Osteoarthritis
- Being tested
- High-intensity laser therapy (HILT), Sham laser
- Keywords
- High-intensity, pain, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity laser therapy (HILT)Device
Also called High-power laser therapy (HPLT)
HILT was done by Multiwave Locked System (MLS) laser therapy combining 2 laser wavelengths (808 and 905 nm) in order to strengthen the effects of HILT. The laser was applied on medial, lateral and posterior parts around the knee joint. The total energy per session was 562.5 Joules (J) which was done 2-3 times a week for a total of 10 sessions.
Additionally, the participants received conservative treatment for knee OA such as education about the disease, proper activities, and exercise.
Sham laserDevice
The control group received a sham laser (2-3 times a week for a total of 10 sessions) plus conservative treatment as in the intervention group. The laser machine was the same as in the intervention group; however, the laser was applied without releasing laser energy to the knee joint.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity laser therapy (HILT) | Experimental | The participants in the intervention group were treated by HILT which was applied to the knee joint (2-3 sessions a week for a total of 10 sessions) plus conservative treatment. Receives: Device: High-intensity laser therapy (HILT) |
| Sham laser | Sham comparator | The control group received a sham laser by the same laser machine (2-3 sessions a week for a total of 10 sessions) plus conservative treatment. Receives: Device: Sham laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
VAS is the standardized pain measurement which allows subjects to rate pain score by using the ruler scale. This pain scale starts from 0 which means no pain to 10 which means maximum pain.
Measured: VAS was recorded in the two time points. The first time point was at the baseline or before starting the treatment. After that, VAS was recorded post-intervention (at 4 weeks from baseline) as the second time point.
Secondary outcomes (1)
Thai version of the Western Ontario and McMaster (WOMAC) Osteoarthritis Index for knee osteoarthritis (T-WOMAC)
WOMAC score is the questionnaire used to assess pain and function in patients with knee OA. This score consists of 3 subscale including pain, function and joint stiffness. The total scores of all subscales are 96 points in which the higher score reflects the more disabled of the patient. For Thai version of WOMAC, this score has been proven valid for using in patients with knee OA.
Measured: T-WOMAC was recorded in the two time points. First, T-WOMAC was recorded at the baseline and was then recorded post-intervention (at 4 weeks from baseline) as the second time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Jun 2016
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889885
- Sponsor's protocol ID
- MURA2016/242
- Status last verified
- May 2021
- First submitted
- 7 May 2021
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Siriratna P, Ratanasutiranont C, Manissorn T, Santiniyom N, Chira-Adisai W. Short-Term Efficacy of High-Intensity Laser Therapy in Alleviating Pain in Patients with Knee Osteoarthritis: A Single-Blind Randomised Controlled Trial. Pain Res Manag. 2022 Oct 21;2022:1319165. doi: 10.1155/2022/1319165. eCollection 2022.
PubMed 36313402
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Efficacy of High-intensity Laser Therapy to Alleviate Pain in Patients With Knee Osteoarthritis: a Double-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04889885
- Acronym / sponsor ID
- MURA2016/242
- Conditions
- Knee Osteoarthritis
- Keywords
- High-intensity, pain, knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 17 May 2021 (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.
Knee osteoarthritis (KOA) is one of the most common health problems around the world. According to this, several interventions have been used to treat this group of patients including pharmacological and non-pharmacological management such as weight reduction, behavior modification, and physical therapy. Recently, high-intensity laser therapy (HILT) has been used to treat patients with KOA. The results of previous studies showed that HILT could help to reduce pain as well as improved function in patients with mild to moderate KOA. However, there were still no standardized guidelines for HILT treatment in KOA. Also, no previous studies evaluated the efficacy of HILT in patients with severe KOA. The present study, therefore, recruited not only mild to a moderate degree but also severe degree. The study aim was to determine the efficacy of HILT in terms of pain relief in patients with mild, moderate, and severe KOA. The hypothesis was HILT would effectively reduce pain in patients with KOA compared to sham laser plus conservative treatment.
Detailed description
- This study is a double-blinded randomized control trial that compared the efficacy of HPLT to sham laser in patients with KOA.
- 42 patients who had KOA diagnosed by the American college of rheumatology (ACR) 2016 guidelines were recruited including a drop out of 20%.
- The participants were then randomly allocated into two groups (21 participants per group), mainly HILT and sham laser. Also, both groups received conservative treatment such as disease education, exercise, and advice for weight reduction.
- The intervention group received HILT which was applied on the medial, lateral, and posterior part of the knee joint. The total energy was 562.5 J per session which was done 2-3 sessions a week, for a total of 10 sessions.
- The control group received sham laser by the same device for 10 sessions plus conservative treatment as in the intervention group.
- The outcome measures, VAS and T-WOMAC score were recorded before and at the end of the study.
- Statistical analysis was performed using SPSS 18.0 version to evaluate the statistically significant change within the same group and the difference between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-intensity laser therapy (HILT) | Experimental | Device: High-intensity laser therapy (HILT)The participants in the intervention group were treated by HILT which was applied to the knee joint (2-3 sessions a week for a total of 10 sessions) plus conservative treatment. |
| Sham laser | Sham comparator | Device: Sham laserThe control group received a sham laser by the same laser machine (2-3 sessions a week for a total of 10 sessions) plus conservative treatment. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with primary knee OA diagnosed based on the American college of rheumatology (ACR) guidelines for early diagnosis of knee osteoarthritis 2016.
- Patients who had knee pain for at least 6 months and had VAS score greater than 4 out of 10 points
- Patients with knee OA who have Kellgren And Lawrence (KL) classification stages 2-4.
Key exclusion criteria (5 listed)
- Patients who have secondary knee OA caused by other pathologies
- Patients who have a history of corticosteroid or hyaluronate injecting into the knee joint within the past 6 months
- Patients who were treated by physical therapy equipment within 1 month before the study
- History of stroke, bleeding disorders, cancer, deep vein thrombosis, cognitive impairment, or mental disorders
- Contraindicate to laser therapy
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 |
|---|---|---|
| High-intensity laser therapy (HILT)Also: High-power laser therapy (HPLT)HILT was done by Multiwave Locked System (MLS) laser therapy combining 2 laser wavelengths (808 and 905 nm) in order to strengthen the effects of HILT. The laser was applied on medial, lateral and posterior parts around the knee joint. The total energy per session was 562.5 Joules (J) which was done 2-3 times a week for a total of 10 sessions. Additionally, the participants received conservative treatment for knee OA such as education about the disease, proper activities, and exercise. | Device | High-intensity laser therapy (HILT) |
| Sham laserThe control group received a sham laser (2-3 times a week for a total of 10 sessions) plus conservative treatment as in the intervention group. The laser machine was the same as in the intervention group; however, the laser was applied without releasing laser energy to the knee joint. | Device | Sham laser |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: VAS was recorded in the two time points. The first time point was at the baseline or before starting the treatment. After that, VAS was recorded post-intervention (at 4 weeks from baseline) as the second time point.
VAS is the standardized pain measurement which allows subjects to rate pain score by using the ruler scale. This pain scale starts from 0 which means no pain to 10 which means maximum pain.
1 secondary outcome
Thai version of the Western Ontario and McMaster (WOMAC) Osteoarthritis Index for knee osteoarthritis (T-WOMAC)
Time frame: T-WOMAC was recorded in the two time points. First, T-WOMAC was recorded at the baseline and was then recorded post-intervention (at 4 weeks from baseline) as the second time point.
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 17 May 2021.
- Derived from this study: PubMed 36313402Siriratna P, Ratanasutiranont C, Manissorn T, Santiniyom N, Chira-Adisai W. Short-Term Efficacy of High-Intensity Laser Therapy in Alleviating Pain in Patients with Knee Osteoarthritis: A Single-Blind Randomised Controlled Trial. Pain Res Manag. 2022 Oct 21;2022:1319165. doi: 10.1155/2022/1319165. eCollection 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity laser therapy (HILT) in people with Knee Osteoarthritis, run by Mahidol University.
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 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual Analogue Scale (VAS) (time frame: VAS was recorded in the two time points. The first time point was at the baseline or before starting the treatment. After that, VAS was recorded post-intervention (at 4 weeks from baseline) as the second time point.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889885, which also lists 1 linked publication.
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 17 May 2021.