Osteoarthritis, KneeNCT06549543
High-Intensity Laser Therapy: Effectiveness on Knee Osteoarthritis Patients
A study testing High Intensity Laser Therapy, Transcutaneous Electrical Nerve Stimulation and Hotpacks in people with Osteoarthritis, Knee, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective, randomized, double-blinded study is to investigate the additional benefits of high-intensity laser therapy (HILT) over conventional physiotherapy, related to pain and function, in patients with knee osteoarthritis (KOA). Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- High Intensity Laser Therapy, Transcutaneous Electrical Nerve Stimulation and Hotpacks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Feb 2024
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both sexes and age between 40 and 65;
- pain at least 3 months on single or both knees
- diagnosed as KOA with Kellgren Lawrence (KL) Grade 2 or 3 KOA on weight-bearing anteroposterior X-ray images
- normal serum acute phase reactants and uric acid levels
- had no major effusion in the joint.
Who cannot join
- therapeutic joint injection in the last 6 months
- physical therapy and/or HILT in the last 3 months
- any surgical invention for the knee joint
- malignancy in the last 5 years.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başkent University Faculty of Medicine
Yüreğir, Adana, 01060
About this study
Official title: Additional Effect of High-Intensity Laser Therapy Over Conventional Physiotherapy Related to Pain and Function in Patients With Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled, 12-Week Follow-up Study
The aim of this prospective, randomized, double-blinded study is to investigate the additional benefits of high-intensity laser therapy (HILT) over conventional physiotherapy, related to pain and function, in patients with knee osteoarthritis (KOA).
Read the detailed description
The study was performed in Baskent University Physical Therapy and Rehabilitation Unit. 43 patients of both sexes, who were diagnosed clinical and radiographic knee osteoarthritis, with Kellgren Lawrence Grade 2 and 3, were randomly assigned in two groups. Group 1 (n = 21) received TENS, HP, exercises (EX), and High-Intensity Laser Therapy (HILT; Nd:yag laser, 10W). Group 2 (n = 22) received the same interventions but placebo HILT. All interventions were applied for 10 sessions. The Visual Analog Scale (VAS), Western Ontario \& McMaster Universities Osteoarthritis Questionnaire (WOMAC), and Lequesne Algofunctional Index (LAI) were performed before, after, and at 12-week follow-up.
- Conditions
- Osteoarthritis, Knee
- Being tested
- High Intensity Laser Therapy, Transcutaneous Electrical Nerve Stimulation, Hotpacks, SHAM - High Intensity Laser Therapy
- Keywords
- high-intensity laser, rehabilitation, pain, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity Laser TherapyOther
HILT is applied per session, with a maximum of 10.0 W, a mean of 5.7 W, a dose of 99 J/cm², and a total energy flux of 2079 J were applied over 6 minutes and 5 seconds on a 21 cm² field on the medial aspect of the knee joint.
Transcutaneous Electrical Nerve StimulationOther
TENS is an analgesic modality of physical therapy
HotpacksOther
Hotpacks is a thermoanalgesia modality of physical therapy
SHAM - High Intensity Laser TherapyOther
for control group, sham HILT was applied, with lights on but no laser beam
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Laser Therapy | Experimental | This group (n = 21) received transcutaneous electrical nerve stimulation (TENS), hotpack (HP), exercises, and high-intensity laser therapy (HILT) for 10 consecutive sessions. Receives: Other: High Intensity Laser Therapy; Other: Transcutaneous Electrical Nerve Stimulation; Other: Hotpacks |
| Control | Sham comparator | This group (n = 22) received TENS, HP, exercises, and placebo HILT for 10 consecutive sessions. Receives: Other: Transcutaneous Electrical Nerve Stimulation; Other: Hotpacks; Other: SHAM - High Intensity Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Visual Analog Scale (VAS)
The VAS was assessed before treatment, at the end of 10 sessions, and at the 12 week follow-up. Min score was 0 and max score was 100. Higher scores on the VAS indicate greater pain.
Measured: 12 weeks
Secondary outcomes (2)
Western Ontario & McMaster Universities Osteoarthritis Questionnaire (WOMAC)
The WOMAC was assessed before treatment, at the end of 10 sessions, and at the 12 week follow-up. Higher scores on the WOMAC indicate poorer functional capacity and greater pain and stiffness.
Measured: 12 weeks
Lequesne Algofunctional Index (LAI)
The LAI was assessed before treatment, at the end of 10 sessions, and at the 12 week follow-up. Higher scores on the LAI indicate poorer functional capacity and greater pain and stiffness.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Apr 2022
- Primary completion30 Nov 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- Model description
- patients were assigned into two groups. Both groups received conventional physiotherapy and exercise therapy. Group 1 was the experimental group, and group 2 was the control group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selen Özgözen, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549543
- Sponsor's protocol ID
- KA22/129
- Status last verified
- Aug 2024
- First submitted
- 2 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Akaltun MS, Altindag O, Turan N, Gursoy S, Gur A. Efficacy of high intensity laser therapy in knee osteoarthritis: a double-blind controlled randomized study. Clin Rheumatol. 2021 May;40(5):1989-1995. doi: 10.1007/s10067-020-05469-7. Epub 2020 Oct 19.
PubMed 33074393Ekici B, Ordahan B. Evaluation of the effect of high-intensity laser therapy (HILT) on function, muscle strength, range of motion, pain level, and femoral cartilage thickness in knee osteoarthritis: randomized controlled study. Lasers Med Sci. 2023 Sep 25;38(1):218. doi: 10.1007/s10103-023-03887-y.
PubMed 37743421Hardie EM, Carlson CS, Richardson DC. Effect of Nd:YAG laser energy on articular cartilage healing in the dog. Lasers Surg Med. 1989;9(6):595-601. doi: 10.1002/lsm.1900090610.
PubMed 2601554Ahmad MA, A Hamid MS, Yusof A. Effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis: a systematic review and meta-analysis. Physiotherapy. 2022 Mar;114:85-95. doi: 10.1016/j.physio.2021.03.011. Epub 2021 Mar 26.
PubMed 34654554
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effect of High-Intensity Laser Therapy Over Conventional Physiotherapy Related to Pain and Function in Patients With Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled, 12-Week Follow-up Study
- ClinicalTrials.gov ID
- NCT06549543
- Acronym / sponsor ID
- KA22/129
- Conditions
- Osteoarthritis, Knee
- Keywords
- high-intensity laser, rehabilitation, pain, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 12 Aug 2024 (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.
The aim of this prospective, randomized, double-blinded study is to investigate the additional benefits of high-intensity laser therapy (HILT) over conventional physiotherapy, related to pain and function, in patients with knee osteoarthritis (KOA).
Detailed description
The study was performed in Baskent University Physical Therapy and Rehabilitation Unit. 43 patients of both sexes, who were diagnosed clinical and radiographic knee osteoarthritis, with Kellgren Lawrence Grade 2 and 3, were randomly assigned in two groups. Group 1 (n = 21) received TENS, HP, exercises (EX), and High-Intensity Laser Therapy (HILT; Nd:yag laser, 10W). Group 2 (n = 22) received the same interventions but placebo HILT. All interventions were applied for 10 sessions. The Visual Analog Scale (VAS), Western Ontario \& McMaster Universities Osteoarthritis Questionnaire (WOMAC), and Lequesne Algofunctional Index (LAI) were performed before, after, and at 12-week follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- patients were assigned into two groups. Both groups received conventional physiotherapy and exercise therapy. Group 1 was the experimental group, and group 2 was the control group.
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser Therapy | Experimental | Other: High Intensity Laser Therapy, Other: Transcutaneous Electrical Nerve Stimulation, Other: HotpacksThis group (n = 21) received transcutaneous electrical nerve stimulation (TENS), hotpack (HP), exercises, and high-intensity laser therapy (HILT) for 10 consecutive sessions. |
| Control | Sham comparator | Other: Transcutaneous Electrical Nerve Stimulation, Other: Hotpacks, Other: SHAM - High Intensity Laser TherapyThis group (n = 22) received TENS, HP, exercises, and placebo HILT for 10 consecutive sessions. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- both sexes and age between 40 and 65;
- pain at least 3 months on single or both knees
- diagnosed as KOA with Kellgren Lawrence (KL) Grade 2 or 3 KOA on weight-bearing anteroposterior X-ray images
- normal serum acute phase reactants and uric acid levels
- had no major effusion in the joint.
Key exclusion criteria (4 listed)
- therapeutic joint injection in the last 6 months
- physical therapy and/or HILT in the last 3 months
- any surgical invention for the knee joint
- malignancy in the last 5 years.
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 TherapyHILT is applied per session, with a maximum of 10.0 W, a mean of 5.7 W, a dose of 99 J/cm², and a total energy flux of 2079 J were applied over 6 minutes and 5 seconds on a 21 cm² field on the medial aspect of the knee joint. | Other | High-Intensity Laser Therapy |
| Transcutaneous Electrical Nerve StimulationTENS is an analgesic modality of physical therapy | Other | Control, High-Intensity Laser Therapy |
| HotpacksHotpacks is a thermoanalgesia modality of physical therapy | Other | Control, High-Intensity Laser Therapy |
| SHAM - High Intensity Laser Therapyfor control group, sham HILT was applied, with lights on but no laser beam | Other | Control |
Primary outcome
The Visual Analog Scale (VAS)
Time frame: 12 weeks
The VAS was assessed before treatment, at the end of 10 sessions, and at the 12 week follow-up. Min score was 0 and max score was 100. Higher scores on the VAS indicate greater pain.
2 secondary outcomes
Western Ontario & McMaster Universities Osteoarthritis Questionnaire (WOMAC)
Time frame: 12 weeks
Lequesne Algofunctional Index (LAI)
Time frame: 12 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 13 Aug 2024.
- Background: PubMed 33074393Akaltun MS, Altindag O, Turan N, Gursoy S, Gur A. Efficacy of high intensity laser therapy in knee osteoarthritis: a double-blind controlled randomized study. Clin Rheumatol. 2021 May;40(5):1989-1995. doi: 10.1007/s10067-020-05469-7. Epub 2020 Oct 19.
- Background: PubMed 37743421Ekici B, Ordahan B. Evaluation of the effect of high-intensity laser therapy (HILT) on function, muscle strength, range of motion, pain level, and femoral cartilage thickness in knee osteoarthritis: randomized controlled study. Lasers Med Sci. 2023 Sep 25;38(1):218. doi: 10.1007/s10103-023-03887-y.
- Background: PubMed 2601554Hardie EM, Carlson CS, Richardson DC. Effect of Nd:YAG laser energy on articular cartilage healing in the dog. Lasers Surg Med. 1989;9(6):595-601. doi: 10.1002/lsm.1900090610.
- Background: PubMed 34654554Ahmad MA, A Hamid MS, Yusof A. Effects of low-level and high-intensity laser therapy as adjunctive to rehabilitation exercise on pain, stiffness and function in knee osteoarthritis: a systematic review and meta-analysis. Physiotherapy. 2022 Mar;114:85-95. doi: 10.1016/j.physio.2021.03.011. Epub 2021 Mar 26.
- Individual participant dataSharing planned: No
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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 High Intensity Laser Therapy, Transcutaneous Electrical Nerve Stimulation and Hotpacks in people with Osteoarthritis, Knee, run by Baskent University at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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 13 Aug 2024. 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 Turkey (Türkiye). 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?
The Visual Analog Scale (VAS) (time frame: 12 weeks). 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 NCT06549543, which also lists 4 linked publications.
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 13 Aug 2024.