Osteo Arthritis KneeNCT04320914
High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis
A study testing High Intensity LASER Therapy and Ibuprofen gel phonophoresis in people with Osteo Arthritis Knee, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
Trial summary
A total of 80 patients with knee osteoarthritis (KOA) aged between fourty five and seventy years will be recruited by simple random sampling to participate in two group, randomized, double blind, controlled study. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- High Intensity LASER Therapy and Ibuprofen gel phonophoresis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 28 Sep 2020to 30 Jun 2023
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR were included in the study
Who cannot join
- Unwillingness to participate in the study
- Recent history (within the last 3 months) of physical therapy to the same joint
- Recent history (within the last 3 months) of intra-articular procedure (injection and/or lavage) to the knee
- History of knee surgery/fracture
- Acute synovitis/arthritis including the infectious conditions
- Presence of malignancy
- Pregnancy
- Taking pain relief medications
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Dr Vipin Saini
Solan, Himachal Pradesh, 173229
Vipin Saini
About this study
Official title: High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis Among People Living in Hilly Terrain: A Randomized, Double Blind, Controlled Study
A total of 80 patients with knee osteoarthritis (KOA) aged between fourty five and seventy years will be recruited by simple random sampling to participate in two group, randomized, double blind, controlled study. Recruited patients will be randomly divided in to two groups high intensity-laser therapy (HILT) group and ibuprofen gel phonophoresis (IGP) group. Duration of the treatment will be 8 minutes in one session/knee joint for each day for 3 days/week for 8 weeks.The pain and quality of life will be assessed at the baseline and at the end of 8-week post-intervention period.
- Conditions
- Osteo Arthritis Knee
- Being tested
- High Intensity LASER Therapy, Ibuprofen gel phonophoresis
- Keywords
- Knee osteoarthritis, Incline walking, degeneration, Ultrasound, laser therapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity LASER TherapyOther
Also called HILT
The total energy will be delivered to the patient during one session will be 1,250 J through three phases of treatment.
- Initial phase (710 and 810 mJ/cm2 for a total of 500 J)
- Intermediate phase (handpiece will be applied on the joint line just proximal to the medial and lateral tibial condyles with 25 J, a fluency of 610 mJ/cm2, and a time of 14 s for each point and a total of 250 J)
- Final phase (same as the initial phase (500 J) except that scanning will be slow manual scanning ) The application time for all three phases will be approximately 15 min with the total energy delivered to the patient during one session of 1,250 J Duration of the treatment will be 8 minutes in one session/knee joint for each day for 3 days/week for 8 weeks.
Ibuprofen gel phonophoresisOther
Also called IGP
Continuous ultrasound set at a frequency of 1 MHz and an intensity of 1 W/cm2 was applied on a circular basis. Each treatment session will last for 8 min with one session each day for 3 days/week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| High Intensity LASER Therapy group (HILT) | Experimental | Fourty patients with chronic KOA in HILT group will receive Class IV LASER therapy. A Class IV LASER emits power more than 500 mW . Receives: Other: High Intensity LASER Therapy |
| Ibuprofen gel phonophoresis (IGP) group | Active comparator | Patients with chronic KOA in IGP group will administered with continuous ultrasound set at a frequency of 1 MHz and an intensity of 1 W/cm2 was applied on a circular basis Receives: Other: Ibuprofen gel phonophoresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digitalized pain pressure algometer (ALGO-DS-01)
Sensor digital algometer is force gauge with computer size which is highly accurate. The ALGO-DS-01 is chosen for the assessment of pain, which is a reliable and valid tool
Measured: Changes will be measured at baseline, end of 8-week post-intervention period
Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)
The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) will be used to evaluate the disease-specific self-reported symptoms of OA. This form is comprised of 24 questions in three categories including pain (5 questions), stiffness (2 questions), and physical function (17 questions).
Measured: Changes will be measured at baseline, end of 8-week post-intervention period
Secondary outcomes (1)
36-Item Short Form Health Survey (SF-36)
The 36-Item Short Form Health Survey questionnaire (SF-36) is a very popular instrument for evaluating Health-Related Quality of Life (QoL). The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH).
Measured: Changes will be measured at baseline, end of 8-week post-intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start28 Sep 2020
- Primary completion21 May 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Collaborators
- Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE)
- Responsible party
- Principal investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Vipin Saini, Ph.D, Principal investigator, Maharishi Markandeshwar Medical College and HospitalAsir J Samuel, Principal investigator, Maharishi Markandeshwar Institute of physiotherapy and RehabilitationAdarsh K Srivastav, MPT, Principal investigator, Maharishi Markandeshwar Medical College and HospitalDeeksha Sharma, MPT, Principal investigator, Maharishi Markandeshwar Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320914
- Sponsor's protocol ID
- MMDU/IEC/140E
- Other IDs
- U1111-1237-6893
- Status last verified
- Sep 2022
- First submitted
- 23 Mar 2020
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Larkin KA, Martin JS, Zeanah EH, True JM, Braith RW, Borsa PA. Limb blood flow after class 4 laser therapy. J Athl Train. 2012 Mar-Apr;47(2):178-83. doi: 10.4085/1062-6050-47.2.178.
PubMed 22488283de Matos Brunelli Braghin R, Libardi EC, Junqueira C, Rodrigues NC, Nogueira-Barbosa MH, Renno ACM, Carvalho de Abreu DC. The effect of low-level laser therapy and physical exercise on pain, stiffness, function, and spatiotemporal gait variables in subjects with bilateral knee osteoarthritis: a blind randomized clinical trial. Disabil Rehabil. 2019 Dec;41(26):3165-3172. doi: 10.1080/09638288.2018.1493160. Epub 2018 Oct 16.
PubMed 30324827Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
PubMed 3741515Loyola-Sanchez A, Richardson J, Beattie KA, Otero-Fuentes C, Adachi JD, MacIntyre NJ. Effect of low-intensity pulsed ultrasound on the cartilage repair in people with mild to moderate knee osteoarthritis: a double-blinded, randomized, placebo-controlled pilot study. Arch Phys Med Rehabil. 2012 Jan;93(1):35-42. doi: 10.1016/j.apmr.2011.07.196.
PubMed 22200383Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004376. doi: 10.1002/14651858.CD004376.pub2.
PubMed 18843657Sharma D, Saini V, Srivastav AK, Samuel AJ. Comparative efficacy of high intensity laser therapy (Class IV) and ibuprofen gel phonophoresis in the treatment of knee osteoarthritis among people living in hilly terrain: A randomized controlled study. Lasers Med Sci. 2025 Oct 20;40(1):440. doi: 10.1007/s10103-025-04613-6.
PubMed 41114869
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis Among People Living in Hilly Terrain: A Randomized, Double Blind, Controlled Study
- ClinicalTrials.gov ID
- NCT04320914
- Acronym / sponsor ID
- MMDU/IEC/140E
- Conditions
- Osteo Arthritis Knee
- Keywords
- Knee osteoarthritis, Incline walking, degeneration, Ultrasound, laser therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Collaborators
- Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 21 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 25 Mar 2020 (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.
A total of 80 patients with knee osteoarthritis (KOA) aged between fourty five and seventy years will be recruited by simple random sampling to participate in two group, randomized, double blind, controlled study. Recruited patients will be randomly divided in to two groups high intensity-laser therapy (HILT) group and ibuprofen gel phonophoresis (IGP) group. Duration of the treatment will be 8 minutes in one session/knee joint for each day for 3 days/week for 8 weeks.The pain and quality of life will be assessed at the baseline and at the end of 8-week post-intervention period.
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 group (HILT) | Experimental | Other: High Intensity LASER TherapyFourty patients with chronic KOA in HILT group will receive Class IV LASER therapy. A Class IV LASER emits power more than 500 mW . |
| Ibuprofen gel phonophoresis (IGP) group | Active comparator | Other: Ibuprofen gel phonophoresisPatients with chronic KOA in IGP group will administered with continuous ultrasound set at a frequency of 1 MHz and an intensity of 1 W/cm2 was applied on a circular basis |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR were included in the study
Key exclusion criteria (8 listed)
- Unwillingness to participate in the study
- Recent history (within the last 3 months) of physical therapy to the same joint
- Recent history (within the last 3 months) of intra-articular procedure (injection and/or lavage) to the knee
- History of knee surgery/fracture
- Acute synovitis/arthritis including the infectious conditions
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 TherapyAlso: HILTThe total energy will be delivered to the patient during one session will be 1,250 J through three phases of treatment. 1. Initial phase (710 and 810 mJ/cm2 for a total of 500 J) 2. Intermediate phase (handpiece will be applied on the joint line just proximal to the medial and lateral tibial condyles with 25 J, a fluency of 610 mJ/cm2, and a time of 14 s for each point and a total of 250 J) 3. Final phase (same as the initial phase (500 J) except that scanning will be slow manual scanning ) The application time for all three phases will be approximately 15 min with the total energy delivered to the patient during one session of 1,250 J Duration of the treatment will be 8 minutes in one session/knee joint for each day for 3 days/week for 8 weeks. | Other | High Intensity LASER Therapy group (HILT) |
| Ibuprofen gel phonophoresisAlso: IGPContinuous ultrasound set at a frequency of 1 MHz and an intensity of 1 W/cm2 was applied on a circular basis. Each treatment session will last for 8 min with one session each day for 3 days/week for 8 weeks. | Other | Ibuprofen gel phonophoresis (IGP) group |
Primary outcome
Digitalized pain pressure algometer (ALGO-DS-01)
Time frame: Changes will be measured at baseline, end of 8-week post-intervention period
Sensor digital algometer is force gauge with computer size which is highly accurate. The ALGO-DS-01 is chosen for the assessment of pain, which is a reliable and valid tool
Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)
Time frame: Changes will be measured at baseline, end of 8-week post-intervention period
The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) will be used to evaluate the disease-specific self-reported symptoms of OA. This form is comprised of 24 questions in three categories including pain (5 questions), stiffness (2 questions), and physical function (17 questions).
1 secondary outcome
36-Item Short Form Health Survey (SF-36)
Time frame: Changes will be measured at baseline, end of 8-week post-intervention period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Results publication: PubMed 22488283Larkin KA, Martin JS, Zeanah EH, True JM, Braith RW, Borsa PA. Limb blood flow after class 4 laser therapy. J Athl Train. 2012 Mar-Apr;47(2):178-83. doi: 10.4085/1062-6050-47.2.178.
- Results publication: PubMed 30324827de Matos Brunelli Braghin R, Libardi EC, Junqueira C, Rodrigues NC, Nogueira-Barbosa MH, Renno ACM, Carvalho de Abreu DC. The effect of low-level laser therapy and physical exercise on pain, stiffness, function, and spatiotemporal gait variables in subjects with bilateral knee osteoarthritis: a blind randomized clinical trial. Disabil Rehabil. 2019 Dec;41(26):3165-3172. doi: 10.1080/09638288.2018.1493160. Epub 2018 Oct 16.
- Results publication: PubMed 3741515Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
- Results publication: PubMed 22200383Loyola-Sanchez A, Richardson J, Beattie KA, Otero-Fuentes C, Adachi JD, MacIntyre NJ. Effect of low-intensity pulsed ultrasound on the cartilage repair in people with mild to moderate knee osteoarthritis: a double-blinded, randomized, placebo-controlled pilot study. Arch Phys Med Rehabil. 2012 Jan;93(1):35-42. doi: 10.1016/j.apmr.2011.07.196.
- Results publication: PubMed 18843657Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004376. doi: 10.1002/14651858.CD004376.pub2.
- Derived from this study: PubMed 41114869Sharma D, Saini V, Srivastav AK, Samuel AJ. Comparative efficacy of high intensity laser therapy (Class IV) and ibuprofen gel phonophoresis in the treatment of knee osteoarthritis among people living in hilly terrain: A randomized controlled study. Lasers Med Sci. 2025 Oct 20;40(1):440. doi: 10.1007/s10103-025-04613-6.
- 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.
Vipin Saini, Ph.D principal investigator
Maharishi Markandeshwar Medical College and Hospital
Asir J Samuel principal investigator
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Adarsh K Srivastav, MPT principal investigator
Maharishi Markandeshwar Medical College and Hospital
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 and Ibuprofen gel phonophoresis in people with Osteo Arthritis Knee, run by Maharishi Markendeswar University (Deemed to be University) at 1 site in India.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 14 Sep 2022. 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 India. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vipin Saini, Ph.D (+919729430413, vipinsaini31@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digitalized pain pressure algometer (ALGO-DS-01) (time frame: Changes will be measured at baseline, end of 8-week post-intervention period). 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?
On the ClinicalTrials.gov record for NCT04320914, which also lists 6 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 14 Sep 2022.