Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1237-6893 | Other Identifier | Universal Trial Number (UTN) by WHO ICTRP |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 . |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Intensity LASER Therapy | Other | The total energy will be delivered to the patient during one session will be 1,250 J through three phases of treatment.
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). | Changes will be measured at baseline, end of 8-week post-intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Changes will be measured at baseline, end of 8-week post-intervention period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vipin Saini, Ph.D | Contact | +919729430413 | vipinsaini31@rediffmail.com | |
| Asir J Samuel, Ph.D | Contact | +918059930222 | asirjohnsamuel@mmumullana.org |
| Name | Affiliation | Role |
|---|---|---|
| Vipin Saini, Ph.D | Maharishi Markandeshwar Medical College and Hospital | Principal Investigator |
| Asir J Samuel | Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Vipin Saini | Recruiting | Solan | Himachal Pradesh | 173229 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22488283 | Result | 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. | |
| 30324827 | Result | de 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Ibuprofen gel phonophoresis | Other | 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. |
|
|
| Adarsh K Srivastav, MPT | Maharishi Markandeshwar Medical College and Hospital | Principal Investigator |
| Deeksha Sharma, MPT | Maharishi Markandeshwar Medical College and Hospital | Principal Investigator |
| 3741515 | Result | Altman 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. |
| 22200383 | Result | Loyola-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. |
| 18843657 | Result | Fransen M, McConnell S. Exercise for osteoarthritis of the knee. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004376. doi: 10.1002/14651858.CD004376.pub2. |
| 41114869 | Derived | Sharma 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. |
| D012216 |
| Rheumatic Diseases |