Clinical trial NCT04320914: High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteo Arthritis Knee
Keywords: Knee osteoarthritis
Incline walking
degeneration
Ultrasound
laser therapy
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
Collaborators: name: Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE)
First posted: 2020-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR were included in the study

Exclusion Criteria:

* 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

Primary outcomes:
measure: Digitalized pain pressure algometer (ALGO-DS-01)
timeFrame: Changes will be measured at baseline, end of 8-week post-intervention period
measure: Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)
timeFrame: Changes will be measured at baseline, end of 8-week post-intervention period
Secondary outcomes:
measure: 36-Item Short Form Health Survey (SF-36)
timeFrame: Changes will be measured at baseline, end of 8-week post-intervention period
Other outcomes:
Locations:
city: Solan
country: India
facility: Dr Vipin Saini
state: Himachal Pradesh
Study officials:
affiliation: Maharishi Markandeshwar Medical College and Hospital
name: Vipin Saini, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
name: Asir J Samuel
role: PRINCIPAL_INVESTIGATOR
affiliation: Maharishi Markandeshwar Medical College and Hospital
name: Adarsh K Srivastav, MPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Maharishi Markandeshwar Medical College and Hospital
name: Deeksha Sharma, MPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.