Osteo Arthritis Knee Clinical Trial
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 30, 2023 |
Est. primary completion date | May 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
India | Dr Vipin Saini | Solan | Himachal Pradesh |
Lead Sponsor | Collaborator |
---|---|
Maharishi Markendeswar University (Deemed to be University) | Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE) |
India,
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 Th — View 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 subjec — View 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. Review. Update in: Cochrane Database Syst Rev. 2015;1:CD004376. — View 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. — View Citation
Loyola-Sánchez 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 p — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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 |
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