High Intensity Laser Therapy (Classes IV) and Ibuprofen Gel Phonophoresis for Treating Knee Osteoarthritis

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04320914
• Other study ID #: MMDU/IEC/140E
• Secondary ID: U1111-1237-6893
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: September 2022
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: Vipin Saini, Ph.D
• Phone: +919729430413
• Email: vipinsaini31[@]rediffmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• High Intensity LASER Therapy
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 phonophoresis
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.

Locations

Country	Name	City	State
India	Dr Vipin Saini	Solan	Himachal Pradesh

Sponsors (2)

Lead Sponsor	Collaborator
Maharishi Markendeswar University (Deemed to be University)	Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE)

Country where clinical trial is conducted

India, 

References & Publications (5)

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

Outcome

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