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

Not Applicable

Recruiting

• Conditions: Osteo Arthritis Knee
• Interventions: Other: Ibuprofen gel phonophoresis; Other: High Intensity LASER Therapy

• Registration Number: NCT04320914
• Lead Sponsor: Maharishi Markendeswar University (Deemed to be University)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-23
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Study Start: 2020-09-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-14
• Primary Completion: 2023-05-21
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ibuprofen gel phonophoresis (IGP) group	Ibuprofen gel phonophoresis	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
High Intensity LASER Therapy group (HILT)	High Intensity LASER Therapy	Fourty patients with chronic KOA in HILT group will receive Class IV LASER therapy. A Class IV LASER emits power more than 500 mW .

Primary Outcome Measures

Name	Time	Method
Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)	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).
Digitalized pain pressure algometer (ALGO-DS-01)	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

Secondary Outcome Measures

Name	Time	Method
36-Item Short Form Health Survey (SF-36)	Changes will be measured at baseline, end of 8-week post-intervention period	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).

Trial Locations

Locations (1)

Dr Vipin Saini; 🇮🇳 Solan, Himachal Pradesh, India