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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04320914
Enrollment
80
Registered
2020-03-25
Start date
2020-09-28
Completion date
2023-06-30
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteo Arthritis Knee

Keywords

Knee osteoarthritis, Incline walking, degeneration, Ultrasound, laser therapy

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.

Interventions

OTHERHigh 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. 1. Initial phase (710 and 810 mJ/cm2 for a total of 500 J) 2. 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) 3. 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.

OTHERIbuprofen 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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
45 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Digitalized pain pressure algometer (ALGO-DS-01)Changes will be measured at baseline, end of 8-week post-intervention periodSensor 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
Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)Changes will be measured at baseline, end of 8-week post-intervention periodThe 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).

Secondary

MeasureTime frameDescription
36-Item Short Form Health Survey (SF-36)Changes will be measured at baseline, end of 8-week post-intervention periodThe 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).

Countries

India

Contacts

Primary ContactVipin Saini, Ph.D
vipinsaini31@rediffmail.com+919729430413
Backup ContactAsir J Samuel, Ph.D
asirjohnsamuel@mmumullana.org+918059930222

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026