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

Primary Purpose

Osteo Arthritis Knee

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
High Intensity LASER Therapy
Ibuprofen gel phonophoresis
Sponsored by
Maharishi Markendeswar University (Deemed to be University)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteo Arthritis Knee focused on measuring Knee osteoarthritis, Incline walking, degeneration, Ultrasound, laser therapy

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr Vipin SainiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High Intensity LASER Therapy group (HILT)

Ibuprofen gel phonophoresis (IGP) group

Arm Description

Fourty patients with chronic KOA in HILT group will receive Class IV LASER therapy. A Class IV LASER emits power more than 500 mW .

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

Outcomes

Primary Outcome Measures

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
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).

Secondary Outcome Measures

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).

Full Information

First Posted
March 23, 2020
Last Updated
September 13, 2022
Sponsor
Maharishi Markendeswar University (Deemed to be University)
Collaborators
Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE)
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1. Study Identification

Unique Protocol Identification Number
NCT04320914
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2020 (Actual)
Primary Completion Date
May 21, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maharishi Markendeswar University (Deemed to be University)
Collaborators
Himachal Pradesh Council for Science Technology and Environment (HIMCOSTE)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee
Keywords
Knee osteoarthritis, Incline walking, degeneration, Ultrasound, laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High Intensity LASER Therapy group (HILT)
Arm Type
Experimental
Arm Description
Fourty patients with chronic KOA in HILT group will receive Class IV LASER therapy. A Class IV LASER emits power more than 500 mW .
Arm Title
Ibuprofen gel phonophoresis (IGP) group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
High Intensity LASER Therapy
Other Intervention Name(s)
HILT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ibuprofen gel phonophoresis
Other Intervention Name(s)
IGP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Digitalized pain pressure algometer (ALGO-DS-01)
Description
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
Time Frame
Changes will be measured at baseline, end of 8-week post-intervention period
Title
Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)
Description
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).
Time Frame
Changes will be measured at baseline, end of 8-week post-intervention period
Secondary Outcome Measure Information:
Title
36-Item Short Form Health Survey (SF-36)
Description
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).
Time Frame
Changes will be measured at baseline, end of 8-week post-intervention period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vipin Saini, Ph.D
Phone
+919729430413
Email
vipinsaini31@rediffmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Asir J Samuel, Ph.D
Phone
+918059930222
Email
asirjohnsamuel@mmumullana.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vipin Saini, Ph.D
Organizational Affiliation
Maharishi Markandeshwar Medical College and Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asir J Samuel
Organizational Affiliation
Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adarsh K Srivastav, MPT
Organizational Affiliation
Maharishi Markandeshwar Medical College and Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deeksha Sharma, MPT
Organizational Affiliation
Maharishi Markandeshwar Medical College and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Vipin Saini
City
Solan
State/Province
Himachal Pradesh
ZIP/Postal Code
173229
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vipin Saini

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22488283
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.
Results Reference
result
PubMed Identifier
30324827
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.
Results Reference
result
PubMed Identifier
3741515
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.
Results Reference
result
PubMed Identifier
22200383
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.
Results Reference
result
PubMed Identifier
18843657
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.
Results Reference
result

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

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