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Reduce Pain and Improve Quality of Life in Patient With Knee Osteoarthritis by Light, Sound and Brain Stimulation

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High Intensity LASER Therapy (HILT)
Ibuprofen Gel Phonophoresis (IGP)
Transcranial Direct Current Stimulation (tDCS)
Conventional Physiotherapy (CPT)
Sponsored by
Asir John Samuel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, uphill, incline walking, degeneration, laser therapy, ultrasound, tDCS

Eligibility Criteria

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

Inclusion Criteria:

  • Patients diagnosed with clinical chronic knee OA according to the diagnostic criteria of American College of Rheumatology (ACR) were included in the study
  • Age between 45-70
  • Both sex male and female

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
  • Any metal implants near the site of stimulation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Arm Label

    High Intensity LASER Therapy group (HILT)

    Ibuprofen gel phonophoresis (IGP) group

    Transcranial direct current stimulation (tDCS) group

    Conventional physiotherapy group (CPT)

    Arm Description

    Forty patients with chronic KOA in HILT group will received Class IV LASER therapy. A Class IV LASER emits power more than 500 milliwatt (mW) .

    Patients with chronic KOA in ibuprofen gel phonophoresis (IGP) group will administered with continuous ultrasound set at a frequency of 1 megahertz (MHz) and an intensity of 1 W/cm2 was applied on a circular basis.

    Fourty patients with chronic KOA will receive structured tDCS (MA-tDCS, Walnut-Medical, Johnstown, PA) treatment. Two pair of sponge electrodes soaked with saline and fixed to head with elastic bands. The transcranial direct current stimulation will be applied by a constant current device with an intensity of 2mA

    Individual with chronic KOA will be educated on how to do the set of exercises correctly at their home during the first session. All the groups will receive the same, standardized exercise protocol for KOA which consisted of nine exercises including muscle strengthening and flexibility training.

    Outcomes

    Primary Outcome Measures

    Digitalized pain pressure algometer
    Pain intensity will be measured using calibrated digitalized pain pressure algometer (ALGO-DS-01) in patients with KOA. Sensor digital algometer is force gauge with computer size which is highly accurate. The ALGO-DS-01 is chosen for the assessment of pain for Mechanical sacroiliac joint dysfunction, which is a reliable and valid tool for assessing sacroiliac joint dysfunction. The inter rater reliability of pressure pain algometer was demonstrated to be moderate to good reliability with interclass correlation coefficient (ICC) of (0.62-0.84)
    Western Ontario and Mc Master Universities Osteoarthritis Index
    The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) will be was used to evaluate the disease-specific self-reported symptoms of OA.48 This form is comprised of 24 questions in three categories including pain (5 questions), stiffness (2 questions), and physical function (17 questions). These 24 items are presented in a five-point Likert (0-4) scale, where higher scores indicate the higher intensity of the related symptom. The minimal clinical important difference of WOMAC at 2 month of intervention is found to be, 14.1 The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

    Secondary Outcome Measures

    36-Item Short Form Health Survey
    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). There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). SF-36 is used to assess QoL in patient with KOA. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Full Information

    First Posted
    March 17, 2020
    Last Updated
    September 30, 2021
    Sponsor
    Asir John Samuel
    Collaborators
    Maharishi Markendeswar University (Deemed to be University)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04321655
    Brief Title
    Reduce Pain and Improve Quality of Life in Patient With Knee Osteoarthritis by Light, Sound and Brain Stimulation
    Official Title
    Reduce Pain and Improve Quality of Life in Patient With Knee Osteoarthritis by Light, Sound and Brain Stimulation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    October 31, 2022 (Anticipated)
    Study Completion Date
    August 2, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Asir John Samuel
    Collaborators
    Maharishi Markendeswar University (Deemed to be University)

    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
    Patients affected with osteoarthritis knee have associated with pain and inflammation of the joint capsule, impaired muscular stabilization, decrease range of motion and functional disability. Laser therapy, phonophoresis, transcranial direct current stimulation (tDCS) and conventional physiotherapy exercises has innumerable benefits to the patients with knee osteoarthritis (KOA).However, it is still not clear which treatment is effective among them in rehabilitating the patients with chronic knee osteoarthritis (KOA). Aim is to establish the benefits of High intensity Laser therapy, phonophoresis, tDCS and conventional physiotherapy in the treatment of patient with chronic KOA living in the hilly terrain. A total of 160 patients with chronic KOA will be recruited by the simple random sampling (random number generator) to participate in randomized, double blind randomized controlled, study. Recruited patients with chronic KOA will be randomly divided into four groups, high intensity-laser therapy (HILT) group, ibuprofen gel phonophoresis (IGP) group, transcranial direct current stimulation (tDCS) group and conventional physiotherapy (CPT) group. Duration of the treatment will be 8 minutes in one session/knee joint for HILT and IGP and 30 minutes in one session for tDCS each day for 3 days/week for 8 weeks. Thus, each patient with chronic KOA will receive 24 sessions in total. The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC), Digitalized pain pressure algometer (ALGO-DS-01) and 36-Item Short Form Health Survey (SF-36) questionnaire are the outcome measures will be recorded at baseline, 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
    Knee Osteoarthritis
    Keywords
    Knee osteoarthritis, uphill, incline walking, degeneration, laser therapy, ultrasound, tDCS

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    High Intensity LASER Therapy group (HILT)
    Arm Type
    Experimental
    Arm Description
    Forty patients with chronic KOA in HILT group will received Class IV LASER therapy. A Class IV LASER emits power more than 500 milliwatt (mW) .
    Arm Title
    Ibuprofen gel phonophoresis (IGP) group
    Arm Type
    Experimental
    Arm Description
    Patients with chronic KOA in ibuprofen gel phonophoresis (IGP) group will administered with continuous ultrasound set at a frequency of 1 megahertz (MHz) and an intensity of 1 W/cm2 was applied on a circular basis.
    Arm Title
    Transcranial direct current stimulation (tDCS) group
    Arm Type
    Experimental
    Arm Description
    Fourty patients with chronic KOA will receive structured tDCS (MA-tDCS, Walnut-Medical, Johnstown, PA) treatment. Two pair of sponge electrodes soaked with saline and fixed to head with elastic bands. The transcranial direct current stimulation will be applied by a constant current device with an intensity of 2mA
    Arm Title
    Conventional physiotherapy group (CPT)
    Arm Type
    Active Comparator
    Arm Description
    Individual with chronic KOA will be educated on how to do the set of exercises correctly at their home during the first session. All the groups will receive the same, standardized exercise protocol for KOA which consisted of nine exercises including muscle strengthening and flexibility training.
    Intervention Type
    Other
    Intervention Name(s)
    High Intensity LASER Therapy (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 (millijoule)/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
    Intervention Type
    Other
    Intervention Name(s)
    Ibuprofen Gel Phonophoresis (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. (8 min/ one session each day for 3 days/week for 8 weeks).
    Intervention Type
    Other
    Intervention Name(s)
    Transcranial Direct Current Stimulation (tDCS)
    Intervention Description
    Anode electrode -C3/C4 (contralateral side of the most affected knee), Cathode electrode- contralateral supraorbital area. (2 mA intensity for 20 minutes, one session/day for 3 days/week for 8 weeks)
    Intervention Type
    Other
    Intervention Name(s)
    Conventional Physiotherapy (CPT)
    Intervention Description
    Warm-up exercises: Walking at the usual speed on a flat surface for 10 min ( 3sets X10 Reps X 3 min rest in between) Hamstring and calf gentle stretches. ( 3sets X10 Reps X 3 min rest in between) Straight leg raise (SLR) ( 3sets X10 Reps X 3 min rest in between) Quadriceps setting ( 3sets X10 Reps X 3 min rest in between) Pillow squeeze ( 3sets X10 Reps X 3 min rest in between) Heel raise ( 3sets X10 Reps X 3 min rest in between) One leg balance ( 3sets X10 Reps X 3 min rest in between) Step ups ( 3sets X10 Reps X 3 min rest in between) Quadriceps strengthening exercises ( 3sets X10 Reps X 3 min rest in between)
    Primary Outcome Measure Information:
    Title
    Digitalized pain pressure algometer
    Description
    Pain intensity will be measured using calibrated digitalized pain pressure algometer (ALGO-DS-01) in patients with KOA. Sensor digital algometer is force gauge with computer size which is highly accurate. The ALGO-DS-01 is chosen for the assessment of pain for Mechanical sacroiliac joint dysfunction, which is a reliable and valid tool for assessing sacroiliac joint dysfunction. The inter rater reliability of pressure pain algometer was demonstrated to be moderate to good reliability with interclass correlation coefficient (ICC) of (0.62-0.84)
    Time Frame
    Changes will be measured at baseline and end of 8 week intervention
    Title
    Western Ontario and Mc Master Universities Osteoarthritis Index
    Description
    The Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC) will be was used to evaluate the disease-specific self-reported symptoms of OA.48 This form is comprised of 24 questions in three categories including pain (5 questions), stiffness (2 questions), and physical function (17 questions). These 24 items are presented in a five-point Likert (0-4) scale, where higher scores indicate the higher intensity of the related symptom. The minimal clinical important difference of WOMAC at 2 month of intervention is found to be, 14.1 The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68). Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
    Time Frame
    Changes will be measured at baseline and end of 8 week intervention
    Secondary Outcome Measure Information:
    Title
    36-Item Short Form Health Survey
    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). There are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). SF-36 is used to assess QoL in patient with KOA. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
    Time Frame
    Changes will be measured at baseline and end of 8 week intervention

    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 chronic knee OA according to the diagnostic criteria of American College of Rheumatology (ACR) were included in the study Age between 45-70 Both sex male and female 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 Any metal implants near the site of stimulation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vipin Saini, Ph.D
    Phone
    +918059930160
    Email
    vipinsaini31@rediffmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asir J Samuel, MPT, Ph.D
    Phone
    +918059930222
    Email
    asirjohnsamuel@mmumullana.org
    Overall Study Officials:
    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
    Asir J Samuel, MPT, Ph.D
    Organizational Affiliation
    Maharishi Markandeshwar Medical College and Hospital
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Vipin Saini, Ph.D
    Organizational Affiliation
    Maharishi Markandeshwar Medical College and Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28665989
    Citation
    Chang WJ, Bennell KL, Hodges PW, Hinman RS, Young CL, Buscemi V, Liston MB, Schabrun SM. Addition of transcranial direct current stimulation to quadriceps strengthening exercise in knee osteoarthritis: A pilot randomised controlled trial. PLoS One. 2017 Jun 30;12(6):e0180328. doi: 10.1371/journal.pone.0180328. eCollection 2017.
    Results Reference
    background
    PubMed Identifier
    22220431
    Citation
    Stiglic-Rogoznica N, Stamenkovic D, Frlan-Vrgoc L, Avancini-Dobrovic V, Vrbanic TS. Analgesic effect of high intensity laser therapy in knee osteoarthritis. Coll Antropol. 2011 Sep;35 Suppl 2:183-5.
    Results Reference
    result
    PubMed Identifier
    30003324
    Citation
    Coskun Benlidayi I, Gokcen N, Basaran S. Comparative short-term effectiveness of ibuprofen gel and cream phonophoresis in patients with knee osteoarthritis. Rheumatol Int. 2018 Oct;38(10):1927-1932. doi: 10.1007/s00296-018-4099-9. Epub 2018 Jul 12.
    Results Reference
    result
    PubMed Identifier
    32147282
    Citation
    Srivastav AK, Sharma N, Samuel AJ. tDCS combined with cognitive training in a patient with chronic traumatic head injury. Neurophysiol Clin. 2020 Apr;50(2):133-134. doi: 10.1016/j.neucli.2020.02.004. Epub 2020 Mar 5. No abstract available.
    Results Reference
    result

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    Reduce Pain and Improve Quality of Life in Patient With Knee Osteoarthritis by Light, Sound and Brain Stimulation

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