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Stimulate Brain and Reduce Knee Pain Due to Degeneration

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Conventional Physiotherapy
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 Knee Osteoarthritis focused on measuring Transcranial direct current stimulation, Pain, knee osteoarthritis, Exercise 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
  • Taking pain relief medications
  • Any metal implantation near site of stimulation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Transcranial direct current stimulation (tDCS) group

    Conventional Physiotherapy (CPT) group

    Arm Description

    Fourty patients with 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 KOA will be educated on how to do the set of exercises correctly at their home during the first session. Consisted of nine exercises including muscle strengthening and flexibility training.

    Outcomes

    Primary Outcome Measures

    Digitalized pain pressure algometer (ALGO-DS-01)
    Pain intensity will be measured using calibrated digitalized pain pressure algometer (ALGO-DS-01) in patients with KOA.

    Secondary Outcome Measures

    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)

    Full Information

    First Posted
    March 23, 2020
    Last Updated
    September 30, 2021
    Sponsor
    Maharishi Markendeswar University (Deemed to be University)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04320875
    Brief Title
    Stimulate Brain and Reduce Knee Pain Due to Degeneration
    Official Title
    Stimulate Brain to Reduce Pain Among Patients With Knee Osteoarthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    September 2023 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    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
    Osteoarthritis (OA) knee is chronic, slowly progressive, degenerative disease of joint which affects articular cartilage and accompanied by pain, swelling and loss of function . OA is often considered as the serious joint disease as it has negative impact on quality of life among elderly population, it is the major cause for the reduced mobility. At cental level, due to imbalance in endogenous pain modulation there is reduce capacity of brain to inhibit the pain. Therefore, dysregulation in the central modulation of pain further leads to maladaptive changes in the brain structure. Transcranial direct current stimulation is a non-invasive method to modulate the brain structure by using a week direct current applied through the scalp in painless way. Multi-session for prolonged time can induce neuroplastic changes in the brain. The aim of the study is to demonstrate the effectiveness of tDCS in reducing the pain among patients with chronic knee OA and to modulate the plastic changes in brain structure. A total of 80 patients with KOA will be recruited by the convenience sampling to participate in this two group pretest-posttest, double blinded randomized clinical study. After the demographics, recruited 80 patients with KOA will be randomly divided into two groups, transcranial direct current stimulation (tDCS) group and conventional physiotherapy (CPT) group with by block randomization. Patients with KOA in tDCS group will be provided with Active tDCS and conventional physiotherapy and CPT group will receive structured exercises protocol. Pre-post changes in the outcome measures will be documented at baseline and end of 8-week post intervention. Each session will last for approximately 30 minutes duration.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Osteoarthritis
    Keywords
    Transcranial direct current stimulation, Pain, knee osteoarthritis, Exercise 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
    Transcranial direct current stimulation (tDCS) group
    Arm Type
    Experimental
    Arm Description
    Fourty patients with 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 (CPT) group
    Arm Type
    Active Comparator
    Arm Description
    Individual with KOA will be educated on how to do the set of exercises correctly at their home during the first session. Consisted of nine exercises including muscle strengthening and flexibility training.
    Intervention Type
    Other
    Intervention Name(s)
    Transcranial direct current stimulation
    Other Intervention Name(s)
    tDCS
    Intervention Description
    Anode electrode -C3/C4 (International 10-20 electroencephalogram system), 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
    Other Intervention Name(s)
    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 (ALGO-DS-01)
    Description
    Pain intensity will be measured using calibrated digitalized pain pressure algometer (ALGO-DS-01) in patients with KOA.
    Time Frame
    Changes will be measured at baseline and end of 8 week intervention
    Secondary Outcome Measure Information:
    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 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 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 Taking pain relief medications Any metal implantation near site of stimulation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Asir J Samuel, Ph.D
    Phone
    8059930222
    Email
    asirjohnsamuel@mmumullana.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adarsh K Srivastav, MPT
    Phone
    8618889003
    Email
    adarsh.srivastav@mmumullana.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Asir J Samuel, Ph.D
    Organizational Affiliation
    Maharishi Markandeshwar Medical College and Hospital
    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
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    28566193
    Citation
    Ahn H, Woods AJ, Kunik ME, Bhattacharjee A, Chen Z, Choi E, Fillingim RB. Efficacy of transcranial direct current stimulation over primary motor cortex (anode) and contralateral supraorbital area (cathode) on clinical pain severity and mobility performance in persons with knee osteoarthritis: An experimenter- and participant-blinded, randomized, sham-controlled pilot clinical study. Brain Stimul. 2017 Sep-Oct;10(5):902-909. doi: 10.1016/j.brs.2017.05.007. Epub 2017 May 19.
    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
    PubMed Identifier
    22563589
    Citation
    Hochberg MC, Altman RD, April KT, Benkhalti M, Guyatt G, McGowan J, Towheed T, Welch V, Wells G, Tugwell P; American College of Rheumatology. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken). 2012 Apr;64(4):465-74. doi: 10.1002/acr.21596.
    Results Reference
    result
    PubMed Identifier
    24700605
    Citation
    Lluch E, Torres R, Nijs J, Van Oosterwijck J. Evidence for central sensitization in patients with osteoarthritis pain: a systematic literature review. Eur J Pain. 2014 Nov;18(10):1367-75. doi: 10.1002/j.1532-2149.2014.499.x. Epub 2014 Apr 3.
    Results Reference
    result

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    Stimulate Brain and Reduce Knee Pain Due to Degeneration

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