Stimulate Brain and Reduce Knee Pain Due to Degeneration
Stimulate Brain to Reduce Pain Among Patients With Knee Osteoarthritis
2 other identifiers
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Started Oct 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2020
CompletedFirst Posted
Study publicly available on registry
March 25, 2020
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedOctober 1, 2021
September 1, 2021
11 months
March 23, 2020
September 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Changes will be measured at baseline and end of 8 week intervention
Secondary Outcomes (1)
Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)
Changes will be measured at baseline and end of 8 week intervention
Study Arms (2)
Transcranial direct current stimulation (tDCS) group
EXPERIMENTALFourty 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
Conventional Physiotherapy (CPT) group
ACTIVE COMPARATORIndividual 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.
Interventions
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)
1. Warm-up exercises: Walking at the usual speed on a flat surface for 10 min ( 3sets X10 Reps X 3 min rest in between) 2. Hamstring and calf gentle stretches. ( 3sets X10 Reps X 3 min rest in between) 3. Straight leg raise (SLR) ( 3sets X10 Reps X 3 min rest in between) 4. Quadriceps setting ( 3sets X10 Reps X 3 min rest in between) 5. Pillow squeeze ( 3sets X10 Reps X 3 min rest in between) 6. Heel raise ( 3sets X10 Reps X 3 min rest in between) 7. One leg balance ( 3sets X10 Reps X 3 min rest in between) 8. Step ups ( 3sets X10 Reps X 3 min rest in between) 9. Quadriceps strengthening exercises ( 3sets X10 Reps X 3 min rest in between)
Eligibility Criteria
You may qualify if:
- Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR were included in the study
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (4)
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.
PMID: 28566193RESULTSrivastav 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.
PMID: 32147282RESULTHochberg 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.
PMID: 22563589RESULTLluch 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.
PMID: 24700605RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asir J Samuel, Ph.D
Maharishi Markandeshwar Medical College and Hospital
- STUDY DIRECTOR
Adarsh K Srivastav, MPT
Maharishi Markandeshwar Medical College and Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 23, 2020
First Posted
March 25, 2020
Study Start
October 1, 2022
Primary Completion
September 1, 2023
Study Completion
March 1, 2024
Last Updated
October 1, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share