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Stimulate Brain and Reduce Knee Pain Due to Degeneration

Stimulate Brain to Reduce Pain Among Patients With Knee Osteoarthritis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04320875
Enrollment
80
Registered
2020-03-25
Start date
2022-10-31
Completion date
2024-03-31
Last updated
2021-10-01

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

Conditions

Knee Osteoarthritis

Keywords

Transcranial direct current stimulation, Pain, knee osteoarthritis, Exercise therapy

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.

Interventions

OTHERTranscranial direct current stimulation

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)

OTHERConventional Physiotherapy

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)

Sponsors

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 * Taking pain relief medications * Any metal implantation near site of stimulation

Design outcomes

Primary

MeasureTime frameDescription
Digitalized pain pressure algometer (ALGO-DS-01)Changes will be measured at baseline and end of 8 week interventionPain intensity will be measured using calibrated digitalized pain pressure algometer (ALGO-DS-01) in patients with KOA.

Secondary

MeasureTime frameDescription
Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)Changes will be measured at baseline and end of 8 week interventionThe 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)

Contacts

Primary ContactAsir J Samuel, Ph.D
asirjohnsamuel@mmumullana.org8059930222
Backup ContactAdarsh K Srivastav, MPT
adarsh.srivastav@mmumullana.org8618889003

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026