Knee OsteoarthritisNCT04320875
Stimulate Brain and Reduce Knee Pain Due to Degeneration
A study testing Transcranial direct current stimulation and Conventional Physiotherapy in people with Knee Osteoarthritis, run by Maharishi Markendeswar University (Deemed to be University).
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Transcranial direct current stimulation and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR were included in the study
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Stimulate Brain to Reduce Pain Among Patients With Knee Osteoarthritis
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.
- Conditions
- Knee Osteoarthritis
- Being tested
- Transcranial direct current stimulation, Conventional Physiotherapy
- Keywords
- Transcranial direct current stimulation, Pain, knee osteoarthritis, Exercise therapy
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationOther
Also called tDCS
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)
Conventional PhysiotherapyOther
Also called CPT
- 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)
| Study group | Role | What they receive |
|---|---|---|
| Transcranial direct current stimulation (tDCS) group | Experimental | 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 Receives: Other: Transcranial direct current stimulation |
| Conventional Physiotherapy (CPT) group | Active comparator | 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. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Changes will be measured at baseline and end of 8 week intervention
Secondary outcomes (1)
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)
Measured: Changes will be measured at baseline and end of 8 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study startOct 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Asir J Samuel, Ph.D, Principal investigator, Maharishi Markandeshwar Medical College and HospitalAdarsh K Srivastav, MPT, Study director, Maharishi Markandeshwar Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320875
- Sponsor's protocol ID
- MMDU/IEC/108P
- Other IDs
- U1111-1249-2403
- Status last verified
- Sep 2021
- First submitted
- 23 Mar 2020
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28566193Srivastav 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.
PubMed 32147282Hochberg 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.
PubMed 22563589Lluch 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.
PubMed 24700605
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulate Brain to Reduce Pain Among Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04320875
- Acronym / sponsor ID
- MMDU/IEC/108P
- Conditions
- Knee Osteoarthritis
- Keywords
- Transcranial direct current stimulation, Pain, knee osteoarthritis, Exercise therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial direct current stimulation (tDCS) group | Experimental | Other: Transcranial direct current stimulationFourty 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 comparator | Other: Conventional PhysiotherapyIndividual 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. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with clinical knee OA according to the diagnostic criteria of ACR were included in the study
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial direct current stimulationAlso: tDCSAnode 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) | Other | Transcranial direct current stimulation (tDCS) group |
| Conventional PhysiotherapyAlso: CPT1. 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) | Other | Conventional Physiotherapy (CPT) group |
Primary outcome
Digitalized pain pressure algometer (ALGO-DS-01)
Time frame: Changes will be measured at baseline and end of 8 week intervention
Pain intensity will be measured using calibrated digitalized pain pressure algometer (ALGO-DS-01) in patients with KOA.
1 secondary outcome
Western Ontario and Mc Master Universities Osteoarthritis Index (WOMAC)
Time frame: Changes will be measured at baseline and end of 8 week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Results publication: PubMed 28566193Ahn 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 publication: PubMed 32147282Srivastav 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 publication: PubMed 22563589Hochberg 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 publication: PubMed 24700605Lluch 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.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asir J Samuel, Ph.D principal investigator
Maharishi Markandeshwar Medical College and Hospital
Adarsh K Srivastav, MPT study director
Maharishi Markandeshwar Medical College and Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation and Conventional Physiotherapy in people with Knee Osteoarthritis, run by Maharishi Markendeswar University (Deemed to be University).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asir J Samuel, Ph.D (8059930222, asirjohnsamuel@mmumullana.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digitalized pain pressure algometer (ALGO-DS-01) (time frame: Changes will be measured at baseline and end of 8 week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04320875, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.