Knee OsteoarthritisKOA-tDCSNCT07291791
tDCS for Pain Modulation in Knee Osteoarthritis
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Knee Osteoarthritis, run by Suez Canal University at 1 site in Egypt.
Trial summary
Knee osteoarthritis (KOA) is a common condition that causes long-lasting knee pain and difficulty with daily activities. Many patients have pain that is stronger than expected from joint changes because the nervous system becomes more sensitive to pain. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Dec 2025to 31 May 2026
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) clinical criteria.
- Adults of both sexes aged 35 years or older.
- Clinical knee pain persisting for at least 3 months.
- Average knee pain intensity ≥ 4/10 on the Numerical Rating Scale (NRS; 0-10) during the previous 24 hours, with one dominant affected knee.
- Central sensitization phenotype: impaired conditioned pain modulation (CPM), defined as no change or a reduction in pressure pain threshold (PPT) after the conditioning stimulus, corresponding to a PPT ratio ≥ 1 (pre-to-post stimulus).
- Prior pharmacological pain management with NSAIDs and/or SNRIs discontinued due to adverse effects, intolerance, or contraindications, and able to complete the required washout period (2 weeks for NSAIDs and 4 weeks for SNRIs) before baseline assessment.
- Able and willing to provide written informed consent and comply with study procedures.
Who cannot join
- Participants will be excluded if they have any condition that could affect cortical excitability, confound outcome measures, or interfere with tDCS safety, including:
- Other chronic pain conditions associated with central sensitization (e.g., fibromyalgia).
- Inflammatory arthropathies (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus).
- Neuropathic pain syndromes (e.g., lumbar or cervical radiculopathy).
- Any clinically significant or unstable systemic disease (cardiovascular, hepatic, renal, or metabolic disorders).
- Pregnancy or active malignancy.
Show all 12Show fewer
- Neurological or psychiatric disorders including epilepsy, history of syncope, traumatic brain injury with residual deficit, or major depressive disorder.
- Current participation in physiotherapy, electrotherapy, or exercise rehabilitation programs.
- Metallic implants or implanted electrical devices (e.g., pacemakers, cochlear implants, deep brain stimulators).
- Cognitive impairment interfering with understanding instructions or providing informed consent.
- Dermatological contraindications at stimulation or testing sites (e.g., open wounds, infection, irritation).
- History of alcohol or substance abuse, or current use of centrally acting medications that alter cortical excitability (e.g., benzodiazepines).
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Suez Canal University Hospitals - Physical Medicine, Rheumatology and Rehabilitation Outpatient Clinics
Ismailia, 41522
About this study
Official title: Evaluation of the Neuromodulatory Effects of Transcranial Direct Current Stimulation on Pain in Knee Osteoarthritis Patients: A Double Blind Randomized Controlled Trial
Knee osteoarthritis (KOA) is a common condition that causes long-lasting knee pain and difficulty with daily activities. Many patients have pain that is stronger than expected from joint changes because the nervous system becomes more sensitive to pain. Transcranial direct current stimulation (tDCS) is a non-invasive technique that uses a small electrical current applied to the scalp to help reduce pain sensitivity.
This study will test whether active tDCS over the primary motor cortex can reduce pain and improve function in people with knee osteoarthritis. A total of 102 participants will be randomly assigned to receive either active tDCS or sham (placebo) stimulation. All participants will receive 15 sessions over three weeks. We will measure pain intensity, pain sensitivity, physical function, depression, cognition, and quality of life before the treatment, after the 3-week treatment program, and again at the 1-month follow-up.
Read the detailed description
Knee osteoarthritis (KOA) is a major cause of chronic pain, disability, and reduced quality of life. In many patients, the severity of pain exceeds structural joint damage due to peripheral and central sensitization, including impaired conditioned pain modulation (CPM). Such dysfunction in descending inhibitory pathways contributes to pain amplification and poor response to standard treatments. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulatory technique capable of modulating cortical excitability, enhancing descending inhibition, and potentially restoring altered pain processing mechanisms.
This randomized, assessor- and participant-blinded, sham-controlled clinical trial will investigate the neuromodulatory effects of anodal primary motor cortex (M1) tDCS in patients with KOA exhibiting impaired CPM. A total of 102 participants who meet eligibility criteria will be randomly assigned (1:1) to receive either active anodal M1-tDCS (2 mA, 20 minutes per session) or sham stimulation, using identical electrode placement and brief initial stimulation to maintain blinding. Both groups will receive 15 sessions administered over three consecutive weeks.
Assessments will be conducted at baseline, immediately after the intervention, and at 1-month follow-up. Primary outcomes include changes in pain intensity measured by the Visual Analogue Scale (VAS) and Brief Pain Inventory (BPI). Secondary outcomes include peripheral and central sensitization measures-Pressure Pain Threshold (PPT), Conditioned Pain Modulation (CPM), Central Sensitization Inventory (CSI), and PainDETECT-as well as functional outcomes assessed using the WOMAC index, Timed Up and Go (TUG) test, and One-Leg Stance. Additional outcomes include depressive symptoms (Beck Depression Inventory, BDI), cognitive function (Mini-Mental State Examination, MMSE), and health-related quality of life (SF-12).
This study aims to provide a comprehensive evaluation of the analgesic and neuromodulatory effects of tDCS in KOA, and to clarify its impact on pain modulation, pain sensitization, physical function, depression, cognition, and overall quality of life.
- Conditions
- Knee Osteoarthritis
- Being tested
- Transcranial Direct Current Stimulation (tDCS)
- Keywords
- Knee Pain, Osteoarthritis, tDCS, Neuromodulation, Central Sensitization
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current Stimulation (tDCS)Device
Also called tDCS
Transcranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation technique that applies low-intensity direct current to modulate cortical excitability. In this trial, stimulation is delivered over the primary motor cortex (M1) using saline-soaked sponge electrodes. For the active arm, anodal tDCS is applied at 2 mA for 20 minutes per session, for 15 sessions over three weeks. For the sham arm, the same electrode placement and device settings are used, but the current is ramped down after approximately 30 seconds to mimic the sensation of active stimulation without producing neuromodulatory effects.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Participants in this arm (active tDCS group) will receive active anodal transcranial direct current stimulation (tDCS) applied over the primary motor cortex (M1). Stimulation will be delivered at 2 mA for 20 minutes per session, for a total of 15 sessions (five sessions per week for three consecutive weeks). Electrode placement follows standardized M1 montage protocols. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
| Sham tDCS | Sham comparator | Participants in this arm (sham tDCS group) will receive sham tDCS using identical electrode placement and device settings as the active tDCS arm. The current will be applied for approximately 30 seconds and then gradually ramped down to zero to mimic the initial tingling sensation of active stimulation while delivering no effective stimulation. A total of 15 sessions will be administered over three weeks. Receives: Device: Transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity (VAS and BPI Scores)
Pain intensity will be assessed using the Visual Analogue Scale (VAS) and the Brief Pain Inventory (BPI). The primary outcome is the change in VAS and BPI pain scores from baseline to immediately post-intervention and one-month follow-up.
Measured: Baseline, immediately after the 15-session intervention, and at 1-month follow-up.
Secondary outcomes (9)
Change in Pressure Pain Threshold (PPT)
PPT will be assessed using a digital pressure algometer at two standardized locations on the affected side-the medial knee joint line and the ipsilateral lower leg-to evaluate peripheral sensitization, as well as at a remote site on the forearm to assess central sensitization. The primary outcome will be the change in mean PPT values across three time points: baseline, immediately post-intervention, and 1-month follow-up.
Measured: Baseline, immediately after completing the 15 treatment sessions, and at 1-month follow-up
Change in Central Sensitization using Central Sensitization Inventory (CSI) Score
Central sensitization symptoms will be assessed using the Central Sensitization Inventory (CSI). The outcome is the change in CSI total score (0-100) between baseline, post-intervention, and follow-up.
Measured: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in Conditioned Pain Modulation (CPM) Efficiency
CPM efficiency will be evaluated using the submaximal-effort tourniquet test. Pressure pain threshold (PPT) will be measured immediately before and after the conditioning stimulus. CPM efficiency will be calculated as the ratio of pre-conditioning PPT to post-conditioning PPT. A pre-to-post stimulus PPT ratio greater than or equal to 1 (indicating no change or a reduction in PPT after conditioning) will be classified as impaired CPM, reflecting deficient descending inhibitory pain modulation. The outcome is the change in CPM efficiency across baseline, post-intervention, and 1-month follow-up.
Measured: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in neuropathic-like pain features (PainDETECT Score)
Neuropathic-like pain features will be assessed using the PainDETECT questionnaire. The outcome is the change in PainDETECT total score across baseline, post-intervention, and follow-up.
Measured: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in physical function (WOMAC Score)
Pain, stiffness, and physical function will be evaluated using the WOMAC questionnaire. Higher WOMAC scores indicate greater physical dysfunction. The outcome is the change in WOMAC total and subscale scores from baseline to post-intervention and follow-up.
Measured: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in functional performance using Timed Up and Go (TUG) Performance and One-Leg Stance (OLS) Time.
Functional performance will be assessed using the Timed Up and Go (TUG) test for functional mobility and the One-Leg Stance (OLS) test for balance. The outcome is defined as the change in TUG completion time and the change in maximum OLS stance duration (in seconds) across baseline, post-intervention, and 1-month follow-up.
Measured: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in depressive symptoms using the Beck Depression Inventory (BDI) Score
Depressive symptoms will be assessed using the Beck Depression Inventory (BDI). The outcome is the change in total BDI score between baseline, post-intervention, and follow-up.
Measured: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in cognitive function using Mini-Mental State Examination (MMSE) Score
Cognitive function will be evaluated using the Mini-Mental State Examination (MMSE). The outcome is the change in MMSE score across baseline, post-intervention, and 1-month follow-up.
Measured: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in SF-12 Quality of Life Score
Health-related quality of life will be assessed using the SF-12 questionnaire. The outcome is the change in physical and mental component summary scores from baseline to post-intervention and 1-month follow-up.
Measured: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start20 Dec 2025
- Primary completion20 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Suez Canal UniversityThe sponsor's other registered studies.
- 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
- Model description
- Two parallel arms: active tDCS and sham tDCS.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nourhan E. Elkaraly, M.B.B.Ch.2015; MSc (PMRR)2020, Principal investigator, Suez Canal University, Faculty of MedicineAziza S. Omar, M.D., Study chair, Suez Canal University, Faculty of MedicineAhmed F. Genedy, M.D., Study chair, Faculty of Medicine, Armed Forces Military AcademySamah I. Nasef, M.D., Study chair, Suez Canal University, Faculty of MedicineMaha E. Ibrahim, M.D., Study chair, Suez Canal University, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291791
- Sponsor's protocol ID
- tDCS121225
- Acronym
- KOA-tDCS
- Status last verified
- Dec 2025
- First submitted
- 5 Dec 2025
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this is a single-center academic doctoral research project, and the ethical approval obtained does not permit public sharing of patient-level data. All collected data are confidential and will be used solely for the purposes of this study in accordance with institutional and national data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Neuromodulatory Effects of Transcranial Direct Current Stimulation on Pain in Knee Osteoarthritis Patients: A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07291791
- Acronym / sponsor ID
- KOA-tDCS / tDCS121225
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Pain, Osteoarthritis, tDCS, Neuromodulation, Central Sensitization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 18 Dec 2025 (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.
Knee osteoarthritis (KOA) is a common condition that causes long-lasting knee pain and difficulty with daily activities. Many patients have pain that is stronger than expected from joint changes because the nervous system becomes more sensitive to pain. Transcranial direct current stimulation (tDCS) is a non-invasive technique that uses a small electrical current applied to the scalp to help reduce pain sensitivity.
This study will test whether active tDCS over the primary motor cortex can reduce pain and improve function in people with knee osteoarthritis. A total of 102 participants will be randomly assigned to receive either active tDCS or sham (placebo) stimulation. All participants will receive 15 sessions over three weeks. We will measure pain intensity, pain sensitivity, physical function, depression, cognition, and quality of life before the treatment, after the 3-week treatment program, and again at the 1-month follow-up.
Detailed description
Knee osteoarthritis (KOA) is a major cause of chronic pain, disability, and reduced quality of life. In many patients, the severity of pain exceeds structural joint damage due to peripheral and central sensitization, including impaired conditioned pain modulation (CPM). Such dysfunction in descending inhibitory pathways contributes to pain amplification and poor response to standard treatments. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulatory technique capable of modulating cortical excitability, enhancing descending inhibition, and potentially restoring altered pain processing mechanisms.
This randomized, assessor- and participant-blinded, sham-controlled clinical trial will investigate the neuromodulatory effects of anodal primary motor cortex (M1) tDCS in patients with KOA exhibiting impaired CPM. A total of 102 participants who meet eligibility criteria will be randomly assigned (1:1) to receive either active anodal M1-tDCS (2 mA, 20 minutes per session) or sham stimulation, using identical electrode placement and brief initial stimulation to maintain blinding. Both groups will receive 15 sessions administered over three consecutive weeks.
Assessments will be conducted at baseline, immediately after the intervention, and at 1-month follow-up. Primary outcomes include changes in pain intensity measured by the Visual Analogue Scale (VAS) and Brief Pain Inventory (BPI). Secondary outcomes include peripheral and central sensitization measures-Pressure Pain Threshold (PPT), Conditioned Pain Modulation (CPM), Central Sensitization Inventory (CSI), and PainDETECT-as well as functional outcomes assessed using the WOMAC index, Timed Up and Go (TUG) test, and One-Leg Stance. Additional outcomes include depressive symptoms (Beck Depression Inventory, BDI), cognitive function (Mini-Mental State Examination, MMSE), and health-related quality of life (SF-12).
This study aims to provide a comprehensive evaluation of the analgesic and neuromodulatory effects of tDCS in KOA, and to clarify its impact on pain modulation, pain sensitization, physical function, depression, cognition, and overall quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms: active tDCS and sham tDCS.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: Transcranial Direct Current Stimulation (tDCS)Participants in this arm (active tDCS group) will receive active anodal transcranial direct current stimulation (tDCS) applied over the primary motor cortex (M1). Stimulation will be delivered at 2 mA for 20 minutes per session, for a total of 15 sessions (five sessions per week for three consecutive weeks). Electrode placement follows standardized M1 montage protocols. |
| Sham tDCS | Sham comparator | Device: Transcranial Direct Current Stimulation (tDCS)Participants in this arm (sham tDCS group) will receive sham tDCS using identical electrode placement and device settings as the active tDCS arm. The current will be applied for approximately 30 seconds and then gradually ramped down to zero to mimic the initial tingling sensation of active stimulation while delivering no effective stimulation. A total of 15 sessions will be administered over three weeks. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) clinical criteria.
- Adults of both sexes aged 35 years or older.
- Clinical knee pain persisting for at least 3 months.
- Average knee pain intensity ≥ 4/10 on the Numerical Rating Scale (NRS; 0-10) during the previous 24 hours, with one dominant affected knee.
- Central sensitization phenotype: impaired conditioned pain modulation (CPM), defined as no change or a reduction in pressure pain threshold (PPT) after the conditioning stimulus, corresponding to a PPT ratio ≥ 1 (pre-to-post stimulus).
Key exclusion criteria (12 listed)
- Participants will be excluded if they have any condition that could affect cortical excitability, confound outcome measures, or interfere with tDCS safety, including:
- Other chronic pain conditions associated with central sensitization (e.g., fibromyalgia).
- Inflammatory arthropathies (e.g., rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus).
- Neuropathic pain syndromes (e.g., lumbar or cervical radiculopathy).
- Any clinically significant or unstable systemic disease (cardiovascular, hepatic, renal, or metabolic disorders).
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 Stimulation (tDCS)Also: tDCSTranscranial Direct Current Stimulation (tDCS) is a non-invasive neuromodulation technique that applies low-intensity direct current to modulate cortical excitability. In this trial, stimulation is delivered over the primary motor cortex (M1) using saline-soaked sponge electrodes. For the active arm, anodal tDCS is applied at 2 mA for 20 minutes per session, for 15 sessions over three weeks. For the sham arm, the same electrode placement and device settings are used, but the current is ramped down after approximately 30 seconds to mimic the sensation of active stimulation without producing neuromodulatory effects. | Device | Active tDCS, Sham tDCS |
Primary outcome
Change in Pain Intensity (VAS and BPI Scores)
Time frame: Baseline, immediately after the 15-session intervention, and at 1-month follow-up.
Pain intensity will be assessed using the Visual Analogue Scale (VAS) and the Brief Pain Inventory (BPI). The primary outcome is the change in VAS and BPI pain scores from baseline to immediately post-intervention and one-month follow-up.
9 secondary outcomes
Change in Pressure Pain Threshold (PPT)
Time frame: Baseline, immediately after completing the 15 treatment sessions, and at 1-month follow-up
Change in Central Sensitization using Central Sensitization Inventory (CSI) Score
Time frame: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in Conditioned Pain Modulation (CPM) Efficiency
Time frame: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in neuropathic-like pain features (PainDETECT Score)
Time frame: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in physical function (WOMAC Score)
Time frame: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in functional performance using Timed Up and Go (TUG) Performance and One-Leg Stance (OLS) Time.
Time frame: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in depressive symptoms using the Beck Depression Inventory (BDI) Score
Time frame: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in cognitive function using Mini-Mental State Examination (MMSE) Score
Time frame: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Change in SF-12 Quality of Life Score
Time frame: Baseline, immediately after the 15-session intervention, and at 1-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this is a single-center academic doctoral research project, and the ethical approval obtained does not permit public sharing of patient-level data. All collected data are confidential and will be used solely for the purposes of this study in accordance with institutional and national data protection regulations.
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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.
Nourhan E. Elkaraly, M.B.B.Ch.2015; MSc (PMRR)2020 principal investigator
Suez Canal University, Faculty of Medicine
Aziza S. Omar, M.D. study chair
Suez Canal University, Faculty of Medicine
Ahmed F. Genedy, M.D. study chair
Faculty of Medicine, Armed Forces Military Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation (tDCS) in people with Knee Osteoarthritis, run by Suez Canal University at 1 site in Egypt.
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 7 inclusion and 12 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: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (VAS and BPI Scores) (time frame: Baseline, immediately after the 15-session intervention, and at 1-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2026.