Osteo Arthritis KneeNCT05138471
Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis
A study testing transcranial direct current stimulation (tDCS), TENS and Exercise and General Education in people with Osteo Arthritis Knee and Chronic Pain, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Knee osteoarthritis has a very high prevalence in the population over 50 years of age. Patients with osteoarthritis often suffer from chronic pain that becomes disabling, affecting both quality of life and mental and physical health. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteo Arthritis Knee, Chronic Pain
- What is being tested?
- transcranial direct current stimulation (tDCS), TENS and Exercise and General Education
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteSpain
- Study dates
- 17 Nov 2021to 1 May 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over fifty years of age with a diagnosis of knee osteoarthritis by radiography.
- Chronic pain of more than six months, compliance with the diagnostic criteria for knee osteoarthritis according to the Osteoarthritis Research Society International (OARSI) guideline:
- Pain in Analog Visual Scale more than 4/10
- Matutinal less than 30 minutes
- Absence of hyperthermia upon palpation in the joint
- Alteration of the bone image
- Crepitus
Who cannot join
- Patients who can provide low-quality or biased information discriminated by the Mini-Mental State Examination (Score less than 24).
- Severe hearing, visual or sensory impairment or comorbidities that prevent the correct completion of the questionnaires and mobility activities.
- Patients who have undergone knee replacement surgery on the contralateral knee.
- Patients who have received intervention (infiltration, blockages, etc...) in the last 6 weeks.
- Pain due to tendinopathy, knee fracture, low back pain radiating to the knee, or fibromyalgia.
- Patients who decline to participate out of fear or denial of therapy.
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- Severe heart disease that prevent exercise.
- Body Mass Index above 45.
- Patients with neuropsychiatric disorders (schizophrenia, epilepsy or bipolar disorders) or taking medication for these conditions (antiepileptic drugs).
- Patients with metallic implants in the area (skull or knee).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis.
Knee osteoarthritis has a very high prevalence in the population over 50 years of age. Patients with osteoarthritis often suffer from chronic pain that becomes disabling, affecting both quality of life and mental and physical health. This pathology has also been linked to maladaptive plasticity in the brain, which can contribute to chronic pain. Therapies with neuromodulatory approaches, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (TENS), have been used therapeutically to counteract the maladaptive plasticity of the brain.
Transcranial therapy and TENS can be a possible effective treatment in the rehabilitation services of the health system for the improvement of chronic pain and quality of life in different pathologies, such as chronic low back pain, fibromyalgia or knee and hip osteoarthritis.
- Conditions
- Osteo Arthritis Knee, Chronic Pain
- Being tested
- transcranial direct current stimulation (tDCS), TENS, Exercise and General Education
- Keywords
- tDCS, transcranial direct current stimulation, knee osteoarthritis, TENS, chronic knee pain
- Medical subject headings
- Chronic Pain, Osteoarthritis, Knee
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
tDCS intervention will consist in placing two electrodes, the cathode on the supraorbital surface on the same side as the painful knee, and the anode on the parietal area, corresponding to the area of the primary motor cortex, on the opposite side. The intensity will be 2 milli amperes (mA) and stimulation will be 20 minutes. The placebo will generate an initial sensation, and then descend until the stimulation is turned off.
TENSDevice
TENS intervention will consist in placing two electrodes on the sides of the patella of the affected knee. The frequency will be 10Herzts and the intensity will remain at a sensitive threshold level, without reaching the motor. The placebo will generate a sensation of current to descend to the minimum value that the equipment allows. Stimulation will last for 20 minutes.
Exercise and General EducationBehavioural
The General Education Intervention consisting in an educational program will be applied to all groups using audiovisual material to increase the subject's knowledge about his/her pathology, about chronic pain and recommendations for supervised exercise based on the NEMEX protocol for osteoarthritis (Ageberg et al.)18: the participants will be taught analytical strengthening exercises (quadriceps and hamstrings) and neuromuscular functional exercises (getting up from the chair or going up a step), with their detailed dosage (2 to 3 series with 10 to 15 repetitions) and a home follow-up model where the participant must record compliance with exercise as well as pain during activity.
| Study group | Role | What they receive |
|---|---|---|
| tDCS Active vs TENS Active | Experimental | Not described Receives: Device: transcranial direct current stimulation (tDCS); Device: TENS; Behavioral: Exercise and General Education |
| tDCS Active vs TENS Placebo | Experimental | Not described Receives: Device: transcranial direct current stimulation (tDCS); Behavioral: Exercise and General Education |
| tDCS Placebo vs TENS Placebo | Placebo comparator | Not described Receives: Behavioral: Exercise and General Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Knee Pain
The Visual Analogic Scale will be used to assess the impact on chronic knee pain. The values range from 0 to 10 (0 = No pain, 10 = the worst pain).
Measured: Through study completion, an average of 1 year.
Secondary outcomes (9)
Function and Quality of Life
The Western Ontario and McMaster (WOMAC) scale will be used to assess pain, function, and quality of life in knee osteoarthritis and range from 0 to 96 (higher score, worst outcome).
Measured: Through study completion, an average of 1 year.
Force
Using a dynamometer for quadriceps muscle (measurement in Kg, higher score means better outcome).
Measured: Through study completion, an average of 1 year.
Balance
A short physical performance battery (SPPB) will be used to measure balance. SPPB ranges from 0 (worst) to 12 (best).
Measured: Through study completion, an average of 1 year.
Gait properties.
6 Minutes Walk Test (meters) measure exercise tolerance, less than 350 meters is high risk of death in some patients. More meters, more score.
Measured: Through study completion, an average of 1 year.
Coordination and Balance
Timed Up and Go Test (TUG), less than 10 seconds (low risk of falls) more than 20 seconds (high risk of falls).
Measured: Through study completion, an average of 1 year.
Uncertainly
Mishel's Uncertainly Scale (MUIS) range from 55 to 121 (more score, greater uncertainly, worst outcome).
Measured: Through study completion, an average of 1 year.
Catastrophizing
The Pain Catastrophizing Scale (PCS) range from 0 to 52 (more score, greater catastrophizing, worst outcome).
Measured: Through study completion, an average of 1 year.
Kinesiophobia
The Tampa Scale of Kinesiophobia (TSK) range from 11 to 44 (higher values are worst outcome).
Measured: Through study completion, an average of 1 year.
Central Sensitization
8Central Sensitization Inventory (CSI) range from 0 to 100 (higher values are worst outcome)
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start17 Nov 2021
- Primary completion1 Mar 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joaquina JM Montilla, PhD, PT, Study director, DirectorMariano MG Gacto, PhD, PT, Study director, Co-Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05138471
- Sponsor's protocol ID
- JOS-2021-01
- Status last verified
- Jan 2024
- First submitted
- 4 Oct 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addition of Transcranial Direct Current Stimulation and Transcutaneous Electrical Nerve Stimulation to an Education and Exercise Program in Subjects With Chronic Pain Due to Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT05138471
- Acronym / sponsor ID
- JOS-2021-01
- Conditions
- Osteo Arthritis Knee, Chronic Pain
- Keywords
- tDCS, transcranial direct current stimulation, knee osteoarthritis, TENS, chronic knee pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 1 Dec 2021 (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 has a very high prevalence in the population over 50 years of age. Patients with osteoarthritis often suffer from chronic pain that becomes disabling, affecting both quality of life and mental and physical health. This pathology has also been linked to maladaptive plasticity in the brain, which can contribute to chronic pain. Therapies with neuromodulatory approaches, such as transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (TENS), have been used therapeutically to counteract the maladaptive plasticity of the brain.
Transcranial therapy and TENS can be a possible effective treatment in the rehabilitation services of the health system for the improvement of chronic pain and quality of life in different pathologies, such as chronic low back pain, fibromyalgia or knee and hip osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS Active vs TENS Active | Experimental | Device: transcranial direct current stimulation (tDCS), Device: TENS, Behavioral: Exercise and General Education |
| tDCS Active vs TENS Placebo | Experimental | Device: transcranial direct current stimulation (tDCS), Behavioral: Exercise and General Education |
| tDCS Placebo vs TENS Placebo | Placebo comparator | Behavioral: Exercise and General Education |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults over fifty years of age with a diagnosis of knee osteoarthritis by radiography.
- Chronic pain of more than six months, compliance with the diagnostic criteria for knee osteoarthritis according to the Osteoarthritis Research Society International (OARSI) guideline:
- Pain in Analog Visual Scale more than 4/10
- Matutinal less than 30 minutes
- Absence of hyperthermia upon palpation in the joint
Key exclusion criteria (10 listed)
- Patients who can provide low-quality or biased information discriminated by the Mini-Mental State Examination (Score less than 24).
- Severe hearing, visual or sensory impairment or comorbidities that prevent the correct completion of the questionnaires and mobility activities.
- Patients who have undergone knee replacement surgery on the contralateral knee.
- Patients who have received intervention (infiltration, blockages, etc...) in the last 6 weeks.
- Pain due to tendinopathy, knee fracture, low back pain radiating to the knee, or fibromyalgia.
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)tDCS intervention will consist in placing two electrodes, the cathode on the supraorbital surface on the same side as the painful knee, and the anode on the parietal area, corresponding to the area of the primary motor cortex, on the opposite side. The intensity will be 2 milli amperes (mA) and stimulation will be 20 minutes. The placebo will generate an initial sensation, and then descend until the stimulation is turned off. | Device | tDCS Active vs TENS Active, tDCS Active vs TENS Placebo |
| TENSTENS intervention will consist in placing two electrodes on the sides of the patella of the affected knee. The frequency will be 10Herzts and the intensity will remain at a sensitive threshold level, without reaching the motor. The placebo will generate a sensation of current to descend to the minimum value that the equipment allows. Stimulation will last for 20 minutes. | Device | tDCS Active vs TENS Active |
| Exercise and General EducationThe General Education Intervention consisting in an educational program will be applied to all groups using audiovisual material to increase the subject's knowledge about his/her pathology, about chronic pain and recommendations for supervised exercise based on the NEMEX protocol for osteoarthritis (Ageberg et al.)18: the participants will be taught analytical strengthening exercises (quadriceps and hamstrings) and neuromuscular functional exercises (getting up from the chair or going up a step), with their detailed dosage (2 to 3 series with 10 to 15 repetitions) and a home follow-up model where the participant must record compliance with exercise as well as pain during activity. | Behavioural | tDCS Active vs TENS Active, tDCS Active vs TENS Placebo, tDCS Placebo vs TENS Placebo |
Primary outcome
Chronic Knee Pain
Time frame: Through study completion, an average of 1 year.
The Visual Analogic Scale will be used to assess the impact on chronic knee pain. The values range from 0 to 10 (0 = No pain, 10 = the worst pain).
9 secondary outcomes
Function and Quality of Life
Time frame: Through study completion, an average of 1 year.
Force
Time frame: Through study completion, an average of 1 year.
Balance
Time frame: Through study completion, an average of 1 year.
Gait properties.
Time frame: Through study completion, an average of 1 year.
Coordination and Balance
Time frame: Through study completion, an average of 1 year.
Uncertainly
Time frame: Through study completion, an average of 1 year.
Catastrophizing
Time frame: Through study completion, an average of 1 year.
Kinesiophobia
Time frame: Through study completion, an average of 1 year.
Central Sensitization
Time frame: Through study completion, an average of 1 year.
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 8 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Joaquina JM Montilla, PhD, PT study director
Director
Mariano MG Gacto, PhD, PT study director
Co-Director
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), TENS and Exercise and General Education in people with Osteo Arthritis Knee and Chronic Pain, run by Universidad de Murcia at 1 site in Spain.
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 10 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 8 May 2024. 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 Spain. 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?
Chronic Knee Pain (time frame: Through study completion, an average of 1 year.). 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 8 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.