Knee OsteoarthritisPhase 2NCT03076294
Repetitive Transcranial Magnetic Stimulation Associated With Manual Therapy in Knee Ostearthritis Pain
A Phase 2 study testing TMS and Manual therapy (MT) in people with Knee Osteoarthritis, run by Universidade Federal de Pernambuco at 2 sites in Brazil.
Trial summary
In this study, the investigators wondered whether the association between high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and manual therapy (peripheral and central approach) is more effective in reducing pain levels and modulation of cortical activity of chronic knee ostearthritis pain subjects… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- TMS and Manual therapy (MT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesBrazil
- Study dates
- Jan 2017to Mar 2019
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of knee OA;
- Absence of severe cognitive deficiency verified by the Mini Mental State Examination;
- Meet the American College of Rheumatology criteria for idiopathic knee osteoarthritis.
Who cannot join
- Individuals diagnosed with osteoporosis, fibromyalgia or other neurological disease;
- Had an opioid or corticosteroid injection in the last 30 days;
- Modified chronic pain medication in the last month before participating in the study;
- History of knee surgery in the last six months;
- Obese;
- Contraindications to the use of non-invasive brain stimulation, such as: metal implant on face or skull, history of seizure, cochlear implant.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-900
Déborah Marques, MSc, +55 81 997479444, deby.marques@gmail.com
Sérgio Rocha, MSc, +55 81 997708502, srocha3105@gmail.com
- Recruiting
Kinesiotherapy and manual therapeutic resources laboratory
Recife, Pernambuco, 50670-900
Maria das Graças Araújo, PhD, +55 81 999729856, mgrodriguesaraujo@hotmail.com
Maria das Graças Araújo, PhD
About this study
In this study, the investigators wondered whether the association between high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and manual therapy (peripheral and central approach) is more effective in reducing pain levels and modulation of cortical activity of chronic knee ostearthritis pain subjects than manual therapy alone (usual peripheral approach). For this purpose, patients included will be submitted to one session with active or sham hf-rTMS followed by a protocol of manual therapy. Besides that another active group will have the sequence of interventions exchanged (manual therapy followed by hf-rTMS) in order to investigate whether this may influence in the final outcomes.
- Conditions
- Knee Osteoarthritis
- Being tested
- TMS, Manual therapy (MT)
- Keywords
- knee ostearthritis, transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, chronic pain, musculoskeletal manipulations
- Medical subject headings
- Osteoarthritis, Knee, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
Also called non invasive brain stimulation, high frequency TMS
Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause minimal discomfort with a mild headache sensation, which usually disappears after a few seconds. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing pain control. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.
Manual therapy (MT)Other
Also called Musculoskeletal manipulation
This intervention uses manual contact for diagnosis and treatment, its practitioners use an enormous amount of manual techniques to preserve the homeostasis through the recovery of dysfunctions, which may cause limitations in the physiological movements, in the accessory movements of the joints (WHO , 2010).
| Study group | Role | What they receive |
|---|---|---|
| MT after rTMS group | Experimental | High frequency TMS will be applied with an eight-shaped coil angled at zero degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1). Twenty four stimulus trains will be provided at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 1200 pulses for approximately 12 minutes, with 90% of resting motor threshold (RMT). After TMS, patients will be submitted to 45 minutes of manual therapy protocol. Receives: Device: TMS; Other: Manual therapy (MT) |
| rTMS after MT group | Experimental | Patients will be submitted to 45 minutes of manual therapy protocol. After that, high frequency TMS will be applied with an eight-shaped coil angled at zero degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1). Twenty four stimulus trains will be provided at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 1200 pulses for approximately 12 minutes, with 90% of resting motor threshold (RMT). Receives: Device: TMS; Other: Manual therapy (MT) |
| Control group | Sham comparator | In this group, the order of interventions will be randomized. Therefore, the volunteer can start with manual therapy or sham TMS. In manual therapy, patients will be submitted to 45 minutes of a protocol. In addition, with regard to sham TMS, the same parameters will be used, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation. Receives: Device: TMS; Other: Manual therapy (MT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain will be evaluated by pressure algometry before and after the interventions. It's a evaluation technique which aims to quantify through physical stimulation (pressure in the nociceptors) the capacity of pain perception and toleration. It will be used with the patient lying in supine and will have the purpose of measure the pressure pain threshold (PPT) in eight points around patellar region. Besides that, two control points will be adopted, one in anterior tibial muscle (five centimeters distal of anterior tibial tuberosity) and another in the extensor carpi radialis longus muscle (five centimeters distal to lateral humerus epicondyle). After marking, the algometer will be setted up 90° in contact with the skin and will be applied a 0,3 kgf/cm²/s pressure until the patient report pain by pressing a pen (Model/Brand: Algomed/Medoc). The measure will be done twice in the demarcated points with a two minutes interval between them. Will be considered a mean of the obtained values.
Measured: Until one day (before and after the interventions)
Pain Rating Scale (NPRS)
Is it used to quantify pain level, where 0 means no pain and 10 means worst pain possible. NPRS is recommended as the main endpoint in chronic pain studies and it has been established that a decrease of at least 2 points or 30% represents a minimal clinically important difference. The MDCI consists of the smaller variation in a clinical outcome perceived by the patient and that results in a relevant change in his state of health.
Measured: Until 30 days (before, after the interventions and until the last day with the same value of the first evaluation)
Secondary outcomes (1)
Cortical excitability
The motor evoked potential (MEP) will be provided by twenty unconditioned stimuli (120% of motor resting threshould).
Measured: One day (before and after the interventions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2017
- Study startJan 2017
- Primary completionMar 2018 (estimated)
- Study completionMar 2019 (estimated)
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kátia Monte-Silva, Universidade Federal de Pernambuco
- Investigators
- Kátia Monte-Silva, PhD, Study director, Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03076294
- Sponsor's protocol ID
- OA_TMS_Pain
- Status last verified
- Mar 2017
- First submitted
- 6 Mar 2017
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation Associated With Manual Therapy in Knee Ostearthritis Pain
- ClinicalTrials.gov ID
- NCT03076294
- Acronym / sponsor ID
- OA_TMS_Pain
- Conditions
- Knee Osteoarthritis
- Keywords
- knee ostearthritis, transcranial magnetic stimulation, repetitive transcranial magnetic stimulation, chronic pain, musculoskeletal manipulations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 10 Mar 2017 (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.
In this study, the investigators wondered whether the association between high frequency repetitive transcranial magnetic stimulation (hf-rTMS) and manual therapy (peripheral and central approach) is more effective in reducing pain levels and modulation of cortical activity of chronic knee ostearthritis pain subjects than manual therapy alone (usual peripheral approach). For this purpose, patients included will be submitted to one session with active or sham hf-rTMS followed by a protocol of manual therapy. Besides that another active group will have the sequence of interventions exchanged (manual therapy followed by hf-rTMS) in order to investigate whether this may influence in the final outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MT after rTMS group | Experimental | Device: TMS, Other: Manual therapy (MT)High frequency TMS will be applied with an eight-shaped coil angled at zero degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1). Twenty four stimulus trains will be provided at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 1200 pulses for approximately 12 minutes, with 90% of resting motor threshold (RMT). After TMS, patients will be submitted to 45 minutes of manual therapy protocol. |
| rTMS after MT group | Experimental | Device: TMS, Other: Manual therapy (MT)Patients will be submitted to 45 minutes of manual therapy protocol. After that, high frequency TMS will be applied with an eight-shaped coil angled at zero degrees from the sagittal axis and positioned at the C3 or C4 in accordance with the international 10-20 marking system (JASPER, 1958), which corresponds to the right or left primary motor cortex (M1). Twenty four stimulus trains will be provided at 10 Hz for five seconds each. The interval between the trains will be 25 seconds, totaling 1200 pulses for approximately 12 minutes, with 90% of resting motor threshold (RMT). |
| Control group | Sham comparator | Device: TMS, Other: Manual therapy (MT)In this group, the order of interventions will be randomized. Therefore, the volunteer can start with manual therapy or sham TMS. In manual therapy, patients will be submitted to 45 minutes of a protocol. In addition, with regard to sham TMS, the same parameters will be used, however, it will be performed using two coils, one connected to the magnetic stimulator, away from the patient's scalp and another uncoupled from the stimulator and positioned in the same way as in real stimulation. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of knee OA;
- Absence of severe cognitive deficiency verified by the Mini Mental State Examination;
- Meet the American College of Rheumatology criteria for idiopathic knee osteoarthritis.
Key exclusion criteria (6 listed)
- Individuals diagnosed with osteoporosis, fibromyalgia or other neurological disease;
- Had an opioid or corticosteroid injection in the last 30 days;
- Modified chronic pain medication in the last month before participating in the study;
- History of knee surgery in the last six months;
- Obese;
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 |
|---|---|---|
| TMSAlso: non invasive brain stimulation, high frequency TMSRepetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause minimal discomfort with a mild headache sensation, which usually disappears after a few seconds. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing pain control. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation. | Device | Control group, MT after rTMS group, rTMS after MT group |
| Manual therapy (MT)Also: Musculoskeletal manipulationThis intervention uses manual contact for diagnosis and treatment, its practitioners use an enormous amount of manual techniques to preserve the homeostasis through the recovery of dysfunctions, which may cause limitations in the physiological movements, in the accessory movements of the joints (WHO , 2010). | Other | Control group, MT after rTMS group, rTMS after MT group |
Primary outcome
Pain
Time frame: Until one day (before and after the interventions)
Pain will be evaluated by pressure algometry before and after the interventions. It's a evaluation technique which aims to quantify through physical stimulation (pressure in the nociceptors) the capacity of pain perception and toleration. It will be used with the patient lying in supine and will have the purpose of measure the pressure pain threshold (PPT) in eight points around patellar region. Besides that, two control points will be adopted, one in anterior tibial muscle (five centimeters distal of anterior tibial tuberosity) and another in the extensor carpi radialis longus muscle (five centimeters distal to lateral humerus epicondyle). After marking, the algometer will be setted up 90° in contact with the skin and will be applied a 0,3 kgf/cm²/s pressure until the patient report pain by pressing a pen (Model/Brand: Algomed/Medoc). The measure will be done twice in the demarcated points with a two minutes interval between them. Will be considered a mean of the obtained values.
Pain Rating Scale (NPRS)
Time frame: Until 30 days (before, after the interventions and until the last day with the same value of the first evaluation)
Is it used to quantify pain level, where 0 means no pain and 10 means worst pain possible. NPRS is recommended as the main endpoint in chronic pain studies and it has been established that a decrease of at least 2 points or 30% represents a minimal clinically important difference. The MDCI consists of the smaller variation in a clinical outcome perceived by the patient and that results in a relevant change in his state of health.
1 secondary outcome
Cortical excitability
Time frame: One day (before and after the interventions)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
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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.
Kátia Monte-Silva, PhD study director
Applied Neuroscience Laboratory, Universidade Federal de Pernambuco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TMS and Manual therapy (MT) in people with Knee Osteoarthritis, run by Universidade Federal de Pernambuco at 2 sites in Brazil.
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 3 inclusion and 6 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 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Kátia Monte-Silva, PhD (+55 81 988631322, monte.silvakk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Until one day (before and after the interventions)). The study lists 2 primary outcomes in all. 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 10 Mar 2017.