FibromyalgiaNCT02723175
The Effects of CBT and tDCS on Fibromyalgia Patients
A study testing Transcranial Direct Current Stimulation in people with Fibromyalgia and Chronic Pain, run by Medical University of South Carolina at 1 site in United States.
Trial summary
Investigators are seeking to determine the effects of CBT, anodal tDCS over left DLPFC, and combined CBT+ tDCS on clinical pain and functioning among a sample of patients with fibromyalgia. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Fibromyalgia, Chronic Pain
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the American College of Rheumatology criteria for diagnosis of fibromyalgia for at least 1 year.
- Between the ages of 21 and 85
Who cannot join
- Other chronic pain conditions
- on chronic opioid therapy
- history of seizures
- are or might be pregnant
- metal/electronic implants or devices above the waist
- moderate to severe depression (HDRS >19)
Show all 10Show fewer
- moderate to severe anxiety (BAI >16)
- Latex allergy
- Psychiatric illness other than mild depression or anxiety
- on medications that lower seizure threshold
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: The Effects of Cognitive Behavioral Therapy (CBT) and Transcranial Direct Current Stimulation (tDCS) on Fibromyalgia Patients
Investigators are seeking to determine the effects of CBT, anodal tDCS over left DLPFC, and combined CBT+ tDCS on clinical pain and functioning among a sample of patients with fibromyalgia. This study will be the first randomized, double-blind, controlled study of tDCS technology as an adjunctive pain management strategy for fibromyalgia pain. Data from this trial will likely yield information regarding the feasibility and efficacy of tDCS+CBT as a chronic pain-management approach.
Read the detailed description
Patients with fibromyalgia will complete questionnaires, six cognitive behavioral therapy sessions, quantitative sensory testing before and after the six therapy sessions, and undergo 30 minutes of tDCS during each of the six therapy sessions.
- Conditions
- Fibromyalgia, Chronic Pain
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Fibromyalgia, Pain
- Medical subject headings
- Fibromyalgia, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.
| Study group | Role | What they receive |
|---|---|---|
| Sham tDCS Stimulation | Experimental | 30 minutes of the sham transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people. Receives: Device: Transcranial Direct Current Stimulation |
| Anodal tDCS Stimulation of DLPFC | Experimental | 30 minutes of the active transcranial Direct Current Stimulation (tDCS)
Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people. Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Quantitative Sensory Testing (QST)
Before treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.
Measured: Before Treatment
Post Baseline Quantitative Sensory Testing (QST)
After treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.
Measured: One week Post Treatment
Secondary outcomes (16)
The Beck Depression Inventory (BDI) at Baseline
The Beck Depression Inventory (BDI) will be used for screening purposes to characterize depression in each participant at baseline. The BDI is a 21 item participant rated inventory that evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. The BDI scale also assesses suicidal ideation, those patients exhibiting suicidal ideations will be referenced to a therapist in order to further manage their depressive symptoms. The Total score range is 0 to 63; higher score indicates more depression. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe.
Measured: Before Treatment
The Beck Anxiety Inventory (BAI) at Baseline
The Beck Anxiety Inventory (BAI) is a well-researched, brief self-report anxiety-screening instrument that assesses different aspects of anxiety experience (e.g., physiological, cognitive, behavioral). It was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.
Measured: Before Treatment
Brief Pain Inventory-Average Pain at Baseline
To assess each participant's average pain at baseline, the Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Measured: Before Treatment
Percent Change in Average Daily Pain at Treatment Visit 3
Participants were asked to rate their pain on average every day from the start of Treatment 1 until Treatment 3. Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. Daily ratings were averaged at treatment 1 and treatment 3. The change in average daily pain ratings from treatment 1 to treatment 3 was calculated below. Time points at week 1 and week 3 were included to calculate percent change.
Measured: Treatment Session 3 (week 3)
Affective Subscale of McGill Pain Questionnaire at Baseline
Participants completed the McGill Pain Questionnaire-short form (MPQ) at Baseline. The possible total range of scores (Sensory and Affective subscales together) is 0 to 45. The MPQ has two pain dimensions: 1.Sensory subscale awith 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the sensory dimension of pain is 0-33. The data below report the mean score for the affective subscale for both groups. The range of scores for the affective subscale being 0-12 with Higher scores indicating worse pain.
Measured: Before Treatment
The Short-Form 12 Healthy Survey at Baseline
To assess each participant's mental and physical functioning at Baseline, The Short-Form 12 Healthy Survey (SF-12) will be administered. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Measured: Before Treatment
The Fibromyalgia (FM) Impact Questionnaire at Baseline
To assess the impact of fibromyalgia on each participant's function at baseline, The Fibromyalgia (FM) Impact Questionnaire will be administered. The FM assesses the following symptoms; physical Impairment, well-being, pain, fatigue, rested, stiffness, anxiety, and depression within the past 24 hours. Each symptom scale ranges from 0 to 10. For example, 0=no pain and 10=extreme pain, 0=not fatigued and 10=extremely fatigued. The final score is the total score which ranges from 0 to 80. Higher scores indicate greater impact of fibromyalgia on functioning.
Measured: Before Treatment
The Beck Depression Inventory (BDI) at 1 Month Follow up
The Beck Depression Inventory (BDI) will be used for screening purposes to characterize depression in each participant at the one month follow up visit. The BDI is a 21 item participant rated inventory that evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex. The BDI scale also assesses suicidal ideation, those patients exhibiting suicidal ideations will be referenced to a therapist in order to further manage their depressive symptoms. The Total score range is 0 to 63; higher score indicates more depression. Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe.
Measured: 1 month follow up
The Beck Anxiety Inventory (BAI) at 3 Month Follow Up
The Beck Anxiety Inventory (BAI) is a well-researched, brief self-report anxiety-screening instrument that assesses different aspects of anxiety experience (e.g., physiological, cognitive, behavioral). It was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.
Measured: 3 Month Follow Up
Brief Pain Inventory-Average Pain at 1 Month Follow Up
At the one month follow up visit, The Brief Pain Inventory (BPI)-short form will be administered to assess each participant's pain on average in the past 30 days. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 30 days using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Measured: 1 Month Follow Up
Percent Change in Average Daily Pain at Treatment Visit Six
Participants were asked to rate their pain on average every day from the start of Treatment 3 until Treatment 6. Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. Daily ratings were averaged at treatment 3 and treatment 6. The change in average daily pain ratings from treatment 3 to treatment 6 was calculated below. Time points at week 3, and week 6 were included to calculate percent change.
Measured: Treatment Session 6 (week 6)
Percent Change in Average Daily Pain at 1 Month Follow Up
Participants were asked to rate their pain on average every day 30 days post treatment 6 (1 month follow up). Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. The 30 Daily ratings (Post Treatment 6) were averaged and The change in average daily pain ratings from treatment 6 to the 1 month follow up (30 days post completion of treatment visit 6) was calculated below. Time points week 6, and the 1 month follow up were included to calculate percent change.
Measured: 1 Month Follow Up
Percent Change in Average Daily Pain at 3 Month Follow Up
Participants were asked to rate their pain on average every day for 60 days, post 1 month follow up visit. Average pain ratings were on 0-10 scale. 0=No Pain at all and 10=Extreme Pain. The 3 Month Follow Up included 60 Daily Pain ratings (Collected Post 1 Month Follow Up) that were averaged. The change in average daily pain ratings from the 1 month follow up (30 days post completion of treatment visit 6) to the 3 Month Follow Up (60 days post completion of the 1 month follow up visit) was calculated below. Time points 1 month follow up, and 3 month follow up were included to calculate percent change.
Measured: 3 Month Follow Up
Affective Subscale of McGill Pain Questionnaire at 1 Month Follow Up
Participants completed the McGill Pain Questionnaire-short form (MPQ) at Baseline. The possible total range of scores is 0 to 45. The MPQ has two pain dimensions: 1.Sensory subscale with 11 words, and 2.Affective subscale with 4 words from the original MPQ. The range of scores for the sensory dimension of pain is 0-33. The data below report the mean score for the affective subscale of the McGill Pain Questionnaire for both groups. The range of scores for the affective subscale being 0-12 with Higher scores indicating worse pain.
Measured: 1 Month Follow Up
The Short-Form 12 Healthy Survey at 1 Month Follow Up
To assess each participant's mental and physical functioning at the 1 Month Follow Up visit, The Short-Form 12 Healthy Survey (SF-12) will be administered. The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey (Ware, Kosinski, and Keller, 1996). The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. Total score range for the summary scores = 0-100, where higher score represents higher level of functioning.
Measured: 1 Month Follow Up
The Fibromyalgia (FM) Impact Questionnaire at 1 Month Follow Up
To assess the impact of fibromyalgia on each participant's function at the 1 Month Follow Up visit, The Fibromyalgia (FM) Impact Questionnaire will be administered. The FM assesses the following symptoms; physical Impairment, well-being, pain, fatigue, rested, stiffness, anxiety, and depression within the past 24 hours. Each symptom scale ranges from 0 to 10. For example, 0=no pain and 10=extreme pain, 0=not fatigued and 10=extremely fatigued. The final score is the total score which ranges from 0 to 80. Higher scores indicate greater impact of fibromyalgia on functioning.
Measured: 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 posted30 Mar 2016 (estimated)
- Study startDec 2014
- Primary completionNov 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Borckardt, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723175
- Sponsor's protocol ID
- Pro00039603
- Other IDs
- 1R21AR066428-01
- Status last verified
- Oct 2018
- First submitted
- 14 Dec 2015
- Last updated
- 28 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cognitive Behavioral Therapy (CBT) and Transcranial Direct Current Stimulation (tDCS) on Fibromyalgia Patients
- ClinicalTrials.gov ID
- NCT02723175
- Acronym / sponsor ID
- Pro00039603
- Conditions
- Fibromyalgia, Chronic Pain
- Keywords
- Fibromyalgia, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Dec 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Posted 28 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators are seeking to determine the effects of CBT, anodal tDCS over left DLPFC, and combined CBT+ tDCS on clinical pain and functioning among a sample of patients with fibromyalgia. This study will be the first randomized, double-blind, controlled study of tDCS technology as an adjunctive pain management strategy for fibromyalgia pain. Data from this trial will likely yield information regarding the feasibility and efficacy of tDCS+CBT as a chronic pain-management approach.
Detailed description
Patients with fibromyalgia will complete questionnaires, six cognitive behavioral therapy sessions, quantitative sensory testing before and after the six therapy sessions, and undergo 30 minutes of tDCS during each of the six therapy sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tDCS Stimulation | Experimental | Device: Transcranial Direct Current Stimulation30 minutes of the sham transcranial Direct Current Stimulation Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people. |
| Anodal tDCS Stimulation of DLPFC | Experimental | Device: Transcranial Direct Current Stimulation30 minutes of the active transcranial Direct Current Stimulation (tDCS) Transcranial Direct Current Stimulation: Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Meet the American College of Rheumatology criteria for diagnosis of fibromyalgia for at least 1 year.
- Between the ages of 21 and 85
Key exclusion criteria (10 listed)
- Other chronic pain conditions
- on chronic opioid therapy
- history of seizures
- are or might be pregnant
- metal/electronic implants or devices above the waist
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 StimulationTranscranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people. | Device | Anodal tDCS Stimulation of DLPFC, Sham tDCS Stimulation |
Primary outcome
Baseline Quantitative Sensory Testing (QST)
Time frame: Before Treatment
Before treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.
Post Baseline Quantitative Sensory Testing (QST)
Time frame: One week Post Treatment
After treatment, Quantitative Sensory Testing (QST) will be completed for all participants. The QST involves a comprehensive laboratory pain assessment including heat stimuli using a Pathway Thermo-sensory Analyzer System which is specifically designed for assessing laboratory pain testing. The QST collects the temperature in celsius of when the participant first begins to feel the stimuli (Sensory), starts to feel pain (average pain threshold), and when the participant can no longer tolerate the stimuli (Tolerance). The temperature ranges from 37 degrees celsius to 50 degrees celsius. The minimum temperature on the scale is 37 degrees celsius and the maximum temperature on the scale is 50 degrees celsius. Average pain threshold: A lower temperature represents a lower pain threshold and a higher temperature represents a higher pain threshold. Tolerance: A lower temperature represents a lower pain tolerance and a higher temperature represents a higher pain tolerance.
16 secondary outcomes
The Beck Depression Inventory (BDI) at Baseline
Time frame: Before Treatment
The Beck Anxiety Inventory (BAI) at Baseline
Time frame: Before Treatment
Brief Pain Inventory-Average Pain at Baseline
Time frame: Before Treatment
Percent Change in Average Daily Pain at Treatment Visit 3
Time frame: Treatment Session 3 (week 3)
Affective Subscale of McGill Pain Questionnaire at Baseline
Time frame: Before Treatment
The Short-Form 12 Healthy Survey at Baseline
Time frame: Before Treatment
The Fibromyalgia (FM) Impact Questionnaire at Baseline
Time frame: Before Treatment
The Beck Depression Inventory (BDI) at 1 Month Follow up
Time frame: 1 month follow up
The Beck Anxiety Inventory (BAI) at 3 Month Follow Up
Time frame: 3 Month Follow Up
Brief Pain Inventory-Average Pain at 1 Month Follow Up
Time frame: 1 Month Follow Up
Percent Change in Average Daily Pain at Treatment Visit Six
Time frame: Treatment Session 6 (week 6)
Percent Change in Average Daily Pain at 1 Month Follow Up
Time frame: 1 Month Follow Up
Percent Change in Average Daily Pain at 3 Month Follow Up
Time frame: 3 Month Follow Up
Affective Subscale of McGill Pain Questionnaire at 1 Month Follow Up
Time frame: 1 Month Follow Up
The Short-Form 12 Healthy Survey at 1 Month Follow Up
Time frame: 1 Month Follow Up
The Fibromyalgia (FM) Impact Questionnaire at 1 Month Follow Up
Time frame: 1 Month Follow Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey Borckardt, Ph.D. principal investigator
Medical University of South Carolina
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 in people with Fibromyalgia and Chronic Pain, run by Medical University of South Carolina at 1 site in United States.
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 2 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 28 Nov 2018. 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 United States. 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. 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?
Yes. Results are posted in the registry (first posted 28 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Baseline Quantitative Sensory Testing (QST) (time frame: Before Treatment). 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 28 Nov 2018; AzTrials last refreshed its copy on 8 Nov 2026.