Chronic Low Back PainPhase 4PICP2NCT02986334
Placebo In Chronic Back Pain (Phase 2)
A Phase 4 study testing Naproxen and Omeprazole in people with Chronic Low Back Pain, run by Apkar Apkarian at 1 site in United States.
Trial summary
This study is designed to examine brain properties for placebo response in chronic back pain patients. The investigators have preliminary data indicating that, in blinded clinical trial studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can be subdivided into placebo responders and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Naproxen and Omeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Jun 2018
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of low back pain for a minimum of 6 months with or without signs and symptoms of radiculopathy
- Male or female, between the ages of 18 and 75 years, with no racial or ethnic restrictions
- Must have a Visual Analog Scale (VAS) pain score of 5 mm (of 10 mm maximum) at the screening visit (for which 0mm = no pain, and 10 mm = worst pain imaginable);
- Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires;
- Must be in generally stable health;
- Must sign an informed consent document after a complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate
- Must have, on average, 5/10 units (VAS scale) of pain over the course of a two-week period prior to visit 1; rounding up from 4.5/10 is permissible.
- Must be willing to complete daily smart phone/computer app ratings.
Who cannot join
- Low back pain associated with any systemic signs or symptoms, e.g., fever, chills;
- Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of tumor in the back;
- Other comorbid chronic pain or neurological conditions;
- Involvement in litigation regarding their back pain or having a disability claim or receiving workman's compensation or seeking either as a result of their low back pain;
- Diagnosis of current depression or psychiatric disorder requiring treatment, or such a diagnosis in the previous 6 months;
- Beck Depression Inventory (BDI) Ia score greater or equal to 19 for two consecutive completions; if the first score meets this criteria, the participant must be re-tested before his/her next visit, but if the second score does not meet this criteria, the participant will be included and followed closely throughout the study
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- Use of therapeutic doses of antidepressant medications (i.e., tricyclic depressants, SSRIs, SNRIs; low doses used for sleep may be allowed);
- Significant other medical disease such as unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, or malignancy;
- History of gastrointestinal ulcer during the past year;
- History of myocardial infarction in the past year;
- Uncontrolled hypertension;
- Renal insufficiency;
- Allergic to, or non-tolerant of, NSAIDs;
- History of aspirin-sensitive asthma;
- Current use of recreational drugs or history of alcohol or drug abuse;
- Any change in medication for back pain in the last 30 days only applicable for visit 1
- High dose opioid prophylaxis, as defined as > 50mg morphine equivalent/day;
- Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
- In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
- Evidence of poor treatment compliance, in the judgment of the investigator;
- Intra-axial implants (e.g. spinal cord stimulators or pumps);
- All exclusion criteria for MR safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia;
- Pregnancy, or inability to use an effective form of contraception in women of child-bearing age;
- Diabetes (Type I or Type II);
- Lactose intolerance or sensitivity to lactose
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Brain Mechanisms For Clinical Placebo in Chronic Pain: A Randomized Clinical Trial of Placebo, Active Treatment, and No Treatment in Chronic Back Pain
This study is designed to examine brain properties for placebo response in chronic back pain patients. The investigators have preliminary data indicating that, in blinded clinical trial studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can be subdivided into placebo responders and non-responders, and these differences are PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have clinical utility and that its properties can be studied by human brain imaging techniques. In Phase I of the study, the investigators seek to identify brain imaging parameters that predict the propensity for the placebo response in an independent CBP cohort. In Phase II, the investigators will evaluate the interaction between placebo response and medication treatment in individuals stratified as placebo responders versus non-responders. This research is designed to critically assess the neurobiology of placebo analgesia for chronic pain in a partially-blind clinical trial.
Read the detailed description
Visit 1 (week -3): Screening visit (90 min):
Participants will be evaluated with inclusion/exclusion criteria and complete the informed consent documents. A medical/pain history will be taken and physical exam will be completed by a physician and participants will be asked to rate their current back pain intensity. Participants will complete a set of 10 questionnaires that will ask about health and medical history, past and current pain levels, personality, and emotions. Participants will be allowed to take breaks and walk around during this time so that participants don't get tired while filling out questionnaires. Finally, participants will have blood drawn for screening purposes including to see if kidneys and liver are functioning as they should (the investigators will take 40 mL or about 8 teaspoons). Participants will be asked to return in 2 weeks for baseline magnetic resonance imaging (MRI) scans. Participants will be asked to discontinue current pain medications 14 days prior to Visit 2 and take only the rescue medication ("rescue" medication that is also known as acetaminophen/Tylenol ®), given for pain during this time (see below) - this is so that the investigators can assess baseline amount of pain. Participants will be informed that they may be randomized in the placebo group and/or the no-treatment group (Visit 3) once one qualifies to continue in the study. Participants must, therefore,a be willing and able to stop taking the medication for pain for up to a maximum of 12 weeks during this study. Participants will be given acetaminophen (500 mg, up to 4 times per day) to take for pain relief (as rescue medication), a dose that can be continued throughout the study. Participants are free to stop participation at any point in the study. Participants randomized into the treatment arm may receive the anti-inflammatory drug naproxen, since it is known to increase the risk of stomach and intestinal side effects, a combined naproxen/esomeprazole drug regimen will be given to participants to provide some protection for these types of side effects.
Visit 2 (week -1): Baseline Scan (90 min):
Participants will rate their pain intensity, complete questionnaires, and undergo brain scanning (anatomical and functional scans). Participants will receive medication, which can be used if the pain becomes too much to handle (500 mg four times per day maximum). The researcher will ask participants about how often participants used the "rescue" medication and any changes in health they may have experienced since the last visit.
Visit 3 (week 0): Start of Treatment Period and Randomization (30-45 min):
Participants will rate their pain intensity and complete questionnaires. Participants will be randomized into either a drug (placebo or naproxen and esomeprazole) treatment group or no treatment group; if participants are assigned to a treatment group (active or placebo), neither participants nor the clinical coordinator/assistant will know which group participants are allocated in. Enough medication will be given to participants to last until the next visit. The placebo group will receive two placebo capsules twice daily and the active drug group will receive one naproxen capsule (500mg) and one esomeprazole capsule (20mg) twice daily (morning and night) for the treatment period. The medication (Naproxen or Placebo) needs to be taken with at least one full glass (8 oz) of water and the other medication (Esomeprazole or Placebo) should be taken one hour before a meal. The researcher will provide the study medication; if participants were randomized into the no treatment group, participants will only receive rescue medication. The researcher will ask participants about how often participants used the "rescue" medication and any side effects participants experienced since Visit 2 took place. Additional "rescue" medication will be given.
Visit 4 (week 3): Continuing Assessment (30-45 min). The procedures described for Visit 3 will be repeated during this visit. The researcher will ask participants about how often they used the "rescue" medication and any side effects experienced since Visit 3 took place. As well, the researcher will ask how often participants took the study medication (if in a treatment group) and document the total pills ingested.
Visit 5 (week 6): End of Treatment/Start of Washout and Final Scan (60-90 min):
The procedures described for Visit 2 will be repeated during this visit. The researcher will ask participants about how often and reliably participants took the medication (if in a treatment group), as well as how often they used the "rescue" medication and any side effects experienced since Visit 4 took place. Participants will only receive the "rescue" medication for the upcoming 3 weeks.
Visit 6 (week 9): Final Visit/End of Washout (30-45 min):
Participants will return to complete questionnaires, but no brain scans will be done. The researcher will ask participants about how often they used the "rescue" medication and any side effects experienced since Visit 5 took place. If participants are in one of the treatment groups, participants will be asked to return all of the study medication and rescue medication at this time, and all treatment will be stopped at this visit.
- Conditions
- Chronic Low Back Pain
- Being tested
- Naproxen, Omeprazole, Placebo
- Keywords
- chronic, low back, back, pain, brain, MRI
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
Also called Aleve, Anaprox, Antalgin, Feminax Ultra
Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening.
OmeprazoleDrug
Also called Prilosec, Iosepine
Subjects enrolled in the active treatment arm will receive 20mg of Omeprazole prescribed twice daily, once in the morning and evening. Furthermore, subjects should take this one hour before a meal.
PlaceboDrug
Also called Sugar Pill
Subjects enrolled in the inactive treatment arm will receive two prescriptions, however, there are no active ingredients and are intended to look identical to the active treatment. Therefore, subjects will be instructed exactly the same way as if they were ingesting the active treatment.
| Study group | Role | What they receive |
|---|---|---|
| No Treatment Intervention | No intervention | Observational Subjects randomized to this arm will be asked to discontinue their current pain medications for the length of the study. This arm is not blinded, as both study staff and participants will be aware that they are not receiving a study treatment. |
| Active Treatment Intervention | Active comparator | Naproxen \& Omeprazole Subjects randomized to this arm will be asked to discontinue their current pain medications and take one 500mg naproxen capsule and one 40mg omeprazole capsule twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment). Receives: Drug: Naproxen; Drug: Omeprazole |
| Placebo Treatment Intervention | Placebo comparator | Subjects randomized to this arm will be asked to discontinue their current pain medications and take two placebo capsules twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Pain Assessed by Visual Analogue Scale (VAS)
Self-report pain using a VAS scale (0-10) : 0 represents no pain and 10 the worst imaginable pain.
Results are presented as percentage (%) change in pain before and after the intervention (baseline and post-intervention, 12 weeks).
Percentage change is calculated with post-intervention pain minus baseline pain, divided by baseline pain i.e. (post - baseline) / baseline.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2018
- Study completionJun 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apkar Apkarian
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
- Responsible party
- Sponsor-investigator, Apkar Apkarian, Northwestern University
- Investigators
- Apkar V Apkarian, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986334
- Sponsor's protocol ID
- STU00080585 (Phase 2)
- Other IDs
- 5R01AT007987-03
- Acronym
- PICP2
- Status last verified
- Oct 2022
- First submitted
- 6 Dec 2016
- Last updated
- 7 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Vachon-Presseau E, Abdullah TB, Berger SE, Huang L, Griffith JW, Schnitzer TJ, Apkarian AV. Validating a biosignature-predicting placebo pill response in chronic pain in the settings of a randomized controlled trial. Pain. 2022 May 1;163(5):910-922. doi: 10.1097/j.pain.0000000000002450.
PubMed 34433773
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Mechanisms For Clinical Placebo in Chronic Pain: A Randomized Clinical Trial of Placebo, Active Treatment, and No Treatment in Chronic Back Pain
- ClinicalTrials.gov ID
- NCT02986334
- Acronym / sponsor ID
- PICP2 / STU00080585 (Phase 2)
- Conditions
- Chronic Low Back Pain
- Keywords
- chronic, low back, back, pain, brain, MRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Apkar ApkarianUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 8 Dec 2016 (estimated)
- Results
- Posted 7 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to examine brain properties for placebo response in chronic back pain patients. The investigators have preliminary data indicating that, in blinded clinical trial studies with neutral instructions regarding treatment, chronic back pain (CBP) patients can be subdivided into placebo responders and non-responders, and these differences are PREDICTABLE a priori, by brain activity. The results imply that CBP placebo may have clinical utility and that its properties can be studied by human brain imaging techniques. In Phase I of the study, the investigators seek to identify brain imaging parameters that predict the propensity for the placebo response in an independent CBP cohort. In Phase II, the investigators will evaluate the interaction between placebo response and medication treatment in individuals stratified as placebo responders versus non-responders. This research is designed to critically assess the neurobiology of placebo analgesia for chronic pain in a partially-blind clinical trial.
Detailed description
Visit 1 (week -3): Screening visit (90 min):
Participants will be evaluated with inclusion/exclusion criteria and complete the informed consent documents. A medical/pain history will be taken and physical exam will be completed by a physician and participants will be asked to rate their current back pain intensity. Participants will complete a set of 10 questionnaires that will ask about health and medical history, past and current pain levels, personality, and emotions. Participants will be allowed to take breaks and walk around during this time so that participants don't get tired while filling out questionnaires. Finally, participants will have blood drawn for screening purposes including to see if kidneys and liver are functioning as they should (the investigators will take 40 mL or about 8 teaspoons). Participants will be asked to return in 2 weeks for baseline magnetic resonance imaging (MRI) scans. Participants will be asked to discontinue current pain medications 14 days prior to Visit 2 and take only the rescue medication ("rescue" medication that is also known as acetaminophen/Tylenol ®), given for pain during this time (see below) - this is so that the investigators can assess baseline amount of pain. Participants will be informed that they may be randomized in the placebo group and/or the no-treatment group (Visit 3) once one qualifies to continue in the study. Participants must, therefore,a be willing and able to stop taking the medication for pain for up to a maximum of 12 weeks during this study. Participants will be given acetaminophen (500 mg, up to 4 times per day) to take for pain relief (as rescue medication), a dose that can be continued throughout the study. Participants are free to stop participation at any point in the study. Participants randomized into the treatment arm may receive the anti-inflammatory drug naproxen, since it is known to increase the risk of stomach and intestinal side effects, a combined naproxen/esomeprazole drug regimen will be given to participants to provide some protection for these types of side effects.
Visit 2 (week -1): Baseline Scan (90 min):
Participants will rate their pain intensity, complete questionnaires, and undergo brain scanning (anatomical and functional scans). Participants will receive medication, which can be used if the pain becomes too much to handle (500 mg four times per day maximum). The researcher will ask participants about how often participants used the "rescue" medication and any changes in health they may have experienced since the last visit.
Visit 3 (week 0): Start of Treatment Period and Randomization (30-45 min):
Participants will rate their pain intensity and complete questionnaires. Participants will be randomized into either a drug (placebo or naproxen and esomeprazole) treatment group or no treatment group; if participants are assigned to a treatment group (active or placebo), neither participants nor the clinical coordinator/assistant will know which group participants are allocated in. Enough medication will be given to participants to last until the next visit. The placebo group will receive two placebo capsules twice daily and the active drug group will receive one naproxen capsule (500mg) and one esomeprazole capsule (20mg) twice daily (morning and night) for the treatment period. The medication (Naproxen or Placebo) needs to be taken with at least one full glass (8 oz) of water and the other medication (Esomeprazole or Placebo) should be taken one hour before a meal. The researcher will provide the study medication; if participants were randomized into the no treatment group, participants will only receive rescue medication. The researcher will ask participants about how often participants used the "rescue" medication and any side effects participants experienced since Visit 2 took place. Additional "rescue" medication will be given.
Visit 4 (week 3): Continuing Assessment (30-45 min). The procedures described for Visit 3 will be repeated during this visit. The researcher will ask participants about how often they used the "rescue" medication and any side effects experienced since Visit 3 took place. As well, the researcher will ask how often participants took the study medication (if in a treatment group) and document the total pills ingested.
Visit 5 (week 6): End of Treatment/Start of Washout and Final Scan (60-90 min):
The procedures described for Visit 2 will be repeated during this visit. The researcher will ask participants about how often and reliably participants took the medication (if in a treatment group), as well as how often they used the "rescue" medication and any side effects experienced since Visit 4 took place. Participants will only receive the "rescue" medication for the upcoming 3 weeks.
Visit 6 (week 9): Final Visit/End of Washout (30-45 min):
Participants will return to complete questionnaires, but no brain scans will be done. The researcher will ask participants about how often they used the "rescue" medication and any side effects experienced since Visit 5 took place. If participants are in one of the treatment groups, participants will be asked to return all of the study medication and rescue medication at this time, and all treatment will be stopped at this visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Treatment Intervention | No intervention | –Observational Subjects randomized to this arm will be asked to discontinue their current pain medications for the length of the study. This arm is not blinded, as both study staff and participants will be aware that they are not receiving a study treatment. |
| Active Treatment Intervention | Active comparator | Drug: Naproxen, Drug: OmeprazoleNaproxen \& Omeprazole Subjects randomized to this arm will be asked to discontinue their current pain medications and take one 500mg naproxen capsule and one 40mg omeprazole capsule twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment). |
| Placebo Treatment Intervention | Placebo comparator | Drug: PlaceboSubjects randomized to this arm will be asked to discontinue their current pain medications and take two placebo capsules twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- History of low back pain for a minimum of 6 months with or without signs and symptoms of radiculopathy
- Male or female, between the ages of 18 and 75 years, with no racial or ethnic restrictions
- Must have a Visual Analog Scale (VAS) pain score of 5 mm (of 10 mm maximum) at the screening visit (for which 0mm = no pain, and 10 mm = worst pain imaginable);
- Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires;
- Must be in generally stable health;
Key exclusion criteria (25 listed)
- Low back pain associated with any systemic signs or symptoms, e.g., fever, chills;
- Evidence of rheumatoid arthritis, ankylosing spondylitis, acute vertebral fractures, fibromyalgia, history of tumor in the back;
- Other comorbid chronic pain or neurological conditions;
- Involvement in litigation regarding their back pain or having a disability claim or receiving workman's compensation or seeking either as a result of their low back pain;
- Diagnosis of current depression or psychiatric disorder requiring treatment, or such a diagnosis in the previous 6 months;
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 |
|---|---|---|
| NaproxenAlso: Aleve, Anaprox, Antalgin, Feminax UltraSubjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening. | Drug | Active Treatment Intervention |
| OmeprazoleAlso: Prilosec, IosepineSubjects enrolled in the active treatment arm will receive 20mg of Omeprazole prescribed twice daily, once in the morning and evening. Furthermore, subjects should take this one hour before a meal. | Drug | Active Treatment Intervention |
| PlaceboAlso: Sugar PillSubjects enrolled in the inactive treatment arm will receive two prescriptions, however, there are no active ingredients and are intended to look identical to the active treatment. Therefore, subjects will be instructed exactly the same way as if they were ingesting the active treatment. | Drug | Placebo Treatment Intervention |
Primary outcome
Percent Change in Pain Assessed by Visual Analogue Scale (VAS)
Time frame: 12 weeks
Self-report pain using a VAS scale (0-10) : 0 represents no pain and 10 the worst imaginable pain. Results are presented as percentage (%) change in pain before and after the intervention (baseline and post-intervention, 12 weeks). Percentage change is calculated with post-intervention pain minus baseline pain, divided by baseline pain i.e. (post - baseline) / baseline.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34433773Vachon-Presseau E, Abdullah TB, Berger SE, Huang L, Griffith JW, Schnitzer TJ, Apkarian AV. Validating a biosignature-predicting placebo pill response in chronic pain in the settings of a randomized controlled trial. Pain. 2022 May 1;163(5):910-922. doi: 10.1097/j.pain.0000000000002450.
- Individual participant dataSharing planned: No
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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.
Apkar V Apkarian, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen and Omeprazole in people with Chronic Low Back Pain, run by Apkar Apkarian 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 8 inclusion and 25 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 7 Nov 2022. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2022). 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?
Percent Change in Pain Assessed by Visual Analogue Scale (VAS) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02986334, which also lists 1 linked publication.
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 7 Nov 2022.