Chronic Non-malignant PainPhase 4NCT03761277

Embrace TDD: Post-Market Study to Evaluate Intrathecal Morphine as an Alternative to Systemic Opioids for Chronic Pain

A Phase 4 study testing Medtronic SynchroMed™ II infusion system and Preservative-free morphine sulfate (PFMS) in people with Chronic Non-malignant Pain and Chronic Pain, run by MedtronicNeuro at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an alternative to systemic opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Non-malignant Pain, Chronic Pain, Pain, Back
What is being tested?: Medtronic SynchroMed™ II infusion system and Preservative-free morphine sulfate (PFMS)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 16 sitesUnited States
Study dates: 16 Jan 2019to 6 Dec 2021
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Willing and able to provide a signed and dated (Medtronic and Institutional Review Board (IRB) approved) Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to any study procedures being performed
A candidate per labeling for the Intrathecal Drug Delivery System (IDDS)
A diagnosis of chronic, intractable, non-malignant primary back pain with or without leg pain, treatable with the IDDS
Current daily systemic opioid dose of >0 and ≤ 120 Morphine Milligram Equivalents (MME)
A Visual Analogue Scale (VAS) of ≥50 mm for pain intensity at the Baseline Visit and/or a Numerical Opioid Side Effect (NOSE) Assessment Tool ≥40 for intolerable side effects at the Baseline Visit
Psychological evaluation or investigator assessment of patient psychological suitability for study participation

Show all 10Show fewer

Has an MRI or CT prior to enrollment verifying patent spinal canal and no clinical change in status since last imaging
At least 18 years old at time of enrollment
Willing and able to attend visits and comply with the study protocol
Male or non-pregnant, non-lactating female. Females must be post-menopausal or surgically sterile; or be utilizing a medically acceptable form of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide) for the duration of the study

Who cannot join

Previously trialed or implanted with an IDDS
Concomitant stimulation device implanted for the treatment of pain
Any ongoing health condition that would be expected to interfere with pain and/or quality of life ratings (i.e. active malignancy, other painful conditions not treatable with IT therapy, etc.)
Psychological or other health conditions, financial and/or legal concerns that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's discretion
Substance Use Disorder (SUD) within the last 2 years or current Medication Assisted Treatment (MAT) for substance use disorder
Currently using cannabinoids or illicit drugs
History of allergy or significant adverse reaction to morphine per investigator discretion
Currently participating or plans to participate in another investigational study unless written approval is provided by Medtronic Study Team

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Neuroversion
Anchorage, Alaska, 99508
Regional Brain & Spine, LLC
Cape Girardeau, Missouri, 63701
Coastal Pain and Spinal Diagnostics
Carlsbad, California, 92009
University of Virginia Pain Management Center
Charlottesville, Virginia, 22908
Clinical Investigations, LLC
Edmond, Oklahoma, 73013
Moss Rehabilitation-Einstein Healthcare Network
Elkins Park, Pennsylvania, 19027
University of Texas Medical Branch
Galveston, Texas, 77555
Comprehensive and Interventional Pain Management
Henderson, Nevada, 89052
Florida Pain Institute
Merritt Island, Florida, 32935
Premier Pain Treatment Institute
Mount Orab, Ohio, 45154
Napa Valley Orthopaedic Medical Group
Napa, California, 94558
Eastern Virginia Medical School
Norfolk, Virginia, 23507
Northwest Pain Care, Inc.
Spokane, Washington, 99201
Christian Hospital Pain Management
St Louis, Missouri, 63136
Precision Spine Care
Tyler, Texas, 75701
The Pain Management Center
Voorhees Township, New Jersey, 08043

Other trials in United States

About this study

Official title: Embrace TDD: Prospective, Multi-Center, Post Market Study to Evaluate Intrathecal (IT) Morphine as an Alternative to Systemic Opioids for the Treatment of Chronic, Intractable, Non-Malignant Primary Back Pain With or Without Leg Pain

Read the detailed description

Subjects will be assessed for pain control and opioid-related side effects following a route of delivery change from systemic opioids to IT morphine therapy.

Conditions: Chronic Non-malignant Pain, Chronic Pain, Pain, Back, Pain, Leg
Being tested: Medtronic SynchroMed™ II infusion system, Preservative-free morphine sulfate (PFMS)
Keywords: Pain, Intrathecal, Targeted Drug Delivery (TDD), Non-Malignant Pain, Systemic Opioids, Opioid Weaning, Pain Pump, Drug Pump, Medtronic Pump
Medical subject headings: Chronic Pain, Back Pain, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Medtronic SynchroMed™ II infusion systemDevice
Implanted infusion system consisting of a pump and catheter, as well as external components of a clinician programmer, refill and catheter access port kits, and the Personal Therapy Manager (myPTM™).
Preservative-free morphine sulfate (PFMS)Drug
The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS).

Study groups in NCT03761277
Study group	Role	What they receive
Intrathecal Therapy	Other	Enrolled subjects who successfully wean from all systemic opioids and have a successful intrathecal trial, proceed to the intervention phase. This includes implantation with a SynchroMed™ II infusion system in the intrathecal space for targeted drug delivery of preservative-free morphine sulfate (PFMS). Receives: Device: Medtronic SynchroMed™ II infusion system; Drug: Preservative-free morphine sulfate (PFMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Clinical Success at the 6-Month Visit
To characterize the number of subjects with Clinical Success at the 6-Month Visit. Clinical Success is defined as any of the following: 1) Reduced opioid-related side effects (at least a 20% reduction) with equal pain (less than 20% increase or decrease) 2) Reduced pain (at least a 20% reduction) with equal opioid-related side effects (less than 20% increase or decrease) 3) Reduced pain and reduced opioid-related side effects (at least a 20% reduction in both). The number of subjects with Clinical Success at the 6-Month Visit is presented.
Measured: Baseline to 6-Month Visit

Secondary outcomes (3)

Visual Analog Scale (VAS) Pain Intensity at the 6-Month Visit
To demonstrate pain intensity scores (Visual Analog Scale, VAS) at the 6-Month Visit is non-inferior to VAS at Baseline, with a non-inferiority margin of 10mm. Pain was assessed using a Visual Analog Scale, ranging from 0-100, where 0 is no pain and 100 is the worst pain. The VAS is a 100mm line, with "No pain" on the left side of the line and "Worst pain imaginable" on the right side of the line. Subjects made a perpendicular mark on the VAS line that best describes their average pain in the last 24 hours. Change in VAS is calculated as 6-Months - Baseline, with a negative change indicating a reduction (i.e., improvement) in pain intensity.
Measured: Baseline to 6-Month Visit
Numerical Opioid Side Effect (NOSE) Assessment Tool
To characterize the change in opioid-related side effects scores (NOSE) from Baseline to the 6-Month Visit. The Numerical Opioid Side Effect (NOSE) Assessment Tool is a tool to evaluate 10 opioid-related side effects using a 11-point numerical scale. Subjects are asked to evaluate each of the 10 opioid-related side effects on a scale of 0 - 10 with 0 being "not present" and 10 being "as bad as you can imagine". A total sum score can range from 0 - 100, where 0 is no opioid-related side effects and 100 is the worst opioid-related side effects. Change in NOSE is calculated as 6-Months - Baseline, with a negative change indicating a reduction (i.e., improvement) in opioid-related side effects.
Measured: Baseline to 6-Month Visit
Number of Participants With Systemic Opioid Elimination Through the 6-Month Visit
To characterize the number of subjects who eliminate systemic opioids through the 6-Month Visit. Four drug tests for systemic opioid use are administered from intrathecal therapy initiation through the 6-Month Visit. If all of the available drug tests are negative for systemic opioid use, the subject is counted as eliminating systemic opioids through the 6-Month Visit. The number of subjects who eliminated systemic opioids through the 6-Month Visit is presented.
Measured: Baseline to 6-Month Visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jan 20196 Dec 2021

First posted3 Dec 2018
Study start16 Jan 2019
Primary completion6 Dec 2021
Study completion6 Dec 2021

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 (6)Papers the sponsor has linked to this study.
Other trials for Chronic Non-malignant 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03761277
Sponsor's protocol ID: MDT18026
Status last verified: Jan 2023
First submitted: 15 Nov 2018
Last updated: 8 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Smith TJ, Staats PS, Deer T, Stearns LJ, Rauck RL, Boortz-Marx RL, Buchser E, Catala E, Bryce DA, Coyne PJ, Pool GE; Implantable Drug Delivery Systems Study Group. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002 Oct 1;20(19):4040-9. doi: 10.1200/JCO.2002.02.118.
PubMed 12351602
Hamza M, Doleys D, Wells M, Weisbein J, Hoff J, Martin M, Soteropoulos C, Barreto J, Deschner S, Ketchum J. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012 Oct;13(10):1304-13. doi: 10.1111/j.1526-4637.2012.01451.x. Epub 2012 Jul 30.
PubMed 22845187
Grider JS, Etscheidt MA, Harned ME, Lee J, Smith B, Lamar C, Bux A. Trialing and Maintenance Dosing Using a Low-Dose Intrathecal Opioid Method for Chronic Nonmalignant Pain: A Prospective 36-Month Study. Neuromodulation. 2016 Feb;19(2):206-19. doi: 10.1111/ner.12352. Epub 2015 Oct 19.
PubMed 26477685
Hamza M, Doleys DM, Saleh IA, Medvedovsky A, Verdolin MH, Hamza M. A Prospective, Randomized, Single-Blinded, Head-to-Head Long-Term Outcome Study, Comparing Intrathecal (IT) Boluses With Continuous Infusion Trialing Techniques Prior to Implantation of Drug Delivery Systems (DDS) for the Treatment of Severe Intractable Chronic Nonmalignant Pain. Neuromodulation. 2015 Oct;18(7):636-48; discussion 649. doi: 10.1111/ner.12342. Epub 2015 Aug 26.
PubMed 26307558
Wilkes DM, Orillosa SJ, Hustak EC, Williams CG, Doulatram GR, Solanki DR, Garcia EA, Huang LM. Efficacy, Safety, and Feasibility of the Morphine Microdose Method in Community-Based Clinics. Pain Med. 2018 Sep 1;19(9):1782-1789. doi: 10.1093/pm/pnx132.
PubMed 29016893
Grider JS, Harned ME, Etscheidt MA. Patient selection and outcomes using a low-dose intrathecal opioid trialing method for chronic nonmalignant pain. Pain Physician. 2011 Jul-Aug;14(4):343-51.
PubMed 21785477

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity
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Active, not recruiting
Effectiveness of Acceptance and Commitment Therapy for Chronic Non-Malignant Pain: A Randomized Controlled Trial
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Enrolling by invitation
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All Chronic Non-malignant Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Embrace TDD: Prospective, Multi-Center, Post Market Study to Evaluate Intrathecal (IT) Morphine as an Alternative to Systemic Opioids for the Treatment of Chronic, Intractable, Non-Malignant Primary Back Pain With or Without Leg Pain
ClinicalTrials.gov ID: NCT03761277
Acronym / sponsor ID: MDT18026
Conditions: Chronic Non-malignant Pain, Chronic Pain, Pain, Back, Pain, Leg
Keywords: Pain, Intrathecal, Targeted Drug Delivery (TDD), Non-Malignant Pain, Systemic Opioids, Opioid Weaning, Pain Pump, Drug Pump
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: 16 Jan 2019 (actual)
Primary completion: 6 Dec 2021 (actual)
Study completion: 6 Dec 2021 (actual)
First posted: 3 Dec 2018 (actual)
Results: Posted 8 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Subjects will be assessed for pain control and opioid-related side effects following a route of delivery change from systemic opioids to IT morphine therapy.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intrathecal Therapy	Other	Device: Medtronic SynchroMed™ II infusion system, Drug: Preservative-free morphine sulfate (PFMS)Enrolled subjects who successfully wean from all systemic opioids and have a successful intrathecal trial, proceed to the intervention phase. This includes implantation with a SynchroMed™ II infusion system in the intrathecal space for targeted drug delivery of preservative-free morphine sulfate (PFMS).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Willing and able to provide a signed and dated (Medtronic and Institutional Review Board (IRB) approved) Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to any study procedures being performed
A candidate per labeling for the Intrathecal Drug Delivery System (IDDS)
A diagnosis of chronic, intractable, non-malignant primary back pain with or without leg pain, treatable with the IDDS
Current daily systemic opioid dose of >0 and ≤ 120 Morphine Milligram Equivalents (MME)
A Visual Analogue Scale (VAS) of ≥50 mm for pain intensity at the Baseline Visit and/or a Numerical Opioid Side Effect (NOSE) Assessment Tool ≥40 for intolerable side effects at the Baseline Visit

Key exclusion criteria (8 listed)

Previously trialed or implanted with an IDDS
Concomitant stimulation device implanted for the treatment of pain
Any ongoing health condition that would be expected to interfere with pain and/or quality of life ratings (i.e. active malignancy, other painful conditions not treatable with IT therapy, etc.)
Psychological or other health conditions, financial and/or legal concerns that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's discretion
Substance Use Disorder (SUD) within the last 2 years or current Medication Assisted Treatment (MAT) for substance use disorder

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
Medtronic SynchroMed™ II infusion systemImplanted infusion system consisting of a pump and catheter, as well as external components of a clinician programmer, refill and catheter access port kits, and the Personal Therapy Manager (myPTM™).	Device	Intrathecal Therapy
Preservative-free morphine sulfate (PFMS)The pharmacological agent used in the pump for this study is limited to a preservative-free morphine sulfate (PFMS).	Drug	Intrathecal Therapy

Primary outcome

Number of Participants With Clinical Success at the 6-Month Visit
Time frame: Baseline to 6-Month Visit
To characterize the number of subjects with Clinical Success at the 6-Month Visit. Clinical Success is defined as any of the following: 1) Reduced opioid-related side effects (at least a 20% reduction) with equal pain (less than 20% increase or decrease) 2) Reduced pain (at least a 20% reduction) with equal opioid-related side effects (less than 20% increase or decrease) 3) Reduced pain and reduced opioid-related side effects (at least a 20% reduction in both). The number of subjects with Clinical Success at the 6-Month Visit is presented.

3 secondary outcomes

Visual Analog Scale (VAS) Pain Intensity at the 6-Month Visit
Time frame: Baseline to 6-Month Visit
Numerical Opioid Side Effect (NOSE) Assessment Tool
Time frame: Baseline to 6-Month Visit
Number of Participants With Systemic Opioid Elimination Through the 6-Month Visit
Time frame: Baseline to 6-Month Visit

Results and safety

Results posted to the registry on 8 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enrolled Subjects	93	52

Primary outcome: Number of Participants With Clinical Success at the 6-Month Visit

Time frame: Baseline to 6-Month Visit. Count of participants. Unit: Participants

Measure	Targeted Drug Delivery Subjects n = 42
Value	25

Population analysed: A subset of the Targeted Drug Delivery Subjects who maintained intrathecal morphine monotherapy (ITMM) and provided outcome data at both the Baseline and 6-Month (6M) Visit. Of the 52 implanted subjects, 47 completed the 6M Visit, and 42 maintained ITMM through the 6M Visit. Four of the subjects who did not maintain ITMM through the 6M Visit changed their intrathecal medication, and one subject was explanted prior to the 6M Visit and completed the 6M Visit post-explant.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from date of subject consent through study exit, up to 12 months following intrathecal therapy initiation after implant of the Intrathecal Drug Delivery System, if applicable.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enrolled Subjects	20 of 93 (21.5%)	18 of 93 (19.4%)	1 of 93

Limitations and caveats (from the sponsor): Protocol V3.0 revised the last study visit from the 12-Month Visit to the 6-Month Visit at a point in the study where some subjects, but not all, had already progressed beyond the 6-Month Visit. Thus, subjects consented under Protocol V3.0 may complete the study without completing the 12-Month Visit. This protocol revision did not impact the Primary and Secondary endpoints, which are evaluated at 6 months.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12351602Smith TJ, Staats PS, Deer T, Stearns LJ, Rauck RL, Boortz-Marx RL, Buchser E, Catala E, Bryce DA, Coyne PJ, Pool GE; Implantable Drug Delivery Systems Study Group. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002 Oct 1;20(19):4040-9. doi: 10.1200/JCO.2002.02.118.
Background: PubMed 22845187Hamza M, Doleys D, Wells M, Weisbein J, Hoff J, Martin M, Soteropoulos C, Barreto J, Deschner S, Ketchum J. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012 Oct;13(10):1304-13. doi: 10.1111/j.1526-4637.2012.01451.x. Epub 2012 Jul 30.
Background: PubMed 26477685Grider JS, Etscheidt MA, Harned ME, Lee J, Smith B, Lamar C, Bux A. Trialing and Maintenance Dosing Using a Low-Dose Intrathecal Opioid Method for Chronic Nonmalignant Pain: A Prospective 36-Month Study. Neuromodulation. 2016 Feb;19(2):206-19. doi: 10.1111/ner.12352. Epub 2015 Oct 19.
Background: PubMed 26307558Hamza M, Doleys DM, Saleh IA, Medvedovsky A, Verdolin MH, Hamza M. A Prospective, Randomized, Single-Blinded, Head-to-Head Long-Term Outcome Study, Comparing Intrathecal (IT) Boluses With Continuous Infusion Trialing Techniques Prior to Implantation of Drug Delivery Systems (DDS) for the Treatment of Severe Intractable Chronic Nonmalignant Pain. Neuromodulation. 2015 Oct;18(7):636-48; discussion 649. doi: 10.1111/ner.12342. Epub 2015 Aug 26.
Background: PubMed 29016893Wilkes DM, Orillosa SJ, Hustak EC, Williams CG, Doulatram GR, Solanki DR, Garcia EA, Huang LM. Efficacy, Safety, and Feasibility of the Morphine Microdose Method in Community-Based Clinics. Pain Med. 2018 Sep 1;19(9):1782-1789. doi: 10.1093/pm/pnx132.
Background: PubMed 21785477Grider JS, Harned ME, Etscheidt MA. Patient selection and outcomes using a low-dose intrathecal opioid trialing method for chronic nonmalignant pain. Pain Physician. 2011 Jul-Aug;14(4):343-51.
Applicable Product Manual(s) for the SynchroMed II infusion systemLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Chronic Non-malignant Pain

Recruiting
Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity
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Active, not recruiting
Effectiveness of Acceptance and Commitment Therapy for Chronic Non-Malignant Pain: A Randomized Controlled Trial
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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.

The record lists no contact. Use the official record to reach the sponsor.

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 8 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 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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.

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 8 Feb 2023). 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?

Number of Participants With Clinical Success at the 6-Month Visit (time frame: Baseline to 6-Month Visit). 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 NCT03761277, which also lists 6 linked publications.

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 Feb 2023; AzTrials last refreshed its copy on 26 Oct 2026.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (10 listed)

Key exclusion criteria (8 listed)

Interventions

Primary outcome

Results and safety

Participant flow

Primary outcome: Number of Participants With Clinical Success at the 6-Month Visit

Adverse events

Research links

Related trials for Chronic Non-malignant Pain

Integrating Nonpharmacologic Strategies for Pain With Inclusion, Respect, and Equity

Effectiveness of Acceptance and Commitment Therapy for Chronic Non-Malignant Pain: A Randomized Controlled Trial

Collaboratory Treatment Pathway for Chronic Pain Patients.

Referral and contact

Questions about this trial

Participant flow

Primary outcome: Number of Participants With Clinical Success at the 6-Month Visit

Adverse events