Chronic PainRECOUPNCT03675386
Reducing Opioid Use for Chronic Pain Patients Following Surgery
A study testing Interventional Group in people with Chronic Pain and Opioid Use, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Patients with chronic pain are often prescribed long-term opioid therapy, despite the serious risks and growing concerns related to opioid use. The Toronto General Hospital has created the world's first multidisciplinary perioperative Transitional Pain Service Program (TPSP) aimed at reducing the incidence and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Opioid Use, Postoperative Pain
- What is being tested?
- Interventional Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteCanada
- Study dates
- 15 Oct 2018to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥ 18 years of age
- Taking 10 -- 400 mg of preoperative oral morphine equivalents daily
- Any type of surgical procedure, with the exception of those with palliative intent or organ transplantation
- Able to read and understand English as posed on the questionnaire surveys prior to informed consent
- Must be taking opioids for at least one month prior to their operation
- Must have a personal email address for the set-up of the Manage My Pain (MMP) App or online multimedia tool
Who cannot join
- Subjects who are undergoing palliative care or procedures, organ transplantation, or prescribed with Methadone/Buprenorphine will be excluded from the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto General Hospital- University Health Network
Toronto, Ontario, M5G 2N2
Karim Ladha, MD, (416) 719-0030, karim.ladha@uhn.ca
Hance Clarke, MD, PhD, (416) 340-4800, hance.clarke@uhn.ca
About this study
Official title: Ontario Transitional Pain and Opioid Safety Program: Improving Pain and Opioid Practices for Complex Chronic Pain Patients Following Surgery
Patients with chronic pain are often prescribed long-term opioid therapy, despite the serious risks and growing concerns related to opioid use. The Toronto General Hospital has created the world's first multidisciplinary perioperative Transitional Pain Service Program (TPSP) aimed at reducing the incidence and severity of chronic post-surgical pain. The TPSP incorporates a variety of mechanisms and interventions to help patients manage pain and to wean off opioids. The approach consists of: pain education, Acceptance and Commitment Therapy (ACT), and an e-mobile self- management tool to help patients manage chronic pain more effectively. With the TPSP team, the investigators hope to continually assist patients to achieve a balance between the benefits and potential harms of opioid use to promote long-term health and well-being.
Read the detailed description
The proposed research program encompasses several study designs to evaluate the effectiveness and potential implementation of the TPSP across Ontario. The investigators will use three approaches to create a comprehensive evidence-base that can be used to guide future policy and programs related to the management of surgical patients with complex pain and chronic opioid use. In the first phase, a multicenter randomized controlled trial will be conducted in 6 hospital sites to evaluate the effectiveness and potential implementation of TPSP across Ontario. The aim is to recruit a total of 210 patients who are currently taking opioids and also undergoing a surgical intervention. The randomized controlled trial will determine the effectiveness of the TPSP at weaning patients completely off opioids while still managing pain after one year. Secondly, an economic and healthcare utilization analysis of the program via linkage to provincial administrative databases will be carried out to understand the impact the TPSP program has on the healthcare system as a whole. Lastly, a qualitative study will be conducted on both the treatment and control groups. The investigators hope to capture further insight to understand patients and providers experiences of the TPSP intervention.
- Conditions
- Chronic Pain, Opioid Use, Postoperative Pain, Opioid Dependence
- Being tested
- Interventional Group, Control Intervention
- Medical subject headings
- Chronic Pain, Pain, Postoperative, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional GroupOther
Also called Transitional Pain Service Program
The Transitional Pain Service Program enables targeted, mechanism-based, treatment innovations aimed at reducing the incidence and severity of chronic post-surgical pain, disability and enabling safe opioid prescribing/ weaning after major surgery. The investigator's TPSP intervention uses a variety of methods to support patients to manage pain and wean off opioids. This includes physician-guided opioid and non-opioid pharmacotherapy and tapering, and clinical psychology services specializing in pain education, Acceptance \& Commitment Therapy (ACT) and e-mobile self-management tools.
Control InterventionOther
Patients in the control group will receive standard care, which involves standard postoperative follow-up with their surgeon/primary care provider. Patients will also be sent with a link for an online multimedia tool during each follow-up time point that will provide information and education regarding non-pharmacologic techniques for managing pain. At the end, all patients in the control arm will be invited to join the TPSP after one year of follow-up if they are still taking opioids.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Patients in the control group will receive standard care, which involves standard postoperative follow-up with their surgeon/primary care provider. Patients will also be sent with a link for an online multimedia tool during each follow-up time point that will provide information and education regarding non-pharmacologic techniques for managing pain. At the end, all patients in the control arm will be invited to join the TPSP after one year of follow-up if they are still taking opioids. Receives: Other: Control Intervention |
| Interventional Group | Experimental | Patients in the interventional group will be given a Transitional Pain Service follow-up appointment at the following postoperative time points (2 to 6 visits for the first two months, and then 1 to 2 visits on a monthly basis until one year). At each visit, patients will meet with the clinical psychologist and chronic pain specialist. Patients in the intervention group will have access to the Manage My Pain (MMP) App. which allows people living with pain to quickly and easily track their pain and function on a daily basis on their smartphones or a browser on their desktop or mobile device. One-page clinical reports will capture the changes in patients' outcome data between clinical visits over the course in time.Clinic visits can be offered in person at the hospital or over telehealth (video conference) based on the patient's preference and clinician's judgment for telehealth suitability. Receives: Other: Interventional Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Portion of patients weaned off opioids
Opioid weaning measured by number of patients successfully weaned off opioids comparing the intervention arm versus control arm
Measured: 1 year
Pain interference
Brief Pain Inventory Scale is a measure that assess the severity of pain and the impact of pain on daily functions. Measurement of this scale is rated on a 0-10 numerical-rating-scale ( 0= No Pain to 10= Pain as bad as you can imagine or 0= Does not interfere to 10= Completely interferes). The BPI assess pain at its worst, least, average, and now. Pain Severity Score is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10. Pain Interference Score is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start15 Oct 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Ladha, MD, Principal investigator, Toronto General Hospital, University Health NetworkHance Clarke, MD, PhD, Principal investigator, Toronto General Hospital, University Health NetworkElaheh Adly, MD, Principal investigator, Hamilton Health Sciences CentrePaul Tumber, MD, Principal investigator, University Health Network, TorontoAnton Marinov, MD, Principal investigator, Rouge Valley Medical CentreMelanie Toman, MD, Principal investigator, Thunder Bay Reginal Health Sciences CentreYuvaraj Kotteeswaran, MD, Principal investigator, Thunder Bay Reginal Health Sciences CentreDuminda Wijeysundera, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675386
- Sponsor's protocol ID
- 18-5207
- Acronym
- RECOUP
- Status last verified
- Apr 2026
- First submitted
- 11 May 2018
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097/00000542-200603000-00025.
PubMed 16508405Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.
PubMed 24829420Savage SR. Long-term opioid therapy: assessment of consequences and risks. J Pain Symptom Manage. 1996 May;11(5):274-86. doi: 10.1016/0885-3924(95)00202-2.
PubMed 8636626Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.
PubMed 25581257Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother. 2009 May;9(5):723-44. doi: 10.1586/ern.09.20.
PubMed 19402781Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251.
PubMed 24519537Sun EC, Dixit A, Humphreys K, Darnall BD, Baker LC, Mackey S. Association between concurrent use of prescription opioids and benzodiazepines and overdose: retrospective analysis. BMJ. 2017 Mar 14;356:j760. doi: 10.1136/bmj.j760.
PubMed 28292769Katz J, Weinrib A, Fashler SR, Katznelzon R, Shah BR, Ladak SS, Jiang J, Li Q, McMillan K, Santa Mina D, Wentlandt K, McRae K, Tamir D, Lyn S, de Perrot M, Rao V, Grant D, Roche-Nagle G, Cleary SP, Hofer SO, Gilbert R, Wijeysundera D, Ritvo P, Janmohamed T, O'Leary G, Clarke H. The Toronto General Hospital Transitional Pain Service: development and implementation of a multidisciplinary program to prevent chronic postsurgical pain. J Pain Res. 2015 Oct 12;8:695-702. doi: 10.2147/JPR.S91924. eCollection 2015.
PubMed 26508886Weinrib AZ, Burns LC, Mu A, Azam MA, Ladak SS, McRae K, Katznelson R, Azargive S, Tran C, Katz J, Clarke H. A case report on the treatment of complex chronic pain and opioid dependence by a multidisciplinary transitional pain service using the ACT Matrix and buprenorphine/naloxone. J Pain Res. 2017 Mar 27;10:747-755. doi: 10.2147/JPR.S124566. eCollection 2017.
PubMed 28392713Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.
PubMed 15042521Rampakakis E, Ste-Marie PA, Sampalis JS, Karellis A, Shir Y, Fitzcharles MA. Real-life assessment of the validity of patient global impression of change in fibromyalgia. RMD Open. 2015 Sep 14;1(1):e000146. doi: 10.1136/rmdopen-2015-000146. eCollection 2015.
PubMed 26535150Portenoy R. Development and testing of a neuropathic pain screening questionnaire: ID Pain. Curr Med Res Opin. 2006 Aug;22(8):1555-65. doi: 10.1185/030079906X115702.
PubMed 16870080Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. doi: 10.1016/j.jpain.2007.09.005. Epub 2007 Dec 11.
PubMed 18055266Lowe B, Wahl I, Rose M, Spitzer C, Glaesmer H, Wingenfeld K, Schneider A, Brahler E. A 4-item measure of depression and anxiety: validation and standardization of the Patient Health Questionnaire-4 (PHQ-4) in the general population. J Affect Disord. 2010 Apr;122(1-2):86-95. doi: 10.1016/j.jad.2009.06.019. Epub 2009 Jul 17.
PubMed 19616305Darnall BD, Sturgeon JA, Cook KF, Taub CJ, Roy A, Burns JW, Sullivan M, Mackey SC. Development and Validation of a Daily Pain Catastrophizing Scale. J Pain. 2017 Sep;18(9):1139-1149. doi: 10.1016/j.jpain.2017.05.003. Epub 2017 May 19.
PubMed 28528981
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ontario Transitional Pain and Opioid Safety Program: Improving Pain and Opioid Practices for Complex Chronic Pain Patients Following Surgery
- ClinicalTrials.gov ID
- NCT03675386
- Acronym / sponsor ID
- RECOUP / 18-5207
- Conditions
- Chronic Pain, Opioid Use, Postoperative Pain, Opioid Dependence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Sep 2018 (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.
Patients with chronic pain are often prescribed long-term opioid therapy, despite the serious risks and growing concerns related to opioid use. The Toronto General Hospital has created the world's first multidisciplinary perioperative Transitional Pain Service Program (TPSP) aimed at reducing the incidence and severity of chronic post-surgical pain. The TPSP incorporates a variety of mechanisms and interventions to help patients manage pain and to wean off opioids. The approach consists of: pain education, Acceptance and Commitment Therapy (ACT), and an e-mobile self- management tool to help patients manage chronic pain more effectively. With the TPSP team, the investigators hope to continually assist patients to achieve a balance between the benefits and potential harms of opioid use to promote long-term health and well-being.
Detailed description
The proposed research program encompasses several study designs to evaluate the effectiveness and potential implementation of the TPSP across Ontario. The investigators will use three approaches to create a comprehensive evidence-base that can be used to guide future policy and programs related to the management of surgical patients with complex pain and chronic opioid use. In the first phase, a multicenter randomized controlled trial will be conducted in 6 hospital sites to evaluate the effectiveness and potential implementation of TPSP across Ontario. The aim is to recruit a total of 210 patients who are currently taking opioids and also undergoing a surgical intervention. The randomized controlled trial will determine the effectiveness of the TPSP at weaning patients completely off opioids while still managing pain after one year. Secondly, an economic and healthcare utilization analysis of the program via linkage to provincial administrative databases will be carried out to understand the impact the TPSP program has on the healthcare system as a whole. Lastly, a qualitative study will be conducted on both the treatment and control groups. The investigators hope to capture further insight to understand patients and providers experiences of the TPSP intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control InterventionPatients in the control group will receive standard care, which involves standard postoperative follow-up with their surgeon/primary care provider. Patients will also be sent with a link for an online multimedia tool during each follow-up time point that will provide information and education regarding non-pharmacologic techniques for managing pain. At the end, all patients in the control arm will be invited to join the TPSP after one year of follow-up if they are still taking opioids. |
| Interventional Group | Experimental | Other: Interventional GroupPatients in the interventional group will be given a Transitional Pain Service follow-up appointment at the following postoperative time points (2 to 6 visits for the first two months, and then 1 to 2 visits on a monthly basis until one year). At each visit, patients will meet with the clinical psychologist and chronic pain specialist. Patients in the intervention group will have access to the Manage My Pain (MMP) App. which allows people living with pain to quickly and easily track their pain and function on a daily basis on their smartphones or a browser on their desktop or mobile device. One-page clinical reports will capture the changes in patients' outcome data between clinical visits over the course in time.Clinic visits can be offered in person at the hospital or over telehealth (video conference) based on the patient's preference and clinician's judgment for telehealth suitability. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥ 18 years of age
- Taking 10 -- 400 mg of preoperative oral morphine equivalents daily
- Any type of surgical procedure, with the exception of those with palliative intent or organ transplantation
- Able to read and understand English as posed on the questionnaire surveys prior to informed consent
- Must be taking opioids for at least one month prior to their operation
Key exclusion criteria (1 listed)
- Subjects who are undergoing palliative care or procedures, organ transplantation, or prescribed with Methadone/Buprenorphine will be excluded from the trial
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 |
|---|---|---|
| Interventional GroupAlso: Transitional Pain Service ProgramThe Transitional Pain Service Program enables targeted, mechanism-based, treatment innovations aimed at reducing the incidence and severity of chronic post-surgical pain, disability and enabling safe opioid prescribing/ weaning after major surgery. The investigator's TPSP intervention uses a variety of methods to support patients to manage pain and wean off opioids. This includes physician-guided opioid and non-opioid pharmacotherapy and tapering, and clinical psychology services specializing in pain education, Acceptance \& Commitment Therapy (ACT) and e-mobile self-management tools. | Other | Interventional Group |
| Control InterventionPatients in the control group will receive standard care, which involves standard postoperative follow-up with their surgeon/primary care provider. Patients will also be sent with a link for an online multimedia tool during each follow-up time point that will provide information and education regarding non-pharmacologic techniques for managing pain. At the end, all patients in the control arm will be invited to join the TPSP after one year of follow-up if they are still taking opioids. | Other | Control Group |
Primary outcome
Portion of patients weaned off opioids
Time frame: 1 year
Opioid weaning measured by number of patients successfully weaned off opioids comparing the intervention arm versus control arm
Pain interference
Time frame: One year
Brief Pain Inventory Scale is a measure that assess the severity of pain and the impact of pain on daily functions. Measurement of this scale is rated on a 0-10 numerical-rating-scale ( 0= No Pain to 10= Pain as bad as you can imagine or 0= Does not interfere to 10= Completely interferes). The BPI assess pain at its worst, least, average, and now. Pain Severity Score is calculated by adding the scores for questions 2, 3, 4 and 5 and then dividing by 4. This gives a severity score out of 10. Pain Interference Score is calculated by adding the scores for questions 8a, b, c, d, e, f and g and then dividing by 7. This gives an interference score out of 10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 16508405Angst MS, Clark JD. Opioid-induced hyperalgesia: a qualitative systematic review. Anesthesiology. 2006 Mar;104(3):570-87. doi: 10.1097/00000542-200603000-00025.
- Background: PubMed 24829420Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.
- Background: PubMed 8636626Savage SR. Long-term opioid therapy: assessment of consequences and risks. J Pain Symptom Manage. 1996 May;11(5):274-86. doi: 10.1016/0885-3924(95)00202-2.
- Background: PubMed 25581257Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559.
- Background: PubMed 19402781Katz J, Seltzer Z. Transition from acute to chronic postsurgical pain: risk factors and protective factors. Expert Rev Neurother. 2009 May;9(5):723-44. doi: 10.1586/ern.09.20.
- Background: PubMed 24519537Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251.
- Background: PubMed 28292769Sun EC, Dixit A, Humphreys K, Darnall BD, Baker LC, Mackey S. Association between concurrent use of prescription opioids and benzodiazepines and overdose: retrospective analysis. BMJ. 2017 Mar 14;356:j760. doi: 10.1136/bmj.j760.
- Background: PubMed 26508886Katz J, Weinrib A, Fashler SR, Katznelzon R, Shah BR, Ladak SS, Jiang J, Li Q, McMillan K, Santa Mina D, Wentlandt K, McRae K, Tamir D, Lyn S, de Perrot M, Rao V, Grant D, Roche-Nagle G, Cleary SP, Hofer SO, Gilbert R, Wijeysundera D, Ritvo P, Janmohamed T, O'Leary G, Clarke H. The Toronto General Hospital Transitional Pain Service: development and implementation of a multidisciplinary program to prevent chronic postsurgical pain. J Pain Res. 2015 Oct 12;8:695-702. doi: 10.2147/JPR.S91924. eCollection 2015.
- Background: PubMed 28392713Weinrib AZ, Burns LC, Mu A, Azam MA, Ladak SS, McRae K, Katznelson R, Azargive S, Tran C, Katz J, Clarke H. A case report on the treatment of complex chronic pain and opioid dependence by a multidisciplinary transitional pain service using the ACT Matrix and buprenorphine/naloxone. J Pain Res. 2017 Mar 27;10:747-755. doi: 10.2147/JPR.S124566. eCollection 2017.
- Background: PubMed 15042521Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.
- Background: PubMed 26535150Rampakakis E, Ste-Marie PA, Sampalis JS, Karellis A, Shir Y, Fitzcharles MA. Real-life assessment of the validity of patient global impression of change in fibromyalgia. RMD Open. 2015 Sep 14;1(1):e000146. doi: 10.1136/rmdopen-2015-000146. eCollection 2015.
- Background: PubMed 16870080Portenoy R. Development and testing of a neuropathic pain screening questionnaire: ID Pain. Curr Med Res Opin. 2006 Aug;22(8):1555-65. doi: 10.1185/030079906X115702.
- 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.
Karim Ladha, MD principal investigator
Toronto General Hospital, University Health Network
Hance Clarke, MD, PhD principal investigator
Toronto General Hospital, University Health Network
Elaheh Adly, MD principal investigator
Hamilton Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventional Group in people with Chronic Pain and Opioid Use, run by University Health Network, Toronto at 1 site in Canada.
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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karim Ladha, MD (416-719-0030, Karim.Ladha@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Portion of patients weaned off opioids (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT03675386, which also lists 17 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 30 Apr 2026.