Clinical trial · Interventional
Improving Outcomes and Lowering Costs by Integration of Primary Care Providers and Pain Medicine Physicians for Pain Pts
Improving Functional Outcomes and Lowering Health Care Costs by Enhanced Integration of Primary Care Providers and Pain Medicine Physicians for Chronic Non-cancer Pain Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Recruitment issues
Summary
Brief summary (as posted)
This study will demonstrate that functional improvement measures over a 6-month period for chronic low back patients under the care of Primary Care Provider (PCP), using a therapeutic plan formulated initially by the Pain Medicine Specialist (PMS), are equivalent to those under the care of the PMS only. Chronic low back pain patient will be initially be evaluated by the PMS. If no interventional pain therapy is required, a multimodal therapeutic plan (pharmacological and/or non-pharmacological) will be formulated to manage the chronic low back pain. Patients will be randomized into one of the two groups: Group 1 - Subjects will be treated monthly for the following 6 months by PMS, and Group 2 - Subjects will be treated by their own PCP for monthly visits for 6 months.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Back Pain | — | UNRESOLVED | — |
| Chronic Pain | — | UNRESOLVED | — |
| Pain, Intractable | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Group 1 (PMS Treatment) | Other | — | UNRESOLVED |
| Group 2 (PCP Treatment) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1 (PMS Treatment)
- description
- Subjects will be treated monthly for 6 months by Pain Medicine Specialist (PMS) per standard protocol. The PCP will not be involved in the treatment.
- interventionNames
- Other: Group 1 (PMS Treatment)
- type
- EXPERIMENTAL
- label
- Group 2 (PCP Treatment)
- description
- Subjects will be treated monthly for 6 months by the Primary Care Provider (PCP).The PCP will be involved and a multimodal therapeutic strategy will be communicated to the PCP by the PMS. The PCP will make dosage based on an algorithm provided by the PMS on how to adjust drug doses over time. It is not intended that the PCP may have ongoing engagement with the PMS. A direct line of communication will be set up between the PCP and the data integration clinical coordinator to handle serious medical concerns.
- interventionNames
- Other: Group 2 (PCP Treatment)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1.Non-structural non-specific chronic low back pain of a least 3 months duration 2.18 years of age or older 3.Has a primary care provider (PCP) Exclusion Criteria: 1. Unable to communicate with health care providers 2. Refuses to complete the required outcome measures 3. Unable to provide consent 4. Advanced medical illness (severe systemic disease) 5. Significant psychiatric history: a diagnosis of schizophrenia, bipolar disorder, or severe depression. 6. History of psychosis or psychiatric hospitalization, suicidal ideation or attempt.
References
Publications (0)
Data not yet available