Persistent Spinal Pain SyndromePhase 4NCT07091123
Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.
A Phase 4 study testing Pain pump, Bupivacain 0.625%/Fentanyl 2mcg/ml and Spinal Cord Stimulator (SCS) in people with Persistent Spinal Pain Syndrome, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Spinal cord stimulation (SCS) or intrathecal drug delivery (pain pump) can be effective in providing pain relief for patients with low back pain who have not responded to other treatments. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Persistent Spinal Pain Syndrome
- What is being tested?
- Pain pump, Bupivacain 0.625%/Fentanyl 2mcg/ml and Spinal Cord Stimulator (SCS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2025to 11 Aug 2027
- Phase
- Phase 4
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30 years or greater
- Previous lumbar or thoracic spine surgery
- Intractable pain of trunk (more than limbs; ≥ 75%/25% ratio back/leg pain)
- Patient who passed psychological evaluations as part of the usual clinical care prior to consideration of IDDS and are stable with current pain condition and medications
- Failed more conservative management, including physical therapy, medications and injections.
Who cannot join
- Untreated infection or coagulopathy/patient unable to stop anticoagulants
- Immune compromised state precluding having an implant
- Allergic reactions to bupivacaine or fentanyl
- Pregnancy.
- Patients using > 15 mg oral equivalents of morphine daily or who are unable to wean down below that dosage for 4 weeks or more before the prognostic test date
- Neurological deficits characterized as weakness in lower extremities with evidence of nerve damage resulting in difficulty ambulating
- Patients deemed by Spine Surgery to be candidates for revision lumbar spine surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Spinal cord stimulation (SCS) or intrathecal drug delivery (pain pump) can be effective in providing pain relief for patients with low back pain who have not responded to other treatments. While both treatments, SCS and pain pump, may help with low back pain relief, it is not known which treatment may work better for patients. SCS and pain pumps involve an implanted device in the body.
In this study, we are asking patients to undergo a trial of both treatment modalities, SCS and pain pump, as screening tests prior to considering an implant. A total of 36 patients will be enrolled in this study. After both trials are completed, participants will be seen in the office and asked which treatment modality they believe has been more effective for relieving pain during the trial periods by completing questionnaires. If neither treatment was effective in improving baseline pain by at least 50%, participants would not qualify for either implant whether or not they are part of this study. Direct study participation would end here. If either or both treatment modalities improved baseline pain by at least 50%, participants will be asked to choose the treatment that worked better: SCS or pain pump. Participants will then have the option to proceed to the permanent implant of choice: SCS or pain pump. Direct study participation would end here but participants will then be followed in the doctor's office after implant as is customary for usual clinical care. The study data collection will conclude when the screening tests are completed.
- Conditions
- Persistent Spinal Pain Syndrome
- Being tested
- Pain pump, Bupivacain 0.625%/Fentanyl 2mcg/ml, Spinal Cord Stimulator (SCS)
- Keywords
- Pain pump, neuromodulation prognostic tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain pumpDevice
Spinal catheter place under local anesthesia.
Bupivacain 0.625%/Fentanyl 2mcg/mlDrug
A solution containing fentanyl 2 mcg/mL and bupivacaine 0.625 mg/mL at an infusion rate of 0.5 ml/hr.
Spinal Cord Stimulator (SCS)Device
Two spinal cord stimulation leads will then be advanced under fluoroscopy to the target area, typically around T7-T9 in the posterior epidural space.
Currently, there are six manufacturers of spinal cord stimulation devices with implanted programmable generators or receivers.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | SCS prognostic test performed first followed about 2-4 weeks later with continuous IDD test with bupivacaine 0.625 mg/ml and fentanyl 2 mcg/ml for 8-23 hours. Receives: Device: Pain pump; Drug: Bupivacain 0.625%/Fentanyl 2mcg/ml; Device: Spinal Cord Stimulator (SCS) |
| Group B | Active comparator | IDD prognostic test for 8-23 hours followed 2-4 weeks later by SCS prognostic test. Receives: Device: Pain pump; Drug: Bupivacain 0.625%/Fentanyl 2mcg/ml; Device: Spinal Cord Stimulator (SCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity as measured by Numerical Rating Scale [NRS]
Numerical Rating Scale [NRS] is a numbered scale, from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable
Measured: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group) 3, 6, 12 months for implanted patients
Change in pain intensity as measured by Oswestry disability index [ODI]
Oswestry disability index [ODI] is a questionnaire used to assess the impact of low back pain on a person's daily life. The ODI score ranges from 0 to 100, with lower scores indicating less disability.
Measured: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group), 3, 6, 12 months for implanted patients
Change in pain intensity as measured by painDETECT
painDETECT is a nine-item questionnaire. A total score of 19 or more is indicative of likely neuropathic pain.
Measured: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group), 3, 6, 12 months for implanted patients
Secondary outcomes (3)
Change in quality of life as measured by the PROMIS-29.
PROMIS-29 is 29 item patient reported outcome tool measuring health-related quality of life. With higher scores indicating higher quality of life.
Measured: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group), 3, 6, 12 months for implanted patients
Number of adverse events as measured by patient report,
Measured: Up to 12 months
Change in daily opioid consumption as measured by Rx report
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start13 Oct 2025
- Primary completion11 Aug 2027 (estimated)
- Study completion11 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Spinal Pain SyndromeStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salim M Hayek, University Hospitals Cleveland Medical Center
- Investigators
- Salim Hayek, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07091123
- Sponsor's protocol ID
- STUDY20241226
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Preference and Long-term Outcomes in Persistent Spinal Pain Syndrome: A Prospective Study Comparing Spinal Cord Stimulation to Intrathecal Drug Delivery.
- ClinicalTrials.gov ID
- NCT07091123
- Acronym / sponsor ID
- STUDY20241226
- Conditions
- Persistent Spinal Pain Syndrome
- Keywords
- Pain pump, neuromodulation prognostic tests
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 11 Aug 2027 (estimated)
- Study completion
- 11 Aug 2027 (estimated)
- First posted
- 29 Jul 2025 (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.
Spinal cord stimulation (SCS) or intrathecal drug delivery (pain pump) can be effective in providing pain relief for patients with low back pain who have not responded to other treatments. While both treatments, SCS and pain pump, may help with low back pain relief, it is not known which treatment may work better for patients. SCS and pain pumps involve an implanted device in the body.
In this study, we are asking patients to undergo a trial of both treatment modalities, SCS and pain pump, as screening tests prior to considering an implant. A total of 36 patients will be enrolled in this study. After both trials are completed, participants will be seen in the office and asked which treatment modality they believe has been more effective for relieving pain during the trial periods by completing questionnaires. If neither treatment was effective in improving baseline pain by at least 50%, participants would not qualify for either implant whether or not they are part of this study. Direct study participation would end here. If either or both treatment modalities improved baseline pain by at least 50%, participants will be asked to choose the treatment that worked better: SCS or pain pump. Participants will then have the option to proceed to the permanent implant of choice: SCS or pain pump. Direct study participation would end here but participants will then be followed in the doctor's office after implant as is customary for usual clinical care. The study data collection will conclude when the screening tests are completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Pain pump, Drug: Bupivacain 0.625%/Fentanyl 2mcg/ml, Device: Spinal Cord Stimulator (SCS)SCS prognostic test performed first followed about 2-4 weeks later with continuous IDD test with bupivacaine 0.625 mg/ml and fentanyl 2 mcg/ml for 8-23 hours. |
| Group B | Active comparator | Device: Pain pump, Drug: Bupivacain 0.625%/Fentanyl 2mcg/ml, Device: Spinal Cord Stimulator (SCS)IDD prognostic test for 8-23 hours followed 2-4 weeks later by SCS prognostic test. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30 years or greater
- Previous lumbar or thoracic spine surgery
- Intractable pain of trunk (more than limbs; ≥ 75%/25% ratio back/leg pain)
- Patient who passed psychological evaluations as part of the usual clinical care prior to consideration of IDDS and are stable with current pain condition and medications
- Failed more conservative management, including physical therapy, medications and injections.
Key exclusion criteria (7 listed)
- Untreated infection or coagulopathy/patient unable to stop anticoagulants
- Immune compromised state precluding having an implant
- Allergic reactions to bupivacaine or fentanyl
- Pregnancy.
- Patients using > 15 mg oral equivalents of morphine daily or who are unable to wean down below that dosage for 4 weeks or more before the prognostic test date
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 |
|---|---|---|
| Pain pumpSpinal catheter place under local anesthesia. | Device | Group A, Group B |
| Bupivacain 0.625%/Fentanyl 2mcg/mlA solution containing fentanyl 2 mcg/mL and bupivacaine 0.625 mg/mL at an infusion rate of 0.5 ml/hr. | Drug | Group A, Group B |
| Spinal Cord Stimulator (SCS)Two spinal cord stimulation leads will then be advanced under fluoroscopy to the target area, typically around T7-T9 in the posterior epidural space. Currently, there are six manufacturers of spinal cord stimulation devices with implanted programmable generators or receivers. | Device | Group A, Group B |
Primary outcome
Change in pain intensity as measured by Numerical Rating Scale [NRS]
Time frame: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group) 3, 6, 12 months for implanted patients
Numerical Rating Scale [NRS] is a numbered scale, from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable
Change in pain intensity as measured by Oswestry disability index [ODI]
Time frame: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group), 3, 6, 12 months for implanted patients
Oswestry disability index [ODI] is a questionnaire used to assess the impact of low back pain on a person's daily life. The ODI score ranges from 0 to 100, with lower scores indicating less disability.
Change in pain intensity as measured by painDETECT
Time frame: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group), 3, 6, 12 months for implanted patients
painDETECT is a nine-item questionnaire. A total score of 19 or more is indicative of likely neuropathic pain.
3 secondary outcomes
Change in quality of life as measured by the PROMIS-29.
Time frame: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group), 3, 6, 12 months for implanted patients
Number of adverse events as measured by patient report,
Time frame: Up to 12 months
Change in daily opioid consumption as measured by Rx report
Time frame: 3, 6, 12 months
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 3 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Persistent Spinal Pain Syndrome
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Persistent Pain Syndrome
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Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome
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SPINE-RISK VE: Multimodal Predictive Model for Failed Back Surgery Syndrome in Venezuelan Surgical Patients
Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine, Chronic Low Back Pain
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Evaluation of Medication Tapering on the Sensitivity of the Spinal Cord Using Closed-Loop Spinal Cord Stimulation (Pilot Study)
Failed Back Surgery Syndrome (FBSS), Persistent Spinal Pain Syndrome Type 2 (PSPS-T) Lower Spine
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.
Salim Hayek, MD principal investigator
University Hospitals
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 Pain pump, Bupivacain 0.625%/Fentanyl 2mcg/ml and Spinal Cord Stimulator (SCS) in people with Persistent Spinal Pain Syndrome, run by University Hospitals Cleveland Medical Center 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 5 inclusion and 7 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 3 Feb 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 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?
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 Ayse Ulucay, MD (216-844-3771, Ayse.Ulucay@UHhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity as measured by Numerical Rating Scale [NRS] (time frame: Baseline, up to 23 hours after catheter placement (for IDD group) Baseline, one week after lead placement (for SCS group) 3, 6, 12 months for implanted patients). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.