Lumbosacral RadiculopathyPEACENCT07498140
Procedural Framing and Epidural Steroid Injection Outcomes
A study testing Behavioral manipulation of ESI expectations, No behavioral manipulation of ESI expectations and No behavioral manipulation of pharmacotherapy expectations in people with Lumbosacral Radiculopathy, run by Northwestern University at 4 sites in 3 countries.
Trial summary
Back pain is the leading cause of disability and military medical boards across the globe. Epidural steroid injections (ESI) are the most commonly performed pain procedure in the world. There is strong evidence that the placebo effect for all pain treatments, including ESI, is greater than the intrinsic effect. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- Behavioral manipulation of ESI expectations, No behavioral manipulation of ESI expectations and No behavioral manipulation of pharmacotherapy expectations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 30 Mar 2026to 30 Jun 2028
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 18
- Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.)
- Duration of pain >6 weeks
- NRS leg pain score >/= 4 (or if 3/10, greater or equal to back pain \& worst leg pain is >/=4)
- MRI evidence of spinal pathology consistent with symptoms
- Candidates for ESI and pharmacotherapy
Who cannot join
- Untreated coagulopathy
- Previous spine surgery
- No MRI or non-concordant MRI study
- Leg pain > 15 years duration
- Epidural steroid injection within past 2 years
- Signs or symptoms of cauda equina syndrome
Show all 12Show fewer
- Previous failed trials with gabapentin and pregabalin and tricyclic antidepressants and duloxetine
- Allergic reactions to contrast dye prohibiting injection (e.g., tranforaminal ESI), gabapentinoids, tricyclic antidepressants or duloxetine, and contraindications to all of the above medications
- Referrals from surgery for diagnostic injections for surgical evaluation
- Serious medical (e.g. congestive heart failure) or psychiatric (untreated depression) condition that might preclude optimal outcome
- Pregnancy
- Inability to understand basic English
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
United States2 sites, 2 recruiting
- Enrolling by invitation
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Steven P Cohen, MD, 312-695-2500, steven.cohen@northwestern.edu
Jordan Wood, BS, 3126952500, Jordan.Wood1@northwestern.edu
Thailand1 site, 1 recruiting
- Recruiting
Phramongkutklao Military Hospital
Bangkok
Chartchai Maschunchai, MD, 662-763-9300, oattee87@gmail.com
Ukraine1 site, 1 recruiting
- Not yet recruiting
First Lviv Medical Union
Lviv
Roma Smolynets, MD, 380-32-258-1101, smoroman9@gmail.com
About this study
Official title: PEACE Study: Psychophysical Enhancement to Augment Conservative and Epidural Steroid Injection Outcomes: A Multi-Center International Randomized Trial
Back pain is the leading cause of disability and military medical boards across the globe. Epidural steroid injections (ESI) are the most commonly performed pain procedure in the world.
There is strong evidence that the placebo effect for all pain treatments, including ESI, is greater than the intrinsic effect. The placebo effect is highly dependent on a patient's 'expectations', and therefore how the procedure is framed.
Read more
This study aims to compare ESI when the procedure is framed very positively- as is often done in clinical practice vs. more neutrally (which is less commonly done in clinical practice but consistent with evidence). The placebo effect is also stronger for procedures than medications. The evidence on the benefits of ESI is highly dependent on whether it is compiled by interventional doctors who perform the procedure or non-interventional researchers.
In order to determine how 'framing' a treatment affects pain outcomes, the investigative team will conduct a 3-arm randomized trial comparing positive framing of ESI, neutral framing of ESI, and medications, in patients with lumbosacral radiculopathy.
Read the detailed description
Two hundred and ten eligible individuals will be randomized in blocks of 10 in a 2:2:1 ratio to receive positive framing for ESI (treatment group), neutral framing for ESI (control group), or pharmacological therapy and instructions to exercise (active control group), respectively. There will suballocation based on whether the patient has unilateral or bilateral pain (i.e., whether the participant would receive a transforaminal ESI or an interlaminar ESI, respectively). This is because there may be differences in outcomes (transforaminal injections for unilateral pain may be more effective than an interlaminar injection for bilateral pain), as well as possible differences in side effects.
For the 84 individuals randomized to the study group (positive framing of ESI), the investigators will provide 5 slides with bullet points and images outlining peer-reviewed studies, reviews and guidelines on ESI that present the treatment in a more positive light (consistent with the views of most people who perform ESIs), but still consistent with evidence. These slides will contain references to high-quality articles and there will be an investigator present to answer questions. There is a very wide range in how a procedure is presented to patients, and this framework is consistent with how ESI are presented to patients by pain practitioners from all over the world. This material is all publicly available but has been compiled in presentation form.
For the 84 individuals in the ESI control group, the investigative team will provide a 1-slide overview on ESI that is slightly less optimistic, consistent with how many non-pain-physicians view ESI including that the evidence for surgery reduction is questionable.
For the 42 individuals in the active control group who will receive a first-line medication for neuropathic and non-structured instructions to exercise, the investigators will provide a 1-side overview that presents the raw, neutral facts on adjuvants for sciatica (some guidelines recommend them, others do not, but some recommend a trial of conservative care for back pain before interventions; there are no medications across the globe approved for lumbosacral radiculopathy).
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- Behavioral manipulation of ESI expectations, No behavioral manipulation of ESI expectations, No behavioral manipulation of pharmacotherapy expectations
- Keywords
- Back pain, Lumbar radiculopathy, Epidural steroid injection, Placebo effect, Sciatica, Positive framing
- Medical subject headings
- Back Pain, Radiculopathy, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral manipulation of ESI expectationsBehavioural
5-slide summary of ESI portrayed in a positive light, accompanied by a study investigator.
No behavioral manipulation of ESI expectationsOther
1-slide summary of ESI portrayed in a neutral light.
No behavioral manipulation of pharmacotherapy expectationsOther
1-slide summary of medications for neuropathic pain portrayed in a neutral light.
| Study group | Role | What they receive |
|---|---|---|
| Positive framing- ESI | Experimental | Patients will review around 5 slides detailing ESI in a very positive light and references, with study personnel available to answer questions. Receives: Behavioral: Behavioral manipulation of ESI expectations |
| Neutral framing- ESI | Placebo comparator | Patients will review 1 slide that portrays ESI in a neutral light. Receives: Other: No behavioral manipulation of ESI expectations |
| Pharmacotherapy with gabapentin, nortriptyline and/or duloxetine | Placebo comparator | Patients will review 1 neutrally-framed slide that portrays adjuvant medications for neuropathic pain in a neutral light. Receives: Other: No behavioral manipulation of pharmacotherapy expectations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reduction in average leg pain
Mean reduction in average leg pain on a 0-10 numerical rating pain scale over the past week. This is the study's primary endpoint. 0=no pain, 10= worst pain imaginable.
Measured: 4 weeks
Secondary outcomes (25)
Leg pain at rest
Leg pain at rest on a 0-10 verbal rating scale while in the recovery area. 0=no pain, 10= worst pain imaginable.
Measured: Up to 15 minutes after the procedure
Leg pain with activity
Leg pain with walking and bending on a 0-10 verbal rating scale while in the recovery area
Measured: Up to 15 minutes after the procedure
Back pain at rest
Back pain at rest on a 0-10 verbal rating scale while in the recovery area
Measured: Up to 15 minutes after the procedure
Back pain with activity
Back pain with activity (walking, bending) on a 0-10 verbal rating scale while in the recovery area
Measured: Up to 15 minutes after the procedure
Patient satisfaction
Patient satisfaction with ESI on 1-5 Likert scale (1= very unsatisfied, 3= neutral, 5= very satisfied), recorded upon recovery area discharge
Measured: Up to 15 minutes after the procedure
Average leg pain
Average leg pain on a 0-10 numerical rating scale over the past week
Measured: 4 weeks
Average back pain
Average back pain on a 0-10 numerical rating scale over the past week
Measured: 4 weeks
Worst leg pain
Worst leg pain on a 0-10 numerical rating scale over the past week
Measured: 4 weeks
Worst back pain
Worst back pain on a 0-10 numerical rating scale over the past week
Measured: 4 weeks
Oswestry Disability Index (ODI)
Oswestry Disability Index on 0-50 scale (converted to %), with higher scores indicating greater back pain-related disability
Measured: 4 weeks
Hospital Anxiety and Depression Scale (HADS)
Anxiety and Depression scores (0-21 for each subscale), with higher scores indicating greater disease burden (anxiety and depression)
Measured: 4 weeks
Athens Insomnia Scale
Measure of insomnia scored from 0-24, with higher scores indicating greater sleep dysfunction
Measured: 4 weeks
Analgesic medication reduction
>20% reduction in opioids or cessation of non-opioid analgesic
Measured: 4 weeks
Patient global impression of change (PGIC)
Patient satisfaction with ESI on 1-7 Likert scale (1= no change, 3= a little better, 4= somewhat better 5= moderately better, 7= a great deal better)
Measured: 4 weeks
Positive categorical outcome
>/=30% reduction in average leg pain (or worst leg pain if average leg pain </=4) with a PGIC >/=4
Measured: 4 weeks
Average leg pain
Average leg pain on a 0-10 numerical rating scale over the past week
Measured: 12 weeks
Average back pain
Average back pain on a 0-10 numerical rating scale over the past week
Measured: 12 weeks
Worst leg pain
Worst leg pain on a 0-10 numerical rating scale over the past week
Measured: 12 weeks
Worst back pain
Worst back pain on a 0-10 numerical rating scale over the past week
Measured: 12 weeks
Oswestry Disability Index (ODI)
Oswestry Disability Index on 0-50 scale (converted to %)
Measured: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Anxiety and Depression scores (0-21 for each subscale)
Measured: 12 weeks
Athens Insomnia Scale
Measure of insomnia scored from 0-24
Measured: 12 weeks
Analgesic medication reduction
>20% reduction in opioids or cessation of non-opioid analgesic
Measured: 12 weeks
Patient global impression of change (PGIC)
Patient satisfaction with ESI on 1-7 Likert scale (1= no change, 3= a little better, 4= somewhat better 5= moderately better, 7= a great deal better)
Measured: 12 weeks
Positive categorical outcome
>/=30% reduction in average leg pain (or worst leg pain if average leg pain </=4) with a PGIC >/=4
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 posted27 Mar 2026
- Study start30 Mar 2026
- Primary completion25 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lumbosacral RadiculopathyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Phramongkutklao College of Medicine and Hospital, Ramathibodi Hospital, Walter Reed National Military Medical Center, First Lviv Medical Union
- Responsible party
- Sponsor
- Investigators
- Steven P Cohen, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498140
- Sponsor's protocol ID
- STU00225684
- Acronym
- PEACE
- Status last verified
- Aug 2026
- First submitted
- 23 Mar 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Military (U.S. and Thai) will require special permission to shar.
Publications
Schmidt S, Loef M, Ostermann T, Walach H. Treatment effects in pharmacological clinical randomized controlled trials are mainly due to placebo. J Clin Epidemiol. 2025 Mar;179:111658. doi: 10.1016/j.jclinepi.2024.111658. Epub 2024 Dec 27.
PubMed 39733973Kaptchuk TJ, Stason WB, Davis RB, Legedza AR, Schnyer RN, Kerr CE, Stone DA, Nam BH, Kirsch I, Goldman RH. Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ. 2006 Feb 18;332(7538):391-7. doi: 10.1136/bmj.38726.603310.55. Epub 2006 Feb 1.
PubMed 16452103Sebastian A, Wyld L, Morgan JL. Examining the variation in consent in general surgery. Ann R Coll Surg Engl. 2024 Feb;106(2):140-149. doi: 10.1308/rcsann.2023.0020. Epub 2023 May 23.
PubMed 37218649Kern A, Kramm C, Witt CM, Barth J. The influence of personality traits on the placebo/nocebo response: A systematic review. J Psychosom Res. 2020 Jan;128:109866. doi: 10.1016/j.jpsychores.2019.109866. Epub 2019 Nov 7.
PubMed 31760341Kang H, Miksche MS, Ellingsen DM. Association between personality traits and placebo effects: a preregistered systematic review and meta-analysis. Pain. 2023 Mar 1;164(3):494-508. doi: 10.1097/j.pain.0000000000002753. Epub 2022 Aug 10.
PubMed 35947877
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEACE Study: Psychophysical Enhancement to Augment Conservative and Epidural Steroid Injection Outcomes: A Multi-Center International Randomized Trial
- ClinicalTrials.gov ID
- NCT07498140
- Acronym / sponsor ID
- PEACE / STU00225684
- Conditions
- Lumbosacral Radiculopathy
- Keywords
- Back pain, Lumbar radiculopathy, Epidural steroid injection, Placebo effect, Sciatica, Positive framing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Phramongkutklao College of Medicine and Hospital, Ramathibodi Hospital, Walter Reed National Military Medical Center, First Lviv Medical Union
- Study start
- 30 Mar 2026 (actual)
- Primary completion
- 25 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 27 Mar 2026 (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.
Back pain is the leading cause of disability and military medical boards across the globe. Epidural steroid injections (ESI) are the most commonly performed pain procedure in the world.
There is strong evidence that the placebo effect for all pain treatments, including ESI, is greater than the intrinsic effect. The placebo effect is highly dependent on a patient's 'expectations', and therefore how the procedure is framed.
This study aims to compare ESI when the procedure is framed very positively- as is often done in clinical practice vs. more neutrally (which is less commonly done in clinical practice but consistent with evidence). The placebo effect is also stronger for procedures than medications. The evidence on the benefits of ESI is highly dependent on whether it is compiled by interventional doctors who perform the procedure or non-interventional researchers.
In order to determine how 'framing' a treatment affects pain outcomes, the investigative team will conduct a 3-arm randomized trial comparing positive framing of ESI, neutral framing of ESI, and medications, in patients with lumbosacral radiculopathy.
Detailed description
Two hundred and ten eligible individuals will be randomized in blocks of 10 in a 2:2:1 ratio to receive positive framing for ESI (treatment group), neutral framing for ESI (control group), or pharmacological therapy and instructions to exercise (active control group), respectively. There will suballocation based on whether the patient has unilateral or bilateral pain (i.e., whether the participant would receive a transforaminal ESI or an interlaminar ESI, respectively). This is because there may be differences in outcomes (transforaminal injections for unilateral pain may be more effective than an interlaminar injection for bilateral pain), as well as possible differences in side effects.
For the 84 individuals randomized to the study group (positive framing of ESI), the investigators will provide 5 slides with bullet points and images outlining peer-reviewed studies, reviews and guidelines on ESI that present the treatment in a more positive light (consistent with the views of most people who perform ESIs), but still consistent with evidence. These slides will contain references to high-quality articles and there will be an investigator present to answer questions. There is a very wide range in how a procedure is presented to patients, and this framework is consistent with how ESI are presented to patients by pain practitioners from all over the world. This material is all publicly available but has been compiled in presentation form.
For the 84 individuals in the ESI control group, the investigative team will provide a 1-slide overview on ESI that is slightly less optimistic, consistent with how many non-pain-physicians view ESI including that the evidence for surgery reduction is questionable.
For the 42 individuals in the active control group who will receive a first-line medication for neuropathic and non-structured instructions to exercise, the investigators will provide a 1-side overview that presents the raw, neutral facts on adjuvants for sciatica (some guidelines recommend them, others do not, but some recommend a trial of conservative care for back pain before interventions; there are no medications across the globe approved for lumbosacral radiculopathy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Positive framing- ESI | Experimental | Behavioral: Behavioral manipulation of ESI expectationsPatients will review around 5 slides detailing ESI in a very positive light and references, with study personnel available to answer questions. |
| Neutral framing- ESI | Placebo comparator | Other: No behavioral manipulation of ESI expectationsPatients will review 1 slide that portrays ESI in a neutral light. |
| Pharmacotherapy with gabapentin, nortriptyline and/or duloxetine | Placebo comparator | Other: No behavioral manipulation of pharmacotherapy expectationsPatients will review 1 neutrally-framed slide that portrays adjuvant medications for neuropathic pain in a neutral light. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18
- Lumbosacral radicular pain based on history and physical exam (e.g. pain radiating into one or both lower extremities, sensory loss, muscle weakness, positive straight leg raising test etc.)
- Duration of pain >6 weeks
- NRS leg pain score >/= 4 (or if 3/10, greater or equal to back pain \& worst leg pain is >/=4)
- MRI evidence of spinal pathology consistent with symptoms
Key exclusion criteria (12 listed)
- Untreated coagulopathy
- Previous spine surgery
- No MRI or non-concordant MRI study
- Leg pain > 15 years duration
- Epidural steroid injection within past 2 years
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 |
|---|---|---|
| Behavioral manipulation of ESI expectations5-slide summary of ESI portrayed in a positive light, accompanied by a study investigator. | Behavioural | Positive framing- ESI |
| No behavioral manipulation of ESI expectations1-slide summary of ESI portrayed in a neutral light. | Other | Neutral framing- ESI |
| No behavioral manipulation of pharmacotherapy expectations1-slide summary of medications for neuropathic pain portrayed in a neutral light. | Other | Pharmacotherapy with gabapentin, nortriptyline and/or duloxetine |
Primary outcome
Mean reduction in average leg pain
Time frame: 4 weeks
Mean reduction in average leg pain on a 0-10 numerical rating pain scale over the past week. This is the study's primary endpoint. 0=no pain, 10= worst pain imaginable.
25 secondary outcomes
Leg pain at rest
Time frame: Up to 15 minutes after the procedure
Leg pain with activity
Time frame: Up to 15 minutes after the procedure
Back pain at rest
Time frame: Up to 15 minutes after the procedure
Back pain with activity
Time frame: Up to 15 minutes after the procedure
Patient satisfaction
Time frame: Up to 15 minutes after the procedure
Average leg pain
Time frame: 4 weeks
Average back pain
Time frame: 4 weeks
Worst leg pain
Time frame: 4 weeks
Worst back pain
Time frame: 4 weeks
Oswestry Disability Index (ODI)
Time frame: 4 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 4 weeks
Athens Insomnia Scale
Time frame: 4 weeks
Analgesic medication reduction
Time frame: 4 weeks
Patient global impression of change (PGIC)
Time frame: 4 weeks
Positive categorical outcome
Time frame: 4 weeks
Average leg pain
Time frame: 12 weeks
Average back pain
Time frame: 12 weeks
Worst leg pain
Time frame: 12 weeks
Worst back pain
Time frame: 12 weeks
Oswestry Disability Index (ODI)
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Athens Insomnia Scale
Time frame: 12 weeks
Analgesic medication reduction
Time frame: 12 weeks
Patient global impression of change (PGIC)
Time frame: 12 weeks
Positive categorical outcome
Time frame: 12 weeks
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 18 Aug 2026.
- Background: PubMed 39733973Schmidt S, Loef M, Ostermann T, Walach H. Treatment effects in pharmacological clinical randomized controlled trials are mainly due to placebo. J Clin Epidemiol. 2025 Mar;179:111658. doi: 10.1016/j.jclinepi.2024.111658. Epub 2024 Dec 27.
- Background: PubMed 16452103Kaptchuk TJ, Stason WB, Davis RB, Legedza AR, Schnyer RN, Kerr CE, Stone DA, Nam BH, Kirsch I, Goldman RH. Sham device v inert pill: randomised controlled trial of two placebo treatments. BMJ. 2006 Feb 18;332(7538):391-7. doi: 10.1136/bmj.38726.603310.55. Epub 2006 Feb 1.
- Background: PubMed 37218649Sebastian A, Wyld L, Morgan JL. Examining the variation in consent in general surgery. Ann R Coll Surg Engl. 2024 Feb;106(2):140-149. doi: 10.1308/rcsann.2023.0020. Epub 2023 May 23.
- Background: PubMed 31760341Kern A, Kramm C, Witt CM, Barth J. The influence of personality traits on the placebo/nocebo response: A systematic review. J Psychosom Res. 2020 Jan;128:109866. doi: 10.1016/j.jpsychores.2019.109866. Epub 2019 Nov 7.
- Background: PubMed 35947877Kang H, Miksche MS, Ellingsen DM. Association between personality traits and placebo effects: a preregistered systematic review and meta-analysis. Pain. 2023 Mar 1;164(3):494-508. doi: 10.1097/j.pain.0000000000002753. Epub 2022 Aug 10.
- Individual participant dataSharing planned: Undecided. Military (U.S. and Thai) will require special permission to shar.
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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.
Steven P Cohen, MD principal investigator
Northwestern University
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral manipulation of ESI expectations, No behavioral manipulation of ESI expectations and No behavioral manipulation of pharmacotherapy expectations in people with Lumbosacral Radiculopathy, run by Northwestern University at 4 sites in 3 countries.
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 12 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 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Thailand, Ukraine. 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.
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 Steven P Cohen, MD (312-695-2500, steven.cohen@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean reduction in average leg pain (time frame: 4 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 NCT07498140, which also lists 5 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 18 Aug 2026.