An interventional study of Behavioral manipulation of ESI expectations and No behavioral manipulation of ESI expectations in Lumbosacral Radiculopathy, sponsored by Northwestern University. Recruiting at 4 sites in 3 countries. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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.
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).
728 studies on the registry are indexed under Back Pain; 109 are open to participants now.
This study's planned enrollment of 210 is above the median of 70 across 593 interventional studies indexed under Back Pain.
Browse Back Pain studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will review around 5 slides detailing ESI in a very positive light and references, with study personnel available to answer questions.
Behavioral: Behavioral manipulation of ESI expectations
Patients will review 1 slide that portrays ESI in a neutral light.
Other: No behavioral manipulation of ESI expectations
Patients will review 1 neutrally-framed slide that portrays adjuvant medications for neuropathic pain in a neutral light.
Other: No behavioral manipulation of pharmacotherapy expectations
5-slide summary of ESI portrayed in a positive light, accompanied by a study investigator.
1-slide summary of ESI portrayed in a neutral light.
1-slide summary of medications for neuropathic pain portrayed in a neutral light.
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.
Time frame: 4 weeks
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 15 minutes after the procedure
Average leg pain
Average leg pain on a 0-10 numerical rating scale over the past week
Time frame: 4 weeks
Average back pain
Average back pain on a 0-10 numerical rating scale over the past week
Time frame: 4 weeks
Worst leg pain
Worst leg pain on a 0-10 numerical rating scale over the past week
Time frame: 4 weeks
Worst back pain
Worst back pain on a 0-10 numerical rating scale over the past week
Time frame: 4 weeks
Oswestry Disability Index (ODI)
Oswestry Disability Index on 0-50 scale (converted to %), with higher scores indicating greater back pain-related disability
Time frame: 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)
Time frame: 4 weeks
Athens Insomnia Scale
Measure of insomnia scored from 0-24, with higher scores indicating greater sleep dysfunction
Time frame: 4 weeks
Analgesic medication reduction
\>20% reduction in opioids or cessation of non-opioid analgesic
Time frame: 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)
Time frame: 4 weeks
Positive categorical outcome
\>/=30% reduction in average leg pain (or worst leg pain if average leg pain \</=4) with a PGIC \>/=4
Time frame: 4 weeks
Average leg pain
Average leg pain on a 0-10 numerical rating scale over the past week
Time frame: 12 weeks
Average back pain
Average back pain on a 0-10 numerical rating scale over the past week
Time frame: 12 weeks
Worst leg pain
Worst leg pain on a 0-10 numerical rating scale over the past week
Time frame: 12 weeks
Worst back pain
Worst back pain on a 0-10 numerical rating scale over the past week
Time frame: 12 weeks
Oswestry Disability Index (ODI)
Oswestry Disability Index on 0-50 scale (converted to %)
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Anxiety and Depression scores (0-21 for each subscale)
Time frame: 12 weeks
Athens Insomnia Scale
Measure of insomnia scored from 0-24
Time frame: 12 weeks
Analgesic medication reduction
\>20% reduction in opioids or cessation of non-opioid analgesic
Time frame: 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)
Time frame: 12 weeks
Positive categorical outcome
\>/=30% reduction in average leg pain (or worst leg pain if average leg pain \</=4) with a PGIC \>/=4
Time frame: 12 weeks
Adverse events
Any adverse event or complication
Time frame: 10-15 minutes (for ESI)
Adverse events
Any adverse event, attributed to treatments or not
Time frame: 4 weeks
Adverse events
Any adverse event, attributed to treatments or not, at all time points
Time frame: 12 weeks
Plan to share: Undecided — Military (U.S. and Thai) will require special permission to shar.
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