Clinical trial NCT05402631: Can Patient Expectations Influence Pain Reduction After Epidural Injections in Patients With Low Back Pain?
Official title: Can Patient Expectations Influence Pain Reduction After Epidural Injections in Patients With Low Back Pain? An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Expectations
Back Pain
Back Pain Lower Back Chronic
Satisfaction, Patient
Injections, Epidural
Injections, Periradicular
Pain, Back
Keywords: Expectations
Influence of Expectations on Outcome
Back Pain
Epidural Injections
Periradicular Injections
Lead sponsor: Ospedale Regionale di Lugano
Sponsor class: OTHER
Collaborators: name: Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
First posted: 2022-06-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of our pain management center that get a transforaminal, translaminar or caudal injection of the spine.

Brief summary: Investigators hypothesize that patients with higher expectations regarding their epidural injection experience a higher pain reduction of their lower back pain and/or leg pain after an epidural injection. Patients' expectations of an epidural injection can influence their level of pain reduction. The primary objective of this study is to investigate the prognostic significance of patient expectations on pain reduction after epidural injections ('expected benefits', see under) in patients with low back pain and/or leg pain.

Investigators furthermore hypothesize that patients that have a higher match between their expectations of improvement and actual improvement are more satisfied. A secondary objective of this study is to investigate the prognostic significance of a high match between expectations of improvement and actual improvement on patient satisfaction of the treatment.

Detailed description: Chronic low back pain (with or without lower extremity pain) is extremely common problem in primary care and the leading cause worldwide for disability. Approximately 70 to 85% of the western population will develop low back pain at least once during their lifetime.

Low back pain is pain, muscle tension, or stiffness localized below the costal margin and above the inferior gluteal folds, with or without sciatica, and is defined as chronic when it persists for 12 weeks or more. The burden on the economy of low back pain were estimated at €2.6 billion and the direct medical costs at 6.1% of the total healthcare expenditure in Switzerland. Multiple modalities of treatments are utilized in managing chronic low back pain including analgesics, physiotherapy, injections, acupuncture, or surgery. Intralaminar and transforaminal lumbar epidural injections of corticosteroids have shown to be effective in patients with chronic low back pain and or leg pain.

Several studies demonstrated how patients' expectations are important predictors of the postsurgical health outcome. Patients' expectations are frequently studied as prognostic factors in knee and hip arthroplasty. It was shown that patients undergoing elective orthopaedic surgery whose expectations were fulfilled were found to be more satisfied with the overall treatment as compared to those whose expectations were not fulfilled. Furthermore, it was found that there is a robust small positive association between patients' positive preoperative expectations and better patient-reported postoperative outcomes. Investigators hypothesize that patient expectations of the pain treatment is also an important predictor of the pain reduction after epidural injections in patients with low back pain and/or leg pain. Therefore, the aim of this study is to investigate the prognostic significance of patient expectations on pain reduction after epidural injections in patients with low back pain and/or leg pain.

Eligibility criteria: Inclusion criteria

Subjects fulfilling all of the following inclusion criteria are eligible for the investigation:

* Age \> 18 years old.
* Patients treated with a fluoroscopic guided lumbar epidural injection (transforaminal/translaminar/caudal) for back and/or leg pain

Exclusion criteria The presence of any one of the following exclusion criteria will lead to the exclusion of the subject

* patients who did not complete the questionnaires
* patient did not sign the general consent form (EOC_M-AFRI-001/A)

Primary outcomes:
measure: Reduction of the average pain severity
timeFrame: 10 days after injection
Secondary outcomes:
measure: Brief Pain Inventory Short form: average pain interference score
timeFrame: 10 days after injection
measure: The reduction of the immediate pain severity score of the Brief Pain Inventory Short form
timeFrame: 1 hour after injection
measure: Patient Global Impression of Change (PGIC)
timeFrame: 10 days after injection
measure: Patients' satisfaction
timeFrame: 10 days after injection
Other outcomes:
Locations:
city: Lugano
country: Switzerland
facility: Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
Study officials:
affiliation: Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
name: Eva Koetsier, PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
name: Valeria Scheiwiller
role: PRINCIPAL_INVESTIGATOR
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