Can Patient Expectations Influence Pain Reduction After Epidural Injections in Patients With Low Back Pain?

September 30, 2022 updated by: Eva Koetsier MD PhD LLM, Ospedale Regionale di Lugano

Can Patient Expectations Influence Pain Reduction After Epidural Injections in Patients With Low Back Pain? An Observational Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Lugano, Switzerland, 6900
        • Recruiting
        • Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
        • Contact:
          • Eva Koetsier, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients of our pain management center that get a transforaminal, translaminar or caudal injection of the spine.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
New patient with lower back pain
Procedure: Epidural Injection
patient receives an epidural injection due to lower back pain
Procedure: Periradicular Injection
patient receives a periradicular injection due to lower back pain
known patient with lower back pain
Procedure: Epidural Injection
patient receives an epidural injection due to lower back pain
Procedure: Periradicular Injection
patient receives a periradicular injection due to lower back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of the average pain severity
Time Frame: 10 days after injection
The reduction of the average pain severity score of the Brief Pain Inventory Short form [Time Frame: 10 days after injection in comparison to baseline]. Brief Pain Inventory (BPI) Short form will be used to assess pain intensity after lumbar epidural injection. BPI assess for pain and its scale is measured between 0 - 10, where '0' indicates no pain and '10' indicates severe pain in the last 24 hours. A decrease in the BPI score of 2 or more from the baseline score is considered clinically significant and indicates an improvement in severity of the patient's pain.15 We will examine the prognostic significance of patient expectations ('expected benefits', see under) on pain reduction after epidural injections in patients with low back pain and/or leg pain.
10 days after injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Pain Inventory Short form: average pain interference score
Time Frame: 10 days after injection
BPI average pain interference score assesses the interference the pain has on the patient's functioning. BPI interference is measured between 0-10, where '0' indicates no interference and '10' indicates severe interference with functioning
10 days after injection
The reduction of the immediate pain severity score of the Brief Pain Inventory Short form
Time Frame: 1 hour after injection
Again the scale is measured between 0 - 10, where '0' indicates no pain and '10' indicates severe pain. A decrease in the BPI score of 2 or more from the baseline score is considered clinically significant and indicates an improvement in severity of the patient's pain
1 hour after injection
Patient Global Impression of Change (PGIC)
Time Frame: 10 days after injection
The PGIC rating is increasingly being used for determining clinically important change in measures such as ratings of pain. This scale is designed to quantify patient's improvement or deterioration over time, usually either to determine the effect of an intervention or to chart the clinical course of a condition. The scales ask that a person assess his or her current health status, recall that status at a previous time-point, and then calculate the difference between the two.
10 days after injection
Patients' satisfaction
Time Frame: 10 days after injection
o This scale is designed to quantify patient's satisfaction with the treatment. Patients will be asked to define the one number that best shows how satisfied they are with the results of their pain treatment. Its scale is measured between 0 - 10, where '0' indicates extremely dissatisfied and '10' indicates extremely satisfied.
10 days after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Regionale di Lugano

Collaborators

Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland

Investigators

  • Study Director: Eva Koetsier, PhD, Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland
  • Principal Investigator: Valeria Scheiwiller, Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2022

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

May 30, 2022

First Submitted That Met QC Criteria

May 30, 2022

First Posted (ACTUAL)

June 2, 2022

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The EXPECT study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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