Back Pain Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | September 30, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Switzerland | Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland | Lugano |
Lead Sponsor | Collaborator |
---|---|
Ospedale Regionale di Lugano | Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland |
Switzerland,
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of the average pain severity | 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 | Brief Pain Inventory Short form: average pain interference score | 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 | |
Secondary | The reduction of the immediate pain severity score of the Brief Pain Inventory Short form | 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 | |
Secondary | Patient Global Impression of Change (PGIC) | 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 | |
Secondary | Patients' satisfaction | 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 |
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