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

NCT05402631 | Unknown

• 1 other identifier: The EXPECT study
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Brief Pain Inventory Short form: average pain interference score

  10 days after injection

• The reduction of the immediate pain severity score of the Brief Pain Inventory Short form

  1 hour after injection

• Patient Global Impression of Change (PGIC)

  10 days after injection

• Patients' satisfaction

  10 days after injection

Study Arms (2)

New patient with lower back pain

Procedure: Epidural Injection; Procedure: Periradicular Injection

known patient with lower back pain

Procedure: Epidural Injection; Procedure: Periradicular Injection

Interventions

Epidural Injection PROCEDURE

patient receives an epidural injection due to lower back pain

New patient with lower back pain; known patient with lower back pain

Periradicular Injection PROCEDURE

patient receives a periradicular injection due to lower back pain

New patient with lower back pain; known patient with lower back pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• patients who did not complete the questionnaires
• patient did not sign the general consent form (EOC\_M-AFRI-001/A)

Sponsors & Collaborators

• Ospedale Regionale di Lugano: lead
• Faculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, Switzerland: collaborator

Study Sites (1)

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

Lugano, 6900, Switzerland

RECRUITING

Related Publications (15)

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  PMID: 30854609 RESULT

• GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.

  PMID: 30496104 RESULT

• Hurwitz EL, Randhawa K, Yu H, Cote P, Haldeman S. The Global Spine Care Initiative: a summary of the global burden of low back and neck pain studies. Eur Spine J. 2018 Sep;27(Suppl 6):796-801. doi: 10.1007/s00586-017-5432-9. Epub 2018 Feb 26.

  PMID: 29480409 RESULT

• Last AR, Hulbert K. Chronic low back pain: evaluation and management. Am Fam Physician. 2009 Jun 15;79(12):1067-74.

  PMID: 19530637 RESULT

• Andersson GB. Epidemiological features of chronic low-back pain. Lancet. 1999 Aug 14;354(9178):581-5. doi: 10.1016/S0140-6736(99)01312-4.

  PMID: 10470716 RESULT

• Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, Grusing S, Brodt ED. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017 Apr 4;166(7):493-505. doi: 10.7326/M16-2459. Epub 2017 Feb 14.

  PMID: 28192793 RESULT

• Wieser S, Horisberger B, Schmidhauser S, Eisenring C, Brugger U, Ruckstuhl A, Dietrich J, Mannion AF, Elfering A, Tamcan O, Muller U. Cost of low back pain in Switzerland in 2005. Eur J Health Econ. 2011 Oct;12(5):455-67. doi: 10.1007/s10198-010-0258-y. Epub 2010 Jun 5.

  PMID: 20526649 RESULT

• Bredow J, Bloess K, Oppermann J, Boese CK, Lohrer L, Eysel P. [Conservative treatment of nonspecific, chronic low back pain : Evidence of the efficacy - a systematic literature review]. Orthopade. 2016 Jul;45(7):573-8. doi: 10.1007/s00132-016-3248-7. German.

  PMID: 27075679 RESULT

• Abdi S, Datta S, Trescot AM, Schultz DM, Adlaka R, Atluri SL, Smith HS, Manchikanti L. Epidural steroids in the management of chronic spinal pain: a systematic review. Pain Physician. 2007 Jan;10(1):185-212.

  PMID: 17256030 RESULT

• Falco FJ, Irwin L, Zhu J. Lumbar spine injection and interventional procedures in the management of low back pain. Clin Occup Environ Med. 2006;5(3):655-702, vii-viii. doi: 10.1016/j.coem.2006.04.001.

  PMID: 16963381 RESULT

• Brunner M, Schwarz T, Zeman F, Konig M, Grifka J, Benditz A. Efficiency and predictive parameters of outcome of a multimodal pain management concept with spinal injections in patients with low back pain: a retrospective study of 445 patients. Arch Orthop Trauma Surg. 2018 Jul;138(7):901-909. doi: 10.1007/s00402-018-2916-y. Epub 2018 Mar 7.

  PMID: 29511801 RESULT

• Auer CJ, Glombiewski JA, Doering BK, Winkler A, Laferton JA, Broadbent E, Rief W. Patients' Expectations Predict Surgery Outcomes: A Meta-Analysis. Int J Behav Med. 2016 Feb;23(1):49-62. doi: 10.1007/s12529-015-9500-4.

  PMID: 26223485 RESULT

• Ng Kuet Leong VS, Kastner A, Petzke F, Przemeck M, Erlenwein J. The influence of pain expectation on pain experience after orthopedic surgery: an observational cohort study. Minerva Anestesiol. 2020 Oct;86(10):1019-1030. doi: 10.23736/S0375-9393.20.14084-7. Epub 2020 Jul 1.

  PMID: 32613811 RESULT

• Laferton JAC, Oeltjen L, Neubauer K, Ebert DD, Munder T. The effects of patients' expectations on surgery outcome in total hip and knee arthroplasty: a prognostic factor meta-analysis. Health Psychol Rev. 2022 Mar;16(1):50-66. doi: 10.1080/17437199.2020.1854051. Epub 2020 Dec 21.

  PMID: 33228474 RESULT

• Tan G, Jensen MP, Thornby JI, Shanti BF. Validation of the Brief Pain Inventory for chronic nonmalignant pain. J Pain. 2004 Mar;5(2):133-7. doi: 10.1016/j.jpain.2003.12.005.

  PMID: 15042521 RESULT

MeSH Terms

Conditions

Back Pain; Patient Satisfaction

Interventions

Injections, Epidural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Eva Koetsier, PhD

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

  STUDY DIRECTOR

• Valeria Scheiwiller

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Koetsier, PhD

CONTACT

+41 (0)91 811 75 90; eva.koetsier@usi.ch

Valeria Scheiwiller

CONTACT

+41774347031; valeria.scheiwiller@usi.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 2, 2022
• Study Start: April 20, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)