Association of Expectations and Pain Relief After Diagnostic Nerve Blocks

NCT05733039 | Active Not Recruiting

• 1 other identifier: EXPECT 2021-00459
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Expectations are a major driver of changes in health-related outcomes and are related to reduced pain after medical treatment. However, no studies have specifically addressed the role of expectations in connection with the success of interventional pain techniques and the specific effect of expectations on diagnostic and therapeutic procedures in this field. Further, there are no studies on prolonged pain reduction after diagnostic nerve blocks. This prospective cohort study will investigate patients' outcome-related expectations measured by validated questionnaires (i.a. the Expectation for Treatment Scale) before standardized diagnostic nerve blocks (i.e. lumbar medial branch and greater occipital nerve blocks) and their association with immediate pain reduction, calculated using a numeric rating scale (NRS) before and after the block. Secondary outcomes are specificity of pain relief duration in relation to the local anesthetic, changes in pain-related interference, quality of life and function, as well as patients' global impression of change after one week in order to assess possible therapeutic effects of the nerve blocks themselves. The sample size of 110 patients is based on a power of 80% and a significance level of 0.05. Additional endpoints will be evaluated using mixed-effects linear regression, non-linear relationships between expectation and endpoints will be modelled using fractional polynomials. This research will quantify the effect of patients' expectations on pain reduction after nerve blocks, extend our knowledge which patients are likely to respond to interventional pain treatments and under which circumstances nerve blocks may exhibit therapeutic effects.

Conditions

Pain; Expectations

Keywords

Pain; Expectations; Local anaesthetic; Pain treatment

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity

  Change in pain intensity directly after the diagnostic nerve block, calculated on an 11-point numeric rating scale (NRS 0-10, 0=no pain; 10=unbearable pain) before and 30 minutes after the nerve block.

  30 minutes

Secondary Outcomes (4)

• Change in pain intensity (longterm)

  1 week

• Specificity of local anesthetic

  1 day

• Pain-related disability after 1 week

  1 week

• Patient Global Impression of Change (PGIC) after 1 week

  1 week

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

All referred pain patients (acute and chronic), scheduled for a first diagnostic nerve block.

You may qualify if:

• referral to our pain clinic
• interventions: Lumbar medial branch block or greater occipital nerve block, both with lidocaine 2%

You may not qualify if:

• Psychiatric co-morbidities other than depression
• Inability to express pain scores on a numeric rating scale
• Refusal of informed consent
• Insufficient knowledge of German, French or English

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, Bern University Hospital

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Michael Harnik, Dr. med.

  Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med., senior physician

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: February 17, 2023
• Study Start: June 1, 2021
• Primary Completion: February 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

CH (1)