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PainEXPECTNCT05733039

Association of Expectations and Pain Relief After Diagnostic Nerve Blocks

An observational study of Pain and Expectations, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Expectations
How many people
115 participants
Where
1 siteSwitzerland
Study dates
1 Jun 2021to 3 Feb 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • Inselspital, Bern University Hospital

    Bern, Canton of Bern, 3010

Other trials in Switzerland

About this study

Official title: Association of Expectations and Pain Relief After Diagnostic Nerve Blocks (EXPECT) - A Prospective Cohort Study

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.

Read the detailed description

Expectations are a major driver of change in health-related outcomes and are related to reduced pain after medical treatment. However, studies on expectations and their relation to pain relief after nerve blocks are largely lacking and there is a paucity of high-quality research in this area. These blocks are frequently used in interventional pain therapy to confirm a particular diagnosis (diagnostic blocks), and to predict if a patient could profit from a particular therapy (prognostic blocks). To current knowledge, there are no studies that specifically assess the association of expectation and response to pain relief after nerve blocks. A further aspect is longer lasting pain relief (i.e. sometimes for days or even weeks) that is sometimes observed in clinical practice after diagnostic nerve blocks and often attributed to a placebo effect. This may lead clinicians to perform block "series" in a therapeutic attempt. Such efforts can be controversial, since the duration of action of local anesthetics is limited to a few hours only - e.g. typically to 2-4 hours in the case of lidocaine, a short acting amino amide and one of the most widely used substances.

There are no investigations on prolonged pain relief after nerve blocks and despite decades of their use in clinical practice, there is hardly any research available.

Hypothesis and primary objective The investigators' goal is to evaluate the association of patients' outcome-related expectations with the short-term success of diagnostic blocks and to assess whether expectations contribute to longer-lasting therapeutic effects. Therefore, they will conduct a prospective cohort study of patients receiving diagnostic nerve blocks in our tertiary pain clinic. According to current recommendations on clinical outcome assessment, pain intensity, physical functioning, emotional functioning and ratings of improvements are all collected. We hypothesize that expectations play a major role in the extent of pain relief in % as well as its duration after the application of local anesthetics, i.e. in this case longer than 2-4 hours for lidocaine.

They will also analyze other potentially influential factors such as depressive symptoms, anxiety and catastrophizing - these are secondary objectives. Thus, they aim to quantify the effect of expectations, assess the therapeutic potential of nerve blocks, improve the accuracy of pretests and exclude patients from clinical pathways who are unlikely to profit from them.

Conditions
Pain, Expectations
Keywords
Pain, Expectations, Local anaesthetic, Pain treatment
Medical subject headings
Pain, Agnosia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 minutes

Secondary outcomes (4)
  1. Change in pain intensity (longterm)

    Change in pain intensity on the same day and during one week after diagnostic block, calculated on an 11-point numeric rating scale (NRS 0-10, 0=no pain; 10=unbearable pain).

    Measured: 1 week

  2. Specificity of local anesthetic

    Specificity of local anesthetic within one day after diagnostic block (duration of pain relief corresponds to substance: yes/no)

    Measured: 1 day

  3. Pain-related disability after 1 week

    Pain-related disability using the Brief Pain Inventory: Pain severities for worst, least, average and actual pain are calculated on an 11-point numeric rating scale (NRS 0-10, 0=no pain; 10=unbearable pain). The 7 interference items (sleep disturbance, general activity, mood, work, relations with others, walking, and enjoyment of life) are assessed on a 0-10 scale, with 0 being "did not interfere" and 10 being "interfered completely.

    Measured: 1 week

  4. Patient Global Impression of Change (PGIC) after 1 week

    Patient Global Impression of Change (PGIC) one week after diagnostic block with the items "pain intensity", "quality of life" and "ability to function", measured on a 7-point scale (1="very much better", 7="very much worse")

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2023
  2. Study start1 Jun 2021
  3. Primary completion1 Feb 2024
  4. Study completion3 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05733039
Sponsor's protocol ID
EXPECT 2021-00459
Acronym
EXPECT
Status last verified
Mar 2025
First submitted
14 Jul 2022
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pain and Expectations, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in pain intensity (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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