NCT05359900

Brief Summary

Chronic pain is the leading cause of disability worldwide affecting just under 28 million people in the UK. Chronic pain conditions require a biopsychosocial rather than a biomedical model of care. Biomedical management lacks evidence of effectiveness but also has the potential to exacerbate the condition by raising fears and anxiety about potential pathological abnormalities. Thus, the pre-registration phase is an important point where an individual's understanding of, and beliefs about, pain and people with pain may be shaped for the future. The need for improved and better education of healthcare professionals to support best practice for low back pain with the aim of integrating professionals' management of low back pain and fostering innovation in practice is well recognised. Pain education research with pre-registration chiropractors is lacking. Therefore, this study aims to: To compare the effect of two pain education intervention, through a multi-site randomised control trial, on the following three questionnaire based outcome measures:

  1. 1.Knowledge (understanding) of chronic pain
  2. 2.Attitudes towards chronic pain patients
  3. 3.Pain management behaviours

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

January 6, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2024

Completed
Last Updated

November 20, 2024

Status Verified

November 1, 2024

Enrollment Period

1.4 years

First QC Date

March 11, 2022

Last Update Submit

November 19, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • The 12-item Revised Pain Neurophysiology Quiz (change assessed)

    This is a validated tool for assessing knowledge of pain physiology. Measures knowledge of pain physiology using a 12 point validated questionnaire. Low score is poor sign. Scores range from 0-12.

    Immediate and 6-month follow-up

  • The 10-item Red Flags knowledge questionnaire (change assessed)

    This is a questionnaire containing 10 yes/no questions to assess participants knowledge of red flags. Low score is a poor sign. Scores range from 0-10.

    Immediate and 6-month follow-up

  • The 13-item Health Care Providers' Pain and Impairment Relationship Scale (HC-PAIRS) (change assessed)

    this a validated measure of health care professionals attitudes towards the ability of patients with pain to function despite their pain. The Health Care Providers Pain and Impairment Relationship Scale assesses attitudes and beliefs towards pain using a 13 item validated questionnaire. High score is a worse outcome. Scores range from 13-91.

    Immediate and 6-month follow-up

  • Case vignette (change assessed)

    Measures clinical practise behaviours in pain management. A validated proxy measure of clinical behaviour, MCQ weighted as appropriate or inappropriate according to current national clinical guidelines. A low score is considered good, and scores range from 4 to 20.

    Immediate and 6-month follow-up

Secondary Outcomes (1)

  • Semi-structured Interviews

    6-month follow-up

Study Arms (2)

Pain neuroscience education

EXPERIMENTAL

Pain neuroscience education group. One-off, 70 minute duration session delivered by Dr Cormac Ryan.

Other: Pain neuroscience education

Red flag education

ACTIVE COMPARATOR

Red flags education group. One-off 70 minute duration session delivered by Dr Cormac Ryan.

Other: Red Flag Education

Interventions

Pain neuroscience education lecture

Pain neuroscience education

Red Flag education lecture

Red flag education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current Chiropractic students enrolled at either: Teesside University; The Welsh institute of Chiropractic - University of South Wales; The AECC University College; McTimoney College of Chiropractic; London Southbank University
  • Willing to consent to attending two educational sessions followed by completing questionnaires

You may not qualify if:

  • Chiropractic students not actively enrolled at either: Teesside University; The Welsh institute of Chiropractic - University of South Wales; The AECC University College; McTimoney College of Chiropractic; London Southbank University
  • Participants will be excluded if they have previously received in depth education on red flags and or pain neurophysiology.
  • Students not willing to consent to attending two educational sessions followed by the completion of questionnaires

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

McTimoney College of Chiropractic

Abingdon, United Kingdom

Location

The AECC University College

Bournemouth, United Kingdom

Location

London Southbank University

London, United Kingdom

Location

The Welsh institute of Chiropractic - University of South Wales

Pontypridd, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participant information is pseudonymised using student numbers only. As soon is data is generated data will be fully anonymised. The outcome assessor will be blinded to group allocation.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Multi-site, single-blind two arm, randomised control trial. The study would be conducted an five sites in total: Teesside University; The Welsh institute of Chiropractic - University of South Wales; The AECC University College; McTimoney College of Chiropractic; London Southbank University. Each site will follow the same protocol. Randomisation will occur at each individual site. Data will be pooled for analysis.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 11, 2022

First Posted

May 4, 2022

Study Start

January 6, 2023

Primary Completion

May 30, 2024

Study Completion

November 19, 2024

Last Updated

November 20, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations