Condition category
Musculoskeletal Diseases
Date applied
28/06/2013
Date assigned
28/06/2013
Last edited
03/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Vikki Wylde

ORCID ID

Contact details

Bristol Implant Research Centre
Southmead Hospital
Southmead Road Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
v.wylde@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11270

Study information

Scientific title

A feasibility randomised controlled trial of a pain self-management group for patients undergoing total hip replacement

Acronym

SPIRAL

Study hypothesis

This pilot randomised controlled trial will involve delivering a pain self-management course to patients undergoing total hip replacement (THR). The course will be delivered by Arthritis Care and will consist of two workshops while patients are on the waiting list for a THR and one workshop at 6-9 weeks post-operative. Eighty patients will be recruited into the study and randomised to the control or intervention arm and then followed-up by postal questionnaire for 6-months after surgery. The study will assess the feasibility of a full-scale randomised controlled trial in terms of recruitment rates, reasons for non-participation, attendance at the course, the suitability of outcome measures and assessment timings.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=11270

Ethics approval

South West 4 NRES Committee, ref: 11/SW/0056; First MREC approval date 03/06/2011

Study design

Feasibility randomised controlled trial; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Musculoskeletal; Subtopic: Musculoskeletal (all Subtopics); Disease: Osteoarthritis, hip replacement

Intervention

Pain self-management course, The Challenging Pain course is a pain self-management course run by Arthritis Care. The course will be delivered to participants by lay trainers who have experience of living with chronic pain. The emphasis of the course is on pain management and introduces participants to a variety of cognitive pain management techniques, with the aim of providing coping skills to enable patients to manage their pain and its impact more effectively.

Follow Up Length: 6 months
Study Entry : Single Randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Feasibility of a full scale randomised controlled trial; Timepoint(s): From recruitment to 6-months after surgery

Secondary outcome measures

Not provided at time of registration

Overall trial start date

20/06/2011

Overall trial end date

27/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Listed for a primary total hip replacement because of osteoarthritis
2. Target Gender: Male & Female ; Lower Age Limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Participant exclusion criteria

Listed for revision surgery
Inability or unwillingness to provide informed consent

Recruitment start date

20/06/2011

Recruitment end date

27/06/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Implant Research Centre
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

Trust Headquarters
Beckspool Road
Frenchay
Bristol
B16 1JE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.nbt.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR (UK) - Programme Grants for Applied Research

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24885915

Publication citations

  1. Results

    Wylde V, Marques E, Artz N, Blom A, Gooberman-Hill R, Effectiveness and cost-effectiveness of a group-based pain self-management intervention for patients undergoing total hip replacement: feasibility study for a randomized controlled trial., Trials, 2014, 15, 176, doi: 10.1186/1745-6215-15-176.

Additional files

Editorial Notes