Condition category
Musculoskeletal Diseases
Date applied
28/10/2011
Date assigned
11/01/2012
Last edited
29/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic low back pain (CLBP) is one of the most common reasons that people go for healthcare in countries around the world, including Ireland. While there are no known treatments that completely cure CLBP symptoms, being physically active, such as walking or swimming, can help this condition. Back exercises have also been found to be useful for this condition, and in Ireland are usually shown to patients by Chartered Physiotherapists. However, people with CLBP often have problems following the advice they have been given about physical activity and exercise. New research suggests that improving patients' motivation and confidence to exercise may increase their adherence to physical activity and exercise advice. To achieve this, previous interventions have focused on improving the communication skills of healthcare professionals. This communication skills training approach has been successful in other healthcare settings. The main aim of this study is to explore if an intervention to enhance physiotherapists' communication skills when discussing the treatment plan with their CLBP patients will improve patient adherence to their treatment.

Who can participate?
Patients aged between 18 and 70 years who have been referred for physiotherapy for chronic low back pain to one of the participating physiotherapy departments.

What does the study involve?
All participating physiotherapists will attend a 1-hour education session by an expert in low back pain. Physiotherapists in 6 of the 12 participating sites will also receive communication skills training, delivered over two 4-hour workshops by an expert in communication skills. To determine if this intervention is more effective for improving patients' adherence to treatment advice and their LBP symptoms than usual practice methods, the study will test the difference in the effects between the patients whose physiotherapists have completed the communication skills workshop (the experimental group) and the patients whose physiotherapists have not completed the workshop and will continue with their usual communication practice (the control group). After the first physiotherapy appointment, the patient will be given a pedometer and complete a simple questionnaire about their motivation to follow the advice from their physiotherapist. Participants will continue attending their physiotherapy treatments as normal. Follow-up assessments will be conducted at Weeks 1, 4, 12, and 24. Follow-up assessments include questionnaires and the total step count from the pedometer for the previous 7 days.

What are the possible benefits and risks of participating?
All participants will receive physiotherapy treatment and a copy of the Back Book which may improve their understanding of low back pain. There are no known risks to participants.

Where is the study run from?
The study takes place at various physiotherapy outpatient departments at four hospitals and eight Primary Care Centres in Dublin, Ireland.

When is the study starting and how long is it expected to run for?
Patients will be enrolled in the study between April 2011 and February 2012. Follow-up assessment will continue until July 2012.

Who is funding the study?
Health Research Board, Dublin, Ireland.

Who is the main contact?
Dr Deirdre Hurley-Osing
deirdre.hurleyosing@ucd.ie

Trial website

Contact information

Type

Scientific

Primary contact

Dr Deirdre Hurley-Osing

ORCID ID

Contact details

School of Public Health
Physiotherapy and Population Science
University College Dublin
Health Sciences Centre
Belfield
Dublin
4
Ireland
+353 (0)1 716 6502
deirdre.hurleyosing@ucd.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

hra_por/2010/102

Study information

Scientific title

Testing a theory-based intervention designed to increase chronic low back pain patients adherence to physiotherapists recommendations

Acronym

CONNECT

Study hypothesis

1. Patients in the experimental arm will report significantly greater weekly physical activity (PA) participation compared with their pre-treatment PA levels and compared with patients in the control arm. They will also report greater self-rated adherence to physiotherapists' recommendations about exercise compared with the patients in the control arm.
2. Patients in the experimental arm will report significantly decreased pain, increased function, greater low back pain (LBP)-related well-being and greater perceived global improvement after treatment compared with their pre-intervention scores, and compared to the patients in the control arm.
3. Patients in the experimental arm will rate their physiotherapists as significantly more autonomy supportive than patients whose physiotherapists were assigned to the control arm.
4. Patients in the experimental arm will report significantly reduced fear-avoidance beliefs, significantly greater competence, autonomous motivation and significantly lower controlled motivation compared with their pre-treatment scores and compared with patients in the control arm
5. The influence of the experimental manipulation on outcomes (pain, function, and well-being) will be mediated by patients' rating of the physiotherapist's autonomy support, perceived competence, autonomous motivation, fear-avoidance beliefs and adherence.

Ethics approval

A list of the eight research ethics committee approvals and the site(s) they cover:
1. Adelaide and Meath Hospital Ethics Approval, 22/022011
2. Connolly Hospital Ethics Approval, 11/03/2011
3. Beaumont Hospital Ethics Approval, 11/03/2011
4. St Vincent's University Hospital Ethics Approval, 03/032011
5. HSE Areas :Kildare/West Wicklow/Dublin South West Approval, 16/06/2011
6. HSE Area: North DublinApproval, 30/05/2011
7. HSE Area: Dublin North City Approval, 28/06/2011
8. HSE Areas: Dun Laoghaire, Dublin South East, Dublin South West, Wicklow and Dublin South City Approval, 25/05/2011

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic low back pain

Intervention

Patients (n = 146) in the experimental arm will receive treatment from physiotherapists who have participated in self-determination theory (SDT)-communication skills training. Patients in the control arm (n = 146) will receive treatment from physiotherapists who have not received SDT-communication skills training.

SDT-communication skills training will be based on self-determination theory principles, implemented via the '5A' framework (ask, advise, agree, assist, arrange) and delivered in two 4-hour workshops.

All physiotherapists (in both the control and experimental arms of the study) will participate in a 1-hour workshop on evidence-based management guidelines for chronic low back pain (CLBP), including recommendations regarding exercise-based strategies and inclusion of advice on physical activity as part of home-based rehabilitation.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Adherence; measured at weeks 1, 4, 12 and 24
1.1. The Injury-Rehabilitation Adherence Scale completed by the therapists
1.2. The Injury-Rehabilitation Adherence Scale completed by the patient
1.3. A Home-Exercise Compliance Assessment
2. Self-reported physical activity; measured at baseline (week 0) and at weeks 1, 4, 12 and 24 with the International Physical Activity Questionnaire
3. Low back pain symptoms; measured at baseline (week 0) and at weeks 4, 12 and 24 with pain intensity and pain bothersomeness
4. Pain-related activity limitation; measured at baseline (week 0) and at weeks 4, 12 and 24 measures with:
4.1. The Roland Morris Disability Questionnaire
4.2. The Patient Specific Functional Scale
5. Quality of life; measured at baseline (week 0) and at weeks 4, 12 and 24 with the European Quality of Life Questionnaire.

Baseline (week 0) refers to the 24 hours before the initial physiotherapy session.

Secondary outcome measures

1. Objective Physical Activity: measured at weeks 4, 12 and 24 with pedometers
2. Fear avoidance; measured at baseline (week 0) and at weeks 4, 12 and 24 with Fear Avoidance Back Beliefs Questionnaire
3. Global Perception of improvement; measured at baseline (week 0) and at weeks 4, 12 and 24 with the Global Perceived Effect scale
4. Motivation; measured at baseline (week 0), immediately after the initial physiotherapy session and at weeks 4, 12 and 24 with the Treatment Self-Regulation Questionnaire
5. Perceived competence; measured at baseline (week 0), immediately after the initial physiotherapy session and at weeks 4, 12 and 24 with the Perceived Competence Scale
6. Autonomy support; measured immediately after the initial physiotherapy session and at week 4, with the Health Care Climate Questionnaire completed by the patients

Overall trial start date

01/04/2011

Overall trial end date

01/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Between 18-70 years
2. Low back pain (LBP) of mechanical origin with/without radiation to the lower limb
3. Chronic (≥3 months)
4. English speaking and English literate
5. Access to a telephone

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

292 participants, 50 physiotherapists

Participant exclusion criteria

1. Spinal surgery or history of systemic/inflammatory disease
2. Scheduled for major surgery during treatment
3. Received treatment for CLBP within previous 3 months
4. Suspected or confirmed pregnancy
5. Unstable angina/uncontrolled cardiac dysrhythmias/severe aortic stenosis/acute systemic infection accompanied by fever
6. Patients with acute (< 6 weeks) or subacute LBP (6-12 weeks)

Recruitment start date

01/04/2011

Recruitment end date

01/06/2012

Locations

Countries of recruitment

Ireland

Trial participating centre

University College Dublin
Dublin
4
Ireland

Sponsor information

Organisation

Health Research Board (HRB) (Ireland)

Sponsor details

73 Lower Baggot St
Dublin
2
Ireland

Sponsor type

Government

Website

http://www.hrb.ie/

Funders

Funder type

Government

Funder name

Health Research Board (HRB) (Ireland)

Alternative name(s)

HRB

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Ireland

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

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22703639
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25433220

Publication citations

  1. Protocol

    Lonsdale C, Hall AM, Williams GC, McDonough SM, Ntoumanis N, Murray A, Hurley DA, Communication style and exercise compliance in physiotherapy (CONNECT): a cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients' adherence to physiotherapists' recommendations: study rationale, design, and methods., BMC Musculoskelet Disord, 2012, 13, 104, doi: 10.1186/1471-2474-13-104.

  2. Results

    Murray A, Hall AM, Williams GC, McDonough SM, Ntoumanis N, Taylor IM, Jackson B, Matthews J, Hurley DA, Lonsdale C, Effect of a self-determination theory-based communication skills training program on physiotherapists' psychological support for their patients with chronic low back pain: a randomized controlled trial, Arch Phys Med Rehabil, 2015, 96, 5, 809-816, doi: 10.1016/j.apmr.2014.11.007.

Additional files

Editorial Notes