Condition category
Signs and Symptoms
Date applied
04/08/2010
Date assigned
13/09/2010
Last edited
13/09/2010
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 Brona Fullen

ORCID ID

Contact details

School of Public Health
Physiotherapy and Population Science
Health Science Centre
Belfield Campus
University College Dublin
Dublin
4
Ireland
+353 (0)1 716 6516
brona.fullen@ucd.ie

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Cognitive behavioural pain management programmes: impact on sleep quality in patients with chronic pain

Acronym

Study hypothesis

1. That a cognitive behavioural pain management pain management programme will have long term positive effects on subjective and objective sleep quality in patients with chronic pain by comparison with a control group
2. To investigate the relationship between objective and subjective sleep quality and physical and psychological outcome measures

Ethics approval

St James/Adelaide and Meath Hospitals Research Ethics Committee approved in October 2008

Study design

Clinically wait-list controlled trial

Primary study design

Interventional

Secondary study design

Non randomised controlled 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 non-malignant pain

Intervention

Cognitive Behavioural Pain Management Programme (CBT-PMP):
A multi-disciplinary CBT-PMP provides the patient with multiple therapies involving comprehensive rehabilitation in each of the specialised areas. The core multi-disciplinary team includes a pain management physician, an occupational therapist, a physiotherapist and a clinical psychologist. They identify and change unhelpful thoughts and beliefs, promote relaxation, and help to change habits that contribute to disability. The multi-disciplinary team focuses on specific achievable goals established between the individual therapist and the patient. Participants are advised to practice the skills they have learned both at home, and in other environments, integrating them into their everyday lives in order to help them to manage their pain more effectively.

Participants will attend three days a week for four consecutive weeks (10 am - 4 pm). The programme includes daily two-hour group sessions with physiotherapy (stretching programme, core-stability strengthening programme, paced individual exercise on a range of gym equipment, and functional restoration), occupational therapy (improving occupational function and environmental adaptation), and clinical psychology (cognitive behavioural therapy, relaxation techniques). Weekly education sessions with the Pain consultant are also held.

Control group:
The control group were taken from the waiting list for the cognitive behavioural pain management programme.

Both arms of the trial were assessed at baseline; the intervention group were re-assessed on completion of the 4-week pain management programme and again 2 months later. The waiting list control group were reassessed after three months.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patients and controls will be assessed one week prior to the commencement of the CBT-PMP, 4 weeks later on completion of the CBT-PMP (or usual care), and two months later:
1. Sleep:
1.1. Objective: Patients will be instructed to wear the Actiwatch (AW4, CamTech, Cambridge, UK) for 7 days (24 hours a day)
1.2. Self-report: Pittsburgh Sleep diary (PghSD) for 7 days
2. Physical Function (objective): The Simmond's functional assessment battery of tests
3. Pain (self-report): Numerical rating scale for current pain, pain at worst/best in last 7 days
4. Psychosocial beliefs (self-report): Tampa Scale of Kinesophobia (fear of re-injury), Hospital Anxiety and Depression Questionnaire
5. Health-related Quality of Life and function (self-report): 36-item short form health survey (SF-36)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

02/02/2009

Overall trial end date

22/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged over 18 years, either sex
2. Patients with a diagnosis of chronic pain (pain greater than 6 months)
3. Patients who fulfil the criteria for the Adelaide and Meath Hospitals incorporating the National Children's Hospital (AMNCH) cognitive behavioural pain management programme (CBT-PMP) as per the multidisciplinary team
4. Patients willing to take part in the study
5. Patients who are suffering from sleep disturbance due to pain as determined by the Pittsburgh Sleep Quality Index questionnaire (a score greater than 5 indicating sleep disturbance)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50

Participant exclusion criteria

1. Patients under 18 years
2. Patients who do not have a diagnosis of pain greater than 6 months duration
3. Deemed unsuitable for the AMNCH CBT-PMP as per the multidisciplinary pain team
4. Unwilling to take part in the study
5. Do not suffer from sleep disturbance due to pain as determined by the Pittsburgh Sleep Quality Index questionnaire (a score greater than 5 indicating sleep disturbance)
6. Pregnancy

Recruitment start date

02/02/2009

Recruitment end date

22/05/2010

Locations

Countries of recruitment

Ireland

Trial participating centre

School of Public Health, Physiotherapy and Population Science
Dublin
4
Ireland

Sponsor information

Organisation

Pfizer Healthcare Ireland (PHI) (Ireland)

Sponsor details

9
Riverwalk
National Digital Park
Citywest Business Campus
Dublin
24
Ireland

Sponsor type

Industry

Website

http://www.pfizer.ie

Funders

Funder type

Industry

Funder name

Pfizer Healthcare Ireland (PHI) (Ireland)

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

Publication citations

Additional files

Editorial Notes