To evaluate a group treatment program to stimulate effective coping with chronic neuropathic pain following spinal cord injury.
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pain severity and impact of pain: Chronic Pain Grade questionnaire.
Secondary outcome
- Level of activation and participation: Utrecht Activities List,
- Life satisfaction: Life Satisfaction Questionnaire, and
- Mood: Hospital Anxiety and Depression Scale.
Demographic (e.g., age and gender), disease and pain characteristics (e.g.,
type of SCI), pain treatment, and functional independence (Barthel Index) will
be registered at the baseline measurement (t1). The participants complete a
questionnaire on satisfaction with the program immediately after completion of
the program at 3 months.
Psychological variables:
- Pain coping: Coping with Pain Questionnaire and Pain Coping Inventory List,
and
- Pain cognitions: Pain Cognition List.
Background summary
Most persons with spinal cord injury suffer from chronic pain and about
one-third of them experience their pain as severe. The effective treatment of
pain following spinal cord is difficult. Particularly in regards to neuropathic
spinal cord injury pain, there are no treatments that produce satisfactory pain
relief. Therefore, psychosocial factors in the maintenance and aggravation of
chronic pain following spinal cord injury have been considered. One small-scale
Swedish study showed promising effects of a cognitive-behavioural group
program.
Study objective
To evaluate a group treatment program to stimulate effective coping with
chronic neuropathic pain following spinal cord injury.
Study design
A multi-centre, randomised intervention study with a waiting-list control group
in four rehabilitation centres. A total of 80 persons will be included (four
intervention groups of 10 persons and four control groups of 10 persons).
Measurements will be performed in both groups before starting the
program/entering the control group (t1), immediately after completion of the
program at 3 months (t2), at 6 (t3), at 9 (t4), and 12 months (t5). The control
group will be invited for the program after the follow-up measurement at 6
months (t3) and will be measured with the same protocol, so that the t3, t4 and
t5 measurements of the control group are equivalent to the t1, t2 and t3
measurements of the intervention group. Care as usual will continue, but pain
medication and other pain treatments will be held constant during the
intervention period (3 months).
Intervention
The multidisciplinary program, comprising educational, cognitive, and
behavioural interventions in the treatment of coping with chronic neuropathic
pain, consists of ten sessions of 3 hours over a 10-week period and a comeback
session three weeks later. Each meeting will be supervised by a psychologist
and physical therapist assisted by guest speakers and a role model. The
intervention is directed at knowledge about chronic neuropathic pain, modifying
passive coping, negative illness cognitions and feelings of depression and
hopelessness, at relaxation and attention-distraction techniques and at
stimulating an active lifestyle. Elements of the intervention are: (1)
provision of information, (2) guided group discussions, (3) exercises and sport
workshops, and (4) homework.
Study burden and risks
Not applicable.
Rembrandtkade 10
3583 TM Utrecht
Nederland
Rembrandtkade 10
3583 TM Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
(1) spinal cord injury;
(2) at least 18 years old;
(3) at least one year and at most five years after discharge from first inpatient spinal cord injury rehabilitation;
(4) main type of pain is severe chronic neuropathic pain.
Exclusion criteria
(1) spinal cord injury by a malignant tumor;
(2) former cognitive behavioural therapy for coping with pain after spinal cord injury;
(3) inability to function in a group by major language problems or psychopathology;
(4) insufficient mastery of the Dutch language.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL22866.041.08 |