musculoskeletale pijnaandoening: aspecifieke chronisch lage rugpijn chronic low back pain lumbago non specific low back pain
Conditions
Interventions
The study entails a replicated single-case experimental design in 12 patients
with chronic low back pain. Participants are randomly assigned to one of three
groups: 1) an Exposure-neutral group (SB-
Sponsors
Universiteit Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Potential participants: - suffer from chronic low back pain not caused by serious spinal injury, for at least 3 to 6 months - are between 18 and 65 years of age - report a sufficient level of disability and - moderate to high levels of pain-related fear (total TSK score >= 37 or at least 4 TSk items with a rating >= 3) - having a partner willing to participate as well
Exclusion criteria
Exclusion criteria: Patients are excluded if one or more of the following criteria is applicable: - Specific medical disorder or cardiovascular disease preventing participation in physical exercise - Serious psychopathologic co-morbidity (checked during the intake session with the rehab. physician and during the general screening) - Alcohol or drug abuse - Illiteracy - Pregnancy - Involvement in litigation concerning the patient*s ability to work or disability income - Non-Dutch speaking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| I. On a daily basis: a. Manipulation check: measures of fearful cognitions with a questionnaire consisting of items from the TSK, PASS, PCS and IUS (also used in 4, 5) b. Self-reported achievement of therapy goals and valued life goals in general (reported by patient as well as spouse/partner) c. Pain intensity d. Self-reported use of safety behaviour (reported by the patient as well as by the spouse/partner) II. At 7 different assessment moments (see flowchart of the study, section C, p. 18): a. Pain disability (QBPDQ) b. Pain-related fear (TSK, PHODA and PHODA-SeV) c. Pain catastrophizing (PCS) d. Need to control questionnaire e. Safety behaviour questionnaire f. Pain Solutions Questionnaire (PaSol) g. Two behavioural performance tasks (BAT): A standardized bag carrying task and a personalized task h. Positive and Negative Affect Schedule (PANAS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of within-session fear reduction is measured. This will allow us to investigate how within-session fear reduction and between-session fear reduction are related to each other. For this purpose, patients are asked to rate the following items on a scale from 0 to 10 before and after each exposure exercise: a) *If you had to do the exercise again, how much damage to your back do you expect to be done?* (0= no damage at all, 10= a lot of damage) b) *If you had to do the exercise again, what are the odds you will not be able to do this?* (0= zero odds, 10= I am sure I can do this) c) *How sure are you of this expectation?* (0= not sure at all, 10= very sure) 2. Furthermore, we will use *subjective units of distress* (SUDs) to measure the amount of distress that is experienced by the patient before, during and after the exposure exercise. Participants are asked to indicate their experienced level of distress on a scale from 0 (complete relaxation) to 10 (extreme distress). 3 . Other parameters: a) Credibility check (CEQ) b) Fidelity check (for researchers only) c) Demographic information of patient: age, gender, educational level, employment status, duration of complaints, previous treatment including surgery, pain radiation | — |
Countries
Netherlands
Outcome results
None listed