Skip to content

Single-Case Study on Therapeutic Change in Chronic Low Back Pain

Comparing Therapeutic Change During Exposure and Cognitive-Behavioral Therapy in the Context Chronic Low Back Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03157622
Enrollment
12
Registered
2017-05-17
Start date
2015-06-30
Completion date
2017-06-30
Last updated
2017-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain

Keywords

Chronic Low Back Pain, Cognitive-Behavioural Therapy, Exposure, Therapeutic processes, Single-case study

Brief summary

Exploration of treatment processes during exposure and cognitive-behavioral therapy in the context of chronic low back pain in a multiple baseline single-case design.

Detailed description

The present study intends to specifically investigate treatment elements during exposure and cognitive-behavioral therapy, which are especially powerful in electing time contingent therapeutic change. hereby, it is the goal to explore further change processes, which play an important role during psychological treatment of individuals with CLBP and high levels of fear-avoidance.

Interventions

10 sessions based on an individualized fear hierarchy

graded activity, relaxation techniques and cognitive interventions

Sponsors

Psychotherapie-Ambulanz Marburg e.V.
CollaboratorOTHER
Philipps University Marburg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \> 6 months chronic low back pain * Sufficient level on fear avoidance scores (PCS \> 35, PASS \>20, QBPDS \> 30, PDI \> 20 and Phoda harm ratings of 13 activities \> 50, including 8 \> 80) * German-speaking * Agreeing to participate, verified by completion of informed consent

Exclusion criteria

* Red flags * Pregnancy * Illiteracy * Psychoses * Alcohol addiction * Surgeries during the last 6 months or planed surgeries * Specific medical disorders or cardiovascular diseases preventing participation in physical exercise * Participating in another psychotherapy

Design outcomes

Primary

MeasureTime frameDescription
Therapeutic changes during the course of treatment compared to baselinefrom baseline phase (1-3 weeks) to intervention phase (5 weeks)Specifically developed questionnaire on therapeutic change processes

Secondary

MeasureTime frameDescription
Pain-related anxiety at posttest and follow-up compared to baseline pain-related anxietyfrom pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)Pain Anxiety Symptom Scale, PASS- D 20
Pain catastrophizing thoughts at posttest and follow-up compared to baseline pain catastrophizing thoughtsfrom pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)Pain Catastrophizing Scale, PCS
Perceived harmfulness of daily activities at posttest and follow-up compared to baseline perceived harmfulness of daily activitiesfrom pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)Photo Series of Daily Actives, Phoda
Pain-related avoidance behavior at posttest and follow-up compared to baseline pain-related avoidance behaviorfrom pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)Behavioral Avoidance Test, BAT Back
Pain severity at posttest and follow-up compared to baseline pain severityfrom pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)Brief Pain Inventory, BPI
Change from baseline in specific pain disability at posttest and follow-up compared to baseline specific pain disabilityfrom pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)Quebec Back Pain Disability Scale, QBPDS
Emotional distress at posttest and follow-up compared to baseline emotional distressfrom pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)Hospital Anxiety and Depression Scale, HADS
Biological stress markers distress at posttest and follow-up compared to baseline biological stress markersfrom pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)collection of salivary cortisol using SaliCaps during the behavioral test, collection of hair samples
Change from baseline in global pain disability at posttest and follow-up compared to baseline global pain disabilityfrom pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)Pain Disability Index, PDI

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026