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

Not Applicable

Completed

• Conditions: Chronic Low Back Pain

• Registration Number: NCT03157622
• Lead Sponsor: Philipps University Marburg Medical Center

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-03
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Therapeutic changes during the course of treatment compared to baseline	from baseline phase (1-3 weeks) to intervention phase (5 weeks)	Specifically developed questionnaire on therapeutic change processes

Secondary Outcome Measures

Name	Time	Method
Pain severity at posttest and follow-up compared to baseline pain severity	from 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
Pain-related anxiety at posttest and follow-up compared to baseline pain-related anxiety	from 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 thoughts	from 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 activities	from 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 behavior	from 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
Change from baseline in global pain disability at posttest and follow-up compared to baseline global pain disability	from 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
Change from baseline in specific pain disability at posttest and follow-up compared to baseline specific pain disability	from 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 distress	from 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 markers	from 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

Trial Locations

Locations (1)

Philipps University Marburg, Department of Clinical Psychology and Psychotherapy; 🇩🇪 Marburg, Germany