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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157622
• Other study ID #: 2015-17k
• Status: Completed
• Phase: N/A
• First received: November 10, 2015
• Last updated: July 3, 2017
• Start date: June 2015
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Behavioral:
• Exposure in vivo
10 sessions based on an individualized fear hierarchy
• Cognitive Behavioural Psychotherapy
graded activity, relaxation techniques and cognitive interventions

Locations

Country	Name	City	State
Germany	Philipps University Marburg, Department of Clinical Psychology and Psychotherapy	Marburg

Sponsors (2)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center	Psychotherapie-Ambulanz Marburg e.V.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic changes during the course of treatment compared to baseline	Specifically developed questionnaire on therapeutic change processes	from baseline phase (1-3 weeks) to intervention phase (5 weeks)
Secondary	Pain severity at posttest and follow-up compared to baseline pain severity	Brief Pain Inventory, BPI	from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
Secondary	Pain-related anxiety at posttest and follow-up compared to baseline pain-related anxiety	Pain Anxiety Symptom Scale, PASS- D 20	from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
Secondary	Pain catastrophizing thoughts at posttest and follow-up compared to baseline pain catastrophizing thoughts	Pain Catastrophizing Scale, PCS	from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
Secondary	Perceived harmfulness of daily activities at posttest and follow-up compared to baseline perceived harmfulness of daily activities	Photo Series of Daily Actives, Phoda	from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
Secondary	Pain-related avoidance behavior at posttest and follow-up compared to baseline pain-related avoidance behavior	Behavioral Avoidance Test, BAT Back	from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
Secondary	Change from baseline in global pain disability at posttest and follow-up compared to baseline global pain disability	Pain Disability Index, PDI	from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
Secondary	Change from baseline in specific pain disability at posttest and follow-up compared to baseline specific pain disability	Quebec Back Pain Disability Scale, QBPDS	from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
Secondary	Emotional distress at posttest and follow-up compared to baseline emotional distress	Hospital Anxiety and Depression Scale, HADS	from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)
Secondary	Biological stress markers distress at posttest and follow-up compared to baseline biological stress markers	collection of salivary cortisol using SaliCaps during the behavioral test, collection of hair samples	from pretest (admission) to posttests (an expected average of 8 weeks after admission) to follow-up (an expected average of 6 months after completion)

External Links

•   CV of Principle Investigator