EFFECT-BACK: Tackling Back Pain - Effects of Exposure Therapy and Cognitive Behavioural Therapy for Chronic Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 392
- Locations
- 5
- Primary Endpoint
- Change in pain related disability
Study Overview
Brief Summary
The overall aim of the present study is to compare two different psychological methods, Cognitive Behavioural Therapy (CBT) and Graduated Exposure in vivo (EXP) in the treatment of chronic back pain with regard to effectiveness and improvement of pain related disability.
Exploratory research will also be conducted to identify predictors of which patient groups benefit more from which method. This should optimise treatment options and create effective treatment offers for subgroups of pain patients.
Exposure therapy is an effective and economical treatment modality and was shown in a previous pilot study to be superior to CBT in reducing perceived movement limitation. CBT, on the other hand, appeared to be more effective in establishing coping strategies. With the help of the current study it should be possible to compare the effectiveness of both treatment methods and, in perspective, to identify those patient groups that benefit from exposure therapy and thus create a tailor-made treatment programme for subgroups of pain patients.
A total of 380 patients (age: ≥ 18) with chronic back pain and a sufficient degree of impairment will be included and analysed in the study.
Detailed Description
According to a recently published study by the Robert Koch Institute with over 62 000 participants, one in six men (17.1%) and one in four women (24.4%) in Germany reported having suffered from chronic low back pain (CLBP) in the last 12 months. CLBP is a major cause of medical costs, absenteeism and disability. Despite apparent advances in medical care, the prevalence of CLBP continues to rise.
According to current guidelines, most of the commonly offered treatments such as injections or surgery are ineffective; only pharmacotherapy shows small effects but carries a high risk of side effects.
Cognitive behavioural therapy (CBT), multidisciplinary approaches with psychological treatment components such as CBT and exercise, supported by psychological elements, improve pain and condition-related disability in the long term. Disappointingly, however, in most studies the effects of multidisciplinary or psychological treatment approaches are small to moderate, and in the case of multidisciplinary approaches, do not always justify the high costs of inpatient programmes. In outpatient care, specific psychological services in addition to pharmacotherapy and physiotherapy are rare.
EXP treatment for pain is a rarely used psychological treatment that specifically addresses the avoidance of physical activity in people with CLBP. In a previous pilot study with 88 participants, the investigators conducted for the first time a short (10 sessions) and a longer (15 sessions) outpatient EXP therapy programme and compared it with a standard 15-session CBT programme:
- EXP was more effective than CBT in reducing movement-related impairment.
- EXP-short outperformed EXP-long in efficiency after 10 sessions, meaning that individuals improved faster when offered fewer sessions.
- EXP could be safely delivered in the outpatient psychological setting, however CBT was more effective than EXP in improving coping strategies.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Chronic low back pain (duration > 6 months, pain on most days of the week)
- •Sufficient level of disability, as defined by QBPDS ≥ 15 (Quebec Back Pain Disability Scale)
- •Age 18 and above
- •Agreeing to participate, verified by completion of informed consent
Exclusion Criteria
- •Back surgeries during the last six months or planned surgeries
- •Red Flags
- •inability to read or write in German
- •pregnancy
- •severe alcohol or drug addiction
- •psychotic disorders
- •another current psychological treatment
- •physical inability to attend sessions
- •parallel participation in another intervention study
- •Depression will be controlled for, medication will be required to stay stable until Follow-up and any changes will be controlled for, on-demand ("rescue") medication will be not allowed.
Arms & Interventions
Exposure (EXP)
Exposure in vivo for fear avoidant chronic low back pain patients. This treatment means that the individual is exposed to movements and tasks that have been avoided due to fear of (re)injury. The treatment begins after three educational lessons including the rational and developing a fear hierarchy. Exposure phase includes 10 exposures sessions which are highly individualized. Behavioral experiments can be included to correct catastrophic misinterpretations. The main purpose of this intervention type is to reduce pain related disability via diminishing fear avoidance.
Intervention: Exposure therapy (Behavioral)
Cognitive Behavioural Therapy (CBT)
Cognitive behavioural psychotherapy for fear avoidant chronic low back patients. The therapy is modularized in three main parts. The educational lesson is followed by the module graded activity which represents the behavioral part of the program. The second module comprises relaxation. And the last part contains cognitive interventions. Cognitive behavioural intervention techniques are employed to support the patient in the process of coping with chronic pain: i.e. reduction of disability and improving functional ability.
Intervention: Cognitive behavioral therapy (Behavioral)
Outcomes
Primary Outcomes
Change in pain related disability
Time Frame: from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months after Posttest and 2 years after Posttest)
Clinically significant change in pain-related impairment at the end of therapy and at 6-months and 2-years follow-up compared to baseline. Quebec Back Pain Disability Scale (QBPDS). Each item is scored from 0 to 5 (0 = not difficult at all, 5 = unable to do). Higher total scores reflect higher disability.
Secondary Outcomes
- Change in pain disability(from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest))
- Change in pain intensity(from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest))
- Change in coping(from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest))
- Change in emotional distress(from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest))
- Change in pain catastrophizing(from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest))
- Change in kinesiophobia(from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest))
- Change in pain anxiety(from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest))
- Change in psychological inflexibility(from Baseline to Posttest (an expected average of 15 weeks) to Follow Up Assessments (an expected average of 6 months and 2 years after Posttest))