Chronic Low Back PainNCT01971151
Exposure Therapy and Safety-seeking Behavior in Chronic Low Back Pain
A study testing Exposure therapy in people with Chronic Low Back Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
RATIONALE: Exposure in vivo therapy aims to reduce pain-related fear - a key maintaining factor of chronic low back pain- while increasing level of daily functioning, despite the pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Exposure therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffer from chronic low back pain not caused by serious spinal injury, for at least 3 to 6 months
- Report a sufficient level of disability (this is in itself already a criterion to start treatment at the Rehabilitation department) and
- Moderate to high levels of pain-related fear (TSK > 37 or at least 4 items with a score of 3 or >3)
- Have a partner willing to participate
Who cannot join
- Specific medical disorder or cardiovascular disease preventing participation in physical exercise
- Serious psychopathologic co-morbidity. This is checked during anamnesis in the intake session with the rehabilitation physician and during the screening (standard care, see session 1 and session 2). When psychopathologic co-morbidity is detected, patients cannot participate in the study and may not be suitable candidates for exposure therapy entirely. Any decision regarding treatment recommendation is made with the entire treatment team. Furthermore, the researcher performing the therapy has a Master's degree in Clinical Psychology, which adds to the treatment team's expertise on psychopathology.
- Alcohol or drug abuse, i.e., at least one out of the four following criteria needs to be fulfilled: continued use despite social or interpersonal problems; repeated use resulting in failure to fulfill obligations at work, school, or home; repeated use resulting in physically hazardous situations; use resulting in legal problems (according to the Diagnostic Statistical Manual of Mental disorders, 4th ed.). This is assessed by the rehabilitation physician during the first session.
- Illiteracy
- Pregnancy
- Involvement in litigation concerning the patient's ability to work or disability income
- Non-Dutch speaking
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht medical care center, department of rehabilitation
Maastricht, Maastricht, 6202
About this study
Official title: An Investigation Into the Effectiveness of Treatment of Chronic Low Back Pain
RATIONALE: Exposure in vivo therapy aims to reduce pain-related fear - a key maintaining factor of chronic low back pain- while increasing level of daily functioning, despite the pain. This is done by exposing patients to their most feared activities/movements, while behavioral experiments are performed that serve to correct catastrophic (erroneous) beliefs about pain. Yet, performing exposure exercises might be very threatening for patients and might encourage them to build in subtle safety-seeking behavior. Whether safety-seeking behavior should be allowed or not during therapy is heavily debated. Whereas some argue that it will only interfere with therapeutic progress because it prevents the disconfirming experience exposure tries to offer, other argue that it will facilitate therapeutic progress because it enhances one's sense of control, if used judiciously. So far (clinical-)experimental studies have provided mixed evidence nor have they lead to any clinical recommendation. Hence, in a replicated single-case experiment, we will compare exposure therapy with versus exposure without safety-seeking behavior versus exposure only.
STUDY POPULATION: Participants are chronic low back pain patients seeking treatment, who fulfill all inclusion and exclusion criteria and participate voluntarily.
Read more
INTERVENTION: All participants receive exposure therapy at the rehabilitation department of the academic hospital in Maastricht, but with different recommendations for the use of safety-seeking behavior.
We will assess: 1) daily measures of fear, pain intensity and self-reported achievement of goals and 2) non-daily measures of pain disability, pain-related fear, pain catastrophizing, pain solutions, need to control and safety-seeking behavior. To measure to the influence of safety-seeking behavior on actual level of functioning, two behavioral performance tasks will also be presented, ie. a bag carrying task and a personalized task.
BURDEN AND RISKS: There are no risks associated with participation to this study that are not otherwise related to rehabilitation and movement in general and participation is completely voluntary. Participants are requested to fill out questionnaires on a daily basis at home (computerized if possible), as well as on different time points during the study and at follow up and perform two behavioral performance tasks. This study could help to further improve the beneficial long-term effects of exposure.
- Conditions
- Chronic Low Back Pain
- Being tested
- Exposure therapy
- Keywords
- Chronic, Back pain, Low back
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure therapyBehavioural
Also called Cognitive-behavioural therapy
Treatment protocol:
- preparation consisting of intake and identification of feared movements, activities and situations and their underlying catastrophic beliefs. 2) education, 3)exposure sessions: patients confront threatening situations and behavioral experiments are performed that are targeted at correcting erroneous catastrophic beliefs. 4) homework assignments.
| Study group | Role | What they receive |
|---|---|---|
| Exposure with safety-seeking behavior | Experimental | Patients receive exposure therapy. In the current condition, exposure is offered while patients are allowed to use their own safety-seeking behaviors (i.e., behavior believed to be necessary to prevent a feared catastrophe). Receives: Behavioral: Exposure therapy |
| Exposure without safety-seeking behavior | Experimental | Patients receive exposure therapy.In the current condition, exposure is offered while patients are instructed to omit their safety-seeking behavior. Receives: Behavioral: Exposure therapy |
| Exposure therapy only | Active comparator | Patients receive exposure therapy. In the current condition, exposure is offered while patients do not receive any specific instructions about what to do with their safety-seeking behavior. Receives: Behavioral: Exposure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain-related fear level from baseline to end of treatment at 9 weeks and to follow-up at 20 weeks to 51 weeks
Three self-report measures are used: 1) daily measures of fear, 2) The Tampa Scale of Kinesiophobia (TSK): a questionnaire to o assess general level of fear of (re)injury due to movement, 2) The Photograph Series of Daily activities(PHODA) and the PHODA-Short electronic version (PHODA-SeV): a tool to assess the perceived harmfulness of specific daily activities.
Measured: baseline and 9 weeks , 20 weeks, and 51 weeks
Secondary outcomes (3)
Change in back pain-related disability from baseline to end of treatment at 9 weeks and to follow-up at 20 weeks and 51 weeks
Two behavioral tasks assessed at baseline and follow-up. Two types of self-report measure are used: 1) daily measures of perceived level of functioning and ability to achieve desired activities and goals 2) non-daily questionnaire of back pain specific disability
Measured: baseline, 9 weeks, 20, 51 weeks
Change in pain from baseline to end of treatment at 9 weeks and to follow up at 20 weeks and 51 weeks
Self-reported pain intensity, pain unpleasantness via daily measures
Measured: baseline, 9 weeks, 20 weeks and 51 weeks
Change in pain catastrophizing from baseline to end of treatment at 9 weeks and to follow up at 20 weeks and 51 weeks
Self-report: 1) daily measures of catastrophizing levels, 2) pain catastrophizing questionnaire, assessed at baseline and follow-up
Measured: baseline, 9 weeks, 20 weeks and 51 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, Maastricht University
- Responsible party
- Sponsor
- Investigators
- Johan Vlaeyen, PhD, Principal investigator, Maastricht University and University of Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971151
- Sponsor's protocol ID
- Exp_SSB_LBP
- Status last verified
- Oct 2013
- First submitted
- 23 Oct 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Vlaeyen JW, de Jong J, Geilen M, Heuts PH, van Breukelen G. Graded exposure in vivo in the treatment of pain-related fear: a replicated single-case experimental design in four patients with chronic low back pain. Behav Res Ther. 2001 Feb;39(2):151-66. doi: 10.1016/s0005-7967(99)00174-6.
PubMed 11153970
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Effectiveness of Treatment of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01971151
- Acronym / sponsor ID
- Exp_SSB_LBP
- Conditions
- Chronic Low Back Pain
- Keywords
- Chronic, Back pain, Low back
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- KU Leuven, Maastricht University
- Study start
- Feb 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Exposure in vivo therapy aims to reduce pain-related fear - a key maintaining factor of chronic low back pain- while increasing level of daily functioning, despite the pain. This is done by exposing patients to their most feared activities/movements, while behavioral experiments are performed that serve to correct catastrophic (erroneous) beliefs about pain. Yet, performing exposure exercises might be very threatening for patients and might encourage them to build in subtle safety-seeking behavior. Whether safety-seeking behavior should be allowed or not during therapy is heavily debated. Whereas some argue that it will only interfere with therapeutic progress because it prevents the disconfirming experience exposure tries to offer, other argue that it will facilitate therapeutic progress because it enhances one's sense of control, if used judiciously. So far (clinical-)experimental studies have provided mixed evidence nor have they lead to any clinical recommendation. Hence, in a replicated single-case experiment, we will compare exposure therapy with versus exposure without safety-seeking behavior versus exposure only.
STUDY POPULATION: Participants are chronic low back pain patients seeking treatment, who fulfill all inclusion and exclusion criteria and participate voluntarily.
INTERVENTION: All participants receive exposure therapy at the rehabilitation department of the academic hospital in Maastricht, but with different recommendations for the use of safety-seeking behavior.
We will assess: 1) daily measures of fear, pain intensity and self-reported achievement of goals and 2) non-daily measures of pain disability, pain-related fear, pain catastrophizing, pain solutions, need to control and safety-seeking behavior. To measure to the influence of safety-seeking behavior on actual level of functioning, two behavioral performance tasks will also be presented, ie. a bag carrying task and a personalized task.
BURDEN AND RISKS: There are no risks associated with participation to this study that are not otherwise related to rehabilitation and movement in general and participation is completely voluntary. Participants are requested to fill out questionnaires on a daily basis at home (computerized if possible), as well as on different time points during the study and at follow up and perform two behavioral performance tasks. This study could help to further improve the beneficial long-term effects of exposure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exposure with safety-seeking behavior | Experimental | Behavioral: Exposure therapyPatients receive exposure therapy. In the current condition, exposure is offered while patients are allowed to use their own safety-seeking behaviors (i.e., behavior believed to be necessary to prevent a feared catastrophe). |
| Exposure without safety-seeking behavior | Experimental | Behavioral: Exposure therapyPatients receive exposure therapy.In the current condition, exposure is offered while patients are instructed to omit their safety-seeking behavior. |
| Exposure therapy only | Active comparator | Behavioral: Exposure therapyPatients receive exposure therapy. In the current condition, exposure is offered while patients do not receive any specific instructions about what to do with their safety-seeking behavior. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Suffer from chronic low back pain not caused by serious spinal injury, for at least 3 to 6 months
- Report a sufficient level of disability (this is in itself already a criterion to start treatment at the Rehabilitation department) and
- Moderate to high levels of pain-related fear (TSK > 37 or at least 4 items with a score of 3 or >3)
- Have a partner willing to participate
Key exclusion criteria (7 listed)
- Specific medical disorder or cardiovascular disease preventing participation in physical exercise
- Serious psychopathologic co-morbidity. This is checked during anamnesis in the intake session with the rehabilitation physician and during the screening (standard care, see session 1 and session 2). When psychopathologic co-morbidity is detected, patients cannot participate in the study and may not be suitable candidates for exposure therapy entirely. Any decision regarding treatment recommendation is made with the entire treatment team. Furthermore, the researcher performing the therapy has a Master's degree in Clinical Psychology, which adds to the treatment team's expertise on psychopathology.
- Alcohol or drug abuse, i.e., at least one out of the four following criteria needs to be fulfilled: continued use despite social or interpersonal problems; repeated use resulting in failure to fulfill obligations at work, school, or home; repeated use resulting in physically hazardous situations; use resulting in legal problems (according to the Diagnostic Statistical Manual of Mental disorders, 4th ed.). This is assessed by the rehabilitation physician during the first session.
- Illiteracy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure therapyAlso: Cognitive-behavioural therapyTreatment protocol: 1) preparation consisting of intake and identification of feared movements, activities and situations and their underlying catastrophic beliefs. 2) education, 3)exposure sessions: patients confront threatening situations and behavioral experiments are performed that are targeted at correcting erroneous catastrophic beliefs. 4) homework assignments. | Behavioural | Exposure therapy only, Exposure with safety-seeking behavior, Exposure without safety-seeking behavior |
Primary outcome
Change in pain-related fear level from baseline to end of treatment at 9 weeks and to follow-up at 20 weeks to 51 weeks
Time frame: baseline and 9 weeks , 20 weeks, and 51 weeks
Three self-report measures are used: 1) daily measures of fear, 2) The Tampa Scale of Kinesiophobia (TSK): a questionnaire to o assess general level of fear of (re)injury due to movement, 2) The Photograph Series of Daily activities(PHODA) and the PHODA-Short electronic version (PHODA-SeV): a tool to assess the perceived harmfulness of specific daily activities.
3 secondary outcomes
Change in back pain-related disability from baseline to end of treatment at 9 weeks and to follow-up at 20 weeks and 51 weeks
Time frame: baseline, 9 weeks, 20, 51 weeks
Change in pain from baseline to end of treatment at 9 weeks and to follow up at 20 weeks and 51 weeks
Time frame: baseline, 9 weeks, 20 weeks and 51 weeks
Change in pain catastrophizing from baseline to end of treatment at 9 weeks and to follow up at 20 weeks and 51 weeks
Time frame: baseline, 9 weeks, 20 weeks and 51 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
- Background: PubMed 11153970Vlaeyen JW, de Jong J, Geilen M, Heuts PH, van Breukelen G. Graded exposure in vivo in the treatment of pain-related fear: a replicated single-case experimental design in four patients with chronic low back pain. Behav Res Ther. 2001 Feb;39(2):151-66. doi: 10.1016/s0005-7967(99)00174-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Vlaeyen, PhD principal investigator
Maastricht University and University of Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure therapy in people with Chronic Low Back Pain, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain-related fear level from baseline to end of treatment at 9 weeks and to follow-up at 20 weeks to 51 weeks (time frame: baseline and 9 weeks , 20 weeks, and 51 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01971151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.