Low Back PainNCT02298764
Back Pain and PostTraumaticStressDisorder. A Randomized Clinical Trial
A study testing Standard back pain treatment and Standard back pain treatment + 10 psychotherapeutic sessions in people with Low Back Pain and PTSD, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
Aim The aim is to test whether a short psychotherapeutic intervention targeting Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the outcomes of the Standard Multidisciplinary Program (SMP) against chronic back pain development. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, PTSD
- What is being tested?
- Standard back pain treatment and Standard back pain treatment + 10 psychotherapeutic sessions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Sep 2016
- 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
- Back pain: from 1/2 Y duration or longer
- Trauma according to HTQ
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Somatic Experiencing for Patients With Comorbid Posttraumatic Stress and Back Pain - A Randomized Controlled Trial.
Aim The aim is to test whether a short psychotherapeutic intervention targeting Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the outcomes of the Standard Multidisciplinary Program (SMP) against chronic back pain development.
Read the detailed description
Focus Patients with back pain often demonstrate symptoms of PTSD measured via the Harvard Trauma Questionnaire Scale (HTQ). It has been found that PTSD and pain may maintain each other.
Methods Thousand consecutive patients with Low Back Pain (LBP) referred to the Spine Center are screened for PTSD. It is expected that 100 patients will meet the inclusion criteria and be randomized to SMP or to SMP plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.
Conclusion The project started in 2013, so there have not yet been any results. Currently total reached 65 back pain patients; 34 patients in the SMP + sessions intervention arm.
Effect parameters are: Pain, daily function, EuroQOL and (HTQ), anxiety and depression, fear avoidance (Tampa Scale for Kinesiophobia) on entry, and at 6/12 months.
This "Nested Randomized Trial in a Cohort Design" is one of the very first studies targeting both PTSD and chronic pain-related symptomatology.
- Conditions
- Low Back Pain, PTSD
- Being tested
- Standard back pain treatment, Standard back pain treatment + 10 psychotherapeutic sessions
- Medical subject headings
- Low Back Pain, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard back pain treatmentOther
Standard back pain treatment
Standard back pain treatment + 10 psychotherapeutic sessionsOther
Standard back pain treatment plus 10 psychotherapeutic session, that will include the shock-trauma method "somatic experiencing".
| Study group | Role | What they receive |
|---|---|---|
| standard + 10 psychotherapeutic sessions | Active comparator | - standard back pain treatment plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'. Receives: Other: Standard back pain treatment + 10 psychotherapeutic sessions |
| Standard back pain treatment | Active comparator | Standard back pain treatment Receives: Other: Standard back pain treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional status, Roland Morris Scale
scale ranging from 0-24
Measured: 0, 1 year
Secondary outcomes (2)
Harvard Trauma Questionnaire
scale ranging from 17-68
Measured: 0, 1 year
Back pain intensity, numeric rating scale
scale ranging from 0-10
Measured: 0, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startFeb 2013
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Spine Centre of Southern Denmark
- Responsible party
- Principal investigator, Tonny Elmose Andersen, phd., University of Southern Denmark
- Investigators
- Tonny E Andersen, PhD, Principal investigator, University of Southern Denmark, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298764
- Sponsor's protocol ID
- RCT2014PTSD
- Status last verified
- Nov 2016
- First submitted
- 12 Nov 2014
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Somatic Experiencing for Patients With Comorbid Posttraumatic Stress and Back Pain - A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02298764
- Acronym / sponsor ID
- RCT2014PTSD
- Conditions
- Low Back Pain, PTSD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Spine Centre of Southern Denmark
- Study start
- Feb 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 24 Nov 2014 (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.
Aim The aim is to test whether a short psychotherapeutic intervention targeting Post Traumatic Stress Disorder (PTSD) symptoms will have an additional positive effect on the outcomes of the Standard Multidisciplinary Program (SMP) against chronic back pain development.
Detailed description
Focus Patients with back pain often demonstrate symptoms of PTSD measured via the Harvard Trauma Questionnaire Scale (HTQ). It has been found that PTSD and pain may maintain each other.
Methods Thousand consecutive patients with Low Back Pain (LBP) referred to the Spine Center are screened for PTSD. It is expected that 100 patients will meet the inclusion criteria and be randomized to SMP or to SMP plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'.
Conclusion The project started in 2013, so there have not yet been any results. Currently total reached 65 back pain patients; 34 patients in the SMP + sessions intervention arm.
Effect parameters are: Pain, daily function, EuroQOL and (HTQ), anxiety and depression, fear avoidance (Tampa Scale for Kinesiophobia) on entry, and at 6/12 months.
This "Nested Randomized Trial in a Cohort Design" is one of the very first studies targeting both PTSD and chronic pain-related symptomatology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard + 10 psychotherapeutic sessions | Active comparator | Other: Standard back pain treatment + 10 psychotherapeutic sessions- standard back pain treatment plus 10 psychotherapeutic sessions, that will include the shock-trauma method 'Somatic Experiencing'. |
| Standard back pain treatment | Active comparator | Other: Standard back pain treatmentStandard back pain treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Back pain: from 1/2 Y duration or longer
- Trauma according to HTQ
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Standard back pain treatmentStandard back pain treatment | Other | Standard back pain treatment |
| Standard back pain treatment + 10 psychotherapeutic sessionsStandard back pain treatment plus 10 psychotherapeutic session, that will include the shock-trauma method "somatic experiencing". | Other | standard + 10 psychotherapeutic sessions |
Primary outcome
Functional status, Roland Morris Scale
Time frame: 0, 1 year
scale ranging from 0-24
2 secondary outcomes
Harvard Trauma Questionnaire
Time frame: 0, 1 year
Back pain intensity, numeric rating scale
Time frame: 0, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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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.
Tonny E Andersen, PhD principal investigator
University of Southern Denmark, Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard back pain treatment and Standard back pain treatment + 10 psychotherapeutic sessions in people with Low Back Pain and PTSD, run by University of Southern Denmark at 1 site in Denmark.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 15 Nov 2016. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional status, Roland Morris Scale (time frame: 0, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2016.