Back PainPhase 3NCT00454064
Cognitive-behavioural Treatment of Chronic Back Pain
A Phase 3 study testing cognitive-behavioral treatment in people with Back Pain, run by Philipps University Marburg at 1 site in Germany.
Trial summary
The purpose of the study: to compare two cognitive-behavioral treatments Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Back Pain
- What is being tested?
- cognitive-behavioral treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2004to Feb 2008
- Phase
- Phase 3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Back pain since 6 months
Who cannot join
- Patients with psychosis, borderline psychopathy, drug dependence i.e. alcohol
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Marburg, Department of Clinical Psychology and Psychotherapy
Marburg, Hesse, 35032
About this study
Official title: Study to Compare a Cognitive-behavioral Treatment With a Cognitive-behavioral Treatment With Biofeedback Elements to Patients With Chronic (Low) Back Pain
The purpose of the study:
- to compare two cognitive-behavioral treatments
Read the detailed description
128 patients suffering from chronic back pain were randomly assigned to either Wait List Control, Cognitive Behavioral Treatment or Cognitive Behavioral Treatment and Biofeedback.
Measures were conducted 6 months before treatment (Wait List Control) immediately before and after treatment and at 6-months follow-up.
25 weekly 1-hr sessions of individualized outpatient cognitive behavioral treatment of chronic back pain
Treatment elements:
Cognitive treatment: identification, evaluation and correction of dysfunctional beliefs about themselves and pain by cognitive restructuring, problem-solving training and coping skills training
Behavioural treatment: increasing activity levels (sports, social activities, work), reducing medication intake and unnecessary health care utilization Relaxation training: progressive muscle relaxation, biofeedback.
- Conditions
- Back Pain
- Being tested
- cognitive-behavioral treatment
- Keywords
- cognitive-behavioral therapy, back pain, low back pain, biofeedback, randomized controlled study, EMG biofeedback
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive-behavioral treatmentBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | cognitive-behavioral treatment Receives: Behavioral: cognitive-behavioral treatment |
| 2 | Active comparator | cognitive-behavioral treatment with biofeedback elements Receives: Behavioral: cognitive-behavioral treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
Measured: start of treatment, end of treatment, 6-months follow-up
Secondary outcomes (2)
pain disability
Measured: start of treatment, end of treatment, 6-months follow-up
depression
Measured: start of treatment, end of treatment, 6-months folow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startSep 2004
- Primary completionSep 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winfried Rief, Philipps University Marburg
- Investigators
- Winfried Rief, Professor, Study chair, University Marburg, Department of Clinical Psychology and Psychotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454064
- Sponsor's protocol ID
- RGT090774
- Status last verified
- Sep 2017
- First submitted
- 28 Mar 2007
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Compare a Cognitive-behavioral Treatment With a Cognitive-behavioral Treatment With Biofeedback Elements to Patients With Chronic (Low) Back Pain
- ClinicalTrials.gov ID
- NCT00454064
- Acronym / sponsor ID
- RGT090774
- Conditions
- Back Pain
- Keywords
- cognitive-behavioral therapy, back pain, low back pain, biofeedback, randomized controlled study, EMG biofeedback
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Sep 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 29 Mar 2007 (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.
The purpose of the study:
- to compare two cognitive-behavioral treatments
Detailed description
128 patients suffering from chronic back pain were randomly assigned to either Wait List Control, Cognitive Behavioral Treatment or Cognitive Behavioral Treatment and Biofeedback.
Measures were conducted 6 months before treatment (Wait List Control) immediately before and after treatment and at 6-months follow-up.
25 weekly 1-hr sessions of individualized outpatient cognitive behavioral treatment of chronic back pain
Treatment elements:
Cognitive treatment: identification, evaluation and correction of dysfunctional beliefs about themselves and pain by cognitive restructuring, problem-solving training and coping skills training
Behavioural treatment: increasing activity levels (sports, social activities, work), reducing medication intake and unnecessary health care utilization Relaxation training: progressive muscle relaxation, biofeedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: cognitive-behavioral treatmentcognitive-behavioral treatment |
| 2 | Active comparator | Behavioral: cognitive-behavioral treatmentcognitive-behavioral treatment with biofeedback elements |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Back pain since 6 months
Key exclusion criteria (1 listed)
- Patients with psychosis, borderline psychopathy, drug dependence i.e. alcohol
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 |
|---|---|---|
| cognitive-behavioral treatment | Behavioural | 1, 2 |
Primary outcome
pain intensity
Time frame: start of treatment, end of treatment, 6-months follow-up
2 secondary outcomes
pain disability
Time frame: start of treatment, end of treatment, 6-months follow-up
depression
Time frame: start of treatment, end of treatment, 6-months folow-up
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 2 Oct 2017.
Related trials for Back Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
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.
Winfried Rief, Professor study chair
University Marburg, Department of Clinical Psychology and Psychotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cognitive-behavioral treatment in people with Back Pain, run by Philipps University Marburg at 1 site in Germany.
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 1 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 2 Oct 2017. 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 Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
pain intensity (time frame: start of treatment, end of treatment, 6-months follow-up). 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 2 Oct 2017.