Low Back PainNCT00329342
Return to Work Interventions for Patients With Low Back Pain
A study testing Occupational ergonomic training in people with Low Back Pain, run by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster at 1 site in Germany.
Trial summary
Low back pain has become a major concern to employees and employers because of its negative impact on employee health and productivity. The objective of this study is to investigate whether a return-to-work intervention conducted during inpatient rehabilitation improves functional limitations that are related with low… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Occupational ergonomic training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2006to Jun 2007
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronic low back pain
- Undergoing inpatient rehabilitation
- Working age
Who cannot join
- Receiving or applying for retirement pension
- Diagnostic findings that require surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Return to Work Interventions for Patients With Low Back Pain During Inpatient Rehabilitation: a Quasi-Experimental Study
Low back pain has become a major concern to employees and employers because of its negative impact on employee health and productivity.
The objective of this study is to investigate whether a return-to-work intervention conducted during inpatient rehabilitation improves functional limitations that are related with low back pain and interfere with job performance.
Read the detailed description
In recent years most industrialized nations have been confronted with a dramatic increase in cases dealing with back pain; in Germany, back pain belongs to the major individual and societal health problems with associated costs that have put a strain not only on health care systems. Besides frequent demand for medical services, loss of production (due to temporal sick leave) and disability allowances are important economic factors. In total, the estimated annual costs caused by back pain range between 16 and 22 billion Euros. Population based studies revealed high life-time prevalence with 80% report having ever experienced back pain. The point prevalence lies between 30 and 40%. Approximately one-fourth to one-third of those affected suffer from clinically significant back pain. Epidemiological evidence for the prevalence of back pain, its severity, course and associated risk factors is extensive; however, little systematic knowledge is available about treatment of back pain especially about return-to-work interventions.
This study is designed as a quasi-experimental study to evaluate benefits of return-to-work interventions during medical rehabilitation. Positive effects are expected for low back pain related functional limitations and subsequently job performance. The intervention tested is based on the biomechanical model of chronic pain that assumes a relationship between external strain, body posture, muscle activity, and intravertebral pressure. According to this model, chronic low back pain is partially caused by overexertion and poor postural habits. The intervention aims at lowering the impact of biomechanical stress by training an adequate body posture while performing activities of daily living or job-related activities. Additionally, performing job-related activities target fear-avoidance beliefs especially assumptions about the connection between pain and work activities. The experimental group training good postural habits while performing activities of daily living or job-related activities (additionally to standard rehabilitation activities such as physiotherapy or education and counselling) will be compared with participants receiving a standard rehabilitation only.
Outcome measures are assessed at baseline, post-intervention, and 6 month post-intervention.
- Conditions
- Low Back Pain
- Being tested
- Occupational ergonomic training
- Keywords
- Low back pain;, Return to work;, Posture
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational ergonomic trainingBehavioural
Adequate postural habits in activities of daily living
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Occupational ergonomic training |
| 2 | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low Back Pain Disability: Oswestry Disability Index (ODI)
Measured: 6 months
Secondary outcomes (4)
Return-to-work (RTW) outcomes: Duration of time out of work, RTW-status
Measured: 6 months
Fear avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) for Patients with Back Pain
Measured: 6 months
Vitality: SF-36 vitality
Measured: 6 months
Ergonomic competence: Rating of posture and movement.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2006 (estimated)
- Study startApr 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Low 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 N/A
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster
- Sponsor type
- Other government
- Collaborators
- European Union, Federal ministry of labour and social affairs
- Investigators
- Martina Markes, Principal investigator, Forschungsinstitut fuer Balneologie und Kurortwissenschaft
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329342
- Sponsor's protocol ID
- RTW-LBP-1
- Status last verified
- Nov 2007
- First submitted
- 23 May 2006
- Last updated
- 27 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Schmidt CO, Kohlmann T. [What do we know about the symptoms of back pain? Epidemiological results on prevalence, incidence, progression and risk factors]. Z Orthop Ihre Grenzgeb. 2005 May-Jun;143(3):292-8. doi: 10.1055/s-2005-836631. German.
PubMed 15977117Keller S, Herda C, Ridder K, Basler HD. Readiness to adopt adequate postural habits: an application of the Transtheoretical Model in the context of back pain prevention. Patient Educ Couns. 2001 Feb;42(2):175-84. doi: 10.1016/s0738-3991(00)00103-8.
PubMed 11118783Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
PubMed 8455963Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
PubMed 6450426Pfingsten M, Kroner-Herwig B, Leibing E, Kronshage U, Hildebrandt J. Validation of the German version of the Fear-Avoidance Beliefs Questionnaire (FABQ). Eur J Pain. 2000;4(3):259-66. doi: 10.1053/eujp.2000.0178.
PubMed 10985869Huppe A, Raspe H. [Efficacy of inpatient rehabilitation for chronic back pain in Germany: a systematic review 1980-2001]. Rehabilitation (Stuttg). 2003 Jun;42(3):143-54. doi: 10.1055/s-2003-40099. German.
PubMed 12813651
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Work Interventions for Patients With Low Back Pain During Inpatient Rehabilitation: a Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT00329342
- Acronym / sponsor ID
- RTW-LBP-1
- Conditions
- Low Back Pain
- Keywords
- Low back pain;, Return to work;, Posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Forschungsinstitut für Balneologie und Kurortwissenschaft Bad ElsterOther government
- Collaborators
- European Union, Federal ministry of labour and social affairs
- Study start
- Apr 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 24 May 2006 (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.
Low back pain has become a major concern to employees and employers because of its negative impact on employee health and productivity.
The objective of this study is to investigate whether a return-to-work intervention conducted during inpatient rehabilitation improves functional limitations that are related with low back pain and interfere with job performance.
Detailed description
In recent years most industrialized nations have been confronted with a dramatic increase in cases dealing with back pain; in Germany, back pain belongs to the major individual and societal health problems with associated costs that have put a strain not only on health care systems. Besides frequent demand for medical services, loss of production (due to temporal sick leave) and disability allowances are important economic factors. In total, the estimated annual costs caused by back pain range between 16 and 22 billion Euros. Population based studies revealed high life-time prevalence with 80% report having ever experienced back pain. The point prevalence lies between 30 and 40%. Approximately one-fourth to one-third of those affected suffer from clinically significant back pain. Epidemiological evidence for the prevalence of back pain, its severity, course and associated risk factors is extensive; however, little systematic knowledge is available about treatment of back pain especially about return-to-work interventions.
This study is designed as a quasi-experimental study to evaluate benefits of return-to-work interventions during medical rehabilitation. Positive effects are expected for low back pain related functional limitations and subsequently job performance. The intervention tested is based on the biomechanical model of chronic pain that assumes a relationship between external strain, body posture, muscle activity, and intravertebral pressure. According to this model, chronic low back pain is partially caused by overexertion and poor postural habits. The intervention aims at lowering the impact of biomechanical stress by training an adequate body posture while performing activities of daily living or job-related activities. Additionally, performing job-related activities target fear-avoidance beliefs especially assumptions about the connection between pain and work activities. The experimental group training good postural habits while performing activities of daily living or job-related activities (additionally to standard rehabilitation activities such as physiotherapy or education and counselling) will be compared with participants receiving a standard rehabilitation only.
Outcome measures are assessed at baseline, post-intervention, and 6 month post-intervention.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Occupational ergonomic training |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Chronic low back pain
- Undergoing inpatient rehabilitation
- Working age
Key exclusion criteria (2 listed)
- Receiving or applying for retirement pension
- Diagnostic findings that require surgery
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 |
|---|---|---|
| Occupational ergonomic trainingAdequate postural habits in activities of daily living | Behavioural | 1 |
Primary outcome
Low Back Pain Disability: Oswestry Disability Index (ODI)
Time frame: 6 months
4 secondary outcomes
Return-to-work (RTW) outcomes: Duration of time out of work, RTW-status
Time frame: 6 months
Fear avoidance: Fear-Avoidance Beliefs Questionnaire (FABQ) for Patients with Back Pain
Time frame: 6 months
Vitality: SF-36 vitality
Time frame: 6 months
Ergonomic competence: Rating of posture and movement.
Time frame: 3 weeks
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 27 Nov 2007.
- Background: PubMed 15977117Schmidt CO, Kohlmann T. [What do we know about the symptoms of back pain? Epidemiological results on prevalence, incidence, progression and risk factors]. Z Orthop Ihre Grenzgeb. 2005 May-Jun;143(3):292-8. doi: 10.1055/s-2005-836631. German.
- Background: PubMed 11118783Keller S, Herda C, Ridder K, Basler HD. Readiness to adopt adequate postural habits: an application of the Transtheoretical Model in the context of back pain prevention. Patient Educ Couns. 2001 Feb;42(2):175-84. doi: 10.1016/s0738-3991(00)00103-8.
- Background: PubMed 8455963Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-168. doi: 10.1016/0304-3959(93)90127-B.
- Background: PubMed 6450426Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980 Aug;66(8):271-3. No abstract available.
- Background: PubMed 10985869Pfingsten M, Kroner-Herwig B, Leibing E, Kronshage U, Hildebrandt J. Validation of the German version of the Fear-Avoidance Beliefs Questionnaire (FABQ). Eur J Pain. 2000;4(3):259-66. doi: 10.1053/eujp.2000.0178.
- Background: PubMed 12813651Huppe A, Raspe H. [Efficacy of inpatient rehabilitation for chronic back pain in Germany: a systematic review 1980-2001]. Rehabilitation (Stuttg). 2003 Jun;42(3):143-54. doi: 10.1055/s-2003-40099. German.
Related trials for Low Back Pain
Recruiting
SENECA - Smart Therapies for Chronic Pain
Chronic Low Back Pain (CLBP)
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Chronic Low Back Pain
Chronic Pain, Low Back Pain
Not yet recruiting
Comparison of Two Patient Education Methods in Women With Chronic Low Back Pain: Online Pain Education vs. AI-Driven Patient Education on Pain Beliefs, Catastrophizing, and Self-Efficacy
Chronic Low Back Pain (CLBP)
Not yet recruiting
Evaluation of a Program to Prevent Recurrences of Episodes of Acute Low Back Pain, Assisted by the Axomove Application
Low Back Pain
Enrolling by invitation
The Influence of Hydration on the Viscoelastic Properties of Soft Tissues, Pain and Mobility of Patients
Low Back Pain (LBP), Fascial Manipulation
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.
Martina Markes principal investigator
Forschungsinstitut fuer Balneologie und Kurortwissenschaft
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational ergonomic training in people with Low Back Pain, run by Forschungsinstitut für Balneologie und Kurortwissenschaft Bad Elster 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 3 inclusion and 2 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 27 Nov 2007. 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.
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?
Low Back Pain Disability: Oswestry Disability Index (ODI) (time frame: 6 months). 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 NCT00329342, which also lists 6 linked publications.
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 27 Nov 2007.