Low Back PainGoBackNCT02015572
Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack)
A study testing Occupational intervention in people with Low Back Pain, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
Low back pain (LBP) is a recognized public health problem with high life time prevalence. Medical treatment may reduce the physical and mental discomfort, while it has not been able to improve the possibilities for retaining or return patients with LBP to work. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Occupational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Dec 2018
- 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
- Working age adults 18-65
- Low back pain (current episode of 2-4 weeks)
- Self-reported physically demanding work
- Sick-listed or at risk
- Speak, read and understand Danish
- Accept workplace visit by the occupational physicians
- Be in gainful employment for at last 30 hours/week
Who cannot join
- Severe somatic or psychiatric comorbidity
- Pregnancy
- Cancer or metastatic disease
- LBP treatment or referral to outside providers (e.g. back-surgery)
- Contraindications for having a MRI.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital
Copenhagen, Frederiksberg, 2000 F
About this study
Low back pain (LBP) is a recognized public health problem with high life time prevalence. Medical treatment may reduce the physical and mental discomfort, while it has not been able to improve the possibilities for retaining or return patients with LBP to work.
This is an occupational intervention study for patients with LBP and physically demanding work, who are at risk of drop out of labour; a randomized controlled trial designed to test the effectiveness of an early intervention for retaining subjects with LBP attached to the labour marked. A work place modification intervention combined with moderate physical activity is given in the intervention group additional to LBP treatments according to best practice recommendations for general practice.
Read more
The study population consists of patients in self-reported physically demanding, who are sick listed or at risk of sick leave due to LBP. Outcome will continually be collected during the intervention as well as 6 and additionally at 12 months follow up.
The primary aim is to evaluate if an occupational intervention with focus on early workplace orientated counselling and work place intervention can retain subjects with physically demanding work and LBP in gainful employment to prevent/reduce the sick leave due to LBP.
The secondary aims are to identify prognostic factors of an occupational intervention using the baseline and follow-up participant-rated outcomes: pain, physically function, generic health status, fear avoidance behaviours, job satisfaction, work-ability, satisfaction with intervention, clinical examination and MRI findings. Among these variables, we also aim to identify subjects, who will benefit from such an occupational intervention, and the subjects, who already have a good prognosis and therefore have no need for a larger scale intervention.
Read the detailed description
Eligible participants are: 1) 18-65 years of age; 2) current episode of 2-4 weeks of LBP; 3) self-reported physically demanding work; 4) express concerns about the ability to maintain their current job.
The exclusion criteria are: 1) pregnancy; 2) server somatic or psychiatric diseases; 3) cancer or metastatic disease
- Conditions
- Low Back Pain
- Being tested
- Occupational intervention, Usual care
- Keywords
- Low back pain, Return to work, Sickness absence, Rehabilitation, Occupational intervention
- 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 interventionBehavioural
Early coordinated occupational intervention and supervision in physically activities by a physiotherapist.
Usual careOther
Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician
| Study group | Role | What they receive |
|---|---|---|
| Occupational intervention | Experimental | Early coordinated occupational intervention. Supervision in physically activities by a physiotherapist. Receives: Behavioral: Occupational intervention |
| Usual care | Active comparator | Intervention from the patient's general physician. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accumulated duration of self-assessed sick leave due to LBP
Measured: 6 months
Secondary outcomes (4)
Changes in pain level
Pain will be evaluated by using the 13 items Pain-Detect questionnaire, which includes measurements of LBP on an ordinal, 11-point numerical rating scale (NRS: 0 = no LBP; 10 = worst LBP possible).
Measured: 6 months
Changes in Fear Avoidance Beliefs scores
Both Fear Avoidance Beliefs Work Subscale and Physical Activity subscale (questionnaires) will be measured.
Measured: 6 months
Change in Disability
The 24-item Roland Morris Disability Questionnaire will measure participant-rated LBP disability.
Measured: 6 months
Satisfaction with the intervention
Measured on an 11-point NRS with the anchors "not at all satisfied" to "extremely satisfied".
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bispebjerg Hospital
- Responsible party
- Principal investigator, Bjarke Brandt Hansen, Frederiksberg University Hospital
- Investigators
- Ann Kryger, MD, PhD, Principal investigator, University Hospital Frederiksberg and Bispebjerg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015572
- Sponsor's protocol ID
- GoBack-001
- Acronym
- GoBack
- Status last verified
- Feb 2017
- First submitted
- 29 Nov 2013
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen C, Jensen OK, Nielsen CV. Sustainability of return to work in sick-listed employees with low-back pain. Two-year follow-up in a randomized clinical trial comparing multidisciplinary and brief intervention. BMC Musculoskelet Disord. 2012 Aug 25;13:156. doi: 10.1186/1471-2474-13-156.
PubMed 22920158Rosenberg NR, Petersen SB, Begtrup LM, Flachs EM, Petersen JA, Hansen BB, Kirkeskov L, Bliddal H, Christensen R, Kristensen LE, Fournier GL, Kryger AI. Early Occupational Intervention for People with Low Back Pain in Physically Demanding Jobs: 1-year Follow-up Results of the Randomized Controlled GOBACK Trial. Spine (Phila Pa 1976). 2021 Mar 15;46(6):347-355. doi: 10.1097/BRS.0000000000003793.
PubMed 33181779Hansen BB, Kirkeskov L, Begtrup LM, Boesen M, Bliddal H, Christensen R, Andreasen DL, Kristensen LE, Flachs EM, Kryger AI. Early occupational intervention for people with low back pain in physically demanding jobs: A randomized clinical trial. PLoS Med. 2019 Aug 16;16(8):e1002898. doi: 10.1371/journal.pmed.1002898. eCollection 2019 Aug.
PubMed 31419219Petersen J, Kirkeskov L, Hansen BB, Begtrup LM, Flachs EM, Boesen M, Hansen P, Bliddal H, Kryger AI. Physical demand at work and sick leave due to low back pain: a cross-sectional study. BMJ Open. 2019 May 22;9(5):e026917. doi: 10.1136/bmjopen-2018-026917.
PubMed 31122982Hansen BB, Kirkeskov L, Christensen R, Begtrup LM, Pedersen EB, Teilya JF, Boesen M, Fournier GL, Bliddal H, Kryger AI. Retention in physically demanding jobs of individuals with low back pain: study protocol for a randomised controlled trial. Trials. 2015 Apr 16;16:166. doi: 10.1186/s13063-015-0684-3.
PubMed 25887302
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retention in Physically Demanding Jobs With Low Back Pain: A Randomised Controlled Trial (GoBack)
- ClinicalTrials.gov ID
- NCT02015572
- Acronym / sponsor ID
- GoBack / GoBack-001
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Return to work, Sickness absence, Rehabilitation, Occupational intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Collaborators
- Bispebjerg Hospital
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Dec 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.
Low back pain (LBP) is a recognized public health problem with high life time prevalence. Medical treatment may reduce the physical and mental discomfort, while it has not been able to improve the possibilities for retaining or return patients with LBP to work.
This is an occupational intervention study for patients with LBP and physically demanding work, who are at risk of drop out of labour; a randomized controlled trial designed to test the effectiveness of an early intervention for retaining subjects with LBP attached to the labour marked. A work place modification intervention combined with moderate physical activity is given in the intervention group additional to LBP treatments according to best practice recommendations for general practice.
The study population consists of patients in self-reported physically demanding, who are sick listed or at risk of sick leave due to LBP. Outcome will continually be collected during the intervention as well as 6 and additionally at 12 months follow up.
The primary aim is to evaluate if an occupational intervention with focus on early workplace orientated counselling and work place intervention can retain subjects with physically demanding work and LBP in gainful employment to prevent/reduce the sick leave due to LBP.
The secondary aims are to identify prognostic factors of an occupational intervention using the baseline and follow-up participant-rated outcomes: pain, physically function, generic health status, fear avoidance behaviours, job satisfaction, work-ability, satisfaction with intervention, clinical examination and MRI findings. Among these variables, we also aim to identify subjects, who will benefit from such an occupational intervention, and the subjects, who already have a good prognosis and therefore have no need for a larger scale intervention.
Detailed description
Eligible participants are: 1) 18-65 years of age; 2) current episode of 2-4 weeks of LBP; 3) self-reported physically demanding work; 4) express concerns about the ability to maintain their current job.
The exclusion criteria are: 1) pregnancy; 2) server somatic or psychiatric diseases; 3) cancer or metastatic disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occupational intervention | Experimental | Behavioral: Occupational interventionEarly coordinated occupational intervention. Supervision in physically activities by a physiotherapist. |
| Usual care | Active comparator | Other: Usual careIntervention from the patient's general physician. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Working age adults 18-65
- Low back pain (current episode of 2-4 weeks)
- Self-reported physically demanding work
- Sick-listed or at risk
- Speak, read and understand Danish
Key exclusion criteria (5 listed)
- Severe somatic or psychiatric comorbidity
- Pregnancy
- Cancer or metastatic disease
- LBP treatment or referral to outside providers (e.g. back-surgery)
- Contraindications for having a MRI.
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 interventionEarly coordinated occupational intervention and supervision in physically activities by a physiotherapist. | Behavioural | Occupational intervention |
| Usual careIntervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician | Other | Usual care |
Primary outcome
Accumulated duration of self-assessed sick leave due to LBP
Time frame: 6 months
4 secondary outcomes
Changes in pain level
Time frame: 6 months
Changes in Fear Avoidance Beliefs scores
Time frame: 6 months
Change in Disability
Time frame: 6 months
Satisfaction with the intervention
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Background: PubMed 22920158Jensen C, Jensen OK, Nielsen CV. Sustainability of return to work in sick-listed employees with low-back pain. Two-year follow-up in a randomized clinical trial comparing multidisciplinary and brief intervention. BMC Musculoskelet Disord. 2012 Aug 25;13:156. doi: 10.1186/1471-2474-13-156.
- Derived from this study: PubMed 33181779Rosenberg NR, Petersen SB, Begtrup LM, Flachs EM, Petersen JA, Hansen BB, Kirkeskov L, Bliddal H, Christensen R, Kristensen LE, Fournier GL, Kryger AI. Early Occupational Intervention for People with Low Back Pain in Physically Demanding Jobs: 1-year Follow-up Results of the Randomized Controlled GOBACK Trial. Spine (Phila Pa 1976). 2021 Mar 15;46(6):347-355. doi: 10.1097/BRS.0000000000003793.
- Derived from this study: PubMed 31419219Hansen BB, Kirkeskov L, Begtrup LM, Boesen M, Bliddal H, Christensen R, Andreasen DL, Kristensen LE, Flachs EM, Kryger AI. Early occupational intervention for people with low back pain in physically demanding jobs: A randomized clinical trial. PLoS Med. 2019 Aug 16;16(8):e1002898. doi: 10.1371/journal.pmed.1002898. eCollection 2019 Aug.
- Derived from this study: PubMed 31122982Petersen J, Kirkeskov L, Hansen BB, Begtrup LM, Flachs EM, Boesen M, Hansen P, Bliddal H, Kryger AI. Physical demand at work and sick leave due to low back pain: a cross-sectional study. BMJ Open. 2019 May 22;9(5):e026917. doi: 10.1136/bmjopen-2018-026917.
- Derived from this study: PubMed 25887302Hansen BB, Kirkeskov L, Christensen R, Begtrup LM, Pedersen EB, Teilya JF, Boesen M, Fournier GL, Bliddal H, Kryger AI. Retention in physically demanding jobs of individuals with low back pain: study protocol for a randomised controlled trial. Trials. 2015 Apr 16;16:166. doi: 10.1186/s13063-015-0684-3.
- Department of Occupational and Environmental Medicine, Copenhagen University, Hospital Bispebjerg and FrederiksbergLink provided by the sponsor.
- The Parker Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg HospitalLink provided by the sponsor.
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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.
Ann Kryger, MD, PhD principal investigator
University Hospital Frederiksberg and Bispebjerg
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 intervention in people with Low Back Pain, run by Frederiksberg University Hospital 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 7 inclusion and 5 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 13 Feb 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 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?
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?
Accumulated duration of self-assessed sick leave due to LBP (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 NCT02015572, which also lists 5 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 13 Feb 2017.