Low Back PainNCT02220543

Chronic Low Back Pain Rehabilitation in Primary Care: an RCT

A study testing Back on Track intervention and Primary care as usual in people with Low Back Pain and Chronic Pain, run by Maastricht University Medical Center at 8 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The aim of this study is to evaluate the effectiveness and cost-effectiveness of a new primary care intervention "Back on Track" as compared to usual primary care in patients with non-specific chronic low back pain in which disability levels are moderate and the role of psychosocial factors to this disability is at… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Low Back Pain, Chronic Pain, Musculoskeletal Pain
What is being tested?: Back on Track intervention and Primary care as usual
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 8 sitesNetherlands
Study dates: Aug 2014to Aug 2017
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

Chronic low back pain; defined as pain between scapulae and gluteal region, whether or not with radiation towards one or both legs, present for at least three months.
Presence of contributing social and psychological factors, however not complex (WPN2 classification)
Age between 18 and 65 year
Sufficient knowledge of the Dutch language
Acceptance towards the biopsychosocial approach instead of biomedical approach

Who cannot join

Chronic low back pain attributable to e.g. infection, tumour, osteoporosis, fracture, structural deformation, inflammatory process, radicular syndrome or cauda equina syndrome
Pregnancy
Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Netherlands8 sites

Fysiotherapie Giessen-Ploemen
Bunde, Limburg, 6241 DK
Fysiohof
Maastricht, Limburg, 6216 PJ
Fysio Zuyd Caberg
Maastricht, Limburg, 6217 CR
Fysiotherapiepraktijk Yvonne Janss
Maastricht, Limburg, 6227 BG
ICM Fysio
Maastricht, Limburg, 6229 EZ
Fysiotherapie Breuers
Margraten, Limburg, 6269 BL
Fysiotherapie Abbink
Ulestraten, Limburg, 6235 BG
Fysio Valkenburg
Valkenburg, Limburg, 6301 GH

Other trials in Netherlands

About this study

Official title: The Effectiveness of a Biopsychosocial Rehabilitation Program in Primary Care (Back on Track) Versus Primary Care as Usual in Patients With Chronic Low Back Pain in Which Psychosocial Factors Minimally Influence Daily Life Functioning: a Randomized Controlled Trial

Conditions: Low Back Pain, Chronic Pain, Musculoskeletal Pain
Being tested: Back on Track intervention, Primary care as usual
Keywords: Cognitive behavioral therapy, Primary health care, Physical Therapy
Medical subject headings: Low Back Pain, Chronic Pain, Musculoskeletal Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Back on Track interventionOther
Biopsychosocial primary care intervention based on multidisciplinary pain rehabiliation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
Primary care as usualOther
Regular physical therapy in primary care. Physical therapists are recommended by their profession (the Royal Dutch Society for Physical Therapy) to work according to a profession-specific guideline for the treatment of patients with low back pain in primary care settings. Maximally 12 individual sessions (30 minutes each) for a maximum of 8 weeks.

Study groups in NCT02220543
Study group	Role	What they receive
Back on Track intervention	Experimental	Back on Track intervention is a biopsychosocial primary care intervention Receives: Other: Back on Track intervention; Other: Primary care as usual
Primary care as usual	Active comparator	Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks. Receives: Other: Back on Track intervention; Other: Primary care as usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Quebec Back Pain Disability Scale (QBPDS)
The QBPDS is a 20-itemed questionnaire designed to determine the individuals' functional disability level (ranging from 0-100). A higher score reflects higher disability.
Measured: Change in functional disability between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up

Secondary outcomes (11)

Credibility and Expectancy Questionnaire (CEQ)
Measured: Directly after the first treatment (in the first week of the intervention)
EuroQol-5D (EQ-5D)
Measured: Change in quality of life between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Hospital Anxiety and Depression Scale (HADS)
Measured: Change in anxiety and depression between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Pain Catastrophizing Scale (PCS)
Measured: Change in catastrophizing between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Numeric Rating Scale (NRS)
Measured: Change in pain intensity between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Tampa Scale of Kinesiophobia
Measured: Change in kinesiophobia between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Pain Self-Efficacy Questionnaire (PSEQ)
Measured: Change in self-efficacy between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Global Perceived Effect (GPE)
Measured: Global perceived effect at post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P)
Measured: Medical consumption at pre-treatment (baseline), post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up after the end of the treatment
Social demographic questionnaire
Measured: pre-treatment
Treatment questionnaire
This questionnaire contains only one question and asks patients directly after the treatment program has finished (post-treatment) to indicate whether they think they have received the new intervention or care as usual.
Measured: Post-treatment (with an expected average of 8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Aug 2017

First posted20 Aug 2014 (estimated)
Study startAug 2014
Primary completionAug 2017
Study completionAug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for 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: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02220543
Sponsor's protocol ID: 14-3-019
Status last verified: Aug 2017
First submitted: 14 Aug 2014
Last updated: 29 Aug 2017
Results posted: No
Data monitoring committee: Yes

Publications

Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.
PubMed 10781906
Lindstrom I, Ohlund C, Eek C, Wallin L, Peterson LE, Fordyce WE, Nachemson AL. The effect of graded activity on patients with subacute low back pain: a randomized prospective clinical study with an operant-conditioning behavioral approach. Phys Ther. 1992 Apr;72(4):279-90; discussion 291-3. doi: 10.1093/ptj/72.4.279.
PubMed 1533941
Leeuw M, Goossens MEJB, van Breukelen GJP, de Jong JR, Heuts PHTG, Smeets RJEM, Koke AJA, Vlaeyen JWS. Exposure in vivo versus operant graded activity in chronic low back pain patients: results of a randomized controlled trial. Pain. 2008 Aug 15;138(1):192-207. doi: 10.1016/j.pain.2007.12.009. Epub 2008 Feb 1.
PubMed 18242858
Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR; Back Skills Training Trial investigators. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010 Mar 13;375(9718):916-23. doi: 10.1016/S0140-6736(09)62164-4. Epub 2010 Feb 25.
PubMed 20189241
Macedo LG, Smeets RJ, Maher CG, Latimer J, McAuley JH. Graded activity and graded exposure for persistent nonspecific low back pain: a systematic review. Phys Ther. 2010 Jun;90(6):860-79. doi: 10.2522/ptj.20090303. Epub 2010 Apr 15.
PubMed 20395306
Brunner E, De Herdt A, Minguet P, Baldew SS, Probst M. Can cognitive behavioural therapy based strategies be integrated into physiotherapy for the prevention of chronic low back pain? A systematic review. Disabil Rehabil. 2013 Jan;35(1):1-10. doi: 10.3109/09638288.2012.683848. Epub 2012 May 21.
PubMed 22607157
van Erp RMA, Huijnen IPJ, Koke AJA, Abbink FE, den Hollander M, Smeets RJEM. Development and content of the biopsychosocial primary care intervention 'Back on Track' for a subgroup of people with chronic low back pain. Physiotherapy. 2017 Jun;103(2):160-166. doi: 10.1016/j.physio.2016.04.004. Epub 2016 May 11.
PubMed 27641497
van Erp RM, Huijnen IP, Verbunt JA, Smeets RJ. A biopsychosocial primary care intervention (Back on Track) versus primary care as usual in a subgroup of people with chronic low back pain: protocol for a randomised, controlled trial. J Physiother. 2015 Jul;61(3):155. doi: 10.1016/j.jphys.2015.03.003. Epub 2015 Apr 23.
PubMed 25922158

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of a Biopsychosocial Rehabilitation Program in Primary Care (Back on Track) Versus Primary Care as Usual in Patients With Chronic Low Back Pain in Which Psychosocial Factors Minimally Influence Daily Life Functioning: a Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02220543
Acronym / sponsor ID: 14-3-019
Conditions: Low Back Pain, Chronic Pain, Musculoskeletal Pain
Keywords: Cognitive behavioral therapy, Primary health care, Physical Therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Maastricht University Medical CenterUniversity, hospital or other
Collaborators: Adelante, Centre of Expertise in Rehabilitation and Audiology, The Province of Limburg, CZ Fonds
Study start: Aug 2014
Primary completion: Aug 2017 (actual)
Study completion: Aug 2017 (actual)
First posted: 20 Aug 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Back on Track intervention	Experimental	Other: Back on Track intervention, Other: Primary care as usualBack on Track intervention is a biopsychosocial primary care intervention
Primary care as usual	Active comparator	Other: Back on Track intervention, Other: Primary care as usualPrimary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Chronic low back pain; defined as pain between scapulae and gluteal region, whether or not with radiation towards one or both legs, present for at least three months.
Presence of contributing social and psychological factors, however not complex (WPN2 classification)
Age between 18 and 65 year
Sufficient knowledge of the Dutch language
Acceptance towards the biopsychosocial approach instead of biomedical approach

Key exclusion criteria (3 listed)

Chronic low back pain attributable to e.g. infection, tumour, osteoporosis, fracture, structural deformation, inflammatory process, radicular syndrome or cauda equina syndrome
Pregnancy
Any suspicion of an (underlying) psychiatric disease, for which psychiatric treatment is better suited, according to the expert opinion of the consultant in rehabilitation medicine.

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
Back on Track interventionBiopsychosocial primary care intervention based on multidisciplinary pain rehabiliation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.	Other	Back on Track intervention, Primary care as usual
Primary care as usualRegular physical therapy in primary care. Physical therapists are recommended by their profession (the Royal Dutch Society for Physical Therapy) to work according to a profession-specific guideline for the treatment of patients with low back pain in primary care settings. Maximally 12 individual sessions (30 minutes each) for a maximum of 8 weeks.	Other	Back on Track intervention, Primary care as usual

Primary outcome

Quebec Back Pain Disability Scale (QBPDS)
Time frame: Change in functional disability between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
The QBPDS is a 20-itemed questionnaire designed to determine the individuals' functional disability level (ranging from 0-100). A higher score reflects higher disability.

11 secondary outcomes

Credibility and Expectancy Questionnaire (CEQ)
Time frame: Directly after the first treatment (in the first week of the intervention)
EuroQol-5D (EQ-5D)
Time frame: Change in quality of life between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Hospital Anxiety and Depression Scale (HADS)
Time frame: Change in anxiety and depression between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Pain Catastrophizing Scale (PCS)
Time frame: Change in catastrophizing between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Numeric Rating Scale (NRS)
Time frame: Change in pain intensity between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Tampa Scale of Kinesiophobia
Time frame: Change in kinesiophobia between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Pain Self-Efficacy Questionnaire (PSEQ)
Time frame: Change in self-efficacy between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Global Perceived Effect (GPE)
Time frame: Global perceived effect at post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up
Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness (TiC-P)
Time frame: Medical consumption at pre-treatment (baseline), post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up after the end of the treatment
Social demographic questionnaire
Time frame: pre-treatment
Treatment questionnaire
Time frame: Post-treatment (with an expected average of 8 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 29 Aug 2017.
Background: PubMed 10781906Vlaeyen JWS, Linton SJ. Fear-avoidance and its consequences in chronic musculoskeletal pain: a state of the art. Pain. 2000 Apr;85(3):317-332. doi: 10.1016/S0304-3959(99)00242-0.
Background: PubMed 1533941Lindstrom I, Ohlund C, Eek C, Wallin L, Peterson LE, Fordyce WE, Nachemson AL. The effect of graded activity on patients with subacute low back pain: a randomized prospective clinical study with an operant-conditioning behavioral approach. Phys Ther. 1992 Apr;72(4):279-90; discussion 291-3. doi: 10.1093/ptj/72.4.279.
Background: PubMed 18242858Leeuw M, Goossens MEJB, van Breukelen GJP, de Jong JR, Heuts PHTG, Smeets RJEM, Koke AJA, Vlaeyen JWS. Exposure in vivo versus operant graded activity in chronic low back pain patients: results of a randomized controlled trial. Pain. 2008 Aug 15;138(1):192-207. doi: 10.1016/j.pain.2007.12.009. Epub 2008 Feb 1.
Background: PubMed 20189241Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR; Back Skills Training Trial investigators. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010 Mar 13;375(9718):916-23. doi: 10.1016/S0140-6736(09)62164-4. Epub 2010 Feb 25.
Background: PubMed 20395306Macedo LG, Smeets RJ, Maher CG, Latimer J, McAuley JH. Graded activity and graded exposure for persistent nonspecific low back pain: a systematic review. Phys Ther. 2010 Jun;90(6):860-79. doi: 10.2522/ptj.20090303. Epub 2010 Apr 15.
Background: PubMed 22607157Brunner E, De Herdt A, Minguet P, Baldew SS, Probst M. Can cognitive behavioural therapy based strategies be integrated into physiotherapy for the prevention of chronic low back pain? A systematic review. Disabil Rehabil. 2013 Jan;35(1):1-10. doi: 10.3109/09638288.2012.683848. Epub 2012 May 21.
Derived from this study: PubMed 27641497van Erp RMA, Huijnen IPJ, Koke AJA, Abbink FE, den Hollander M, Smeets RJEM. Development and content of the biopsychosocial primary care intervention 'Back on Track' for a subgroup of people with chronic low back pain. Physiotherapy. 2017 Jun;103(2):160-166. doi: 10.1016/j.physio.2016.04.004. Epub 2016 May 11.
Derived from this study: PubMed 25922158van Erp RM, Huijnen IP, Verbunt JA, Smeets RJ. A biopsychosocial primary care intervention (Back on Track) versus primary care as usual in a subgroup of people with chronic low back pain: protocol for a randomised, controlled trial. J Physiother. 2015 Jul;61(3):155. doi: 10.1016/j.jphys.2015.03.003. Epub 2015 Apr 23.

Related trials for Low Back 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
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

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.

Ivan PJ Huijnen, Dr. principal investigator

Maastricht University

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Back on Track intervention and Primary care as usual in people with Low Back Pain and Chronic Pain, run by Maastricht University Medical Center at 8 sites 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 5 inclusion and 3 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 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

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?

Quebec Back Pain Disability Scale (QBPDS) (time frame: Change in functional disability between pre-treatment (baseline) and post-treatment (with an expected average of 8 weeks), 3 months follow-up and 12 months follow-up). 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 NCT02220543, which also lists 8 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 29 Aug 2017.