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Chronic Low Back PainNCT02245919

Chronic Low Back Pain Rehabilitation in Primary Care: a Pilot Study

A study testing Back on Track intervention in people with Chronic Low Back Pain, run by Maastricht University Medical Center at 4 sites in Netherlands.

Completed

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

Official record
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Trial summary

Up to now, only little research has been performed in tailoring treatment of patients with chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial intervention in patients with a moderate to high level of disability and in whom the contributing role of psychosocial factors to this… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Low Back Pain
What is being tested?
Back on Track intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
4 sitesNetherlands
Study dates
Nov 2014to Nov 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 (WPN3-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

4 sites in 1 country.

Netherlands4 sites

  • Fysiotherapie Abbink

    Bunde, Limburg, 6235 BG

  • Fysiohof

    Maastricht, Limburg, 6216 PJ

  • ICM Fysio

    Maastricht, Limburg, 6229 EZ

  • Fysiotherapie Breuers

    Margraten, Limburg, 6269 BL

Other trials in Netherlands

About this study

Official title: A Primary Care Biopsychosocial Intervention (Back on Track) for Patients With Chronic Low Back Pain in Which Psychosocial Factors Moderately Influence Daily Life Functioning: a Pilot Study

Up to now, only little research has been performed in tailoring treatment of patients with chronic low back pain (CLBP). It would be interesting to evaluate a biopsychosocial intervention in patients with a moderate to high level of disability and in whom the contributing role of psychosocial factors to this disability is mild to moderate (WPN3-). Nowadays, these patients receive cognitive behavioral-based treatments in multidisciplinary rehabilitation settings but might also benefit from treatments based on these multidisciplinary rehabilitation treatment principles when provided by specifically trained primary care physical therapists. Therefore, the aims of this pilot-study are to evaluate the feasibility of a specifically for primary care physiotherapist developed biopsychosocial intervention ("Back on Track" intervention) in WPN3- classified patients, and to evaluate whether this "Back on Track" intervention results in a significant improvement in functional disability in this subgroup of patients.

Being tested
Back on Track intervention
Keywords
Low Back Pain, Chronic Pain, Cognitive Behavioral Therapy, Primary Health Care, Physical Therapy
Medical subject headings
Low Back Pain, Chronic Pain

What participants receive

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

  • Back on Track interventionOther

    A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.

Study groups in NCT02245919
Study groupRoleWhat they receive
Back on Track interventionExperimentalA biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
Receives: Other: Back on Track intervention

What is being measured

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

  1. 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 (12)

  1. Credibility and Expectancy Questionnaire (CEQ)

    Measured: Directly after the first treatment (in the first week of the intervention)

  2. 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

  3. 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

  4. 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

  5. Numeric Rating Scale (NRS)

    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

  6. Tampa Scale of Kinesiophobia (TSK)

    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

  7. 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

  8. 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

  9. Social demographic questionnaire

    Measured: pre-treatment (baseline)

  10. Treatment satisfaction questionnaire

    This questionnaire will include questions about the patient's opinion regarding the intervention, the workbook, the consultant in rehabilitation medicine, the therapist(s), and the patient's perceived knowledge

    Measured: post-treatment (with an expected average of 8 weeks)

  11. 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

  12. Protocol adherence

    Physiotherapists will audio record all therapy sessions. A random sample will be assessed for protocol adherence using a modified version of the protocol used by Leeuw et al (2009). This protocol includes essential treatment elements and raters will judge whether these essential treatments elements are provided during the therapy or not. Adherence will be regarded sufficient in case a percentage of 70% of the required treatment elements are provided during the treatment.

    Measured: All therapy sessions of the Back on Track intervention will be audio recorded (the intervention period of the trial will last approximately one year and 3 months)

Timeline

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

  1. First posted22 Sep 2014 (estimated)
  2. Study startNov 2014
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02245919
Sponsor's protocol ID
14-3-024
Status last verified
Nov 2017
First submitted
16 Sep 2014
Last updated
5 Feb 2018
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

Questions about this trial

What is this clinical trial studying?

A study testing Back on Track intervention in people with Chronic Low Back Pain, run by Maastricht University Medical Center at 4 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 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 NCT02245919, 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 5 Feb 2018.

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