Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Adelante, Centre of Expertise in Rehabilitation and Audiology | OTHER |
| The Province of Limburg | UNKNOWN |
| CZ Fonds | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 maximum low (classified as WPN2).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Back on Track intervention | Experimental | Back on Track intervention is a biopsychosocial primary care intervention |
|
| Primary care as usual | Active Comparator | Primary care as usual comprises maximally 12 individual regular physical therapy sessions for a maximum of 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Back on Track intervention | Other | Biopsychosocial primary care intervention based on multidisciplinary pain rehabiliation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Credibility and Expectancy Questionnaire (CEQ) | Directly after the first treatment (in the first week of the intervention) | |
| EuroQol-5D (EQ-5D) | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ivan PJ Huijnen, Dr. | Maastricht University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fysiotherapie Giessen-Ploemen | Bunde | Limburg | 6241 DK | Netherlands | ||
| Fysiohof |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10781906 | Background | 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. | |
| 1533941 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| D059352 | Musculoskeletal Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D011320 | Primary Health Care |
| ID | Term |
|---|---|
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Primary care as usual | Other | 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. |
|
| Hospital Anxiety and Depression Scale (HADS) | 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) | 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) | 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 | 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) | 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) | 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) | 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 | 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. | Post-treatment (with an expected average of 8 weeks) |
| Maastricht |
| Limburg |
| 6216 PJ |
| Netherlands |
| Fysio Zuyd Caberg | Maastricht | Limburg | 6217 CR | Netherlands |
| Fysiotherapiepraktijk Yvonne Janss | Maastricht | Limburg | 6227 BG | Netherlands |
| ICM Fysio | Maastricht | Limburg | 6229 EZ | Netherlands |
| Fysiotherapie Breuers | Margraten | Limburg | 6269 BL | Netherlands |
| Fysiotherapie Abbink | Ulestraten | Limburg | 6235 BG | Netherlands |
| Fysio Valkenburg | Valkenburg | Limburg | 6301 GH | Netherlands |
| 18242858 | Background | 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. |
| 20189241 | Background | 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. |
| 20395306 | Background | 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. |
| 22607157 | Background | 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. |
| 27641497 | Derived | 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. |
| 25922158 | Derived | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |