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| Name | Class |
|---|---|
| Ostergotland County Council, Sweden | OTHER |
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The aim is to study if pre-surgery physiotherapy improves function, pain and health in patients with specific low back pain scheduled for surgery. Patients are followed over a two year period. A secondary aim is to study what factors predict short and long term outcomes.
The design is a randomized controlled trial, where patients are allocated either to pre-surgery physiotherapy or waiting-list when scheduled for surgery due to specific low back pain (spinal stenosis, disc herniation, spondylolisthesis, disc degenerative disease (DDD)).
The patients are scheduled for surgery due to specific low back pain diagnosis and randomized to either pre-surgery physiotherapy or waiting-list group. Clinical measurement and treatment-classification is done before and after intervention.
Pre-surgery intervention:
Physiotherapy guided intervention twice a week for nine weeks. The program includes:
Active physiotherapy according to a treatment based classification
Tailor-made general supervised exercise program
Behavioral approach to reduce fear avoidance and increase activity level.
Both groups receive standardized information about surgery, post-surgery rehabilitation and to stay active.
Surgery in performed according to existing guidelines.
Measurements:
Patients fill out a questionnaire at baseline, before surgery (after pre-surgery physiotherapy or waiting-list), three months, one and two years after surgery. The questionnaire includes self-reported measures for function Oswestry Disability Index (ODI) (primary outcome), pain (VAS, pain drawing, pain duration) and health (SF-36, EQ-5D), anxiety, depression (HADS), self efficacy, fear avoidance belief questionnaire (FABQ), workability, (WAI), expectations, general information of work, sick-leave, lifestyle behavior, previous healthcare consumption, patient reported treatment effects, patient enablement instrument (PEI), and adverse events.
Clinical measurement is done before and after intervention. Clinical measurements includes; isometric quadriceps strength, walking-test, neurological tests for L4-S1, SI-joint tests, Posterior-anterior-test (PA-test), test for centralization, test for aberrant movements.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-surgery physiotherapy | Other | Twice a week, in 9 weeks |
|
| Waiting-list | Other | Standard information by the orthopedic surgeon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-surgery physiotherapy | Other | Physiotherapy guided intervention twice a week for nine weeks. The program includes:
|
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Disability Index (ODI) | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale for lumbar pain | Self reported pain in lumbar and leg pain respectively | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery |
| Visual analog scale for leg pain |
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Inclusion Criteria:
Patients that are scheduled for surgery due to following diagnoses;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birgitta Öberg, professor | Div Physiotherapy, department of Health and Science, Linkoping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Linköping | Östergötland County | 58183 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31651299 | Derived | Fors M, Enthoven P, Abbott A, Oberg B. Effects of pre-surgery physiotherapy on walking ability and lower extremity strength in patients with degenerative lumbar spine disorder: Secondary outcomes of the PREPARE randomised controlled trial. BMC Musculoskelet Disord. 2019 Oct 24;20(1):468. doi: 10.1186/s12891-019-2850-3. | |
| 29253630 |
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| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| D013168 | Spondylolisthesis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D013169 | Spondylolysis |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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|
| Waiting-list | Other | Standardized information about:
|
|
Self reported pain in lumbar and leg pain respectively
| Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery |
| Health (SF-36, EQ-5D) | Self reported health | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery |
| Anxiety, depression (HADS) | Self reported anxiety and depression | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery |
| Self efficacy (SES) | Self reported self efficacy | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery |
| Fear avoidance belief questionnaire (FABQ) | Self reported fear avoidance belief questionnaire | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery |
| Workability, (WAI) | Self reported workability | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery |
| Lindback Y, Tropp H, Enthoven P, Abbott A, Oberg B. PREPARE: presurgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial. Spine J. 2018 Aug;18(8):1347-1355. doi: 10.1016/j.spinee.2017.12.009. Epub 2017 Dec 15. |
| 27400960 | Derived | Lindback Y, Tropp H, Enthoven P, Abbott A, Oberg B. PREPARE: Pre-surgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2016 Jul 11;17:270. doi: 10.1186/s12891-016-1126-4. |
| D055009 |
| Spondylosis |