Lumbar Spine Disc Herniation, Spinal Stenosis, Spondylolisthesis, Grade 4
Conditions
Keywords
physical therapy, lumbar spine surgery, pre-surgical intervention, RCT
Brief summary
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.
Detailed description
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: 1. Active physiotherapy according to a treatment based classification 1. Specific exercises and mobilization 2. Motor control exercises 3. Traction 2. Tailor-made general supervised exercise program 3. 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.
Interventions
OTHERPre-surgery physiotherapy
Physiotherapy guided intervention twice a week for nine weeks. The program includes: 1. Active physiotherapy according to a treatment based classification: 1. Specific exercises and mobilization 2. Motor control exercises 3. Traction 2. Tailor-made general supervised exercise program 3. Behavioral approach to reduce fear avoidance and increase activity level. 4. Standardized information about: 1. the surgery 2. post-surgery rehabilitation 3. to stay active
OTHERWaiting-list
Standardized information about: 1. the surgery 2. post-surgery rehabilitation 3. to stay active
Sponsors
Ostergotland County Council, Sweden
Linkoeping University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients that are scheduled for surgery due to following diagnoses; * Disc herniation, * Spinal stenosis, * Spondylolisthesis, * Degenerative disc disease. * Fluent in Swedish.
Exclusion criteria
* need of acute surgery * other severe diagnoses.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale for leg pain | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery | Self reported pain in lumbar and leg pain respectively |
| Health (SF-36, EQ-5D) | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery | Self reported health |
| Anxiety, depression (HADS) | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery | Self reported anxiety and depression |
| Visual analog scale for lumbar pain | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery | Self reported pain in lumbar and leg pain respectively |
| Fear avoidance belief questionnaire (FABQ) | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery | Self reported fear avoidance belief questionnaire |
| Workability, (WAI) | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery | Self reported workability |
| Self efficacy (SES) | Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery | Self reported self efficacy |
Countries
Sweden
Outcome results
None listed