Pre-surgery Physiotherapy for Patients With Specific Low Back Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Specific exercises and mobilization Motor control exercises Traction 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.

Official Title
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Pre-surgery Physiotherapy for Patients With Specific Low Back Pain , RCT

Conditions
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Lumbar Spine Disc Herniation, Spinal Stenosis, Spondylolisthesis, Grade 4

Intervention / Treatment
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* Other: Pre-surgery physiotherapy
* Other: Waiting-list


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pre-surgery physiotherapy<br>Twice a week, in 9 weeks | Other: Pre-surgery physiotherapy<br>* Physiotherapy guided intervention twice a week for nine weeks. The program includes: Active physiotherapy according to a treatment based classification: Specific exercises and mobilization Motor control exercises Traction Tailor-made general supervised exercise program Behavioral approach to reduce fear avoidance and increase activity level. Standardized information about: the surgery post-surgery rehabilitation to stay active<br>|
| Other: Waiting-list<br>Standard information by the orthopedic surgeon | Other: Waiting-list<br>* Standardized information about: the surgery post-surgery rehabilitation to stay active<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical therapy, lumbar spine surgery, pre-surgical intervention, RCT