Overview

This trial is active, not recruiting.

Conditions lumbar spine disc herniation, spinal stenosis, spondylolisthesis, grade 4
Treatments pre-surgery physiotherapy, waiting-list
Sponsor Linkoeping University
Collaborator Ostergotland County Council, Sweden
Start date September 2012
End date October 2017
Trial size 200 participants
Trial identifier NCT02454400, Prepare

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Other)
Twice a week, in 9 weeks
pre-surgery physiotherapy
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
(Other)
Standard information by the orthopedic surgeon
waiting-list
Standardized information about: the surgery post-surgery rehabilitation to stay active

Primary Outcomes

Measure
Oswestry Disability Index (ODI)
time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

Secondary Outcomes

Measure
Visual analog scale for lumbar pain
time frame: 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
time frame: 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)
time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Anxiety, depression (HADS)
time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Self efficacy (SES)
time frame: 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)
time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Workability, (WAI)
time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

Eligibility Criteria

Male or female participants from 25 years up to 80 years old.

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.

Additional Information

Official title Pre-surgery Physiotherapy for Patients With Specific Low Back Pain , RCT
Principal investigator Birgitta Öberg, professor
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Linkoeping University.