Clinical Trials Directory

Trials / Completed

CompletedNCT02454400

Pre-surgery Physiotherapy for Patients With Specific Low Back Pain

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
197 (actual)
Sponsor
Linkoeping University · Other Government
Sex
All
Age
25 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERPre-surgery physiotherapyPhysiotherapy 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-listStandardized information about: 1. the surgery 2. post-surgery rehabilitation 3. to stay active

Timeline

Start date
2012-09-01
Primary completion
2017-10-01
Completion
2017-10-01
First posted
2015-05-27
Last updated
2019-08-13

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT02454400. Inclusion in this directory is not an endorsement.