Pre-surgery Physiotherapy for Patients With Specific Low Back Pain

Not Applicable

Completed

• Conditions: Lumbar Spine Disc Herniation; Spinal Stenosis; Spondylolisthesis, Grade 4
• Interventions: Other: Waiting-list; Other: Pre-surgery physiotherapy

• Registration Number: NCT02454400
• Lead Sponsor: Linkoeping University

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2015-04-29
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-27
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-12
• Last Update Posted: 2019-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Waiting-list	Waiting-list	Standard information by the orthopedic surgeon
Pre-surgery physiotherapy	Pre-surgery physiotherapy	Twice a week, in 9 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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
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
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
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

Trial Locations

Locations (1)

University Hospital; 🇸🇪 Linköping, Östergötland, Sweden