Pre-surgery Physiotherapy for Patients With Specific Low Back Pain

Spinal Stenosis Clinical Trial

— PREPARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454400
• Other study ID #: Prepare
• Status: Completed
• Phase: N/A
• Start date: September 2012
• Est. completion date: October 2017

Study information

• Verified date: August 2019
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Lumbar Spine Disc Herniation
• Spinal Stenosis
• Spondylolisthesis
• Spondylolisthesis, Grade 4

Intervention

Other:
• 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
• Waiting-list
Standardized information about: the surgery post-surgery rehabilitation to stay active

Locations

Country	Name	City	State
Sweden	University Hospital	Linköping	Östergötland

Sponsors (2)

Lead Sponsor	Collaborator
Linkoeping University	Ostergotland County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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