Pre-surgery Physiotherapy for Patients With Specific Low Back Pain (PREPARE)

August 12, 2019 updated by: Birgitta Oberg, Linkoeping University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

197

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Östergötland
      • Linköping, Östergötland, Sweden, 58183
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Pre-surgery physiotherapy
Twice a week, in 9 weeks
Other: Pre-surgery physiotherapy

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.

  4. Standardized information about:

    1. the surgery
    2. post-surgery rehabilitation
    3. to stay active
OTHER: Waiting-list
Standard information by the orthopedic surgeon
Other: Waiting-list

Standardized information about:

  1. the surgery
  2. post-surgery rehabilitation
  3. to stay active

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: 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
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
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)
Time Frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
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)
Time Frame: 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
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
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)
Time Frame: 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
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
Self reported workability
Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Collaborators

Ostergotland County Council, Sweden

Investigators

  • Principal Investigator: Birgitta Öberg, professor, Div Physiotherapy, department of Health and Science, Linkoping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

April 29, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (ESTIMATE)

May 27, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2019

Last Update Submitted That Met QC Criteria

August 12, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PREPARE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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