Pre-surgery Physiotherapy for Patients With Specific Low Back Pain (PREPARE)
Primary Purpose
Lumbar Spine Disc Herniation, Spinal Stenosis, Spondylolisthesis, Grade 4
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Pre-surgery physiotherapy
Waiting-list
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spine Disc Herniation focused on measuring physical therapy, lumbar spine surgery, pre-surgical intervention, RCT
Eligibility Criteria
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.
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Pre-surgery physiotherapy
Waiting-list
Arm Description
Twice a week, in 9 weeks
Standard information by the orthopedic surgeon
Outcomes
Primary Outcome Measures
Oswestry Disability Index (ODI)
Secondary Outcome Measures
Visual analog scale for lumbar pain
Self reported pain in lumbar and leg pain respectively
Visual analog scale for leg pain
Self reported pain in lumbar and leg pain respectively
Health (SF-36, EQ-5D)
Self reported health
Anxiety, depression (HADS)
Self reported anxiety and depression
Self efficacy (SES)
Self reported self efficacy
Fear avoidance belief questionnaire (FABQ)
Self reported fear avoidance belief questionnaire
Workability, (WAI)
Self reported workability
Full Information
NCT ID
NCT02454400
First Posted
April 29, 2015
Last Updated
August 12, 2019
Sponsor
Linkoeping University
Collaborators
Ostergotland County Council, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02454400
Brief Title
Pre-surgery Physiotherapy for Patients With Specific Low Back Pain
Acronym
PREPARE
Official Title
Pre-surgery Physiotherapy for Patients With Specific Low Back Pain , RCT
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
Ostergotland County Council, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spine Disc Herniation, Spinal Stenosis, Spondylolisthesis, Grade 4
Keywords
physical therapy, lumbar spine surgery, pre-surgical intervention, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
197 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-surgery physiotherapy
Arm Type
Other
Arm Description
Twice a week, in 9 weeks
Arm Title
Waiting-list
Arm Type
Other
Arm Description
Standard information by the orthopedic surgeon
Intervention Type
Other
Intervention Name(s)
Pre-surgery physiotherapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Waiting-list
Intervention Description
Standardized information about:
the surgery
post-surgery rehabilitation
to stay active
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Visual analog scale for lumbar pain
Description
Self reported pain in lumbar and leg pain respectively
Time Frame
Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Title
Visual analog scale for leg pain
Description
Self reported pain in lumbar and leg pain respectively
Time Frame
Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Title
Health (SF-36, EQ-5D)
Description
Self reported health
Time Frame
Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Title
Anxiety, depression (HADS)
Description
Self reported anxiety and depression
Time Frame
Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Title
Self efficacy (SES)
Description
Self reported self efficacy
Time Frame
Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Title
Fear avoidance belief questionnaire (FABQ)
Description
Self reported fear avoidance belief questionnaire
Time Frame
Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Title
Workability, (WAI)
Description
Self reported workability
Time Frame
Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Birgitta Öberg, professor
Organizational Affiliation
Div Physiotherapy, department of Health and Science, Linkoping University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Linköping
State/Province
Östergötland
ZIP/Postal Code
58183
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
31651299
Citation
Fors M, Enthoven P, Abbott A, Oberg B. Effects of pre-surgery physiotherapy on walking ability and lower extremity strength in patients with degenerative lumbar spine disorder: Secondary outcomes of the PREPARE randomised controlled trial. BMC Musculoskelet Disord. 2019 Oct 24;20(1):468. doi: 10.1186/s12891-019-2850-3.
Results Reference
derived
PubMed Identifier
29253630
Citation
Lindback Y, Tropp H, Enthoven P, Abbott A, Oberg B. PREPARE: presurgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial. Spine J. 2018 Aug;18(8):1347-1355. doi: 10.1016/j.spinee.2017.12.009. Epub 2017 Dec 15.
Results Reference
derived
PubMed Identifier
27400960
Citation
Lindback Y, Tropp H, Enthoven P, Abbott A, Oberg B. PREPARE: Pre-surgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2016 Jul 11;17:270. doi: 10.1186/s12891-016-1126-4.
Results Reference
derived
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Pre-surgery Physiotherapy for Patients With Specific Low Back Pain
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