NCT02454400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

5.1 years

First QC Date

April 29, 2015

Last Update Submit

August 12, 2019

Conditions

Lumbar Spine Disc HerniationSpinal StenosisSpondylolisthesis, Grade 4

Keywords

physical therapylumbar spine surgerypre-surgical interventionRCT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • 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

  • 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

  • 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

  • Anxiety, depression (HADS)

    Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

  • Self efficacy (SES)

    Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery

  • +2 more secondary outcomes

Study Arms (2)

Pre-surgery physiotherapy

OTHER

Twice a week, in 9 weeks

Other: Pre-surgery physiotherapy

Waiting-list

OTHER

Standard information by the orthopedic surgeon

Other: Waiting-list

Interventions

Pre-surgery physiotherapyOTHER

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

Pre-surgery physiotherapy
Waiting-listOTHER

Standardized information about: 1. the surgery 2. post-surgery rehabilitation 3. to stay active

Waiting-list

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients that are scheduled for surgery due to following diagnoses;
  • Disc herniation,
  • Spinal stenosis,
  • Spondylolisthesis,
  • Degenerative disc disease.
  • Fluent in Swedish.

You may not qualify if:

  • need of acute surgery
  • other severe diagnoses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Linköping, Östergötland County, 58183, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 31651299DERIVED

  • 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.

    PMID: 29253630DERIVED

  • 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.

    PMID: 27400960DERIVED

MeSH Terms

Conditions

Spinal StenosisSpondylolisthesis

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisSpondylosis

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Birgitta Öberg, professor

    Div Physiotherapy, department of Health and Science, Linkoping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 27, 2015

Study Start

September 1, 2012

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations

SE(1)