Pre-surgery Physiotherapy for Patients With Specific Low Back Pain

NCT ID: NCT02454400

Last Updated: 2019-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-10-31

Brief Summary

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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

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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.

Conditions

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Lumbar Spine Disc Herniation Spinal Stenosis Spondylolisthesis, Grade 4

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Pre-surgery physiotherapy

Twice a week, in 9 weeks

Group Type OTHER

Pre-surgery physiotherapy

Intervention Type OTHER

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

Waiting-list

Standard information by the orthopedic surgeon

Group Type OTHER

Waiting-list

Intervention Type OTHER

Standardized information about:

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

Interventions

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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

Intervention Type OTHER

Waiting-list

Standardized information about:

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ostergotland County Council, Sweden

OTHER

Sponsor Role collaborator

Linkoeping University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Birgitta Oberg

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Birgitta Öberg, professor

Role: PRINCIPAL_INVESTIGATOR

Div Physiotherapy, department of Health and Science, Linkoping University

Locations

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University Hospital

Linköping, Östergötland County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 31651299 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29253630 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27400960 (View on PubMed)

Other Identifiers

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Prepare

Identifier Type: -

Identifier Source: org_study_id

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