Clinical trial NCT02454400: Pre-surgery Physiotherapy for Patients With Specific Low Back Pain
Official title: Pre-surgery Physiotherapy for Patients With Specific Low Back Pain , RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spine Disc Herniation
Spinal Stenosis
Spondylolisthesis, Grade 4
Keywords: physical therapy
lumbar spine surgery
pre-surgical intervention
RCT
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Ostergotland County Council, Sweden
First posted: 2015-05-27
Enrollment: 197
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Secondary outcomes:
measure: Visual analog scale for lumbar pain
timeFrame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
measure: Visual analog scale for leg pain
timeFrame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
measure: Health (SF-36, EQ-5D)
timeFrame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
measure: Anxiety, depression (HADS)
timeFrame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
measure: Self efficacy (SES)
timeFrame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
measure: Fear avoidance belief questionnaire (FABQ)
timeFrame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
measure: Workability, (WAI)
timeFrame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University Hospital
state: Östergötland
Study officials:
affiliation: Div Physiotherapy, department of Health and Science, Linkoping University
name: Birgitta Öberg, professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.