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

Linköping University (LiU)

Status: Completed

Conditions: Spondylolisthesis, Grade 4; Spinal Stenosis; Lumbar Spine Disc Herniation

Treatments: Other: Pre-surgery physiotherapy; Other: Waiting-list

Study type: Interventional

Funder types: Other

Identifiers

NCT02454400

Prepare

Details and patient eligibility

About

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.

Full 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.

Enrollment: 197 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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197 participants in 2 patient groups

Pre-surgery physiotherapy

Other group

Description:

Twice a week, in 9 weeks

Treatment:

Other: Pre-surgery physiotherapy

Waiting-list

Other group

Description:

Standard information by the orthopedic surgeon

Treatment:

Other: Waiting-list