An interventional study of Pre-surgery physiotherapy and Waiting-list in Lumbar Spine Disc Herniation, Spinal Stenosis and Spondylolisthesis, Grade 4, sponsored by Linkoeping University. Completed at 1 site in Sweden. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-08-13.
Sponsored by Linkoeping University · Not applicable, Interventional, and Treatment
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.
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
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.
459 studies on the registry are indexed under Spinal Stenosis; 103 are open to participants now.
This study's enrollment of 197 is above the median of 80 across 283 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Linkoeping University is the lead sponsor of 189 studies on the registry; 40 are open to participants now.
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Patients that are scheduled for surgery due to following diagnoses;
Exclusion Criteria:
Twice a week, in 9 weeks
Other: Pre-surgery physiotherapy
Standard information by the orthopedic surgeon
Other: Waiting-list
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
Standardized information about: 1. the surgery 2. post-surgery rehabilitation 3. to stay active
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
Visual analog scale for lumbar pain
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
Visual analog scale for leg pain
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
Health (SF-36, EQ-5D)
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
Anxiety, depression (HADS)
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
Self efficacy (SES)
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
Fear avoidance belief questionnaire (FABQ)
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
Workability, (WAI)
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
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Linkoeping University