Pre-surgery Physiotherapy for Patients With Specific Low Back Pain
NCT ID: NCT02454400
Last Updated: 2019-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
197 participants
INTERVENTIONAL
2012-09-30
2017-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
NCT03673436
PRE Surgery reHABilitation for Spinal Stenosis
NCT04330885
Physiotherapy Following Disc Surgery: Long Term Follow-up of a RCT
NCT01922063
Comparative Effectiveness and Prognostic Factors of Surgical and Non-surgical Management of Lumbar Spinal Stenosis
NCT03548441
Lumbar Stabilization Exercises in Adult Patients With Lumbar Arthrodesis Surgery
NCT03538093
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pre-surgery physiotherapy
Twice a week, in 9 weeks
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
Waiting-list
Standard information by the orthopedic surgeon
Waiting-list
Standardized information about:
1. the surgery
2. post-surgery rehabilitation
3. to stay active
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Waiting-list
Standardized information about:
1. the surgery
2. post-surgery rehabilitation
3. to stay active
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Disc herniation,
* Spinal stenosis,
* Spondylolisthesis,
* Degenerative disc disease.
* Fluent in Swedish.
Exclusion Criteria
* other severe diagnoses.
25 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ostergotland County Council, Sweden
OTHER
Linkoeping University
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Birgitta Oberg
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Birgitta Öberg, professor
Role: PRINCIPAL_INVESTIGATOR
Div Physiotherapy, department of Health and Science, Linkoping University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital
Linköping, Östergötland County, Sweden
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Prepare
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.