Lumbar Spine Disc HerniationPREPARENCT02454400
Pre-surgery Physiotherapy for Patients With Specific Low Back Pain
A study testing Pre-surgery physiotherapy and Waiting-list in people with Lumbar Spine Disc Herniation and Spinal Stenosis, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Lumbar Spine Disc Herniation, Spinal Stenosis, Spondylolisthesis, Grade 4
- What is being tested?
- Pre-surgery physiotherapy and Waiting-list
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2012to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that are scheduled for surgery due to following diagnoses;
- Disc herniation,
- Spinal stenosis,
- Spondylolisthesis,
- Degenerative disc disease.
- Fluent in Swedish.
Who cannot join
- need of acute surgery
- other severe diagnoses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pre-surgery Physiotherapy for Patients With Specific Low Back Pain , RCT
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.
Read the 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:
- Active physiotherapy according to a treatment based classification
- Specific exercises and mobilization
- Motor control exercises
- Traction
- Tailor-made general supervised exercise program
- 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.
- Being tested
- Pre-surgery physiotherapy, Waiting-list
- Keywords
- physical therapy, lumbar spine surgery, pre-surgical intervention, RCT
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-surgery physiotherapyOther
Physiotherapy guided intervention twice a week for nine weeks. The program includes:
- Active physiotherapy according to a treatment based classification:
- Specific exercises and mobilization
- Motor control exercises
- Traction
- Tailor-made general supervised exercise program
- Behavioral approach to reduce fear avoidance and increase activity level.
- Standardized information about:
- the surgery
- post-surgery rehabilitation
- to stay active
Waiting-listOther
Standardized information about:
- the surgery
- post-surgery rehabilitation
- to stay active
| Study group | Role | What they receive |
|---|---|---|
| Pre-surgery physiotherapy | Other | Twice a week, in 9 weeks Receives: Other: Pre-surgery physiotherapy |
| Waiting-list | Other | Standard information by the orthopedic surgeon Receives: Other: Waiting-list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Measured: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Secondary outcomes (7)
Visual analog scale for lumbar pain
Self reported pain in lumbar and leg pain respectively
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startSep 2012
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Ostergotland County Council, Sweden
- Responsible party
- Principal investigator, Birgitta Oberg, Linkoeping University
- Investigators
- Birgitta Öberg, professor, Principal investigator, Div Physiotherapy, department of Health and Science, Linkoping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454400
- Sponsor's protocol ID
- Prepare
- Acronym
- PREPARE
- Status last verified
- Aug 2019
- First submitted
- 29 Apr 2015
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 31651299Lindback 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.
PubMed 29253630Lindback 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.
PubMed 27400960
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-surgery Physiotherapy for Patients With Specific Low Back Pain , RCT
- ClinicalTrials.gov ID
- NCT02454400
- Acronym / sponsor ID
- PREPARE / Prepare
- Keywords
- physical therapy, lumbar spine surgery, pre-surgical intervention, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Ostergotland County Council, Sweden
- Study start
- Sep 2012
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Active physiotherapy according to a treatment based classification
- Specific exercises and mobilization
- Motor control exercises
- Traction
- Tailor-made general supervised exercise program
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-surgery physiotherapy | Other | Other: Pre-surgery physiotherapyTwice a week, in 9 weeks |
| Waiting-list | Other | Other: Waiting-listStandard information by the orthopedic surgeon |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients that are scheduled for surgery due to following diagnoses;
- Disc herniation,
- Spinal stenosis,
- Spondylolisthesis,
- Degenerative disc disease.
Key exclusion criteria (2 listed)
- need of acute surgery
- other severe diagnoses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-surgery physiotherapyPhysiotherapy 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 | Other | Pre-surgery physiotherapy |
| Waiting-listStandardized information about: 1. the surgery 2. post-surgery rehabilitation 3. to stay active | Other | Waiting-list |
Primary outcome
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
7 secondary outcomes
Visual analog scale for lumbar pain
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
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)
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)
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)
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)
Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Workability, (WAI)
Time frame: Change in ODI from baseline to after intervention (after 3 months) and 3 months, 1 and 2 years post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Derived from this study: PubMed 31651299Fors 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.
- Derived from this study: PubMed 29253630Lindback 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.
- Derived from this study: PubMed 27400960Lindback 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birgitta Öberg, professor principal investigator
Div Physiotherapy, department of Health and Science, Linkoping University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-surgery physiotherapy and Waiting-list in people with Lumbar Spine Disc Herniation and Spinal Stenosis, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02454400, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.