Low Back PainNCT03673436
Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
An observational study of Low Back Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The main purpose of this study is to investigate if improvements in patient self-reported pain, symptoms, function and quality of life 12 months after Lumbar spinal fusion among patients that have good projected prognosis differ from those among patients with a poor projected prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lumbar spinal fusion
- Type of treatment
- Surgery or procedure
- How many people
- 202 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Sep 2018to 1 Oct 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consist of 200 patients with lumbar spinal fusion operated at a hospital in Denmark
Who may be able to join
- Received primary LSF surgery for treatment of CLBP
- Degenerative lumbar disease with or without lumbar spondylolisthesis grades 1 to 2
- Fusion of a maximum of 3 adjacent vertebrae
- Above 18 years of age
- Competence in the Danish language
- Has an email address
Who cannot join
- Prior LSF surgery
- Cognitive impairments that preclude reliable answers to patient reported outcome questionnaire
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Occupational and Physiotherapy, Rigshospitalet Glostrup
Glostrup Municipality, 2600
About this study
Official title: Effect of Lumbar Spinal Fusion Predicted by Physiotherapists: A Prospective Cohort Study
The main purpose of this study is to investigate if improvements in patient self-reported pain, symptoms, function and quality of life 12 months after Lumbar spinal fusion among patients that have good projected prognosis differ from those among patients with a poor projected prognosis.
The secondary purpose is to explore the underlying factors of the physiotherapists projected prognosis to identify objective and possible modifiable candidate prognostic factors for recovery.
Read the detailed description
Background:
Over recent decades, an increasing number of patients with Chronic Low Back Pain (CLBP) undergo surgical lumbar spinal fusion (LSF). For many of the patients LSF is their last resort in the hope of a better life with less pain, disability and use of medication. Unfortunately, several reports show, that the pain level remains the same after LSF for many patients, and that consumption of medication remains unchanged in almost 50 % of the patients.
Knowing that characteristics such as maladaptive coping strategies, fear avoidance beliefs and pain catastrophizing seem to be predictive of worse outcome in pain, function and quality of life after surgery. It is important to assess how these individual factors in the postsurgical rehabilitation can be addressed.
The single physiotherapists have an essential role in mobilizing the LSF patient post-operatively. In clinical practice it is not enough for the physiotherapists to use their biomechanical understanding of LSF material and heeling processes, it is also essential to use a so-called "silent knowledge" of experience and personal interaction with the patient.
It remains unknown if this "silent knowledge" is a reliable predictor of the outcome of LSF surgery. If the physiotherapist can predict the outcome, it is important to explore which factors the physiotherapist rely their prognosis upon in order to identify objective and possible modifiable candidate prognostic factors for recovery.
The aim of this study is to assess if physiotherapists attending inpatients at public back surgery hospitals can predict the future course (post hospitalisation) of recovery of patients undergoing LSF. The study will also break down the physiotherapists' "silent knowledge" in an attempt to identify objective (and hopefully modifiable) candidate prognostic markers of recovery.
- Conditions
- Low Back Pain
- Being tested
- Lumbar spinal fusion
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar spinal fusionProcedure or surgery
The patient got a instrumented fusion of a maximum of 3 adjacent vertebrae
| Study group | Role | What they receive |
|---|---|---|
| Patients with low back pain | Cohort of 200 low back pain patients, 18 years+, who have been undergoing a lumbar spinal fusion Receives: Procedure: Lumbar spinal fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
Disability will be measured using the Oswestry Disability Index. ODI is a validated measure of condition-specific disability originally developed for patients with LBP. The ODI consists of ten items regarding pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. For each item the patient chooses one of six answers, with 0 representing no difficulty in the activity and 5 representing maximal difficulty.
Measured: 1 year
Secondary outcomes (5)
Patient reported movement capacity
Patients are asked to mark the position along a horizontal 10-cm line that best corresponded to their movement capacity. The endings of the line have verbal descriptions: 0 (''very poor capacity'') - 100 ("very good capacity")
Measured: 1 year
Back Pain
A visual analogue scale (VAS) is a simple and frequently used method for the assessment of variations in intensity of pain. Patients are asked to mark the position along a horizontal 10-cm line that best corresponded to their pain intensity. The endings of the line have verbal descriptions: 0 (''no pain'') - 100 ("the worst pain imaginable")
Measured: 1 year
Leg Pain
A visual analogue scale (VAS) is a simple and frequently used method for the assessment of variations in intensity of pain. Patients are asked to mark the position along a horizontal 10-cm line that best corresponded to their pain intensity. The endings of the line have verbal descriptions: 0 (''no pain'') - 100 ("the worst pain imaginable")
Measured: 1 year
Health outcome and quality of life
Quality of life will be assessed using the EuroQol 5 Dimensions 3 levels (EQ-5D-3L). The EQ-5D is a generic questionnaire developed by an international research group including re-searchers from Denmark. EQ-5D-3L consist of 5 dimensions in health-related quality of life: Mobility, Self-care, usual activities, Pain/discomfort, and anxiety/depression. Each dimension is divided into three levels: no problems, some problems or extreme problems. EQ-5D-3L also include a 20-cm vertical scale, were the respondent are asked to describe his/her own health with endpoints of 'best imaginable health state' set at 100 and 'worst imaginable health state' set at 0. The EQ-5D has been validated in Danish, including the development of preference values and Danish population norms.
Measured: 1 year
Questionnaire regarding postoperative rehabilitation
We will administer a questionnaire that includes questions regarding the postoperative rehabilitation. It is questions regarding: setting, duration, participation and the degree of relevance to the individual patient. The patient will answer the questionnaire by a yes or no and detailed answers by text.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start30 Sep 2018
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Frederiksberg University Hospital
- Responsible party
- Principal investigator, Heidi Tegner, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673436
- Sponsor's protocol ID
- 1
- Status last verified
- Mar 2021
- First submitted
- 12 Sep 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lumbar Spinal Fusion Predicted by Physiotherapists: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03673436
- Acronym / sponsor ID
- 1
- Conditions
- Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Frederiksberg University Hospital
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 17 Sep 2018 (actual)
- 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 main purpose of this study is to investigate if improvements in patient self-reported pain, symptoms, function and quality of life 12 months after Lumbar spinal fusion among patients that have good projected prognosis differ from those among patients with a poor projected prognosis.
The secondary purpose is to explore the underlying factors of the physiotherapists projected prognosis to identify objective and possible modifiable candidate prognostic factors for recovery.
Detailed description
Background:
Over recent decades, an increasing number of patients with Chronic Low Back Pain (CLBP) undergo surgical lumbar spinal fusion (LSF). For many of the patients LSF is their last resort in the hope of a better life with less pain, disability and use of medication. Unfortunately, several reports show, that the pain level remains the same after LSF for many patients, and that consumption of medication remains unchanged in almost 50 % of the patients.
Knowing that characteristics such as maladaptive coping strategies, fear avoidance beliefs and pain catastrophizing seem to be predictive of worse outcome in pain, function and quality of life after surgery. It is important to assess how these individual factors in the postsurgical rehabilitation can be addressed.
The single physiotherapists have an essential role in mobilizing the LSF patient post-operatively. In clinical practice it is not enough for the physiotherapists to use their biomechanical understanding of LSF material and heeling processes, it is also essential to use a so-called "silent knowledge" of experience and personal interaction with the patient.
It remains unknown if this "silent knowledge" is a reliable predictor of the outcome of LSF surgery. If the physiotherapist can predict the outcome, it is important to explore which factors the physiotherapist rely their prognosis upon in order to identify objective and possible modifiable candidate prognostic factors for recovery.
The aim of this study is to assess if physiotherapists attending inpatients at public back surgery hospitals can predict the future course (post hospitalisation) of recovery of patients undergoing LSF. The study will also break down the physiotherapists' "silent knowledge" in an attempt to identify objective (and hopefully modifiable) candidate prognostic markers of recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with low back pain | – | Procedure: Lumbar spinal fusionCohort of 200 low back pain patients, 18 years+, who have been undergoing a lumbar spinal fusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consist of 200 patients with lumbar spinal fusion operated at a hospital in Denmark
Key inclusion criteria (6 listed)
- Received primary LSF surgery for treatment of CLBP
- Degenerative lumbar disease with or without lumbar spondylolisthesis grades 1 to 2
- Fusion of a maximum of 3 adjacent vertebrae
- Above 18 years of age
- Competence in the Danish language
Key exclusion criteria (2 listed)
- Prior LSF surgery
- Cognitive impairments that preclude reliable answers to patient reported outcome questionnaire
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 |
|---|---|---|
| Lumbar spinal fusionThe patient got a instrumented fusion of a maximum of 3 adjacent vertebrae | Procedure or surgery | Patients with low back pain |
Primary outcome
Oswestry Disability Index
Time frame: 1 year
Disability will be measured using the Oswestry Disability Index. ODI is a validated measure of condition-specific disability originally developed for patients with LBP. The ODI consists of ten items regarding pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. For each item the patient chooses one of six answers, with 0 representing no difficulty in the activity and 5 representing maximal difficulty.
5 secondary outcomes
Patient reported movement capacity
Time frame: 1 year
Back Pain
Time frame: 1 year
Leg Pain
Time frame: 1 year
Health outcome and quality of life
Time frame: 1 year
Questionnaire regarding postoperative rehabilitation
Time frame: 1 year
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 10 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 10 Mar 2021. 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 Denmark. 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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2021.