Lumbar Spine DegenerationPA-LSSNCT03452449
Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery
An observational study of Lumbar Spine Degeneration and Physical Activity, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial summary
To date it is unknown how physical activity levels in adults is limited before and after lumbar spine surgery and if physical activity level is associated with disability and limitations of quality of life. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lumbar Spine Degeneration, Physical Activity, Quality of Life
- What is being tested?
- planned lumbar spine surgery
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jun 2017to 30 Jun 2019
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: patients undergoing planned lumbar spine surgery
Who may be able to join
- primary lumbar spine surgery
- single or multi level surgery on segments L2 to S1 (e.g. discectomy, decompression, laminectomy, foraminotomy)
- German speaking
Who cannot join
- stabilisation or fusion surgery or surgery above L2
- previous lumbar spine surgery
- indication: scoliosis, fracture, trauma, infection, tumor
- limited walking ability due to other conditions
- psychiatric conditions or dementia
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Clinic for Orthopaedics and Traumatology, University Hospital basel
Basel, Canton of Basel-City, 4031
Bethesda Spital AG
Basel, 4002
About this study
Official title: Accelerometry-based Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery: a Prospective Study
To date it is unknown how physical activity levels in adults is limited before and after lumbar spine surgery and if physical activity level is associated with disability and limitations of quality of life. The main objective is to compare physical activity preoperatively and 6 and 12 weeks postoperatively in patients undergoing lumbar spine surgery with norm data. In addition, the investigators will study the association of changes in physical activity, disability and quality of live.
Read the detailed description
Patients scheduled for planned lumbar spine surgery will be contacted to participate in this study. All outcomes will be assessed within 1 week preoperatively and at 6 and 12 weeks postoperatively. Changes in outcome scores will be detected using analysis of variance. Association of changes in physical activity and changes in secondary outcomes will be detected using stepwise linear regression models.
- Being tested
- planned lumbar spine surgery
- Keywords
- activity monitor, questionnaire, Oswestry Disability Index
- Medical subject headings
- Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
planned lumbar spine surgeryProcedure or surgery
planned lumbar spine surgery including decompression, discectomy, foraminotomy, laminectomy
| Study group | Role | What they receive |
|---|---|---|
| Lumbar spine surgery | Patients undergoing planned lumbar spine surgery Receives: Procedure: planned lumbar spine surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity
measured using ActiGraph (accelerometer based activity monitor) as step counts, physical activity intensity during 7-day data capture period
Measured: up to 12 weeks
Secondary outcomes (3)
Disability
measured using Oswestry Disability Index (questionnaire) (best score: 0 - no disability, worst score: 100)
Measured: up to 12 weeks
Quality of life assessed by questionnaire
measured using Short Form (SF)-36 (questionnaire) (worst score: 0; best score: 100 - highest quality of life)
Measured: up to 12 weeks
Pain assessed by questionnaire
measured using 10 cm visual analogue scale (VAS) lower back, legs (best score: 0 - no pain; worst score: 100)
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start1 Jun 2017
- Primary completion31 May 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine DegenerationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Corina Nüesch, PhD, Study chair, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452449
- Sponsor's protocol ID
- 2017-00672
- Other IDs
- 2017
- Acronym
- PA-LSS
- Status last verified
- Sep 2019
- First submitted
- 26 Feb 2018
- Last updated
- 18 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerometry-based Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery: a Prospective Study
- ClinicalTrials.gov ID
- NCT03452449
- Acronym / sponsor ID
- PA-LSS / 2017-00672
- Keywords
- activity monitor, questionnaire, Oswestry Disability Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 2 Mar 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.
To date it is unknown how physical activity levels in adults is limited before and after lumbar spine surgery and if physical activity level is associated with disability and limitations of quality of life. The main objective is to compare physical activity preoperatively and 6 and 12 weeks postoperatively in patients undergoing lumbar spine surgery with norm data. In addition, the investigators will study the association of changes in physical activity, disability and quality of live.
Detailed description
Patients scheduled for planned lumbar spine surgery will be contacted to participate in this study. All outcomes will be assessed within 1 week preoperatively and at 6 and 12 weeks postoperatively. Changes in outcome scores will be detected using analysis of variance. Association of changes in physical activity and changes in secondary outcomes will be detected using stepwise linear regression models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar spine surgery | – | Procedure: planned lumbar spine surgeryPatients undergoing planned lumbar spine surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients undergoing planned lumbar spine surgery
Key inclusion criteria (3 listed)
- primary lumbar spine surgery
- single or multi level surgery on segments L2 to S1 (e.g. discectomy, decompression, laminectomy, foraminotomy)
- German speaking
Key exclusion criteria (5 listed)
- stabilisation or fusion surgery or surgery above L2
- previous lumbar spine surgery
- indication: scoliosis, fracture, trauma, infection, tumor
- limited walking ability due to other conditions
- psychiatric conditions or dementia
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 |
|---|---|---|
| planned lumbar spine surgeryplanned lumbar spine surgery including decompression, discectomy, foraminotomy, laminectomy | Procedure or surgery | Lumbar spine surgery |
Primary outcome
Physical activity
Time frame: up to 12 weeks
measured using ActiGraph (accelerometer based activity monitor) as step counts, physical activity intensity during 7-day data capture period
3 secondary outcomes
Disability
Time frame: up to 12 weeks
Quality of life assessed by questionnaire
Time frame: up to 12 weeks
Pain assessed by questionnaire
Time frame: up to 12 weeks
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 18 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Corina Nüesch, PhD study chair
University Hospital, Basel, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spine Degeneration and Physical Activity, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
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 3 inclusion and 5 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 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Physical activity (time frame: up to 12 weeks). 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 18 Sep 2019.