Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery

NCT ID: NCT03452449

Last Updated: 2019-09-18

Study Results

Results pending

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.

Recruitment Status

COMPLETED

Total Enrollment

29 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Spine Degeneration Physical Activity Quality of Life Disability Physical Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lumbar spine surgery

Patients undergoing planned lumbar spine surgery

planned lumbar spine surgery

Intervention Type PROCEDURE

planned lumbar spine surgery including decompression, discectomy, foraminotomy, laminectomy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

planned lumbar spine surgery

planned lumbar spine surgery including decompression, discectomy, foraminotomy, laminectomy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* primary lumbar spine surgery
* single or multi level surgery on segments L2 to S1 (e.g. discectomy, decompression, laminectomy, foraminotomy)
* German speaking

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Corina NĂ¼esch, PhD

Role: STUDY_CHAIR

University Hospital, Basel, Switzerland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Clinic for Orthopaedics and Traumatology, University Hospital basel

Basel, Canton of Basel-City, Switzerland

Site Status

Bethesda Spital AG

Basel, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-00672

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Spinal Kinematics Variability
NCT03507296 COMPLETED