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

Pain Clinical Trial

— PA-LSS  

Official title:

Accelerometry-based Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03452449
• Other study ID #: 2017-00672
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2019
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 30, 2019
• Est. primary completion date: May 31, 2018
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Disability Physical
• Lumbar Spine Degeneration
• Pain
• Physical Activity
• Quality of Life

Intervention

Procedure:
• planned lumbar spine surgery
planned lumbar spine surgery including decompression, discectomy, foraminotomy, laminectomy

Locations

Country	Name	City	State
Switzerland	Bethesda Spital AG	Basel
Switzerland	Clinic for Orthopaedics and Traumatology, University Hospital basel	Basel	Basel Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical activity	measured using ActiGraph (accelerometer based activity monitor) as step counts, physical activity intensity during 7-day data capture period	up to 12 weeks
Secondary	Disability	measured using Oswestry Disability Index (questionnaire) (best score: 0 - no disability, worst score: 100)	up to 12 weeks
Secondary	Quality of life assessed by questionnaire	measured using Short Form (SF)-36 (questionnaire) (worst score: 0; best score: 100 - highest quality of life)	up to 12 weeks
Secondary	Pain assessed by questionnaire	measured using 10 cm visual analogue scale (VAS) lower back, legs (best score: 0 - no pain; worst score: 100)	up to 12 weeks