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OpenTrials
Completed

NCT Number: NCT03452449

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

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.

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Key information

Conditions

Lumbar Spine Degeneration Behavior Disability Physical Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Physical Activity Quality of Life Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for Orthopaedics and Traumatology, University Hospital basel, Basel, Canton of Basel-City, Switzerland

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

planned lumbar spine surgery

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Disability

    Time frame: up to 12 weeks

    measured using Oswestry Disability Index (questionnaire) (best score: 0 - no disability, worst score: 100)

  2. Quality of life assessed by questionnaire

    Time frame: up to 12 weeks

    measured using Short Form (SF)-36 (questionnaire) (worst score: 0; best score: 100 - highest quality of life)

  3. Pain assessed by questionnaire

    Time frame: up to 12 weeks

    measured using 10 cm visual analogue scale (VAS) lower back, legs (best score: 0 - no pain; worst score: 100)

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: PA-LSS

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Mar 2, 2018
Registry last updated
Sep 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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