Predictive Value of the Five-repetition Sit-to-stand Test After Lumbar Spine surgerySTS-3 Study.

NCT04660656 | Unknown

• 1 other identifier: W20.272
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Sciatica is a disabling condition that affects many people. This condition has an enormous influence on the social functioning of patients. The clinical determination of the severity of back pain is mainly done with validated questionnaires, which express the subjective pattern of complaints in a score. These usually reflect the severity of the complaints, but there is still a lack of objective and quantitative tests. In this study, the aim is to investigate whether there is a connection between the duration of the 5R-STS test and the outcome of low back operations after one year. In other words: What is the predictive value of this test on the result of surgery? The validated five-repetition sit-to-stand test (5R-STS) is a standardized test that has its origin in pneumology and is derived from the 1-minute sit-to-stand test. In this test, the patient stands up and sits down for 1 minute as often as possible from a chair without armrests, counting the number of movements. This not only measures how mobile the patient is, but can also say something about the condition of the heart and lungs. Recently, the 5R-STS has been described, in which the time is measured in which the patient has to stand up straight and sit down again five times from a chair.

Conditions

Back Pain; Sciatica

Outcome Measures

Primary Outcomes (1)

• 5R-STS

  The test time of the five-repetition sit-to-stand test (5R-STS) measures 12 months after surgery

  1 year

Interventions

5 repetition sit-to-stand test DIAGNOSTIC_TEST

The sit-to-stand test with five repetitive movements is used as standard in our clinical routine to determine the patient's mobility objectively. The first measurement is performed preoperatively during surgery (baseline). The follow-up measurement is performed six weeks after the operation and one year after the operation in the clinic. A stool with a fixed height is used for this purpose. The patient should cross his arms over the chest and then slowly stand up until the knees are full of space. Then the patient sits down again, of course without support of the arms. The duration of the five movements is recorded using a stopwatch. The complete movement starts after the "Go" command and ends when the patient is fully upright after the fifth movement. This duration is written down as the patient's score.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this study we will collect and analyze the data of 120 patients. Men and woman, all ages.

You may qualify if:

• All patients with lumbar hernias or with 1-level lumbar canal stenoses will be included (consecutive case series).

You may not qualify if:

• Wheelchair-bound patients, and other patients who cannot walk on their own or are bedridden, as well as pregnant patients, are excluded.

Sponsors & Collaborators

• Bergman Clinics: lead

Study Sites (2)

Department of Neurosurgery, Bergman Clinics

Naarden, 1411 GE, Netherlands

Location

Bergman Clinics

Naarden, GE, Netherlands

Location

Related Links

• The five-repetition sit-to-stand test: evaluation of a simple and objective tool for the assessment of degenerative pathologies of the lumbar spine.
• Can objective functional impairment in lumbar degenerative disease be reliably assessed at home using the five-repetition sit-to-stand test?

MeSH Terms

Conditions

Back Pain; Sciatica

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia

Study Officials

• Marc L Schröder, MD

  Bergman Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. M.L.J.F Schröder

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 9, 2020
• Study Start: November 25, 2020
• Primary Completion: April 1, 2022
• Study Completion: May 1, 2022
• Last Updated: December 9, 2020

Record last verified: 2020-12

Locations

NL (2)