Changes of Pain and Functional Parameters in Back Pain Patients Over Time

Changes of Pain and Functional Parameters in Back Pain Patients With or Without Radiculopathy Over Time

Back pain affects patients' daily life. Patients can suffer from various symptoms which appear intermittent or permanent; pain, sensory malfunction, reduction of muscular strength and coordination. Therefore, patients are impaired in participation and activity.

Physiotherapy is recommended to improve those symptoms and to positively affect the cause of the problem. However, some patients do not benefit from physiotherapeutic treatment and require a surgery.

The investigators intend to attend patients suffering from back pain and to document the changes of pain and functional parameters over a period of 6 months. The investigators include pre-operative, post-operative or non-operated patients which allows to discuss the different treatment options and its effects.

Study Overview

• Status: Completed
• Conditions: Changes Over Time in Pain and Functional Parameters

Detailed Description

To assess pain and functional parameters physicians, medical staff and physiotherapist often use subjective clinical testings which impede the comparability of testings over time, between testers and between subjects.

Therefore, a second aim of this study is to evaluate each subjective clinical test with a standardized objective measurement tool.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• Switzerland
  • Grisons
    • Chur, Grisons, Switzerland, 7000
      • Cantonal Hospital of Grisons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The investigators are looking for subjects suffering from back pain, who visit the neurosurgery department of the Cantonal hospital of Grisons in Chur to discuss the further treatment of their disease. The subjects get their normal medical and physiotherapeutical treatment independent of the study participation.

Description

Inclusion Criteria:

• appointment at the neurosurgery department due to back pain
• German speaking
• willingness to see a physiotherapist
• willingness to participate in 3 measurements over 6 months

Exclusion Criteria:

• no appointment at the neurosurgery department due to back pain
• not German speaking
• no willingness to see a physiotherapist
• no willingness to participate in 3 measurements over 6 months

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline pain sensation at 6 weeks and 6 months	Changes of pain, sensory malfunction and numbness assessed by pain drawings and the visual analog scale. The visual analog scale ranges from 0 to 10 points, where 0 indicates no pain, no numbness or no impairment of sensation and 10 stands for the highest pain value, total numbness or unsustainable paresthesia.	3 measurement time points through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline neurological status at 6 weeks and 6 months	The neurological status will be assessed by the straight leg raise test. The hydrogoniometer serves as assessment tool and measures the range of motion in degrees. The test will be performed following its description and will be stopped when the patient recognises his symptoms or when more than 70 degrees of hip flexion are reached without causing any symptoms.	3 measurement time points through study completion, an average of 6 months
Changes from baseline tissue tenderness status at 6 weeks and 6 months	The neurological status will be assessed by the pressure pain threshold over tenderpoints along the ilica crest. The NOD-algometer device serves as assessment tool and measures the pressure pain threshold in kPa.	3 measurement time points through study completion, an average of 6 months
Changes from baseline reflex activity status at 6 weeks and 6 months	The neurological status will be assessed by the reflex activity of the patellar and achilles tendon reflex. An acceleration attached to the moving limb will measure the amplitude of the limb movement in m/s2.	3 measurement time points through study completion, an average of 6 months
Changes from baseline muscular strength at 6 weeks and 6 months	Muscular strength will be assessed by an handheld dynamometer measuring in Newton.	3 measurement time points through study completion, an average of 6 months
Changes from baseline balance at 6 weeks and 6 months	Balance during the one leg stance with eyes open will be assessed by the SwayStar measurement tool which is based on integrated gyroscopes to measure pitch and roll movements.	3 measurement time points through study completion, an average of 6 months
Changes from baseline quality of life at 6 weeks and 6 months	Quality of life will be assessed by the SF-36 questionnaire. The total score is calculated from subscales by adding the points. The total score ranges from 0 to 100 points. 0 indicates a low quality of life and 100 indicates a high quality of life.	3 measurement time points through study completion, an average of 6 months
Changes from baseline disability at 6 weeks and 6 months	Disability will be assessed by the German version of the Oswestry Disability Questionnaire. The total score is calculated from subscales by adding the points. The total score ranges from 0 to 50 points. 0 indicates no disability, 50 indicates a high degree of disability.	3 measurement time points through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: University of Applied Sciences and Arts of Southern Switzerland
• Collaborators: Cantonal Hospital of Graubünden, Switzerland
• Investigators: Principal Investigator: Ron Clijsen, PhD, SUPSI Landquart, Switzerland

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): December 6, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: KSGR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No