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

Changes Over Time in Pain and Functional Parameters Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689400
• Other study ID #: KSGR
• Status: Completed
• Start date: October 11, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2024
• Source: University of Applied Sciences and Arts of Southern Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 31, 2020
• Est. primary completion date: December 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Changes Over Time in Pain and Functional Parameters

Locations

Country	Name	City	State
Switzerland	Cantonal Hospital of Grisons	Chur	Grisons

Sponsors (2)

Lead Sponsor	Collaborator
University of Applied Sciences and Arts of Southern Switzerland	Cantonal Hospital of Graubünden, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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