Clinical trial NCT03689400: Changes of Pain and Functional Parameters in Back Pain Patients Over Time
Official title: Changes of Pain and Functional Parameters in Back Pain Patients With or Without Radiculopathy Over Time
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Changes Over Time in Pain and Functional Parameters
Lead sponsor: University of Applied Sciences and Arts of Southern Switzerland
Sponsor class: OTHER
Collaborators: name: Cantonal Hospital of Graubünden, Switzerland
First posted: 2018-09-28
Enrollment: 19
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from baseline pain sensation at 6 weeks and 6 months
timeFrame: 3 measurement time points through study completion, an average of 6 months
Secondary outcomes:
measure: Changes from baseline neurological status at 6 weeks and 6 months
timeFrame: 3 measurement time points through study completion, an average of 6 months
measure: Changes from baseline tissue tenderness status at 6 weeks and 6 months
timeFrame: 3 measurement time points through study completion, an average of 6 months
measure: Changes from baseline reflex activity status at 6 weeks and 6 months
timeFrame: 3 measurement time points through study completion, an average of 6 months
measure: Changes from baseline muscular strength at 6 weeks and 6 months
timeFrame: 3 measurement time points through study completion, an average of 6 months
measure: Changes from baseline balance at 6 weeks and 6 months
timeFrame: 3 measurement time points through study completion, an average of 6 months
measure: Changes from baseline quality of life at 6 weeks and 6 months
timeFrame: 3 measurement time points through study completion, an average of 6 months
measure: Changes from baseline disability at 6 weeks and 6 months
timeFrame: 3 measurement time points through study completion, an average of 6 months
Other outcomes:
Locations:
city: Chur
country: Switzerland
facility: Cantonal Hospital of Grisons
state: Grisons
Study officials:
affiliation: SUPSI Landquart, Switzerland
name: Ron Clijsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: