N/A
Completed N=19
Changes of Pain and Functional Parameters in Back Pain Patients Over Time
Changes Over Time in Pain and Functional Parameters
Source: ClinicalTrials.gov NCT03689400 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: Changes in Visual Analog Scale Pain Scores — 3.6; 1.2; 0.5 Units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Visual Analog Scale Pain Scores |
3.6; 1.2; 0.5 | — |
| PRIMARY Changes in Visual Analog Scale Ratings of Numbness |
2.2; 0.8; 0.3 | — |
| PRIMARY Changes in Visual Analog Scale Ratings of Paresthesia |
3.3; 0.9; 0.3 | — |
| PRIMARY Changes in Anterior Flexion Measured in Centimeters |
21.7; 17.8; 11.8 | — |
| PRIMARY Changes in Back Extension Measured in Degrees |
18.7; 21.8; 27.9 | — |
| PRIMARY Changes in Lateral Flexion Measured in Centimeters |
51.3; 49.9; 49.2; 50.2; 49.4; 48.6 | — |
| PRIMARY Changes in the Maximal Isometric Strength in Newton |
91.5; 114.7; 142.0; 22.8; 34.3; 39.5 | — |
| PRIMARY Changes in Nerve Tension Assessed by the Straight Leg Raising Test, Measured in Degrees |
46.3; 56.8; 66.3 | — |
| PRIMARY Changes in Quality of Life Assessed by the Physical Component Summary of the 36-Item Short Form Health Survey |
35.2; 44.0; 51.7 | — |
| PRIMARY Changes in Quality of Life Assessed by the Mental Component Summary of the 36-Item Short Form Health Survey |
44.2; 53.8; 55.6 | — |
| PRIMARY Changes in Physical Activity Assessed Using the International Physical Activity Questionnairee |
2140.9; 2961.2; 3718.0 | — |
| PRIMARY Changes in Disability According to the Oswestry Disability Index |
37.2; 16.7; 8.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT03689400). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.