University of Applied Sciences and Arts of Southern Switzerland
Who can join
Eligibility, any sex, with Changes Over Time in Pain and Functional Parameters. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Changes in Visual Analog Scale Pain ScoresPrimary· Baseline, 6 weeks, 6 months
Changes in pain were assessed using a unidimensional 10-cm Visual Analogue Scale. The scale ranged from one endpoint depicting a happy face, indicating "no pain," to the other endpoint depicting a sad face, indicating "worst possible pain." The distance in centimeters from the low end (0) of the VAS to the patient's mark was used as a numerical measure of pain severity. The lowest score was 0, indicating no pain, the maximum score 10, indicating worst possible pain. Higher scores indicate more severe pain.
Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
3.6
± 3.0
6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
1.2
± 1.6
6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
0.5
± 1.3
Changes in Visual Analog Scale Ratings of NumbnessPrimary· Baseline, 6 weeks, 6 months
Changes in pain were assessed using a unidimensional 10-cm Visual Analogue Scale. The scale ranged from one endpoint depicting a happy face, indicating "no numbness," to the other endpoint depicting a sad face, indicating "worst possible numbness." The distance in centimeters from the low end of the VAS to the patient's mark was used as a numerical measure of pain severity. The lowest score was 0, indicating no numbness, the maximum score 10, indicating worst possible numbness. Higher scores indicate more severe numbness.
Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
2.2
± 2.3
6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
0.8
± 1.8
6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
0.3
± 1.3
Changes in Visual Analog Scale Ratings of ParesthesiaPrimary· Baseline, 6 weeks, 6 months
Changes in pain were assessed using a unidimensional 10-cm Visual Analogue Scale. The scale ranged from one endpoint depicting a happy face, indicating "no paresthesia" to the other endpoint depicting a sad face, indicating "worst possible paresthesia." The distance in centimeters from the low end of the VAS to the patient's mark was used as a numerical measure of pain severity. The lowest score was 0, indicating no paresthesia, the maximum score 10, indicating worst possible paresthesia. Higher scores indicate more severe numbness.
Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
3.3
± 2.7
6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
0.9
± 1.5
6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
0.3
± 1.3
Changes in Anterior Flexion Measured in CentimetersPrimary· Baseline, 6 weeks, 6 months
The fingertip-to-floor (FTF) test (cm) was used to assess the lumbar maximal anterior flexion. Patients performed maximal flexion up to the pain threshold, keeping the elbows, fingers, and knees straight and the heels together.
Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
21.7
± 16.3
6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
17.8
± 14.9
6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
11.8
± 10.4
Changes in Back Extension Measured in DegreesPrimary· Baseline, 6 weeks, 6 months
Extension was measured using a baseline bubble inclinometer. Patients performed maximal extension up to the pain threshold, keeping the elbows, fingers, and knees straight and the heels together.
Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
18.7
± 8.0
6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
21.8
± 5.8
6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
27.9
± 10.0
Changes in Lateral Flexion Measured in CentimetersPrimary· Baseline, 6 weeks, 6 months
The fingertip-to-floor (FTF) test (cm) was used to assess the lumbar maximal lateral flexion. Patients performed maximal flexion up to the pain threshold, keeping the elbows, fingers, and knees straight and the heels together. The contralateral hip remained in contact with the treatment table during lateral flexion.
right side: Basline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
51.3
± 4.4
right side: 6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
49.9
± 4.0
right side: 6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
49.2
± 4.4
Left side: Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
50.2
± 5.4
Left Side: 6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
49.4
± 3.5
Left side: 6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
48.6
± 3.7
Changes in the Maximal Isometric Strength in NewtonPrimary· Baseline, 6 weeks, 6 months
Maximal isometric strength was tested using the NOD hand-held dynamometer. An active strength test of the primary innervated muscle was performed for 3 s using a standardized procedure adapted from Mentiplay et al. The patient was instructed to press against the examiner's hand-and thus the hand-held dynamometer-as hard and as long as possible. The dynamometer recorded the strength and duration of the isometric contraction both graphically and numerically.
The tested muscles included:
L3: M. quadriceps femoris; L4: M. quadriceps femoris; M. tibialis anterior (TA); L5: M. TA; M. extensor hall
M. tibialis anterior: Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
91.5
± 47.6
M. tibialis anterior: 6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
114.7
± 71.8
M. tibialis anterior: 6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
142.0
± 65.9
M. extensor hallucis longus: Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
22.8
± 9.0
M. extensor hallucis longus: 6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
34.3
± 19.3
M. extensor hallucis longus: 6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
39.5
± 12.6
Changes in Nerve Tension Assessed by the Straight Leg Raising Test, Measured in DegreesPrimary· Baseline, 6 weeks, 6 months
Nerve tension of the affected spinal nerve root was assessed using the straight leg raise pain provocation test. A baseline bubble inclinometer was placed directly above the patella to measure the angle in degrees between the examination table and the elevated limb.
Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
46.3
± 23.4
6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
56.8
± 17.0
6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
66.3
± 9.0
Changes in Quality of Life Assessed by the Physical Component Summary of the 36-Item Short Form Health SurveyPrimary· Baseline, 6 weeks, 6 months
General health was evaluated using the German version 2.0 of the 36-item Short Form Health Survey (SF-36). The PCS score aggregates four subscales-Physical Functioning, Role Physical, Bodily Pain, and General Health-into a standardized score ranging from 0 to 100, with higher scores reflecting better physical health.
Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
35.2
± 6.6
6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
44.0
± 8.2
6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
51.7
± 7.5
Changes in Quality of Life Assessed by the Mental Component Summary of the 36-Item Short Form Health SurveyPrimary· Baseline, 6 weeks, 6 months
General health was evaluated using the German version 2.0 of the 36-item Short Form Health Survey (SF-36). The MCS score aggregates four subscales-Vitality, Social Functioning, Role Emotional, and Mental Health-into a standardized score ranging from 0 to 100, with higher scores reflecting better mental health.
Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
44.2
± 15.6
6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
53.8
± 7.5
6 month follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
55.6
± 4.3
Changes in Physical Activity Assessed Using the International Physical Activity QuestionnaireePrimary· Baseline, 6 weeks, 6 months
Physical activity was assessed using the self-administered short German version of the International Physical Activity Questionnaire (IPAQ) with a "last 7 days recall". Data were processed and analyzed according to the official IPAQ scoring protocol and reported in metabolic equivalents of task minutes per week
Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
2140.9
± 2067.6
6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
2961.2
± 2460.1
6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
3718.0
± 2846.5
Changes in Disability According to the Oswestry Disability IndexPrimary· Baseline, 6 weeks, 6 months
Disability was assessed using the German version of the Oswestry Disability Index. The ODI consists of 10 sections, each scored from 0 to 5. Scores are summed and expressed as a percentage ranging from 0 to 100, with higher scores indicating greater disability.
Baseline
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
37.2
± 20.1
6 weeks follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
16.7
± 11.9
6 months follow-up
Group
Value
95% CI
Patients With Lumbar Disc Herniation Associated With Radiculopathy
8.5
± 12.0
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Applied Sciences and Arts of Southern Switzerland
Last refreshed: 17 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03689400.