An observational study in Changes Over Time in Pain and Functional Parameters, sponsored by University of Applied Sciences and Arts of Southern Switzerland. Completed at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by University of Applied Sciences and Arts of Southern Switzerland · Observational
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.
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.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 19 is below the median of 100 across 1,252 observational studies indexed under Pain.
Browse Pain studies →University of Applied Sciences and Arts of Southern Switzerland is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Changes in Visual Analog Scale Pain Scores
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.
Time frame: Baseline, 6 weeks, 6 months
Changes in Visual Analog Scale Ratings of Numbness
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.
Time frame: Baseline, 6 weeks, 6 months
Changes in Visual Analog Scale Ratings of Paresthesia
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.
Time frame: Baseline, 6 weeks, 6 months
Changes in Anterior Flexion Measured in Centimeters
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.
Time frame: Baseline, 6 weeks, 6 months
Changes in Back Extension Measured in Degrees
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.
Time frame: Baseline, 6 weeks, 6 months
Changes in Lateral Flexion Measured in Centimeters
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.
Time frame: Baseline, 6 weeks, 6 months
Changes in the Maximal Isometric Strength in Newton
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 hallucis longus (EHL); S1: M. gastrocnemius; M. triceps surae. Due to the small subgroups, the maximal isometric strengths of the quadriceps femoris muscle and triceps surae muscle were excluded from the analysis.The mean of the two closest of three values (N) was used for further analysis.
Time frame: Baseline, 6 weeks, 6 months
Changes in Nerve Tension Assessed by the Straight Leg Raising Test, Measured in Degrees
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.
Time frame: Baseline, 6 weeks, 6 months
Changes in Quality of Life Assessed by the Physical Component Summary of the 36-Item Short Form Health Survey
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.
Time frame: Baseline, 6 weeks, 6 months
Changes in Quality of Life Assessed by the Mental Component Summary of the 36-Item Short Form Health Survey
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.
Time frame: Baseline, 6 weeks, 6 months
Changes in Physical Activity Assessed Using the International Physical Activity Questionnairee
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
Time frame: Baseline, 6 weeks, 6 months
Changes in Disability According to the Oswestry Disability Index
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.
Time frame: Baseline, 6 weeks, 6 months
| Milestone | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Started | 19 |
| Completed | 15 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 4 |
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.
| Units on a scale | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Baseline | 3.6 ± 3.0 |
| 6 weeks follow-up | 1.2 ± 1.6 |
| 6 months follow-up | 0.5 ± 1.3 |
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.
| Units on a scale | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Baseline | 2.2 ± 2.3 |
| 6 weeks follow-up | 0.8 ± 1.8 |
| 6 months follow-up | 0.3 ± 1.3 |
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.
| Units on a scale | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Baseline | 3.3 ± 2.7 |
| 6 weeks follow-up | 0.9 ± 1.5 |
| 6 months follow-up | 0.3 ± 1.3 |
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.
| Centimeter | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Baseline | 21.7 ± 16.3 |
| 6 weeks follow-up | 17.8 ± 14.9 |
| 6 months follow-up | 11.8 ± 10.4 |
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.
| Degree | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Baseline | 18.7 ± 8.0 |
| 6 weeks follow-up | 21.8 ± 5.8 |
| 6 months follow-up | 27.9 ± 10.0 |
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.
| Centimeter | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| right side: Basline | 51.3 ± 4.4 |
| right side: 6 weeks follow-up | 49.9 ± 4.0 |
| right side: 6 months follow-up | 49.2 ± 4.4 |
| Left side: Baseline | 50.2 ± 5.4 |
| Left Side: 6 weeks follow-up | 49.4 ± 3.5 |
| Left side: 6 months follow-up | 48.6 ± 3.7 |
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 hallucis longus (EHL); S1: M. gastrocnemius; M. triceps surae. Due to the small subgroups, the maximal isometric strengths of the quadriceps femoris muscle and triceps surae muscle were excluded from the analysis.The mean of the two closest of three values (N) was used for further analysis.
| Newton | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| M. tibialis anterior: Baseline | 91.5 ± 47.6 |
| M. tibialis anterior: 6 weeks follow-up | 114.7 ± 71.8 |
| M. tibialis anterior: 6 months follow-up | 142.0 ± 65.9 |
| M. extensor hallucis longus: Baseline | 22.8 ± 9.0 |
| M. extensor hallucis longus: 6 weeks follow-up | 34.3 ± 19.3 |
| M. extensor hallucis longus: 6 months follow-up | 39.5 ± 12.6 |
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.
| Degree | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Baseline | 46.3 ± 23.4 |
| 6 weeks follow-up | 56.8 ± 17.0 |
| 6 months follow-up | 66.3 ± 9.0 |
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.
| score on a scale | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Baseline | 35.2 ± 6.6 |
| 6 weeks follow-up | 44.0 ± 8.2 |
| 6 months follow-up | 51.7 ± 7.5 |
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.
| score on a scale | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Baseline | 44.2 ± 15.6 |
| 6 weeks follow-up | 53.8 ± 7.5 |
| 6 month follow-up | 55.6 ± 4.3 |
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
| Metabolic equivalents of task-min./ week | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Baseline | 2140.9 ± 2067.6 |
| 6 weeks follow-up | 2961.2 ± 2460.1 |
| 6 months follow-up | 3718.0 ± 2846.5 |
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.
| score on a scale | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Baseline | 37.2 ± 20.1 |
| 6 weeks follow-up | 16.7 ± 11.9 |
| 6 months follow-up | 8.5 ± 12.0 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients With Lumbar Disc Herniation Associated With Radiculopathy | 0/19 (0%) | 0/19 (0%) | 0/19 (0%) |
| Age, Continuous(years) | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Mean | 47.3 ± 14.1 |
| Sex: Female, Male(Participants) | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Female | 4 |
| Male | 15 |
| Race and Ethnicity Not Collected(Participants) | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|
| Level of lesion(Participants) | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| first sacral vertebra (S1) | 5 |
| fifth lumbar vertebra (L5) | 9 |
| fourth lumbar vertebra (L4) | 2 |
| third lumbar vertebra (L3) | 3 |
| second lumbar vertebra (L2) | 0 |
| Side of lesion(Participants) | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Right | 9 |
| Left | 10 |
| Type of treatment(Participants) | Patients With Lumbar Disc Herniation Associated With Radiculopathy |
|---|---|
| Conservative only | 9 |
| Surgery and Conservative | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2018 to primary completion in Dec 2019, 13 months.
Results were first posted in Dec 2025, 6 years after primary completion.
Of 504 non-industry observational studies under Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's 13 months is below that.
Counting every sponsor, half of 519 studies reached it within 18 months; a quarter within 8 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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University of Applied Sciences and Arts of Southern Switzerland