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| Name | Class |
|---|---|
| Cantonal Hospital Graubuenden | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ron Clijsen, PhD | SUPSI Landquart, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cantonal Hospital of Grisons | Chur | Kanton Graubünden | 7000 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Bianchi G, Zweifel C, Hohenauer E, Santos JAR and Clijsen R (2025) Reliable outcome parameters in patients with lumbar radiculopathy attributed to disc herniation: an observational study. Front. Musculoskelet. Disord. 3:1672539. doi: 10.3389/fmscd.2025.1672539 |
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| Fulltext | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With Lumbar Disc Herniation Associated With Radiculopathy | Adult patients diagnosed with lumbar disc herniation associated with radiculopathy at the Cantonal Hospital of Graubünden. Physical assessment was done to diagnose LR; an MRI was performed to confirm the presence of an LDH. All patients included in this study received physiotherapy at the Cantonal Hospital Graubünden, regardless of whether they had undergone surgery beforehand. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With Lumbar Disc Herniation Associated With Radiculopathy | Adult patients diagnosed with lumbar disc herniation associated with radiculopathy at the Cantonal Hospital of Graubünden. Physical assessment was done to diagnose LR; an MRI was performed to confirm the presence of an LDH. All patients included in this study received physiotherapy at the Cantonal Hospital Graubünden, regardless of whether they had undergone surgery beforehand. |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | four patients missed the six-month follow-up | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 6 weeks, 6 months |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With Lumbar Disc Herniation Associated With Radiculopathy | Adult patients diagnosed with lumbar disc herniation associated with radiculopathy at the Cantonal Hospital of Graubünden. Physical assessment was done to diagnose LR; an MRI was performed to confirm the presence of an LDH. All patients included in this study received physiotherapy at the Cantonal Hospital Graubünden, regardless of whether they had undergone surgery beforehand. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giannina Bianchi | Rehabilitation and Exercise Science Laboratory (RESlab), Department of Business Economics, Health and Social Care (DEASS), University of Applied Sciences and Arts of Southern Switzerland (SUPSI), Landquart, Switzerland | 00418 300 01 78 | giannina.dias@supsi.ch |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2018 | Aug 21, 2025 | Prot_SAP_000.pdf |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | Baseline, 6 weeks, 6 months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Side of lesion | Count of Participants | Participants |
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| Type of treatment | Count of Participants | Participants |
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| Primary | 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. | four patients missed the six-month follow-up. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 6 weeks, 6 months |
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| Primary | 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. | four patients missed the six-month follow-up. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, 6 weeks, 6 months |
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| Primary | 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. | four patients missed the six-month follow-up. | Posted | Mean | Standard Deviation | Centimeter | Baseline, 6 weeks, 6 months |
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| Primary | 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. | four patients missed the six-month follow-up. | Posted | Mean | Standard Deviation | Degree | Baseline, 6 weeks, 6 months |
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| Primary | 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. | four patients missed the six-month follow-up. | Posted | Mean | Standard Deviation | Centimeter | Baseline, 6 weeks, 6 months |
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| Primary | 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. | Maximal isometric strength was tested from the primary innervated muscle [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. Four patients missed the 6-month follow-up.](streamdown:incomplete-link) | Posted | Mean | Standard Deviation | Newton | Baseline, 6 weeks, 6 months |
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| Primary | 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. | Four patients missed the six-month follow-up. | Posted | Mean | Standard Deviation | Degree | Baseline, 6 weeks, 6 months |
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| Primary | 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. | Four patients missed the six-month follow-up. One participant failed to answer questions 4b-d of the SF-36 questionnaire at the six-week follow-up and questions 5b-c at both follow-ups, leading to missing values. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks, 6 months |
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| Primary | 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. | Four patients missed the six-month follow-up. One participant failed to answer questions 4b-d of the SF-36 questionnaire at the six-week follow-up and questions 5b-c at both follow-ups, leading to missing values. | Posted | Mean | Standard Error | score on a scale | Baseline, 6 weeks, 6 months |
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| Primary | 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 | Four patients missed the six-month follow-up. | Posted | Mean | Standard Deviation | Metabolic equivalents of task-min./ week | Baseline, 6 weeks, 6 months |
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| Primary | 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. | Four patients missed the six-month follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 6 weeks, 6 months |
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| Left side: Baseline |
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