Changes Over Time in Pain and Functional ParametersNCT03689400

Changes of Pain and Functional Parameters in Back Pain Patients Over Time

An observational study of Changes Over Time in Pain and Functional Parameters, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Changes Over Time in Pain and Functional Parameters
How many people: 19 participants
Where: 1 siteSwitzerland
Study dates: 11 Oct 2018to 31 Jan 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

Cantonal Hospital of Grisons
Chur, Kanton Graubünden, 7000

Other trials in Switzerland

About this study

Official title: Changes of Pain and Functional Parameters in Back Pain Patients With or Without Radiculopathy Over Time

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.

Read the 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.

Conditions: Changes Over Time in Pain and Functional Parameters

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, 6 weeks, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 201831 Jan 2020

First posted28 Sep 2018
Study start11 Oct 2018
Primary completion6 Dec 2019
Study completion31 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Changes Over Time in Pain and Functional ParametersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03689400
Sponsor's protocol ID: 2018-00637_KSGR
Other IDs: 2018
Status last verified: Dec 2025
First submitted: 29 Aug 2018
Last updated: 17 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Changes of Pain and Functional Parameters in Back Pain Patients With or Without Radiculopathy Over Time
ClinicalTrials.gov ID: NCT03689400
Acronym / sponsor ID: 2018-00637_KSGR
Conditions: Changes Over Time in Pain and Functional Parameters
Study type: Observational
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: University of Applied Sciences and Arts of Southern SwitzerlandUniversity, hospital or other
Collaborators: Cantonal Hospital Graubuenden
Study start: 11 Oct 2018 (actual)
Primary completion: 6 Dec 2019 (actual)
Study completion: 31 Jan 2020 (actual)
First posted: 28 Sep 2018 (actual)
Results: Posted 17 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Therefore, a second aim of this study is to evaluate each subjective clinical test with a standardized objective measurement tool.

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Changes in Visual Analog Scale Pain Scores
Time frame: 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.
Changes in Visual Analog Scale Ratings of Numbness
Time frame: 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.
Changes in Visual Analog Scale Ratings of Paresthesia
Time frame: 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.
Changes in Anterior Flexion Measured in Centimeters
Time frame: 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.
Changes in Back Extension Measured in Degrees
Time frame: 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.
Changes in Lateral Flexion Measured in Centimeters
Time frame: 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.
Changes in the Maximal Isometric Strength in Newton
Time frame: 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 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.
Changes in Nerve Tension Assessed by the Straight Leg Raising Test, Measured in Degrees
Time frame: 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.
Changes in Quality of Life Assessed by the Physical Component Summary of the 36-Item Short Form Health Survey
Time frame: 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.
Changes in Quality of Life Assessed by the Mental Component Summary of the 36-Item Short Form Health Survey
Time frame: 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.
Changes in Physical Activity Assessed Using the International Physical Activity Questionnairee
Time frame: 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
Changes in Disability According to the Oswestry Disability Index
Time frame: 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.

Results and safety

Results posted to the registry on 17 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With Lumbar Disc Herniation Associated With Radiculopathy	19	15

Primary outcome: Changes in Visual Analog Scale Pain Scores

Time frame: Baseline, 6 weeks, 6 months. Mean (Standard Deviation). Unit: Units on a scale

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n = 19
Baseline	3.6 (3.0)
6 weeks follow-up	1.2 (1.6)
6 months follow-up	0.5 (1.3)

Population analysed: four patients missed the six-month follow-up

Primary outcome: Changes in Visual Analog Scale Ratings of Numbness

Time frame: Baseline, 6 weeks, 6 months. Mean (Standard Deviation). Unit: Units on a scale

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n = 19
Baseline	2.2 (2.3)
6 weeks follow-up	0.8 (1.8)
6 months follow-up	0.3 (1.3)

Population analysed: four patients missed the six-month follow-up.

Primary outcome: Changes in Visual Analog Scale Ratings of Paresthesia

Time frame: Baseline, 6 weeks, 6 months. Mean (Standard Deviation). Unit: Units on a scale

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n = 19
Baseline	3.3 (2.7)
6 weeks follow-up	0.9 (1.5)
6 months follow-up	0.3 (1.3)

Population analysed: four patients missed the six-month follow-up.

Primary outcome: Changes in Anterior Flexion Measured in Centimeters

Time frame: Baseline, 6 weeks, 6 months. Mean (Standard Deviation). Unit: Centimeter

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n = 19
Baseline	21.7 (16.3)
6 weeks follow-up	17.8 (14.9)
6 months follow-up	11.8 (10.4)

Population analysed: four patients missed the six-month follow-up.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With Lumbar Disc Herniation Associated With Radiculopathy	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationBianchi 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
FulltextLink provided by the sponsor.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ron Clijsen, PhD principal investigator

SUPSI Landquart, Switzerland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Changes Over Time in Pain and Functional Parameters, run by University of Applied Sciences and Arts of Southern Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Visual Analog Scale Pain Scores (time frame: Baseline, 6 weeks, 6 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03689400, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.