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

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

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.

Study Overview

• Status: Completed
• Conditions: Changes Over Time in Pain and Functional Parameters

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.

• Study Type: Observational
• Enrollment (Actual): 19

Contacts and Locations

Study Locations

• Switzerland
  • Kanton Graubünden
    • Chur, Kanton Graubünden, Switzerland, 7000
      • Cantonal Hospital of Grisons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline neurological status at 6 weeks and 6 months	The neurological status will be assessed by the straight leg raise test. The hydrogoniometer serves as assessment tool and measures the range of motion in degrees. The test will be performed following its description and will be stopped when the patient recognises his symptoms or when more than 70 degrees of hip flexion are reached without causing any symptoms.	3 measurement time points through study completion, an average of 6 months
Changes from baseline tissue tenderness status at 6 weeks and 6 months	The neurological status will be assessed by the pressure pain threshold over tenderpoints along the ilica crest. The NOD-algometer device serves as assessment tool and measures the pressure pain threshold in kPa.	3 measurement time points through study completion, an average of 6 months
Changes from baseline reflex activity status at 6 weeks and 6 months	The neurological status will be assessed by the reflex activity of the patellar and achilles tendon reflex. An acceleration attached to the moving limb will measure the amplitude of the limb movement in m/s2.	3 measurement time points through study completion, an average of 6 months
Changes from baseline muscular strength at 6 weeks and 6 months	Muscular strength will be assessed by an handheld dynamometer measuring in Newton.	3 measurement time points through study completion, an average of 6 months
Changes from baseline balance at 6 weeks and 6 months	Balance during the one leg stance with eyes open will be assessed by the SwayStar measurement tool which is based on integrated gyroscopes to measure pitch and roll movements.	3 measurement time points through study completion, an average of 6 months
Changes from baseline quality of life at 6 weeks and 6 months	Quality of life will be assessed by the SF-36 questionnaire. The total score is calculated from subscales by adding the points. The total score ranges from 0 to 100 points. 0 indicates a low quality of life and 100 indicates a high quality of life.	3 measurement time points through study completion, an average of 6 months
Changes from baseline disability at 6 weeks and 6 months	Disability will be assessed by the German version of the Oswestry Disability Questionnaire. The total score is calculated from subscales by adding the points. The total score ranges from 0 to 50 points. 0 indicates no disability, 50 indicates a high degree of disability.	3 measurement time points through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: University of Applied Sciences and Arts of Southern Switzerland
• Collaborators: Cantonal Hospital Graubuenden
• Investigators: Principal Investigator: Ron Clijsen, PhD, SUPSI Landquart, Switzerland

Publications and helpful links

General 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

Helpful Links

• Fulltext

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): December 6, 2019
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: 2018-00637_KSGR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No