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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03689400

Enrollment

Registered

2018-09-28

Start date

2018-10-11

Completion date

2020-01-31

Last updated

2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Changes Over Time in Pain and Functional Parameters

Brief 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. 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Changes in Visual Analog Scale Pain Scores	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	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	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	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	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	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	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	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	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	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	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	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.

Countries

Switzerland

Participant flow

Participants by arm

Arm	Count
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.	19
Total	19

Arm

Count

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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	4

Baseline characteristics

Characteristic	Patients With Lumbar Disc Herniation Associated With Radiculopathy	—
Age, Continuous	47.3 years STANDARD_DEVIATION 14.1	—
Level of lesion fifth lumbar vertebra (L5)	9 Participants	—
Level of lesion first sacral vertebra (S1)	5 Participants	—
Level of lesion fourth lumbar vertebra (L4)	2 Participants	—
Level of lesion second lumbar vertebra (L2)	0 Participants	—
Level of lesion third lumbar vertebra (L3)	3 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	4 Participants	—
Sex: Female, Male Male	15 Participants	—
Side of lesion Left	10 Participants	—
Side of lesion Right	9 Participants	—
Type of treatment Conservative only	9 Participants	—
Type of treatment Surgery and Conservative	10 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 19
other Total, other adverse events	0 / 19
serious Total, serious adverse events	0 / 19

Outcome results

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.