Trial Outcomes & Findings for Changes of Pain and Functional Parameters in Back Pain Patients Over Time (NCT NCT03689400)

NCT ID: NCT03689400

Last Updated: 2025-12-17

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 19 participants
• Primary outcome timeframe: Baseline, 6 weeks, 6 months
• Results posted on: 2025-12-17

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	19
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure

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.

Overall Study Lost to Follow-up

4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Age, Continuous	47.3 years STANDARD_DEVIATION 14.1 • n=19 Participants
Sex: Female, Male Female	4 Participants n=19 Participants
Sex: Female, Male Male	15 Participants n=19 Participants
Level of lesion first sacral vertebra (S1)	5 Participants n=19 Participants
Level of lesion fifth lumbar vertebra (L5)	9 Participants n=19 Participants
Level of lesion fourth lumbar vertebra (L4)	2 Participants n=19 Participants
Level of lesion third lumbar vertebra (L3)	3 Participants n=19 Participants
Level of lesion second lumbar vertebra (L2)	0 Participants n=19 Participants
Side of lesion Right	9 Participants n=19 Participants
Side of lesion Left	10 Participants n=19 Participants
Type of treatment Conservative only	9 Participants n=19 Participants
Type of treatment Surgery and Conservative	10 Participants n=19 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 6 months

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

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.

Outcome measures

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Changes in Visual Analog Scale Pain Scores Baseline	3.6 Units on a scale Standard Deviation 3.0
Changes in Visual Analog Scale Pain Scores 6 weeks follow-up	1.2 Units on a scale Standard Deviation 1.6
Changes in Visual Analog Scale Pain Scores 6 months follow-up	0.5 Units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 6 months

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

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.

Outcome measures

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Changes in Visual Analog Scale Ratings of Numbness Baseline	2.2 Units on a scale Standard Deviation 2.3
Changes in Visual Analog Scale Ratings of Numbness 6 weeks follow-up	0.8 Units on a scale Standard Deviation 1.8
Changes in Visual Analog Scale Ratings of Numbness 6 months follow-up	0.3 Units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 6 months

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

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.

Outcome measures

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Changes in Visual Analog Scale Ratings of Paresthesia Baseline	3.3 Units on a scale Standard Deviation 2.7
Changes in Visual Analog Scale Ratings of Paresthesia 6 weeks follow-up	0.9 Units on a scale Standard Deviation 1.5
Changes in Visual Analog Scale Ratings of Paresthesia 6 months follow-up	0.3 Units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 6 months

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

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.

Outcome measures

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Changes in Anterior Flexion Measured in Centimeters Baseline	21.7 Centimeter Standard Deviation 16.3
Changes in Anterior Flexion Measured in Centimeters 6 weeks follow-up	17.8 Centimeter Standard Deviation 14.9
Changes in Anterior Flexion Measured in Centimeters 6 months follow-up	11.8 Centimeter Standard Deviation 10.4

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 6 months

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

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.

Outcome measures

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Changes in Back Extension Measured in Degrees Baseline	18.7 Degree Standard Deviation 8.0
Changes in Back Extension Measured in Degrees 6 weeks follow-up	21.8 Degree Standard Deviation 5.8
Changes in Back Extension Measured in Degrees 6 months follow-up	27.9 Degree Standard Deviation 10.0

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 6 months

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

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.

Outcome measures

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Changes in Lateral Flexion Measured in Centimeters right side: Basline	51.3 Centimeter Standard Deviation 4.4
Changes in Lateral Flexion Measured in Centimeters right side: 6 weeks follow-up	49.9 Centimeter Standard Deviation 4.0
Changes in Lateral Flexion Measured in Centimeters right side: 6 months follow-up	49.2 Centimeter Standard Deviation 4.4
Changes in Lateral Flexion Measured in Centimeters Left side: Baseline	50.2 Centimeter Standard Deviation 5.4
Changes in Lateral Flexion Measured in Centimeters Left Side: 6 weeks follow-up	49.4 Centimeter Standard Deviation 3.5
Changes in Lateral Flexion Measured in Centimeters Left side: 6 months follow-up	48.6 Centimeter Standard Deviation 3.7

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 6 months

Population: 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.

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.

Outcome measures

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Changes in the Maximal Isometric Strength in Newton M. tibialis anterior: Baseline	91.5 Newton Standard Deviation 47.6
Changes in the Maximal Isometric Strength in Newton M. tibialis anterior: 6 weeks follow-up	114.7 Newton Standard Deviation 71.8
Changes in the Maximal Isometric Strength in Newton M. tibialis anterior: 6 months follow-up	142.0 Newton Standard Deviation 65.9
Changes in the Maximal Isometric Strength in Newton M. extensor hallucis longus: Baseline	22.8 Newton Standard Deviation 9.0
Changes in the Maximal Isometric Strength in Newton M. extensor hallucis longus: 6 weeks follow-up	34.3 Newton Standard Deviation 19.3
Changes in the Maximal Isometric Strength in Newton M. extensor hallucis longus: 6 months follow-up	39.5 Newton Standard Deviation 12.6

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 6 months

Population: Four patients missed the six-month follow-up.

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.

Outcome measures

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Changes in Nerve Tension Assessed by the Straight Leg Raising Test, Measured in Degrees Baseline	46.3 Degree Standard Deviation 23.4
Changes in Nerve Tension Assessed by the Straight Leg Raising Test, Measured in Degrees 6 weeks follow-up	56.8 Degree Standard Deviation 17.0
Changes in Nerve Tension Assessed by the Straight Leg Raising Test, Measured in Degrees 6 months follow-up	66.3 Degree Standard Deviation 9.0

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 6 months

Population: 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.

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.

Outcome measures

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Changes in Quality of Life Assessed by the Physical Component Summary of the 36-Item Short Form Health Survey Baseline	35.2 score on a scale Standard Deviation 6.6
Changes in Quality of Life Assessed by the Physical Component Summary of the 36-Item Short Form Health Survey 6 weeks follow-up	44.0 score on a scale Standard Deviation 8.2
Changes in Quality of Life Assessed by the Physical Component Summary of the 36-Item Short Form Health Survey 6 months follow-up	51.7 score on a scale Standard Deviation 7.5

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 6 months

Population: 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.

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.

Outcome measures

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Changes in Quality of Life Assessed by the Mental Component Summary of the 36-Item Short Form Health Survey Baseline	44.2 score on a scale Standard Error 15.6
Changes in Quality of Life Assessed by the Mental Component Summary of the 36-Item Short Form Health Survey 6 weeks follow-up	53.8 score on a scale Standard Error 7.5
Changes in Quality of Life Assessed by the Mental Component Summary of the 36-Item Short Form Health Survey 6 month follow-up	55.6 score on a scale Standard Error 4.3

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 6 months

Population: Four patients missed the six-month follow-up.

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

Outcome measures

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Changes in Physical Activity Assessed Using the International Physical Activity Questionnairee Baseline	2140.9 Metabolic equivalents of task-min./ week Standard Deviation 2067.6
Changes in Physical Activity Assessed Using the International Physical Activity Questionnairee 6 weeks follow-up	2961.2 Metabolic equivalents of task-min./ week Standard Deviation 2460.1
Changes in Physical Activity Assessed Using the International Physical Activity Questionnairee 6 months follow-up	3718.0 Metabolic equivalents of task-min./ week Standard Deviation 2846.5

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 6 months

Population: Four patients missed the six-month follow-up.

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.

Outcome measures

Measure	Patients With Lumbar Disc Herniation Associated With Radiculopathy n=19 Participants 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.
Changes in Disability According to the Oswestry Disability Index Baseline	37.2 score on a scale Standard Deviation 20.1
Changes in Disability According to the Oswestry Disability Index 6 weeks follow-up	16.7 score on a scale Standard Deviation 11.9
Changes in Disability According to the Oswestry Disability Index 6 months follow-up	8.5 score on a scale Standard Deviation 12.0

Adverse Events

Patients With Lumbar Disc Herniation Associated With Radiculopathy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

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

Phone: 00418 300 01 78

Email: giannina.dias@supsi.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place