Trial Outcomes & Findings for Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain (NCT NCT03996980)

Results Overview

This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life.The test is considered the 'gold standard' of low back functional outcome tools 0% to 20%: minimal disability: The patient can cope with most living activities. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

110 participants

Primary outcome timeframe

Baseline

Results posted on

2025-09-12

Participant Flow

. The random allocation to each group was done by a collaborating researcher who established the sequence based on a random numbers table and then the treatment was administered (experimental/control).

Participants are excluded if they have a pregnancy during the study. Pregnancy modifies the curvature of the back. All those processes that alter the physiology of the musculoskeletal system will also be excluded.

Participant milestones

Participant milestones
Measure	Custom-made Foot Orthoses treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)	Placebo a flat insole for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)
Overall Study STARTED	55	55
Overall Study COMPLETED	53	48
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect Mechanism of Custom-made Foot Orthoses in Patients With Chronic Low Back Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Custom-made Foot Orthoses n=53 Participants treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)	Placebo n=48 Participants a flat insole for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=93 Participants	48 Participants n=4 Participants	101 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	28 Participants n=93 Participants	28 Participants n=4 Participants	56 Participants n=27 Participants
Sex: Female, Male Male	25 Participants n=93 Participants	20 Participants n=4 Participants	45 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	53 Participants n=93 Participants	48 Participants n=4 Participants	101 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Oswestry's Disability Index Questionnaire	20.45 units on a scale Minimum 0% Maximum 100 STANDARD_DEVIATION 1.7 • n=93 Participants	19.02 units on a scale Minimum 0% Maximum 100 STANDARD_DEVIATION 1.37 • n=4 Participants	20 units on a scale Minimum 0% Maximum 100 STANDARD_DEVIATION 1.6 • n=27 Participants
visual analogue scale (VAS)	6.36 units on a scale Minimum 0 Maximum 10 STANDARD_DEVIATION 0.23 • n=93 Participants	6.26 units on a scale Minimum 0 Maximum 10 STANDARD_DEVIATION 0.25 • n=4 Participants	6.30 units on a scale Minimum 0 Maximum 10 STANDARD_DEVIATION 0.24 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline

This questionnaire has been designed to give us information as to how your back or leg pain is affecting your ability to manage in everyday life.The test is considered the 'gold standard' of low back functional outcome tools 0% to 20%: minimal disability: The patient can cope with most living activities. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%: These patients are either bed-bound or exaggerating their symptoms.

Outcome measures

Outcome measures
Measure	Custom-made Foot Orthoses n=53 Participants treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)	Placebo n=52 Participants a flat insole for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)
Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain	20.45 Score on 0-100% scale Standard Deviation 12.51	19.02 Score on 0-100% scale Standard Deviation 9.5

PRIMARY outcome

Timeframe: Baseline

Population: The groups are expected to be similar in gender, sex, age, pain at first (VAS and ODI) and at the time of the initial examination.This would allow a comparison avoiding risk of bias.

10 visual analogue scale (VAS).The findings suggested that 10 VAS ratings of no pain (0-2), mild pain(2-4), moderate pain (4-7), and severe pain (7-10)

Outcome measures

Outcome measures
Measure	Custom-made Foot Orthoses n=53 Participants treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)	Placebo n=48 Participants a flat insole for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)
VAS for Chronic Low Back Pain	6.36 Score on 0-10 scale Standard Deviation 0.23	6.56 Score on 0-10 scale Standard Deviation 0.24

PRIMARY outcome

Timeframe: At the moment of inclusion in the study

Foot posture was assessed by a podiatrist during the biomechanical assessment based on the six-item foot posture index (FPI≥+6). The FPI consists of six validated items that are measured in a relaxed standing position of the subject. Each item is assessed on a -2 to +2 scale, where -2 indicates a supinated position, 0 indicates a neutral position and +2 indicates a pronated position, depending on the specific item. The sum of the scores of the six items provides a total score ranging from -12 to +12.

Outcome measures

Outcome measures
Measure	Custom-made Foot Orthoses n=53 Participants treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)	Placebo n=48 Participants a flat insole for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)
Foot Posture Index	5.98 Score on -12 to +12 scale Standard Deviation 1.62	6.42 Score on -12 to +12 scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: at the end of the study, approximately 4 weeks

Oswestry Disability Index Questionnaire (ODI) for chronic low back pain

Outcome measures

Outcome measures
Measure	Custom-made Foot Orthoses n=53 Participants treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)	Placebo n=48 Participants a flat insole for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)
Oswestry Disability Index Questionnaire (ODI)	7.21 Score on 0-100% scale Standard Deviation 6.20	21.17 Score on 0-100% scale Standard Deviation 8.1

SECONDARY outcome

Timeframe: At 4 weeks after baseline

VAS scale for CLBP Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10. A higher score indicates greater pain intensity.

Outcome measures

Outcome measures
Measure	Custom-made Foot Orthoses n=53 Participants treatment intervention custom-made polypropylene foot orthoses for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)	Placebo n=48 Participants a flat insole for a period of 4 weeks Custom-made foot orthoses Versus a flat insole: Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)
VAS	3.02 points on a 0-10 Visual Analogue Scale Standard Deviation 1.80	6.54 points on a 0-10 Visual Analogue Scale Standard Deviation 1.51

Adverse Events

Custom-made Foot Orthoses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Manuel Pabón-Carrasco

Universidad de Sevilla

Phone: 954 350 997

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place