Chronic Low Back Pain, Foot Pronation
Conditions
Keywords
Low back pain, custom-made foot orthoses, Foot, pronation, posture
Brief summary
Excessive foot pronation has been recognized as being linked to chronic low back pain (CLBP). The use of compensating custom-made foot orthoses has not been entirely explored as an effective therapy for CLBP Objective: to investigate the effects of wearing custom made foot orthoses compared to placebo orthoses in patients with pronated feet and chronic low back pain (CLBP).
Detailed description
Excessive foot pronation has been recognized as being linked to CLBP. Foot hyperpronation may cause malalignment of the lower extremity.There is a wide variety of treatments for CLBP, and it is suggested that excessive pronation of the foot has been linked to CLBP.The use of compensating custom-made foot orthoses has not been entirely explored as an effective therapy for CLBP. Customized foot orthoses alter the position of the foot during weight-bearing. The goal is to eliminate compensation of the foot due to structural deformity or misalignment and redistribute abnormal plantar pressures.Custom-made foot orthoses may contribute to improving chronic low back pain. This question represents an important benefit for patients and for the public health system by reducing expensive treatments, such as surgery or long periods of rehabilitation
Interventions
DEVICECustom-made foot orthoses Versus a flat insole
Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)
Sponsors
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females between 18 and 65 years old * Presence of CLBP * Foot Posture Index pronated in one or both feet (henceforth, FPI) ≥ +6
Exclusion criteria
* Serious illness * Current participation in another research study * Pregnancy * Previous back or foot surgery * Current treatment of foot pathology or back, and leg length discrepancy \> 5 mm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS for Chronic Low Back Pain | Baseline | 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) |
| Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain | 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. |
| Foot Posture Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index Questionnaire (ODI) | at the end of the study, approximately 4 weeks | Oswestry Disability Index Questionnaire (ODI) for chronic low back pain |
| VAS | 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. |
Countries
Spain
Participant flow
Recruitment details
. 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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 53 |
| 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) | 48 |
| Total | 101 |
Baseline characteristics
| Characteristic | Custom-made Foot Orthoses | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 48 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 53 Participants | 48 Participants | 101 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Oswestry's Disability Index Questionnaire | 20.45 units on a scale Minimum 0% Maximum 100 STANDARD_DEVIATION 1.7 | 19.02 units on a scale Minimum 0% Maximum 100 STANDARD_DEVIATION 1.37 | 20 units on a scale Minimum 0% Maximum 100 STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 28 Participants | 28 Participants | 56 Participants |
| Sex: Female, Male Male | 25 Participants | 20 Participants | 45 Participants |
| visual analogue scale (VAS) | 6.36 units on a scale Minimum 0 Maximum 10 STANDARD_DEVIATION 0.23 | 6.26 units on a scale Minimum 0 Maximum 10 STANDARD_DEVIATION 0.25 | 6.30 units on a scale Minimum 0 Maximum 10 STANDARD_DEVIATION 0.24 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 52 |
| other Total, other adverse events | 0 / 53 | 0 / 52 |
| serious Total, serious adverse events | 0 / 53 | 0 / 52 |
Outcome results
Primary
Foot Posture Index
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.
Time frame: At the moment of inclusion in the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Custom-made Foot Orthoses | Foot Posture Index | 5.98 Score on -12 to +12 scale | Standard Deviation 1.62 |
| Placebo | Foot Posture Index | 6.42 Score on -12 to +12 scale | Standard Deviation 1.33 |
Primary
Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain
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.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Custom-made Foot Orthoses | Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain | 20.45 Score on 0-100% scale | Standard Deviation 12.51 |
| Placebo | Oswestry Disability Index Questionnaire(ODI) for Lower Back Pain | 19.02 Score on 0-100% scale | Standard Deviation 9.5 |
Primary
VAS for Chronic Low Back Pain
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)
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Custom-made Foot Orthoses | VAS for Chronic Low Back Pain | 6.36 Score on 0-10 scale | Standard Deviation 0.23 |
| Placebo | VAS for Chronic Low Back Pain | 6.56 Score on 0-10 scale | Standard Deviation 0.24 |
Secondary
Oswestry Disability Index Questionnaire (ODI)
Oswestry Disability Index Questionnaire (ODI) for chronic low back pain
Time frame: at the end of the study, approximately 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Custom-made Foot Orthoses | Oswestry Disability Index Questionnaire (ODI) | 7.21 Score on 0-100% scale | Standard Deviation 6.2 |
| Placebo | Oswestry Disability Index Questionnaire (ODI) | 21.17 Score on 0-100% scale | Standard Deviation 8.1 |
Secondary
VAS
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.
Time frame: At 4 weeks after baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Custom-made Foot Orthoses | VAS | 3.02 points on a 0-10 Visual Analogue Scale | Standard Deviation 1.8 |
| Placebo | VAS | 6.54 points on a 0-10 Visual Analogue Scale | Standard Deviation 1.51 |