Disability and Pain in Men and Women With Chronic Low Back Pain and Pronated Foot Treated With Custom-made Foot Orthoses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Seville
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Change in disability due to low back pain measured by the Roland-Morris Disability Questionnaire (RMDQ)
Study Overview
Brief Summary
Purpose: excessive foot pronation has been reported as being related to chronic low back symptoms. Compensating custom-made foot orthotics treatment has not been entirely explored as an effective therapy for chronic low back pain (CLBP). This study aims to observe the effects of custom made foot orthoses, in subjects with foot pronation suffering from CLBP.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Women and men adults up to 65 years old,
- •presence of Chronic Low Back Pain
- •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 a foot or back pathology
- •Leg length discrepancy > 5 mm
Arms & Interventions
Custom-made plantar orthosis (3 mm polyurethane foam + 3 mm polypropylene)
Individually manufactured plantar orthosis, moulded to each patient's pronated foot using 3 mm polyurethane foam laminated with 3 mm polypropylene, designed to control excessive pronation and thus potentially alleviate non-specific chronic low back pain.
Intervention: Foot Orthoses (Device)
Arm/Group Title: Placebo Comparator: Flat insole (placebo orthosis) (3 mm polyurethane foam)
Flat insole made of 3 mm polyurethane foam without corrective elements, used as a placebo comparator to the custom-made orthosis in the management of non-specific chronic low back pain.
Intervention: Foot Orthoses (Device)
Outcomes
Primary Outcomes
Change in disability due to low back pain measured by the Roland-Morris Disability Questionnaire (RMDQ)
Time Frame: Baseline and 4 weeks after intervention
The RMDQ is a 24-item self-reported questionnaire designed to assess physical disability due to low back pain. Scores range from 0 to 24, with higher scores indicating greater disability.
Secondary Outcomes
- Change in pain intensity measured by the Numerical Rating Scale (NRS, 0-10)(Baseline and 4 weeks)
- Change in foot posture measured by the Foot Posture Index (FPI)(Baseline and 4 weeks)
Investigators
MANUEL PABON CARRASCO
Principal Investigator, Assistant Professor, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville
University of Seville