Total Contact Insole for Chronic Nonspecific Low Back Pain (LBP)
CompletedNot applicableNCT03904940
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Non-specific low back pain is a common condition. Insoles are one of the many treatment form for chronic nonspecific LBP. The investigators hypothesized the contact total insole group will present pain reduction and functional improvement. The aim of this study is to assess the effectiveness of contact total insole for people with nonspecific chronic low back pain and the impact of this insole on function, quality of life, load distribution in the plantar region, gait variables and satisfaction with insole use.
Study details
- Official title
- Effectiveness of Total Contact Insole in Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
- Conditions
- Interventions
- Device: Total Contact Insole
- Device: Ethyl vinyl acetate flat insole
- Sponsor
- Federal University of São Paulo
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Start date
- 2019-07-06
- Primary completion
- 2023-12-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Brazil
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Low back pain for more than 3 months, with numeric pain scale between 3 - 8 cm; * Over 18 years; * No distinction of sex; * Understand Portuguese well enough to be able to fill in the questionnaires; * Agree to participate of the study and sign the informed consent form. Exclusion Criteria: * Inflammatory/rheumatological diseases, tumor, infection or vertebral fracture; * Litigation; * Fibromyalgia; * Other symptomatic musculoskeletal diseases in lower limbs; * Symptomatic diseases of the central and peripheral nervous system; * Diabetes Mellitus; * Rigid deformities on foot; * Use of insoles in the last three months; * Medical or physiotherapeutic treatment for low back pain or any problem in lower limbs in the last three months; * People who had changed physical activity or undergone physical therapy in the previous 3 months; * Pregnancy; * Difference of lower limbs greater than 2 cm * Less than 6 months after lumbar spine, lower limb or abdomen surgery * Previous spinal surgery; * Previous spinal infiltration for pain relief in the last 3 months; * Serious scoliosis; * Allergy to the material of the insole. * Planned travel in the next 12 weeks; * Geographic inaccessibility.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03904940