Clinical trial NCT03904940: Total Contact Insole for Chronic Nonspecific Low Back Pain (LBP)
Official title: Effectiveness of Total Contact Insole in Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Nonspecific Low Back Pain
Keywords: Orthotic Devices
Insoles
Quality of life
Function
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2019-04-05
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A randomized, controlled, double-blind, clinical trial with intent-to-treat analysis. Eighty-four patients with nonspecific chronic low back pain will be randomly into a study group and control group. One week following the baseline evaluation, the study group will receive a contact total insole made of ethyl vinyl acetate and the control group will receive a flat insole made of the same material, color and density. The groups will be evaluated after 6, 12 and 24 weeks of insole use. The following assessment parameters will be employed: low back pain numerical pain scale; functional capacity (Oswestry and roland morris questionnaire, six minute walk test and timed to up and go test); quality of life (Short Form-36) and foot pressure analysis using the AMCube FootWalk Pro program.

Eligibility criteria: 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.

Primary outcomes:
measure: Low back of pain intensity measured with Numeric Pain Rating Scale
timeFrame: Baseline, 45, 90 and 180 days
Secondary outcomes:
measure: Functional capacity measured with Oswestry Disability Index
timeFrame: Baseline, 45, 90 and 180 days
measure: Functional capacity measured with Roland Morris Disability
timeFrame: Baseline, 45, 90 and 180 days
measure: Functional capacity measured with the 6-minute walk test
timeFrame: Baseline, 45, 90 and 180 days
measure: Functional capacity measured with the timed to up and go test
timeFrame: Baseline, 45, 90 and 180 days
measure: Quality of life measured with Short form-36 questionnaire
timeFrame: Baseline, 45, 90 and 180 days
measure: Patient's global impression of recovery measured with a likert scale
timeFrame: 45, 90 and 180 days after baseline
measure: Amount Medication consumption
timeFrame: 45, 90 and 180 days after baseline
measure: Foot pressure analysis using the AMCube FootWalk Pro program
timeFrame: baseline, 90 and 180 days after baseline
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
state: SP
Study officials:
References: