Total Contact Insole for Chronic Nonspecific Low Back Pain (LBP)

NCT03904940 | Completed DMC

• 1 other identifier: Federal University Sao Paulo
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Nonspecific Low Back Pain

Keywords

Orthotic Devices; Insoles; Quality of life; Function

Outcome Measures

Primary Outcomes (1)

• Low back of pain intensity measured with Numeric Pain Rating Scale

  It will be measured by the Brazilian version of the Numeric Pain Rating Scale 10 cm. The Numeric Pain Rating Scale goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last week. Change in pain score or an improvement of 2 levels or more is accepted as clinically relevant.

  Baseline, 45, 90 and 180 days

Secondary Outcomes (8)

• Functional capacity measured with Oswestry Disability Index

  Baseline, 45, 90 and 180 days

• Functional capacity measured with Roland Morris Disability

  Baseline, 45, 90 and 180 days

• Functional capacity measured with the 6-minute walk test

  Baseline, 45, 90 and 180 days

• Functional capacity measured with the timed to up and go test

  Baseline, 45, 90 and 180 days

• Quality of life measured with Short form-36 questionnaire

  Baseline, 45, 90 and 180 days

Study Arms (2)

Total Contact Insole Group

EXPERIMENTAL

Ethyl vinyl acetate insole shaped in the cast of the patient's foot, every 6 months.

Device: Total Contact Insole

Flat Insole group

SHAM COMPARATOR

Flat insole made the same material ethyl vinyl acetate, every 6 months.

Device: Ethyl vinyl acetate flat insole

Interventions

Total Contact Insole DEVICE

Ethyl vinyl acetate insole shaped in the cast of the patient's foot.

Also known as: Intervention foot orthoses group

Total Contact Insole Group

Ethyl vinyl acetate flat insole DEVICE

Flat insole made of the same material ethyl vinyl acetate

Also known as: Placebo insole, Ethyl vinyl acetate flat insole group

Flat Insole group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal University of São Paulo: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Universidade Federal de Sao Paulo

São Paulo, São Paulo, 04023-090, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rheumatology Rehabilitation Section - Rheumatology Division

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 5, 2019
• Study Start: July 6, 2019
• Primary Completion: December 6, 2023
• Study Completion: December 6, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

BR (1)