Chronic Nonspecific Low Back Pain(LBP)NCT03904940
Total Contact Insole for Chronic Nonspecific Low Back Pain (LBP)
A study testing Total Contact Insole and Ethyl vinyl acetate flat insole in people with Chronic Nonspecific Low Back Pain, run by Federal University of São Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Nonspecific Low Back Pain
- What is being tested?
- Total Contact Insole and Ethyl vinyl acetate flat insole
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jul 2019to 6 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Total Contact Insole in Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Chronic Nonspecific Low Back Pain
- Being tested
- Total Contact Insole, Ethyl vinyl acetate flat insole
- Keywords
- Orthotic Devices, Insoles, Quality of life, Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Contact InsoleDevice
Also called Intervention foot orthoses group
Ethyl vinyl acetate insole shaped in the cast of the patient's foot.
Ethyl vinyl acetate flat insoleDevice
Also called Placebo insole, Ethyl vinyl acetate flat insole group
Flat insole made of the same material ethyl vinyl acetate
| Study group | Role | What they receive |
|---|---|---|
| Total Contact Insole Group | Experimental | Ethyl vinyl acetate insole shaped in the cast of the patient's foot, every 6 months. Receives: Device: Total Contact Insole |
| Flat Insole group | Sham comparator | Flat insole made the same material ethyl vinyl acetate, every 6 months. Receives: Device: Ethyl vinyl acetate flat insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 45, 90 and 180 days
Secondary outcomes (8)
Functional capacity measured with Oswestry Disability Index
Change in Oswestry Disability Index score. Ranging from 0 to 100 with higher values represent a worse outcome
Measured: Baseline, 45, 90 and 180 days
Functional capacity measured with Roland Morris Disability
Change in Roland Morris Disability score. Ranging from 0 to 24 with higher values represent a worse outcome
Measured: Baseline, 45, 90 and 180 days
Functional capacity measured with the 6-minute walk test
Change in 6-minute walk test. The amount of meters walked in 6 minutes.
Measured: Baseline, 45, 90 and 180 days
Functional capacity measured with the timed to up and go test
Change in timed to up and go test. Amount of time that the patient takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
Measured: Baseline, 45, 90 and 180 days
Quality of life measured with Short form-36 questionnaire
Change in Short form-36 questionnaire score. Ranging from 0 to 100 with higher scores showing a better outcome.
Measured: Baseline, 45, 90 and 180 days
Patient's global impression of recovery measured with a likert scale
The Likert scale. The patients answered the question 'After starting the use the insoles, how do you think your low back is?' with one of the following statements: much worse, a little worse, unchanged, a little better, much better.
Measured: 45, 90 and 180 days after baseline
Amount Medication consumption
Amount of paracetamol (500mg) consumed by patient between the evaluation times
Measured: 45, 90 and 180 days after baseline
Foot pressure analysis using the AMCube FootWalk Pro program
Measured: baseline, 90 and 180 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start6 Jul 2019
- Primary completion6 Dec 2023
- Study completion6 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nonspecific Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Anamaria Jones, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03904940
- Sponsor's protocol ID
- Federal University Sao Paulo
- Acronym
- (LBP)
- Status last verified
- Mar 2024
- First submitted
- 3 Apr 2019
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Total Contact Insole in Chronic Nonspecific Low Back Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03904940
- Acronym / sponsor ID
- (LBP) / Federal University Sao Paulo
- Conditions
- Chronic Nonspecific Low Back Pain
- Keywords
- Orthotic Devices, Insoles, Quality of life, Function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- 6 Jul 2019 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Dec 2023 (actual)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Contact Insole Group | Experimental | Device: Total Contact InsoleEthyl vinyl acetate insole shaped in the cast of the patient's foot, every 6 months. |
| Flat Insole group | Sham comparator | Device: Ethyl vinyl acetate flat insoleFlat insole made the same material ethyl vinyl acetate, every 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Contact InsoleAlso: Intervention foot orthoses groupEthyl vinyl acetate insole shaped in the cast of the patient's foot. | Device | Total Contact Insole Group |
| Ethyl vinyl acetate flat insoleAlso: Placebo insole, Ethyl vinyl acetate flat insole groupFlat insole made of the same material ethyl vinyl acetate | Device | Flat Insole group |
Primary outcome
Low back of pain intensity measured with Numeric Pain Rating Scale
Time frame: Baseline, 45, 90 and 180 days
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.
8 secondary outcomes
Functional capacity measured with Oswestry Disability Index
Time frame: Baseline, 45, 90 and 180 days
Functional capacity measured with Roland Morris Disability
Time frame: Baseline, 45, 90 and 180 days
Functional capacity measured with the 6-minute walk test
Time frame: Baseline, 45, 90 and 180 days
Functional capacity measured with the timed to up and go test
Time frame: Baseline, 45, 90 and 180 days
Quality of life measured with Short form-36 questionnaire
Time frame: Baseline, 45, 90 and 180 days
Patient's global impression of recovery measured with a likert scale
Time frame: 45, 90 and 180 days after baseline
Amount Medication consumption
Time frame: 45, 90 and 180 days after baseline
Foot pressure analysis using the AMCube FootWalk Pro program
Time frame: baseline, 90 and 180 days after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Contact Insole and Ethyl vinyl acetate flat insole in people with Chronic Nonspecific Low Back Pain, run by Federal University of São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low back of pain intensity measured with Numeric Pain Rating Scale (time frame: Baseline, 45, 90 and 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.