Low Back PainNCT07171177
Disability and Pain in Chronic Low Back Pain and Pronated Foot Treated
A study testing Foot Orthoses in people with Low Back Pain and Foot Orthoses, run by University of Seville at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Foot Orthoses, Pronation
- What is being tested?
- Foot Orthoses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 13 Apr 2021to 1 Aug 2021
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disability and Pain in Men and Women With Chronic Low Back Pain and Pronated Foot Treated With Custom-made Foot Orthoses
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.
- Conditions
- Low Back Pain, Foot Orthoses, Pronation
- Being tested
- Foot Orthoses
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot OrthosesDevice
To compare the use of handmade plantar orthoses versus the use of splints in the management of low back pain.
| Study group | Role | What they receive |
|---|---|---|
| Custom-made plantar orthosis (3 mm polyurethane foam + 3 mm polypropylene) | Experimental | 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. Receives: Device: Foot Orthoses |
| Arm/Group Title: Placebo Comparator: Flat insole (placebo orthosis) (3 mm polyurethane foam) | Placebo comparator | 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. Receives: Device: Foot Orthoses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disability due to low back pain measured by the Roland-Morris Disability Questionnaire (RMDQ)
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.
Measured: Baseline and 4 weeks after intervention
Secondary outcomes (2)
Change in pain intensity measured by the Numerical Rating Scale (NRS, 0-10)
The NRS is a 0-10 scale where 0 = no pain and 10 = worst imaginable pain.
Measured: Baseline and 4 weeks
Change in foot posture measured by the Foot Posture Index (FPI)
The FPI is a 6-item clinical tool for quantifying foot posture. Total scores range from -12 (highly supinated) to +12 (highly pronated).
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start13 Apr 2021
- Primary completion15 Jul 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MANUEL PABON CARRASCO, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171177
- Sponsor's protocol ID
- USev-Foot 2
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disability and Pain in Men and Women With Chronic Low Back Pain and Pronated Foot Treated With Custom-made Foot Orthoses
- ClinicalTrials.gov ID
- NCT07171177
- Acronym / sponsor ID
- USev-Foot 2
- Conditions
- Low Back Pain, Foot Orthoses, Pronation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 12 Sep 2025 (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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom-made plantar orthosis (3 mm polyurethane foam + 3 mm polypropylene) | Experimental | Device: Foot OrthosesIndividually 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. |
| Arm/Group Title: Placebo Comparator: Flat insole (placebo orthosis) (3 mm polyurethane foam) | Placebo comparator | Device: Foot OrthosesFlat 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Serious illness.
- Current participation in another research study.
- Pregnancy.
- Previous back or foot surgery
- Current treatment of a foot or back pathology
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 |
|---|---|---|
| Foot OrthosesTo compare the use of handmade plantar orthoses versus the use of splints in the management of low back pain. | Device | Arm/Group Title: Placebo Comparator: Flat insole (placebo orthosis) (3 mm polyurethane foam), Custom-made plantar orthosis (3 mm polyurethane foam + 3 mm polypropylene) |
Primary outcome
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.
2 secondary outcomes
Change in pain intensity measured by the Numerical Rating Scale (NRS, 0-10)
Time frame: Baseline and 4 weeks
Change in foot posture measured by the Foot Posture Index (FPI)
Time frame: Baseline and 4 weeks
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 12 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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 Foot Orthoses in people with Low Back Pain and Foot Orthoses, run by University of Seville at 1 site in Spain.
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 3 inclusion and 6 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 12 Sep 2025. 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 Spain. 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?
Change in disability due to low back pain measured by the Roland-Morris Disability Questionnaire (RMDQ) (time frame: Baseline and 4 weeks after intervention). 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 12 Sep 2025.