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NCT03904940: (LBP)
Total Contact Insole for Chronic Nonspecific Low Back Pain (LBP)
NA trial testing Total Contact Insole in Chronic Nonspecific Low Back Pain in 84 participants. Completed in 6 December 2023.
6 December 2023
Quick facts
| Lead sponsor | Federal University of São Paulo |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 84 |
| Start date | 6 July 2019 |
| Primary completion | 6 December 2023 |
| Estimated completion | 6 December 2023 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Total Contact Insole
- Ethyl vinyl acetate flat insole
Conditions studied
- Chronic Nonspecific Low Back Pain — all drugs for Chronic Nonspecific Low Back Pain →
Sponsor
Federal University of São Paulo
Who can join
18 and older, any sex, with Chronic Nonspecific Low Back Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03904940
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03904940 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Federal University of São Paulo
- Last refreshed: 13 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03904940.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing