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NCT00685880
Randomized, Double Blind Comparison Trial of Prolotherapy (Dextrose) Compared to Corticosteroid Injection for the Treatment of Symptomatic Thumb Carpo-metacarpal Joint Arthritis
NA trial testing Prolotherapy (10% dextrose solution) in Thumb Carpometacarpal Joint Osteoarthritis in 2 participants. Terminated before completion.
1 July 2010
Quick facts
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 2 |
| Start date | 1 May 2008 |
| Primary completion | 1 July 2010 |
| Estimated completion | 1 July 2010 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Prolotherapy (10% dextrose solution) — full drug profile →
- Betamethasone (BETAMETHASONE) — full drug profile →
Conditions studied
- Thumb Carpometacarpal Joint Osteoarthritis — all drugs for Thumb Carpometacarpal Joint Osteoarthritis →
Sponsor
Mayo Clinic
Who can join
45 and older, any sex, with Thumb Carpometacarpal Joint Osteoarthritis. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Participants With a Decreased Pain Score >20%
Time frame: baseline, 6 month follow-up
Pain was measured on a 10 point visual analogue scale (VAS), with 0 meaning no pain, and 10 meaning extreme pain.
Sponsor's own description
Arthritis of the base of the thumb is a common debilitating problem. It is believed that laxity (loosening) of the joint leads to worsening arthritis in this joint. This can be treated by securing the joint surgically or symptoms can be treated with hand therapy and/or injection of corticosteroids. Recently prolotherapy (sugar water) has been shown to decrease looseness of joints and also be helpful for hand and knee arthritis. We hypothesize that prolotherapy injections for thumb arthritis will be equally or more beneficial to the patients than steroids.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
New Trends in Injection-Based Therapy for Thumb-Base Osteoarthritis: Where Are We and where Are We Going?
Tenti S, Cheleschi S, Mondanelli N, Giannotti S, et al · · 2021 · cited 12× · PMID 33927620 · DOI 10.3389/fphar.2021.637904 -
Pharmaceutical therapeutics for articular regeneration and restoration: state-of-the-art technology for screening small molecular drugs.
Chen Y, Sun H, Yao X, Yu Y, et al · · 2021 · cited 9× · PMID 34783870 · DOI 10.1007/s00018-021-03983-8
Verify or expand the search:
- PubMed search for NCT00685880
- 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 NCT00685880 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mayo Clinic
- Last refreshed: 27 July 2012
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/NCT00685880.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing