Evidence map›Paper›PMID 25963758›Full record

Trial reportBMC musculoskeletal disorders2015

Effectiveness of intra-articular injections of sodium bicarbonate and calcium gluconate in the treatment of osteoarthritis of the knee: a randomized double-blind clinical trial.

Sandra García-Padilla, Miguel Angel Duarte-Vázquez, Karla Elena Gonzalez-Romero, María del Carmen Caamaño, Jorge L Rosado

Erratum issued Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00977444 (Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00977444 phase2 / phase3unknown statusnot on this map

Evaluation of a New Formulation Useful for the Osteoarthrosis Treatment

TypeinterventionalSponsorNucitecRan2007 to 2009Enrolled114ConditionsOsteoarthritisArmskondrium, kondrium f, methyl prednisolone (corticosteroid)
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 12 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

Sandra García-PadillaCindetec A.C, Parque Industrial Querétaro, Jurica 122, C.P. 76220, Santiago de Querétaro, Qro, Mexico. sgarcia@cindetecresearch.org.
Miguel Angel Duarte-VázquezNucitec S.A. de C.V, Santiago de Querétaro, Mexico. mduarte@nucitec.com.
Karla Elena Gonzalez-RomeroCindetec A.C, Parque Industrial Querétaro, Jurica 122, C.P. 76220, Santiago de Querétaro, Qro, Mexico. kareladonai@hotmail.com.
María del Carmen CaamañoCindetec A.C, Parque Industrial Querétaro, Jurica 122, C.P. 76220, Santiago de Querétaro, Qro, Mexico. maria.delcarmen.caamano@uaq.mx.
Jorge L RosadoCindetec A.C, Parque Industrial Querétaro, Jurica 122, C.P. 76220, Santiago de Querétaro, Qro, Mexico. jlrosado@prodigy.net.mx.
Autonomous University of Queretaro · MXCenter for Engineering and Industrial Development · MXInstituto Tecnológico de Querétaro · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA novel therapeutic management of osteoarthritis (OA) of the knee was assessed. The study aimed to evaluate the effect of monthly sodium bicarbonate with a single (SBCG1) or double dose (SBCG2) of calcium gluconate injections on OA of the knee; as well as the efficacy and safety of both SBCG interventions in the long term.

methodsA double-blind parallel-group clinical trial with 74 knee OA patients was performed during 12 months, both SBCG interventions were followed-up for another 6mo after intervention. The outcome variables were the Western Ontario-McMaster University Osteoarthritis Index (WOMAC), the Lequesne's functional index and joint-space width changes from serial radiographs.

resultsAfter 12 months, group SBCG1 decreased -14.8 (95% CI:-14.2, -17.0) and group SBCG2 decreased -14.6 (-16.9, -12.4) in the global WOMAC score, the mean changes represent 80% and 82% lessened pain, respectively. In the Lequesne Functional Index scale, SBCG1 decreased -11.9 (-10.4, -14.2) and SBCG2 decreased -11.9 (-13.8, -10.0), representing 66 and 69% of improvement. Both mean scores were maintained after intervention discontinued. SBCG2 improved the knees' joint space width more than SBCG1 at 3 and 18 months. Both SBCG interventions were well tolerated after 12 months of treatment

conclusionA solution of sodium bicarbonate and calcium gluconate is effective on reducing the symptoms associated with OA. Its beneficial effect is maintained for one year of continuous monthly administration and at least for 6 months after the administration is discontinued. When the dose of calcium gluconate is increased, it prevents further narrowing of joint-space.

trial registrationClinicaltrials.gov NCT00977444 September 11, 2009.

Indexed as

AdultCalcium GluconateDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationFemaleHumansInjections, Intra-ArticularMaleMiddle AgedOsteoarthritis, KneePainSodium BicarbonateCalcium GluconateSodium Bicarbonate

Identifiers

PMID25963758
PMCPMC4493958
OpenAlexW1757004388

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.