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Efficacy and safety of two “Carmolis” forms for combined local therapy of knee osteoarthritis: results of a multicenter clinical trial

2020· article· en· W3023514786 on OpenAlexaboutno aff
L N Denisov, V. N. Sorotskaya, Ева Александровна Леонова, L. V. Меn’shykova, M. L. Sukhareva, С. И. Глухова, А. М. Лила

Bibliographic record

VenueThe Clinician · 2020
Typearticle
Languageen
FieldMedicine
TopicOsteoarthritis Treatment and Mechanisms
Canadian institutionsnot available
Fundersnot available
KeywordsOsteoarthritisMedicinePhonophoresisKnee JointClinical trialMassageClinical efficacySurgeryInternal medicinePhysical therapyUltrasound

Abstract

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Objective – to evaluate efficacy and safety of “Carmolis” fluid and gel in patients with knee osteoarthritis, as well as the gel efficacy combined with ultraphonophoresis.Materials and methods. The study included 200 patients, who were divided into 2 groups depending on the way of application of “Carmolis” forms. Group 1 included 165 patients with knee osteoarthritis (the main group included 90 patients, the control group – 75 patients), who underwent complex local treatment with 2 “Carmolis” forms. Group 2 included 35 patients (20 people in the main group and 15 in the control one). The main group received phonophoresis with “Carmolis” gel, and the control group received “Carmolis” gel locally on the affected knee joint. Patients’ average age in group 1 was 62,7 ± 8,5 years, the average age in the control group was 61.4 ± 8.7 years, the disease duration was 10.1 ± 4.7 and 9.2 ± 6, 0 years, respectively. In group 2 the average age and disease duration were 60.1 ± 12.8 and 5.7 ± 5.4 years, respectively.At the initial stage 90 patients of the main group 1 were rubbed “Carmolis” fluid locally in the joint followed by massage. After the fluid absorbed completely, “Carmolis” gel was applied, followed by massage. In the comparison group (75 patients), standard therapy was combined only with “Carmolis” fluid applied on the II knee joint.Twenty patients of the main group 2 were treated with phonophoresis combined with “Carmolis” gel. Clinical efficacy was assessed by pain dynamics.Results. Treatment with two “Carmolis” local forms significantly decreased average on moving from 61.8 ± 14.2 to 30.7 ± 14.2 (р 0,001), at rest – from 49 ± 19, 9 to 20.4 ± 8.5 (р 0,001), on palpation – from 38.7 ± 10.4 to 18.4 ± 5.7 (р 0,001). A similar dynamics was also revealed during WOMAC assessment (Western Ontario McMaster Universities OA Index). Before the treatment start the average WOMAC pain level in the main group was 240.5 ± 39.8, after the treatment – 114.8 ± 30.4 (р 0,001). The control group also showed pain decrease, but to a much lesser extent than in the main one. At the end of the treatment course, patients of both groups demonstrated a pronounced decrease of synovitis sings, but there were no differences between the groups. The dose of non-steroidal anti-inflammatory drugs in the main group was reduced in 70 (77.8 %) patients, in the control group – in 50 (66.7 %). The tolerability of both forms was very good and good. No adverse events were registered. Data on the effectiveness and safety of “Carmolis” gel combined with ultraphonophoresis are presented in the article.Conclusion. According to the results, combined therapy using “Carmolis” liquid and gel significantly reduces joint pain and synovitis severity, increases joints» functional ability and improves patients» general condition, which allows reducing the dose of non-steroidal anti-inflammatory drugs. Both “Carmolis” forms had excellent and good tolerability.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.001
metaresearch head score (Gemma)0.001
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.441
Threshold uncertainty score0.445

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0010.001
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0000.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.073
GPT teacher head0.372
Teacher spread0.298 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designRandomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

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Citations0
Published2020
Admission routes1
Has abstractyes

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