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Effect of Phonophoresis With Vitamin B12 on CTS

Plain-language guide to NCT05260593: not phased randomized trial of Cyanocobalamin (Vitamin B12), carpal tunnel, 54 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05260593
Phase
not phased
Status
status unknown
Start
2022-03-16
Completion (planned or actual)
2022-07-22
Participants
54 (estimated)
Design
randomized, double-blind, treatment
Conditions studied
Carpal Tunnel Syndrome
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Cyanocobalamin (Vitamin B12) for carpal tunnel.

Median nerve distal latency, hand grip strength and numerical pain rating scale will be measured at baseline and after 3 weeks.

It had two arms (groups): Group A (Vit. B12 Phonophoresis group) (experimental) and Group B (Placebo-Phonophoresis with Vitamin B12) (placebo comparator).

The registry classes the interventions as device and other.

Who Took Part

The registry lists 54 planned participants were the target.

It was open to people of any sex aged from 18 years up to 60 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: At least Fifty Four patients with Mild to moderate CTS. Age will range between 18 to 60 years old. All patients will have Body mass index between 18.5 and 29.9 kg/m2. Diagnosed by a physician according to American Association of Electrodiagnostic recent guidelines. (Jablecki et al., 2002). A positive clinical provocative tests for CTS (Tinel test and Phalen test),.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: diabetic patients; hypertension patients; pregnant women.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

The carpal tunnel participants were allocated by chance, so the Cyanocobalamin (Vitamin B12) group and the comparison group should start out alike.

Groups ran in parallel: each of the carpal tunnel participants stayed in one arm throughout.

Blinding on both sides kept the carpal tunnel participants and researchers unaware of who received Cyanocobalamin (Vitamin B12).

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2022-03-16 with completion listed for 2022-07-22.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Changes in Distal latency of median nerve sensory distal latency (time frame: Baseline and after 3 Weeks). Changes in Distal latency of median nerve motor distal latency (time frame: Baseline and after 3 Weeks).

It also tracked 2 secondary outcomes, for example Changes in hand grip strength and Changes in numeric pain rating scale (NPRS).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Cyanocobalamin (Vitamin B12) in 54 people with carpal tunnel.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, Carpal tunnel research.

Our Notes on the Compound

Cyanocobalamin (Vitamin B12): A synthetic form of vitamin B12 (cobalamin), an essential nutrient for DNA synthesis, red blood cell formation and neurological function.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.