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Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study

Recruiting
18 years of age
Both
Phase N/A

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Overview

This is a randomized sham controlled study that will include patients hospitalized in the internal medicine department and the orthopedics department at Bnei Zion Hospital presenting with pain from various sources with an NRS level equal to or above 4.

Description

All patients will complete pain assessment according NSR and ESAS after treatment ( SHAM or BFA) one hour before and every 24 hours until discharge.

If there was no sufficient improvement in pain within 24 hours (decrease of 1.5 points or more in NRS) - additional acupuncture will be performed in the contralateral ear and repeated assessments as above.

Eligibility

Inclusion Criteria:

        -1.Pain of skeletal muscle origin (Musculoskeletal MSK)/rheumatological/orthopedic
        syndromes 2.Visual Analog Score (VAS) grade 4 or higher before receiving the treatment.
        3.Eligible to participate in the study according to the assessment of the investigator
        Exclusion Criteria:
          1. Pain syndromes of non-muscular bony/rheumatological/orthopedic origin
          2. Planned an MRI next week
          3. An infectious process in the ear planned for acupuncture or a history of sensitivity
             to metal
          4. have any participant condition that ' according to the Investigator ' could interfere
             with the conduct of the trial -

Study details

Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study

NCT05969353

Bnai Zion Medical Center

25 January 2024

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