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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-23

Study Completion Date

2026-01-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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sham controlled arm

Group Type SHAM_COMPARATOR

accupunture

Intervention Type OTHER

BFA

battlefield acupunture

Group Type ACTIVE_COMPARATOR

accupunture

Intervention Type OTHER

BFA

Interventions

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accupunture

BFA

Intervention Type OTHER

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No