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

Not Applicable

Recruiting

• Conditions: Assessing the Effectiveness of BFA as a Non-pharmacologic Pain Management Intervention: A Randomised Sham Controlled Study
• Interventions: Other: accupunture

• Registration Number: NCT05969353
• Lead Sponsor: Bnai Zion Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07-23
• Study First Submitted: 2023-07-23
• Study First Submitted QC: 2023-07-23
• Last Update Submitted: 2023-07-23
• Study First Posted: 2023-08-01
• Last Update Posted: 2023-08-01
• Primary Completion: 2025-12-30
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sham controlled arm	accupunture	-
battlefield acupunture	accupunture	-

Primary Outcome Measures

Name	Time	Method
efficacy of BFA	two years	Evaluating the analgesic efficacy of BFA in addition to the standard treatment for pain - Standard of care (SOC) to reduce pain in patients hospitalized in the internal and orthopedic department who experience pain of moderate intensity and above compared to SHAM BFA.

Trial Locations

Locations (1)

BnaiZion MC; 🇮🇱 Haifa, Israel