Acupuncture for Blunt Chest Trauma

NCT04318496 | Completed

• 1 other identifier: CMUH109-REC1-002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Chest blunt trauma accounts in up to 65% of polytrauma patients. In patients with 0-2 rib fracture, the treatment is relatively limited to oral pain killer and breathing exercise. The patients will suffer two weeks of severe pain accompanied with poor sleep and inability to preform simple daily live activities. In this double blind randomized control study, the investigators offer acupuncture as an additional treatment option. Methods: The study is a double blind randomized control trial. the study will include the press needle acupuncture (Acu) and placebo (Con) group. Both groups will receive one treatment, following the first visit to the clinic after chest trauma accident.

Conditions

Chest Trauma; Rib Fractures

Keywords

Blunt chest trauma; Acupuncture; Press tack needle; Rib fracture

Outcome Measures

Primary Outcomes (2)

• Numerical Rating Scale (NRS) - rest

  pain scale form 1-10 when 10 is the most painful

  3 months

• Numerical Rating Scale (NRS) - mobile

  pain scale form 1-10 when 10 is the most painful

  3 months

Secondary Outcomes (6)

• Visual Analogue Pain Scale (VAS)

  4 days

• Face Rating Scale (FRS)

  4 days

• Flow meter

  4 days

• Verran and Snyder-Halpern sleep scale

  4 days

• Chest plain film

  4 days

Study Arms (2)

Acupuncture with press tack needle group (Acu)

EXPERIMENTAL

the press tack needles (PYONEX Φ0.20×0.6 mm made by Seirin Corporation) has a diameter of 0.2 mm and length of 0.6 mm will be used on the following bilateral points; GB 36 (Waiqiu), GB 34 (YangLingQuan), ST 36 (Zusanli), LI 4 (HeGu), LU 7 (LieQue), TH 5 (Waiguan) press tack needles retention time will be 4 days.

Other: Press Tack Acupuncture

Placebo group (Con)

PLACEBO COMPARATOR

The pess tack placebo is PYONEX sticker and pack that is identical to the press needle, except that the needle part was removed. The acupuncturist will apply the stickers on the following bilateral acupoints: GB 36 (Waiqiu), GB 34 (YangLingQuan), ST 36 (Zusanli), LI 4 (HeGu), LU 7 (LieQue), TH 5 (Waiguan) press tack stickers retention time will be 4 days.

Other: Press Tack Placebo

Interventions

Press Tack Acupuncture OTHER

PYONEX Φ0.20×0.6 mm made by Seirin Corporation

Also known as: Press Tack Needle/ sticker needle/ PYONEX

Acupuncture with press tack needle group (Acu)

Press Tack Placebo OTHER

PYONEX placebo sticker made by Seirin Corporation

Also known as: PYONEX placebo

Placebo group (Con)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-80 year-old
• Patients have chest trauma described by themselves or medical chart record within one week
• Injury Severity Score (ISS) is less than 18 points
• Body Mass Index(BMI)\<30

You may not qualify if:

• Sternal fracture
• Injury Severity Score (ISS) is equal or more than 18 points
• History of intercostal nerve injury
• History of cardiovascular disease
• History of chronic lung disease
• Significant lung mass or chest deformity noted in the chest plain film

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

Out-Patient Clinic of China Medical University Hospital

Taichung, 404472, Taiwan

Location

Related Publications (2)

• Kao PY, Lottering B, Lu TY, Ho WC, Lin YS, Huang TM, Chen CK, Chen JX, Lee YC, Chen FP, Ben-Arie E. Press tack needle stimulation for blunt chest trauma: a randomized double-blind control trial. Interact Cardiovasc Thorac Surg. 2022 Jun 15;35(1):ivac158. doi: 10.1093/icvts/ivac158.

  PMID: 35670748 DERIVED

• Kao PY, Ben-Arie E, Lu TY, Ho WC, Lee YC, Lin YS, Chen CK, Chen JX, Huang TM, Chen FP. Acupuncture for blunt chest trauma: A protocol for a double-blind randomized control trial. Medicine (Baltimore). 2021 May 7;100(18):e25667. doi: 10.1097/MD.0000000000025667.

  PMID: 33950945 DERIVED

MeSH Terms

Conditions

Thoracic Injuries; Rib Fractures

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fractures, Bone

Study Officials

• Peiyu Kao, M.D.

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study nurse 1 will be responsible to randomize and prepare the needles in the envelopes. Outside the envelopes, there will be a number belonged to one patient, and inside the envelopes, there will 14 separate sterile needle which can be either placebo or true press tack needles. The envelopes and the pouches of needle will look the same. The acupuncturist will be asked not to check the needles when they insert them. At the time of acupuncture, a nurse will accompany the acupuncturist and will verify that he is not examining the needles closely. Study nurse 2 will do the measurement. The acupuncturist, patients and study nurse 2 will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double Blinded Randomized Control Trial

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: March 23, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)