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NCT Number: NCT04318496

Acupuncture for Blunt Chest Trauma

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.

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Key information

Conditions

Chest Trauma Fractures, Bone Rib Fractures Thoracic Injuries Wounds and Injuries

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Out-Patient Clinic of China Medical University Hospital

Taichung, 404472, Taiwan

About this study

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 goal is to examine the effect of acupuncture on patients with chest trauma. the study will include totally 72 patients and divide them to two group; 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. Follow up time will be 3 months.

Expected outcome:

The results of this study can potentially provide a simple and cost effective provide analgesic solution to blunt chest trauma patients. The study design can serve as supporting evidence for future double blind studies in acupuncture.

Other information:

The study will be conducted in thoracic surgical department and acupuncture department in China medical university hospital, Taichung, Taiwan. The study is conducted on blunt chest injury patients and is anticipated to have minimum risk for adverse events. Enrollment of the patients and data collection will start after March 2020. The study expected completion time will be March 2022.

Keywords: blunt chest trauma, acupuncture, press tack needle, rib fracture

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Press Tack Acupuncture

Other

PYONEX Φ0.20×0.6 mm made by Seirin Corporation

Other names: Press Tack Needle/ sticker needle/ PYONEX

Press Tack Placebo

Other

PYONEX placebo sticker made by Seirin Corporation

Other names: PYONEX placebo

Primary outcomes

  1. Numerical Rating Scale (NRS) - rest

    Time frame: 3 months

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

  2. Numerical Rating Scale (NRS) - mobile

    Time frame: 3 months

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

Secondary outcomes

  1. Visual Analogue Pain Scale (VAS)

    Time frame: 4 days

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

  2. Face Rating Scale (FRS)

    Time frame: 4 days

    Face expression pain scale. scores form 0-5 when 5 is the most painful

  3. Flow meter

    Time frame: 4 days

    Measure the amount of air the patient can exhale, It has three chambers with their own balls that requires air pressures from 600-1200 cc per second. 1200cc is the highest score and indicates good exhalation

  4. Verran and Snyder-Halpern sleep scale

    Time frame: 4 days

    includes 15 question on the patients sleep quality, each question has a 100mm line. Patients will raking each question 0-100 when 100 means no existing insomnia

  5. Chest plain film

    Time frame: 4 days

    Chest X-ray, will help examine the number of rib fractures, the incidence of hemothorax and pneumothorax

  6. Pain killer or muscle relaxant medication does used

    Time frame: 4 days

    We will measure the amount of analgesic or muscle relaxant medication each patient used

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

Acupuncture for Blunt Chest Trauma: A Protocol for a Double-Blind Randomized Control Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2020
Registry last updated
Nov 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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