Analgesic Effect of Acupuncture for Patients With Rib Fractures

Chang Gung Medical Foundation

Status: Completed

Conditions: Analgesia; Acute Pain; Rib Fractures

Treatments: Procedure: Traditional acupuncture (TA); Procedure: Laser acupuncture (LA); Procedure: Sham laser acupuncture (SLA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03822273

201701455A3

Details and patient eligibility

About

Traumatic rib fractures are common, resulting from significant forces impacting on the chest, and are associated with significant morbidity and mortality. Acute pain management in inpatients with traumatic rib fractures has been highly emphasized by practitioners. Inappropriate analgesia may cause respiratory complications, including pneumonia, atelectasis, acute respiratory distress syndrome, and prolonged hospital stay. These may be prevented or reduced by good analgesic therapy. This study is aimed to investigate the analgesic effect of acupuncture on traumatic rib fractures.

Full description

This open-label, randomized controlled trial will involve 150 patients who have traumatic rib fractures. Subjects are randomly assigned to acupuncture group, laser acupuncture group or sham laser acupuncture group with a 1:1:1 ratio. The intervention will be performed on the consecutive three day after allocation. Bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli) and GB34 (Yanglingquan) are used for each group. The traditional acupuncture group will be performed by inserting needles to a depth of 15-35 mm and last for 15 min. The laser acupuncture will be performed with the gallium aluminum arsenide LaserPen, which delivered 0.375 J of energy at each of the acupoints. Subjects in the control group underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in the laser acupuncture group.

Enrollment: 120 patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Chest trauma
• Presence of one or more, unilateral or bilateral rib fractures diagnosed with chest X-ray
• Maximal rib pain score of more than 5 obtained using the numerical rating scale (NRS: 0-10)
• Ability to describe the sites of pain and evaluate the pain intensity accurately

Exclusion Criteria:

• Unable to describe the sites of pain and evaluate the pain intensity accurately
• There are open wounds on the sites of acupuncture points
• Severe multiple trauma or any poorly controlled diseases such as atelectasis, pneumonia, or other infectious diseases, immune system dysfunction, bleeding tendency, psychiatric disorders, and skin problems
• Receive surgical management of rib fractures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups, including a placebo group

Traditional acupuncture (TA)

Experimental group

Description:

The subject will receive real acupuncture treatment once per day for 3 days after enrollment.

Treatment:

Procedure: Traditional acupuncture (TA)

Laser acupuncture (LA)

Active Comparator group

Description:

The subject will receive laser acupuncture treatment once per day for 3 days after enrollment.

Treatment:

Procedure: Laser acupuncture (LA)

Sham laser acupuncture (SLA)

Placebo Comparator group

Description:

The subject will receive sham laser acupuncture treatment once per day for 3 days after enrollment.

Treatment:

Procedure: Sham laser acupuncture (SLA)