Clinical trial NCT03822273: Analgesic Effect of Acupuncture for Patients With Rib Fractures
Official title: Analgesic Effect of Acupuncture for Patients With Rib Fractures: a Randomized-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rib Fractures
Acute Pain
Analgesia
Keywords: Traumatic rib fractures
Acupuncture
Analgesia
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Acupuncture group
2. Laser acupuncture group
3. Sham laser acupuncture group
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Efficacy of pain relief
timeFrame: The NRS will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively. Primary outcome is the change of NRS score on DAY 1 pretreatment and DAY 3 post treatment.
Secondary outcomes:
measure: Sustained maximal inspiration lung volumes
timeFrame: The sustained maximal inspiration lung volumes will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively.
measure: Number of cases with pulmonary complications
timeFrame: Follow-up for one month
measure: Saliva cortisol level
timeFrame: The saliva cortisol level will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively.
measure: Heart rate variation
timeFrame: The heart rate variation will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively.
measure: The dose of narcotic and non-narcotic analgesics used
timeFrame: Record the medication use for 2 weeks after participant enrolled
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chun-Ting Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu CT, Hsieh TM, Wu BY, Huang YC, Shih CH, Hu WL, Tsai MY, Chen YH. Acupuncture Analgesia in Patients With Traumatic Rib Fractures: A Randomized-Controlled Trial. Front Med (Lausanne). 2022 May 27;9:896692. doi: 10.3389/fmed.2022.896692. eCollection 2022.