Analgesic Effect of Acupuncture for Patients With Rib Fractures

Not Applicable

Completed

• Conditions: Rib Fractures; Analgesia; Acute Pain
• Interventions: Procedure: Traditional acupuncture (TA); Procedure: Laser acupuncture (LA); Procedure: Sham laser acupuncture (SLA)

• Registration Number: NCT03822273
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2018-03-01
• Study First Submitted: 2018-12-10
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-30
• Primary Completion: 2020-02-28
• Study Completion: 2020-12-31
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-09
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional acupuncture (TA)	Traditional acupuncture (TA)	The subject will receive real acupuncture treatment once per day for 3 days after enrollment.
Laser acupuncture (LA)	Laser acupuncture (LA)	The subject will receive laser acupuncture treatment once per day for 3 days after enrollment.
Sham laser acupuncture (SLA)	Sham laser acupuncture (SLA)	The subject will receive sham laser acupuncture treatment once per day for 3 days after enrollment.

Primary Outcome Measures

Name	Time	Method
Efficacy of pain relief	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.	Maximal pain intensity (Numerical Rating Scale; NRS: 0-10) evaluated by participants themselves during deep breathing, coughing, and turning over in bed.

Secondary Outcome Measures

Name	Time	Method
Heart rate variation	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.	Heart rate variation
The dose of narcotic and non-narcotic analgesics used	Record the medication use for 2 weeks after participant enrolled	Record the use of narcotic and non narcotic analgesics based on chart reviews. Narcotic drugs include codeine, tramadol, and morphine. Non narcotic drugs include acetaminophen, ibuprofen, diclofenac, ketoprofen, mefenamic acid, and parecoxib.
Number of cases with pulmonary complications	Follow-up for one month	Pulmonary complications including pneumonia, atelectasis, pleural effusion, acute respiratory distress syndrome, and respiratory failure.
Saliva cortisol level	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.	Saliva cortisol level
Sustained maximal inspiration lung volumes	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.	Sustained maximal inspiration lung volumes

Trial Locations

Locations (1)

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan