Analgesic Effect of Acupuncture for Patients With Rib Fractures

Analgesic Effect of Acupuncture for Patients With Rib Fractures: a Randomized-controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Acute Pain; Rib Fractures
• Intervention / Treatment: Procedure: Traditional acupuncture (TA); Procedure: Laser acupuncture (LA); Procedure: Sham laser acupuncture (SLA)

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 833
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 96 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traditional acupuncture (TA); The subject will receive real acupuncture treatment once per day for 3 days after enrollment.	Procedure: Traditional acupuncture (TA); Procedure: real acupuncture. Eight disposable, single use, sterilized, stainless steel needles are inserted at each session, and the bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli) and GB34 (Yanglingquan) are used for acupuncture treatment. The acupuncture needles are to be inserted to a depth of 15-35 mm. All needles are rotated manually at least once at each session to elicit needle sensation (De qi). The needle retention time is 15 min.
Active Comparator: Laser acupuncture (LA); The subject will receive laser acupuncture treatment once per day for 3 days after enrollment.	Procedure: Laser acupuncture (LA); Procedure: laser acupuncture. Participants allocated to the LA group receive laser acupuncture treatment at the same acupoints used in acupuncture group. The laser acupuncture therapy will be performed with the gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; and Bahr frequencies [B1: 599.5 Hz, B2: 1199 Hz, B3: 2398 Hz, B4: 4776 Hz, B5: 9552 Hz, B6: 19,104 Hz, and B7: 38,208 Hz]; RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany). The laser will be applied to each point for 5 seconds, which delivered 0.375 J of energy at each of the acupoints: LI4 (Hegu, B3), SJ6 (Zhigou, B3), ST36 (Zusanli, B2) and GB34 (Yanglingquan, B2).
Placebo Comparator: Sham laser acupuncture (SLA); The subject will receive sham laser acupuncture treatment once per day for 3 days after enrollment.	Procedure: Sham laser acupuncture (SLA); Procedure: sham laser acupuncture. Subjects in the control group receive sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in the LA group.

What is the study measuring?

Primary Outcome Measures

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

Outcome Measure	Measure Description	Time Frame
Sustained maximal inspiration lung volumes	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.
Number of cases with pulmonary complications	Pulmonary complications including pneumonia, atelectasis, pleural effusion, acute respiratory distress syndrome, and respiratory failure.	Follow-up for one month
Saliva cortisol level	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.
Heart rate variation	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.
The dose of narcotic and non-narcotic analgesics used	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.	Record the medication use for 2 weeks after participant enrolled

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chun-Ting Liu, MD, Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: December 10, 2018
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2021
• Last Update Submitted That Met QC Criteria: April 9, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Acupuncture; Analgesia; Traumatic rib fractures
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Thoracic Injuries; Fractures, Bone; Acute Pain; Rib Fractures
• Other Study ID Numbers: 201701455A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No