Analgesic Effect of Acupuncture for Patients With Rib Fractures

NCT03822273 | Completed

• 1 other identifier: 201701455A3
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Rib Fractures; Acute Pain; Analgesia

Keywords

Traumatic rib fractures; Acupuncture; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

  Follow-up for one month

• 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

  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 medication use for 2 weeks after participant enrolled

Study Arms (3)

Traditional acupuncture (TA)

EXPERIMENTAL

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

Procedure: Traditional acupuncture (TA)

Laser acupuncture (LA)

ACTIVE COMPARATOR

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

Procedure: Laser acupuncture (LA)

Sham laser acupuncture (SLA)

PLACEBO COMPARATOR

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

Procedure: Sham laser acupuncture (SLA)

Interventions

Traditional acupuncture (TA) PROCEDURE

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.

Traditional acupuncture (TA)

Laser acupuncture (LA) PROCEDURE

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).

Laser acupuncture (LA)

Sham laser acupuncture (SLA) PROCEDURE

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.

Sham laser acupuncture (SLA)

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 35712110 DERIVED

MeSH Terms

Conditions

Rib Fractures; Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Thoracic Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Chun-Ting Liu, MD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All the patients are told that they will receive one kind of acupuncture treatment in addition to the original oral analgesics and assess the efficacy of acupuncture. The patients are randomly assigned to three groups after providing written informed consent, without being mentioned which kind of acupuncture treatment is applied as control. Patients are not blinded to TA or LA treatment, but they can be blinded to LA or SLA treatment. The outcome assessor is also blinded to the group assignments and is trained to apply the pain scales and conduct physical tests. To avoid unblinding of the assessment of outcomes, the patients are instructed not to discuss any aspect related to their treatment with the assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor

Model Details: 1. Acupuncture group 2. Laser acupuncture group 3. Sham laser acupuncture group

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: January 30, 2019
• Study Start: March 1, 2018
• Primary Completion: February 28, 2020
• Study Completion: December 31, 2020
• Last Updated: April 14, 2021

Record last verified: 2021-04

Locations

TW (1)