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Completed

NCT Number: NCT03822273

Analgesic Effect of Acupuncture for Patients With Rib Fractures

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.

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Key information

Conditions

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

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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).

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.

Primary outcomes

  1. Efficacy of pain relief

    Time frame: 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 outcomes

  1. Sustained maximal inspiration lung volumes

    Time frame: 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

  2. Number of cases with pulmonary complications

    Time frame: Follow-up for one month

    Pulmonary complications including pneumonia, atelectasis, pleural effusion, acute respiratory distress syndrome, and respiratory failure.

  3. Saliva cortisol level

    Time frame: 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

  4. Heart rate variation

    Time frame: 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

  5. The dose of narcotic and non-narcotic analgesics used

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 30, 2019
Registry last updated
Apr 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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