Analgesic Effect of Acupuncture for Patients With Rib Fractures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2020-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Rib Fractures Acute Pain Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. Acupuncture group
2. Laser acupuncture group
3. Sham laser acupuncture group

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Traditional acupuncture (TA)

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

Group Type EXPERIMENTAL

Traditional acupuncture (TA)

Intervention Type 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)

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

Group Type ACTIVE_COMPARATOR

Laser acupuncture (LA)

Intervention Type 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)

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

Group Type PLACEBO_COMPARATOR

Sham laser acupuncture (SLA)

Intervention Type 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.

Interventions

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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.

Intervention Type 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).

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No