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Analgesic Effect of Acupuncture for Patients With Rib Fractures

Primary Purpose

Rib Fractures, Acute Pain, Analgesia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Traditional acupuncture (TA)
Laser acupuncture (LA)
Sham laser acupuncture (SLA)
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rib Fractures focused on measuring Traumatic rib fractures, Acupuncture, Analgesia

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Traditional acupuncture (TA)

Laser acupuncture (LA)

Sham laser acupuncture (SLA)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sustained maximal inspiration lung volumes
Sustained maximal inspiration lung volumes
Number of cases with pulmonary complications
Pulmonary complications including pneumonia, atelectasis, pleural effusion, acute respiratory distress syndrome, and respiratory failure.
Saliva cortisol level
Saliva cortisol level
Heart rate variation
Heart rate variation
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.

Full Information

First Posted
December 10, 2018
Last Updated
April 9, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03822273
Brief Title
Analgesic Effect of Acupuncture for Patients With Rib Fractures
Official Title
Analgesic Effect of Acupuncture for Patients With Rib Fractures: a Randomized-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rib Fractures, Acute Pain, Analgesia
Keywords
Traumatic rib fractures, Acupuncture, Analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Acupuncture group Laser acupuncture group Sham laser acupuncture group
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional acupuncture (TA)
Arm Type
Experimental
Arm Description
The subject will receive real acupuncture treatment once per day for 3 days after enrollment.
Arm Title
Laser acupuncture (LA)
Arm Type
Active Comparator
Arm Description
The subject will receive laser acupuncture treatment once per day for 3 days after enrollment.
Arm Title
Sham laser acupuncture (SLA)
Arm Type
Placebo Comparator
Arm Description
The subject will receive sham laser acupuncture treatment once per day for 3 days after enrollment.
Intervention Type
Procedure
Intervention Name(s)
Traditional acupuncture (TA)
Intervention Description
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
Intervention Name(s)
Laser acupuncture (LA)
Intervention Description
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
Intervention Name(s)
Sham laser acupuncture (SLA)
Intervention Description
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 Outcome Measure Information:
Title
Efficacy of pain relief
Description
Maximal pain intensity (Numerical Rating Scale; NRS: 0-10) evaluated by participants themselves during deep breathing, coughing, and turning over in bed.
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.
Secondary Outcome Measure Information:
Title
Sustained maximal inspiration lung volumes
Description
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.
Title
Number of cases with pulmonary complications
Description
Pulmonary complications including pneumonia, atelectasis, pleural effusion, acute respiratory distress syndrome, and respiratory failure.
Time Frame
Follow-up for one month
Title
Saliva cortisol level
Description
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.
Title
Heart rate variation
Description
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.
Title
The dose of narcotic and non-narcotic analgesics used
Description
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.
Time Frame
Record the medication use for 2 weeks after participant enrolled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Ting Liu, MD
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
35712110
Citation
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.
Results Reference
derived

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Analgesic Effect of Acupuncture for Patients With Rib Fractures

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