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Rib FracturesNCT03822273

Analgesic Effect of Acupuncture for Patients With Rib Fractures

A study testing Traditional acupuncture (TA) and Laser acupuncture (LA) in people with Rib Fractures and Acute Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 100 years
Conditions the study is for
Rib Fractures, Acute Pain, Analgesia
What is being tested?
Traditional acupuncture (TA) and Laser acupuncture (LA)
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteTaiwan
Study dates
1 Mar 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 833

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.

Being tested
Traditional acupuncture (TA), Laser acupuncture (LA), Sham laser acupuncture (SLA)
Keywords
Traumatic rib fractures, Acupuncture, Analgesia
Medical subject headings
Rib Fractures, Acute Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional acupuncture (TA)Procedure or surgery

    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 or surgery

    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 or surgery

    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.

Study groups in NCT03822273
Study groupRoleWhat they receive
Traditional acupuncture (TA)ExperimentalThe subject will receive real acupuncture treatment once per day for 3 days after enrollment.
Receives: Procedure: Traditional acupuncture (TA)
Laser acupuncture (LA)Active comparatorThe subject will receive laser acupuncture treatment once per day for 3 days after enrollment.
Receives: Procedure: Laser acupuncture (LA)
Sham laser acupuncture (SLA)Placebo comparatorThe subject will receive sham laser acupuncture treatment once per day for 3 days after enrollment.
Receives: Procedure: Sham laser acupuncture (SLA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Sustained maximal inspiration lung volumes

    Sustained maximal inspiration lung volumes

    Measured: 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.

  2. Number of cases with pulmonary complications

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

    Measured: Follow-up for one month

  3. Saliva cortisol level

    Saliva cortisol level

    Measured: 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.

  4. Heart rate variation

    Heart rate variation

    Measured: 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.

  5. 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.

    Measured: Record the medication use for 2 weeks after participant enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2019
  2. Study start1 Mar 2018
  3. Primary completion28 Feb 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
1. Acupuncture group 2. Laser acupuncture group 3. Sham laser acupuncture group
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03822273
Sponsor's protocol ID
201701455A3
Status last verified
Apr 2021
First submitted
10 Dec 2018
Last updated
14 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 35712110

Questions about this trial

What is this clinical trial studying?

A study testing Traditional acupuncture (TA) and Laser acupuncture (LA) in people with Rib Fractures and Acute Pain, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03822273, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2021.

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