Analgesic Effect of Acupuncture for Patients With Rib Fractures: a Randomized-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Efficacy of pain relief
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (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.
Eligibility Criteria
- Ages
- 20 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- 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)
- 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.)
- 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.)
Investigators
Chun-Ting Liu
Attending doctor
Chang Gung Memorial Hospital