Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000706875
Ethics application status
Approved
Date submitted
27/06/2012
Date registered
3/07/2012
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Subcutaneous longitudinal acupuncture: a novel and effective approach to acute pain relief in inpatients with rib fracture
Scientific title
Does Subcutaneous longitudinal acupuncture relieve acute pain in inpatients with rib fracture?
Secondary ID [1] 280744 0
Nil known
Universal Trial Number (UTN)
U1111-1132-1692
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rib fracture 286793 0
Condition category
Condition code
Alternative and Complementary Medicine 287104 287104 0 0
Other alternative and complementary medicine
Injuries and Accidents 287112 287112 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is subcutaneous longitudinal acupuncture. We used 2.5cm filiform needles to treat the patients. First, we asked the patient to point at the most painful site. We took this most painful point as an origin of the Y-axis which was parallel with the central line of trunk through the navel. Then we took the transverse line through the navel as the X-axis. The intersection of these two lines was the point which we inserted the needle. After we inserted one needle, we asked the patient to find the most painful site and pointed at it. The same procedure was practiced repeatedly until 5 needles were inserted and taped. In each treatment we used 5 needles totally. The time of retaining needle was 6 hours a day. We treated the patients daily and the overall duration of the treatment was 3 to 5 days based on when the inpatient was discharged from hospital.
Intervention code [1] 285171 0
Treatment: Devices
Comparator / control treatment
We used intradermal needle as control treatment. First, we asked the patient to point at the most painful site, then we found the homologous acupoint at the abdomen and insert the needle. In each treatment we used 5 needles totally. The time of retaining needle was 6 hours a day. We treated the patients daily and the overall duration of the treatment was 3 to 5 days.
Control group
Active

Outcomes
Primary outcome [1] 287425 0
relieve acute pain in patients with multiple rib fracture
We used Numerical Rating Scales (NRS) to assess the outcome.
Timepoint [1] 287425 0
We assessed the primary outcome in each participant immediately prior to and immediately after each acupuncture treatment for 3 to 5 days.
Secondary outcome [1] 298120 0
improve the recovery of lung function assessed by sustained maximal inspiration (SMI) lung volumes
Timepoint [1] 298120 0
We assessed the secondary outcome in each participant immediately prior to and immediately after each acupuncture treatment for 3 to 5 days.

Eligibility
Key inclusion criteria
1.inpatients who had chest wall pain induced by rib fracture
2.ibuprofen used 4 times a day
3.age>18 year-old
4.Numerical Rating Scales (NRS)>5
5.subjects who could describe the painful site and evaluate the pain scale clearly
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.subjects who couldn't test deep breath, cough, and turnover
2.couldn't dicrimintate the painful site
3.There were open wound
4.subjects who suffered form peumonia, tuberculosis, severe infection or ulcer disease, tend to bleeding, immune disease, or other chronic disease under poor control
5.pregnant women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated random sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4379 0
Taiwan, Province Of China
State/province [1] 4379 0
Taoyuan

Funding & Sponsors
Funding source category [1] 285529 0
Self funded/Unfunded
Name [1] 285529 0
Country [1] 285529 0
Primary sponsor type
Individual
Name
Hsin-Yi Ho
Address
Department of Acupuncture and Traumatology, Center for Traditional Chinese Medicine, Chang Gung memorial Hospital,
Taoyuan, 333, Taiwan
Country
Taiwan, Province Of China
Secondary sponsor category [1] 284371 0
Individual
Name [1] 284371 0
Yu-Pao Hsu
Address [1] 284371 0
Division of Trauma & Emergency Surgery
Chang Gung Memorial Hospital
5, Fu-Hsien St., Taoyuan, Taiwan, R.O.C.
Country [1] 284371 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287550 0
Chang Gung Memorial Hospital Institutional Review Board
Ethics committee address [1] 287550 0
Chang Gung memorial Hospital, Taoyuan, 333, Taiwan
Ethics committee country [1] 287550 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 287550 0
Approval date [1] 287550 0
13/12/2011
Ethics approval number [1] 287550 0

Summary
Brief summary
Backgorund Pain control is emphasized as a priority for practitioners and patients with rib fracture. Main acute pain management includes analgesia and nerve block. There are some side effects recorded and the effect can’t be continued. All clinical practitioners expect to create a new and safe therapy which could offer long-term pain relief. Acupuncture has been applied to relieve pain for a long time. No clinical trial has taken acupuncture to treat patients with rib fracture currently.

Methods and Evaluation This is a prospective, randomized, and single-blind study. A creative therapy named “Subcutaneous longitudinal acupuncture” is applied. Intradermal needle is taken as a control to exclude placebo effect. Evaluation including pain intensity of deep breath, cough, turn over the body, and the angle and rate of turn over the body will be taken before and after needling. Quality of sleep and sustained maximal inspiration (SMI) lung volumes are also recorded.


Expected outcome Based on the use of single oral analgesia, the involvement of long needle retention duration of “Subcutaneous longitudinal acupuncture” may relieve acute pain in patients with multiple rib fracture immediately. It may reduce pain when taking deep breath, coughing, and turning over the body, improve sleep quality and recovery of lung function, and decrease the incidence of other lung complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34370 0
Address 34370 0
Country 34370 0
Phone 34370 0
Fax 34370 0
Email 34370 0
Contact person for public queries
Name 17617 0
Ko-Hung Lee
Address 17617 0
123 Dung-Hou Road, Jiou-Lu Tsuen, Kwei-Shan, Tao-Yuan, 333, Taiwan
Country 17617 0
Taiwan, Province Of China
Phone 17617 0
886-3-3196200 ext.2613
Fax 17617 0
Email 17617 0
[email protected]
Contact person for scientific queries
Name 8545 0
Ko-Hung Lee
Address 8545 0
123 Dung-Hou Road, Jiou-Lu Tsuen, Kwei-Shan, Tao-Yuan, 333, Taiwan
Country 8545 0
Taiwan, Province Of China
Phone 8545 0
886-3-3196200 ext.2613
Fax 8545 0
Email 8545 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.