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Trial registered on ANZCTR


Registration number
ACTRN12609000989246
Ethics application status
Approved
Date submitted
11/11/2009
Date registered
17/11/2009
Date last updated
10/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A study on the effects of acupuncture alone compared to acupuncture together with pharmacotherapy on pain relief in emergency department patients with acute migraine, back pain and ankle sprain
Scientific title
A study on the effects of acupuncture alone compared to acupuncture together with pharmacotherapy on pain relief in emergency department patients with acute migraine, back pain and ankle sprain
Secondary ID [1] 262444 0
MEDACT
Universal Trial Number (UTN)
U1111-1112-4605
Trial acronym
MEDACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ankle Sprain 252166 0
Acute Low Back Pain 252167 0
Migraine 252168 0
Condition category
Condition code
Alternative and Complementary Medicine 252370 252370 0 0
Other alternative and complementary medicine
Musculoskeletal 252392 252392 0 0
Other muscular and skeletal disorders
Neurological 252393 252393 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Needle Acupuncture is to be applied to patients based on their condition and randomization. Duration of treatment will be between 20-30minutes and will be selcted from a group of predetermined points and following Standards for Reporting Clinical Trials of Acupuncture (STRICTA) guidelines. All acupuncturists will be registered practioners with the Chinese Medicine Registration Board of Victoria(CMRBV). Patients will be randomized to 1 of 3 groups 1.Acupuncture only 2.Pharmacotherapy only 3. Acupuncture and Pharmacotherapy combined. All 3 groups are one off interventions that will be monitored up to a 72 hour period of the intervention.
Acupuncture is to be applied to points on the body consistant with each of the patients conditions and left in place for between 20-30 minutes these points are at thr discretion of the treating acupuncturist and based on a group of researched points that are supplied to the acupuncturists in the acupuncture protocol along with their location, depth and angle of insertion.
Pharmacotherapy will be applied by treating physicians and a patient may be withdrawn from the trial at the physicians discretion. The choice of pharmacotherapy is at the physicans discretion and is to be selected from a group of drugs in the 1st line treatment category then the 2nd line treatment category if required. These drugs were seleceted by a group of experienced physicians according to common application and effectiveness. The route, time and dosage will be documented.
Intervention code [1] 241534 0
Treatment: Other
Comparator / control treatment
pharmacotherapy administered at the discretion of the treating physician, will differ for each patient. administered at time required by the patient and repeated as needed. administration as to each hospital policy.
Control group
Active

Outcomes
Primary outcome [1] 253239 0
Compared to pharmacotherapy alone does acupuncture, alone or as an adjunct
to pharmacotherapy, provide clinically significant pain relief. Using using a Verbal Numerical Rating
Scale (VNRS) out of 10 (0 = no pain, 10 = worst pain imaginable)
b. Pain relief will be reported as clinically relevant based on the percentage of patients with a pain score 3/10
c. Pain relief will be reported as statistically relevant based on a reduction in
pain score of >2/10.
Timepoint [1] 253239 0
measured at t0, then 1 hour after intervention then hourly til discharge and once 48-72 hours after discharge
Primary outcome [2] 253267 0
Rescue therapy requirements in the ED:
a. At 60 minutes (t1)
b. At any stage following the first 60 minutes (t1).
Timepoint [2] 253267 0
a. At 60 minutes (t1)
b. At any stage following the first 60 minutes (t1).
Secondary outcome [1] 262205 0
Nil
Timepoint [1] 262205 0
nil
Secondary outcome [2] 262263 0
compared to pharmacotherapy alone, does acupuncture alone or as an adjunct
to pharmacotherapy, provide clinically significant improvement in
functionality?a. Back pain: Oswestry low back pain disability questionnaire.
b. Migraine: 24-hour Migraine Quality of Life questionnaire.
c. Acute ankle injuries: Patient?s Global Assessment of Ankle Injury Scale.
Timepoint [2] 262263 0
Timepoints: measured at t0, then 1 hour after intervention then hourly til discharge and once 48-72 hours after discharge
Secondary outcome [3] 262264 0
is acupuncture safe?a. Nausea, dizziness, drowsiness and fatigue using Index scales28
b. Rashes, visual disturbance, constipation, abdominal pain, local complications of acupuncture and other adverse events using a ?Yes/No? response.
c. Vomiting: documenting the amount of times vomited since last assessment.
Timepoint [3] 262264 0
at t1, then hourly till discharge and 48-72 hours later.
Secondary outcome [4] 262265 0
is acupuncture acceptable to patients?a. Satisfaction survey: using a score out of 10 (0 = very dissatisfied, 10 = very satisfied)
b. Willingness to repeat similar management in future: using a 5 options scale (definitely no, probably no, probably yes, definitely yes and unsure).
Timepoint [4] 262265 0
at t1, then hourly till discharge and 48-72 hours later.
Secondary outcome [5] 262266 0
what is the effect of acupuncture on health resource utilisation?
a. Length of stay in the ED
b. Length of stay in the Hospital
c. Admission rate
d. Representation rate
e. Seeking other Health Care Professional advice after initial presentation.
f. Additional analgesia/pharmacotherapy used after initial presentation (prescription as well as non-prescription)
Timepoint [5] 262266 0
48-72 hours after discharge.

Eligibility
Key inclusion criteria
LOWER BACK PAIN requiring analgesia: acute or acute on chronic, with or without referred pain and most recent episode has less than 3 months history.
MIGRAINE requiring analgesia: as defined by the international headache society (complete Migraine Inclusion/Exclusion criteria)
ACUTE ANKLE INJURY: Injury that has occurred within 72 hours and requiring analgesics.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Fever

Acute major trauma.

Skin infections that would preclude certain acupuncture points being used.

Bleeding disorders.

CURRENT Anticoagulation therapy.

PRESENCE OF mechanical heart valve.

Is the patient aged less than 18 years?

Does the patient have a cognitive impairment or refuse to consent?

Has the patient had any form of analgesia up to 60 minutes prior to study t0?

Is the initial pain score at baseline (t0) less than 4 on a pain scale (0-10)?

SPECIFIC

LOWER BACK PAIN: Any suspected non- musculoskeletal cause for the back pain
MIGRAINE: Any suspected condition not consistent with the definition of migraine
ACUTE ANKLE INJURY: Obvious deformity suggestive of ankle dislocation or fracture.

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)
Patients are approached with suitable condition and volunteer to participate. Patients are allocated randomly to acupuncture alone , acupuncture plus pharmacotherapy or pharmaotherapy alone, using a random number
sequence with blocks and sealed envelopes will be used to conceal treatment
allocation until being opened by the triage nurse (not the research nurse) for each
sequential patient. Although the patient is aware of which group they are allocated the follow up questions are to be administered by a blinded nurse not involved in direct patient care.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated using a random number
sequence with blocks and sealed envelopes will be used to conceal treatment
allocation until being opened by the triage nurse (not the research nurse) for each
sequential patient.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2212 0
3076
Recruitment postcode(s) [2] 2213 0
3121
Recruitment postcode(s) [3] 2214 0
3181

Funding & Sponsors
Funding source category [1] 244003 0
Government body
Name [1] 244003 0
National Health and Medical Research Council(NHMRC)
Address [1] 244003 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 244003 0
Australia
Primary sponsor type
University
Name
Royal Melbourne Institute of Techinology (RMIT) University
Address
PO Box 71
Bundoora West Campus
Vic 3083
Country
Australia
Secondary sponsor category [1] 251354 0
None
Name [1] 251354 0
Address [1] 251354 0
Country [1] 251354 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244108 0
Northern Hospital
Ethics committee address [1] 244108 0
185 Cooper St
Epping Vic
3076
Ethics committee country [1] 244108 0
Australia
Date submitted for ethics approval [1] 244108 0
Approval date [1] 244108 0
20/03/2009
Ethics approval number [1] 244108 0
CC16/09

Summary
Brief summary
The proposed research involves a multicentre project of pragmatic randomised
controlled trials of acupuncture vs pharmacotherapy in patients presenting to the Emergency Department(ED)
with low back pain, migraine and acute ankle injuries. For each trial, patients will be
randomly assigned to three groups: an acupuncture alone, pharmacotherapy alone and
a group combining acupuncture and pharmacotherapy
Trial website
Trial related presentations / publications
Acupuncture as analgesia for low back pain, ankle sprain and migraine in emergency departments: study protocol for a randomized controlled trial.
Cohen M, Parker S, Taylor D, Smit de V, Ben-Meir M, Cameron P, Xue C.
Trials. 2011 Nov 15;12:241. doi: 10.1186/1745-6215-12-241.
Public notes

Contacts
Principal investigator
Name 30494 0
Prof Marc Cohen
Address 30494 0
RMIT University
PO Box 71 Bundoora Vic 3083
Country 30494 0
Australia
Phone 30494 0
+61 3 9925 7440
Fax 30494 0
Email 30494 0
e51864@ems.rmit.edu.au
Contact person for public queries
Name 13741 0
Prof Prof Marc Cohen
Address 13741 0
PO Box 71
Bundoora Vic 3083
Country 13741 0
Australia
Phone 13741 0
+61 3 9925 7440
Fax 13741 0
+61 3 9467 2794
Email 13741 0
e51864@ems.rmit.edu.au
Contact person for scientific queries
Name 4669 0
Prof Prof Marc Cohen
Address 4669 0
PO Box 71
Bundoora Vic 3083
Country 4669 0
Australia
Phone 4669 0
+61 3 9925 7440
Fax 4669 0
+61 3 9467 2794
Email 4669 0
e51864@ems.rmit.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary