None listed
Conditions
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
Interventions
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 Pharmacotherapy will be applied by treating physicians and a patient may be withdrawn from the trial at the physicians discretion.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.
Sponsors
Study design
Eligibility
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.
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.