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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2009
INTERVENTION: 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 Pharmacotherapy will be applied by treating physicians and a patient may be withdrawn from the trial at the physicians discretion.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. CONDITION: Acute Ankle Sprain Acute Low Back Pain Migraine PRIMARY OUTCOME: 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. Rescue therapy requirements in the ED: ; a. At 60 minutes (t1) ; b. At any stage following the first 60 minutes (t1). SECONDARY OUTCOME: Nil 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. 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). 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. 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) 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.
Epistemonikos ID: babcb91423cf3d918502eb8bb60150b02bb1ff5f
First added on: Aug 25, 2024