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 sprai

Not Applicable

Completed

• Conditions: Acute Ankle Sprain; Acute Low Back Pain; Migraine; Alternative and Complementary Medicine - Other alternative and complementary medicine; Musculoskeletal - Other muscular and skeletal disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12609000989246
• Lead Sponsor: Royal Melbourne Institute of Techinology (RMIT) University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 505

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rescue therapy requirements in the ED:<br>a. At 60 minutes (t1)<br>b. At any stage following the first 60 minutes (t1).[a. At 60 minutes (t1)<br>b. At any stage following the first 60 minutes (t1).];Compared to pharmacotherapy alone does acupuncture, alone or as an adjunct<br>to pharmacotherapy, provide clinically significant pain relief. Using using a Verbal Numerical Rating<br>Scale (VNRS) out of 10 (0 = no pain, 10 = worst pain imaginable)<br>b. Pain relief will be reported as clinically relevant based on the percentage of patients with a pain score 3/10<br>c. Pain relief will be reported as statistically relevant based on a reduction in<br>pain score of >2/10.[measured at t0, then 1 hour after intervention then hourly til discharge and once 48-72 hours after discharge]