Acupuncture for Pain Control in the Emergency Department

N/ATerminatedNCT02013908

Korean Medicine Hospital of Pusan National University17 enrolled

Overview

Acupuncture is widely used for managing acute and chronic pain conditions. In the context of an emergency department (ED), patients often present with non-emergent acute pain symptoms. This may result in a delayed triage process and inefficient emergent management. An integrative patient-care approach in emergency departments has been explored that may improve patient satisfaction and promote efficient use of healthcare resources for non-emergent patients in the ED. This implies there is a potential role for acupuncture in such contexts. The aim of this pilot study is to assess the effectiveness and safety of acupuncture as an add-on intervention for patients with non-emergent acute musculoskeletal pain and primary headaches in an ED setting. Hypotheses of this study are as follows: 1. A single session of add-on acupuncture, with standard ED management, can reduce pain levels in non-emergent acute pain, compared to standard ED management alone. 2. A single session of add-on acupuncture to standard ED management can reduce additional consumption of healthcare resources for management of non-emergent acute pain, compared to standard ED management alone. This study aimed to include 40 participants, 20 in the acupuncture plus standard ED management group and 20 in the standard ED management alone group.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Neck Pain Ankle Injuries

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged over 19 years with acute pain defined as pain occurring within 72 hours of ED presentation * Acute neck pain with no evidence of neurological abnormality * Acute headache which meets the classification criteria of a primary headache as described by the International Headache Society (code 1 to 4) * Acute ankle injury with no evidence of fracture or complete tear of ligaments Exclusion Criteria: * Any suspected non-musculoskeletal cause (neoplasm or neurological complications) for neck or ankle pain * Any suspected secondary headaches classified by codes 5 to 12 in the International Classification of Headache Disorders, 2nd edition * Pain due to bone fracture or joint dislocation * Pain with fever (defined by a temperature above 37.5 °C) * Inappropriate at the ED physician's discretion * Pain level of less than 4 points of pain intensity on the Numerical Rating Scale (NRS) (range 0 to 10) at the completion of observations after the standard ED management * Pregnant women

Outcomes

Primary Outcomes

Immediate reduction in pain intensity

Participant-perceived reduction of pain intensity will be measured by the pain Numerical Rating Scale (NRS) (Range 0 to 10 referring 0 to no pain and 10 to extreme pain)

Time frame: at ED discharge (within 3 hours from ED admission)

Secondary Outcomes

Short-term reduction in pain intensity

Participant-perceived reduction of pain intensity will be measured by the the pain NRS (Range 0 to 10 referring 0 to no pain and 10 to extreme pain)

Time frame: 72 hours after the ED discharge

Short-term disability due to neck pain (only for patients with neck pain)

Participant-perceived reduction of disability due to neck pain will be measured by a 10-item questionnaire. Changes from baseline on the Neck Disability Index (NDI) will be used.

Time frame: 72 hours after the ED discharge

Immediate and short-term patient global assessment for treatment outcomes

Patients' global assessments for overall treatment outcomes will be measured by a single item with a 5-point Likert scale question (much improved, somewhat improved, the same as baseline, somewhat worsened, much worsened)

Time frame: at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge

Use of rescue medication in the ED

Use of additional rescue medication for relieving pain will be measured by electronic medical charts

Time frame: at ED discharge (within 3 hours from ED admission)

Use of additional medication or healthcare resources

Use of additional medication or healthcare resources (such as hospital admissions and outpatient clinic visits) will be measured by patients' self-reports via telephone interviews.

Time frame: 72 hours after the ED discharge

Length of stay in the ED

Length of stay in the ED (from group allocation to the ED discharge) will be measured by electronic medical charts.

Time frame: at ED discharge (within 3 hours from ED admission)

Proportion of treatment responder

Proportion of treatment responder is defined as patients who have experienced at least a 50% reduction in pain intensity from baseline values; these values will be calculated using the pain intensity VAS scores.

Time frame: at ED discharge (within 3 hours from ED admission) and 72 hours after the ED discharge

Adverse events

All expected or unexpected adverse events in both groups will be measured during the allocated intervention process and during the entire follow-up period. Types and frequency of occurrences of adverse events will be measured.

Time frame: at ED discharge (within 3 hours from ED admission) and 72hours after the ED discharge

Acupuncture for Pain Control in the Emergency Department

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes