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Neck PainNCT02013908

Acupuncture for Pain Control in the Emergency Department

A study testing Acupuncture plus standard ED management and Standard ED management alone in people with Neck Pain and Ankle Injuries, run by Korean Medicine Hospital of Pusan National University at 1 site in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Acupuncture plus standard ED management and Standard ED management alone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteSouth Korea
Study dates
Dec 2013to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Pusan National University Yangsan Hospital

    Yangsan, Kyungsangnamdo, 626770

Other trials in South Korea

About this study

Official title: Acupuncture for Non-emergent Acute Musculoskeletal Pain and Primary Headache in an Emergency Department Setting: a Parallel, Randomized, Controlled Pilot Trial

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:

Read more
  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.

Being tested
Acupuncture plus standard ED management, Standard ED management alone
Keywords
acupuncture, emergency department, acute pain, ankle sprain, neck pain, primary headache
Medical subject headings
Neck Pain, Ankle Injuries, Headache Disorders, Primary, Emergencies, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acupuncture plus standard ED managementProcedure or surgery

  • Standard ED management aloneProcedure or surgery

Study groups in NCT02013908
Study groupRoleWhat they receive
Standard ED management aloneActive comparatorRadiographic and physical examinations to exclude fractures or other serious conditions will be performed for all patients before considering eligibility in the study. After completion of the examination, patients who have pain of at least a level 4, as measured by the Wong-Baker scale (ranges 0 to 10), will receive intravenous or intramuscular injections of non-steroidal anti-inflammatory drugs (NSAIDs) for immediate pain control. All patients will be observed 30 minutes after the administration of the NSAIDs. In patients with primary headaches who respond poorly to the initial NSAID injection, an intravenous injection of opioid analgesics will be provided. After these initial standard ED management interventions, patients who are still suffering from acute pain will be asked to participate in the trial. During the study, rescue medication for immediate pain control will be allowed for patients allocated to both groups.
Receives: Procedure: Standard ED management alone
Acupuncture plus standard ED managementExperimentalThe patients in this group will receive a single session of individualized acupuncture treatment delivered by a certified Korean Medicine Doctor (KMD) specialized (or in-training) in acupuncture and moxibustion medicine and with at least 3 years of clinical experience. The acupuncture formulas will be composed based on the individual patient's symptoms and at the KMD's discretion. Acupuncture treatments will be provided in line with standard ED management, the same as in the control group.
Receives: Procedure: Acupuncture plus standard ED management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: at ED discharge (within 3 hours from ED admission)

Secondary outcomes (8)

  1. 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)

    Measured: 72 hours after the ED discharge

  2. 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.

    Measured: 72 hours after the ED discharge

  3. 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)

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

  4. Use of rescue medication in the ED

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

    Measured: at ED discharge (within 3 hours from ED admission)

  5. 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.

    Measured: 72 hours after the ED discharge

  6. 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.

    Measured: at ED discharge (within 3 hours from ED admission)

  7. 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.

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

  8. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionNov 2015
  4. Study completionNov 2015

Why it stopped: Low recruitment rate (17 patients;43% enrollment for 2 years).

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02013908
Sponsor's protocol ID
ATPED
Status last verified
Dec 2015
First submitted
27 Nov 2013
Last updated
7 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim KH, Ryu JH, Park MR, Kim YI, Min MK, Park YM, Kim YR, Noh SH, Kang MJ, Kim YJ, Kim JK, Lee BR, Choi JY, Yang GY. Acupuncture as analgesia for non-emergent acute non-specific neck pain, ankle sprain and primary headache in an emergency department setting: a protocol for a parallel group, randomised, controlled pilot trial. BMJ Open. 2014 Jun 12;4(6):e004994. doi: 10.1136/bmjopen-2014-004994.

    PubMed 24928587

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture plus standard ED management and Standard ED management alone in people with Neck Pain and Ankle Injuries, run by Korean Medicine Hospital of Pusan National University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Low recruitment rate (17 patients;43% enrollment for 2 years).). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immediate reduction in pain intensity (time frame: at ED discharge (within 3 hours from ED admission)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02013908, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.

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