ClinicalTrials.gg
CompletedNCT01913587Updated Dec 22, 2021

Efficacy Study of Acupuncture on Spinal Compression Fracture

An interventional study of Acupuncture and Nerve block in Spinal Compression Fracture, sponsored by Daegu Catholic University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-12-22.

Sponsored by Daegu Catholic University Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2013, registered Jul 2013).
Phase
Not applicable
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

This study is to investigate the effectiveness of acupuncture for alleviating pain from Spinal Compression Fracture in Patients Treated with Nerve Block.

Read the detailed description

Spinal compression fracture is mainly caused by trauma, furthermore, in old age, osteoporosis increases the risk of spinal compression fracture. Nerve block is effective for the management of pain from inflammation or nerve root stimulation from spinal compression fracture. As one of alternative interventions, acupuncture is effective for controlling spinal compression fracture.

This study aims to investigate that combination with acupuncture and nerve block may relieve spinal compression fracture-related pain versus nerve block alone.

02

Conditions studied

  • Spinal Compression Fracture

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03

In context

Fractures, Compression

50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.

This study's enrollment of 14 is below the median of 73 across 32 interventional studies indexed under Fractures, Compression.

Browse Fractures, Compression studies →

Lead sponsor

Daegu Catholic University Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Vertebral compression fracture by trauma or osteoporosis
  • Minimum 15% height loss of vertebrae
  • Patient diagnosed with x-ray or computed tomography (CT) or magnetic resonance image (MRI)
  • Visual analogue scale (VAS) score of 5 or more
  • Age over 50
  • 2 weeks from onset or more
  • Follow-up possible during the clinical trial
  • Written voluntarily

Exclusion criteria

Exclusion Criteria:

  • Within 2 weeks from onset
  • Pathological fracture due to /myeloma, osteomyelitis
  • Major retropulsion of bony segments into the spinal canal
  • Bone metabolic disease
  • Significant renal or hepatic disease
  • Hypersensitive reaction to acupuncture treatment
  • Senile dementia, impaired cognitive function or other cerebral disease, severe psychiatric or psychological disorders
  • Alcohol/drug abuse
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Acupuncture & Nerve block

    Acupuncture will be performed 3 times per week, total 9 sessions, during 3 weeks. Epidural nerve block and medial branch block will be performed once per week, total 3 sessions, during 3 weeks.

    Device: Acupuncture · Procedure: Nerve block

  • Active comparator
    Nerve block

    Epidural nerve block and medial branch block will be performed once per week, total 3 sessions, during 3 weeks.

    Procedure: Nerve block

Interventions

  • DeviceAcupuncture

    Acupuncture points are ST36, GB34 (bilateral), BL60 (bilateral), BL40 (bilateral), and 2 Back-su points (bilateral). Back-su points are selected as close as possible to pain region. Electroacupuncture will be performed at only 2 Back-su points (bilateral).

  • ProcedureNerve block

    Epidural nerve block uses the mixture (10ml) of dexamethasone (10 mg) and bupivacaine (10 mg) dissolved in saline solution. Medial branch block uses mepivacaine (10 mg).

06

What researchers measure

Primary outcomes

  1. Visual analogue scale (VAS)

    The patients will be required to document 100mm pain VAS, where '0' represents 'no pain' and '100', 'unbearable pain'. The change of pain will be reported by comparing the mean VAS before treatment, after 3 week, and 5 week (2 weeks follow-up).

    Time frame: Change from baseline to 5 weeks

Secondary outcomes

  1. Short form McGill pain questionnaire

    Evaluation will performed before treatment, after 3 week, and 5 week (2 weeks follow-up).

    Time frame: Change from baseline to 5 weeks

  2. Oswestry Disability Index (ODI)

    Evaluation will be performed before treatment, after 3 week, and 5 week (2 weeks follow-up).

    Time frame: Change from baseline to 5 weeks

07

Study locations

1 site
  • Daegu Catholic University Medical Center
    Daegu, Kyungsangbukdo, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2013 to primary completion in Mar 2014, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2013
First posted
Aug 1, 2013
StartActual
Mar 2013
Primary completionActual
Mar 2014
CompletionActual
Mar 2014
Last update
Dec 22, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01913587
Lead sponsor
Daegu Catholic University Medical Center
Responsible party
Jin Yong Jung (Department of anesthesiolgy, Daegu Catholic University Medical Center) — Principal investigator
First posted
Aug 1, 2013
Start date
Mar 2013
Primary completion
Mar 2014
Completion
Mar 2014
Last update
Dec 22, 2021

Study contacts

Jeong-Chul Seo, KMD, Ph.D
principal investigator · Comprehensive and Intergrative Medicine Institute
Min-Ah Gwak, KMD, Ph.D
principal investigator · Daegu Oriental Hospital of Daegu Haany University
Seong-Hoon Park, KMD
principal investigator · Comprehensive and Integrative Medicine Insitute

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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