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Completed

NCT Number: NCT01913587

Efficacy Study of Acupuncture on Spinal Compression Fracture

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

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Key information

Conditions

Spinal Compression Fracture

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Daegu Catholic University Medical Center

Daegu, Kyungsangbukdo, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 informed consent voluntarily

Exclusion criteria

  • Within 2 weeks from onset
  • Pathological fracture due to malignancy/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

Treatment and study plan

acupuncture

Device

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).

Nerve Block

Procedure

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).

Primary outcomes

  1. Visual analogue scale (VAS)

    Time frame: Change from baseline to 5 weeks

    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).

Secondary outcomes

  1. Short form McGill pain questionnaire

    Time frame: Change from baseline to 5 weeks

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

  2. Oswestry Disability Index (ODI)

    Time frame: Change from baseline to 5 weeks

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

Sponsors and collaborators

Lead sponsor

Daegu Catholic University Medical Center

Other

Registry information

Official study title

Efficacy and Safety of Acupuncture on Spinal Compression Fracture in Patients Treated With Nerve Block

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 1, 2013
Registry last updated
Dec 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.