Efficacy Study of Acupuncture on Spinal Compression Fracture

Spinal Compression Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913587
• Other study ID #: CIMI-13-01-21
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: December 2021
• Source: Daegu Catholic University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Compression
• Spinal Compression Fracture

Intervention

Device:
• Acupuncture
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).

Procedure:
• Nerve 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).

Locations

Country	Name	City	State
Korea, Republic of	Daegu Catholic University Medical Center	Daegu	Kyungsangbukdo

Sponsors (1)

Lead Sponsor	Collaborator
Daegu Catholic University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Change from baseline to 5 weeks
Secondary	Short form McGill pain questionnaire	Evaluation will performed before treatment, after 3 week, and 5 week (2 weeks follow-up).	Change from baseline to 5 weeks
Secondary	Oswestry Disability Index (ODI)	Evaluation will be performed before treatment, after 3 week, and 5 week (2 weeks follow-up).	Change from baseline to 5 weeks