Spinal Compression FractureNCT01913587

Efficacy Study of Acupuncture on Spinal Compression Fracture

A study testing Acupuncture and Nerve block in people with Spinal Compression Fracture, run by Daegu Catholic University Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 50 years and older
Conditions the study is for: Spinal Compression Fracture
What is being tested?: Acupuncture and Nerve block
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteSouth Korea
Study dates: Mar 2013to Mar 2014
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Daegu Catholic University Medical Center
Daegu, Kyungsangbukdo

Other trials in South Korea

About this study

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

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.

Conditions: Spinal Compression Fracture
Being tested: Acupuncture, Nerve block

What participants receive

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

AcupunctureDevice
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 blockProcedure or surgery
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).

Study groups in NCT01913587
Study group	Role	What they receive
Acupuncture & Nerve block	Experimental	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. Receives: Device: Acupuncture; Procedure: Nerve block
Nerve block	Active comparator	Epidural nerve block and medial branch block will be performed once per week, total 3 sessions, during 3 weeks. Receives: Procedure: Nerve block

What is being measured

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

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).
Measured: Change from baseline to 5 weeks

Secondary outcomes (2)

Short form McGill pain questionnaire
Evaluation will performed before treatment, after 3 week, and 5 week (2 weeks follow-up).
Measured: Change from baseline to 5 weeks
Oswestry Disability Index (ODI)
Evaluation will be performed before treatment, after 3 week, and 5 week (2 weeks follow-up).
Measured: Change from baseline to 5 weeks

Timeline

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

Mar 2013Mar 2014

First posted1 Aug 2013 (estimated)
Study startMar 2013
Primary completionMar 2014
Study completionMar 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Spinal Compression FractureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01913587
Sponsor's protocol ID: CIMI-13-01-21
Status last verified: Dec 2021
First submitted: 30 Jul 2013
Last updated: 22 Dec 2021
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
RecruitingObservational study
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Vertebral Compression Fractures, Pathological Fracture
Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
Active, not recruiting
Sickle Cell Disease (SCD) Bone Pain Study
Sickle Cell Disease, Sickle Cell Anemia

All Spinal Compression Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Acupuncture on Spinal Compression Fracture in Patients Treated With Nerve Block
ClinicalTrials.gov ID: NCT01913587
Acronym / sponsor ID: CIMI-13-01-21
Conditions: Spinal Compression Fracture
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Daegu Catholic University Medical CenterUniversity, hospital or other
Study start: Mar 2013 (actual)
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 1 Aug 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Acupuncture & Nerve block	Experimental	Device: Acupuncture, Procedure: Nerve blockAcupuncture 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.
Nerve block	Active comparator	Procedure: Nerve blockEpidural nerve block and medial branch block will be performed once per week, total 3 sessions, during 3 weeks.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcupunctureAcupuncture 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).	Device	Acupuncture & Nerve block
Nerve blockEpidural 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).	Procedure or surgery	Acupuncture & Nerve block, Nerve block

Primary outcome

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).

2 secondary outcomes

Short form McGill pain questionnaire
Time frame: Change from baseline to 5 weeks
Oswestry Disability Index (ODI)
Time frame: Change from baseline to 5 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.

Related trials for Spinal Compression Fracture

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
RecruitingObservational study
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Vertebral Compression Fractures, Pathological Fracture
Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
Active, not recruiting
Sickle Cell Disease (SCD) Bone Pain Study
Sickle Cell Disease, Sickle Cell Anemia

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acupuncture and Nerve block in people with Spinal Compression Fracture, run by Daegu Catholic University Medical Center 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 8 inclusion and 8 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: finished, as of the sponsor's last update on 22 Dec 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Visual analogue scale (VAS) (time frame: Change from baseline to 5 weeks). 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 NCT01913587.

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 22 Dec 2021.