Spinal FractureNCT03359941
Acupuncture Treatment for Vertebral Compression Fracture
A study testing acupuncture in people with Spinal Fracture and Compression Fracture, run by Korean Medicine Hospital of Pusan National University at 1 site in South Korea.
Trial summary
Patients with vertebral compression fractures (VCF) may experience pain, limitation of daily activities, and various complications (e.g., insomnia, constipation, urinary infection, depression, diminished quality of life). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Spinal Fracture, Compression Fracture, Fractures, Bone
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2016to 19 Dec 2016
- 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
- Is at least 19 years of age
- Radiographic confirmation of one more subacute or chronic stable vertebral compression fractures (x-ray, computerized tomography, or magnetic resonance imaging)
- Patient-reported pain intensity equal or greater than 4 points on 0 to 10 VAS scale at baseline
- Willingness to participate in the study and provide written informed consent
- Is able to give written consent independently or with a supporter's help
Who cannot join
- Pathological fracture (malignancy, myeloma, metabolic disease, etc.)
- Spine malformation
- Pregnancy, infection, impaired cognitive function
- Hypersensitive reaction to acupuncture treatment
- Need for surgical treatment
- Neurologic deficit: spinal cord injury, cauda equina syndrome
- Unstable fracture: three-column collapse, burst fracture, posterior ligament rupture, distraction fracture
- Scoliotic angle ≥ 12°
Trial locations and contacts
1 site in 1 country.
South Korea1 site
National Clinical Research Centre for Korean Medicine, Korean Medicine Hospital, Pusan National University
Yangsan, Kyung Sang South Province, 626770
About this study
Official title: Acupuncture Treatment for Pain Relief and Functional Recovery in Patients With Vertebral Compression Fracture
Patients with vertebral compression fractures (VCF) may experience pain, limitation of daily activities, and various complications (e.g., insomnia, constipation, urinary infection, depression, diminished quality of life).
Objective:
This study aims to evaluate the effectiveness, safety and feasibility of acupuncture treatments to achieve pain relief and functional recovery in patients with VCF.
Read the detailed description
Patients who have subacute or chronic vertebral compression fracture in one or more thoracic/lumbar vertebral body are eligible. Patients who have willingness to participate and provide written informed consents will be treated to the Pusan National University Korean Medicine Hospital with once to three times per weak for six weeks approximately. (total 12-18 sessions)
- Conditions
- Spinal Fracture, Compression Fracture, Fractures, Bone
- Being tested
- acupuncture
- Keywords
- Integrative Treatments, Korean Traditional medicine
- Medical subject headings
- Spinal Fractures, Fractures, Compression, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Acupuncture points: Examples of acupuncture points to be used include BL23 (Sinsu, bilateral), BL24(Gihaesu, bilateral), BL25(Daejangsu, bilateral), BL40(Wijung, bilateral), BL60(Gollyun, bilateral), BL65(Sokgol, bilateral), LI11(Gokji, bilateral), LI4(Hapgok, bilateral), ST36(Joksamni, bilateral), GB41(Jogimeup, bilateral), LR3(Taechung, bilateral). Electrical stimulation with alternating frequency of 2-100 Hz will be applied to the selected points (e.g., BL 23-25, bilateral). Treatments will be provided by qualified Korean traditional medicine doctors with more than 2 years of clinical experience.
| Study group | Role | What they receive |
|---|---|---|
| Integrative Treatments | Experimental | This study's arm is single, so all participants will receive acupuncture treatments. Receives: Procedure: acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity on the Visual Analog Scale (VAS)
VAS will be used to assess pain intensity reflecting average patient-perceived pain during the previous 24 hours. The scale ranges from 0 (no pain) to 10 (the worst pain imaginable).
Measured: 6 weeks from the first treatment
Secondary outcomes (7)
Patient's satisfaction with treatment using the Patient Global Assessment(PGA)
Response options include very much satisfied, somewhat satisfied, neutral, somewhat dissatisfied, and very much dissatisfied.
Measured: 6 weeks from the first treatment
Back-specific dysfunction using the Oswestry Disability Index (ODI)
The questionnaire has 10 items to assess limitations of various activities of daily living. Each section is scored on a 0-5 score. Total scores are reported from 0 to 100, with higher scores indicating greater disability.
Measured: baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
Quality of life using the Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
QUALEFFO is used to evaluate the effect of back pain and treatment on quality of life. The questionnaire includes 26 items in 5 domains; pain, physical function, social function, general health perception, and mental function. Total scores are reported from 0 to 100, with lower scores corresponding to better quality of life.
Measured: baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
Physical function using Time Up and Go (TUG)
TUG measures the time taken to stand from a chair, walk 3 meters, turn, and return to sitting in the chair.
Measured: baseline, 6 weeks from the first treatment
Adverse events related to integrative treatments as a measure of safety
Expected or unexpected adverse events will be measured during the allocated intervention process and during the entire follow-up period. Both the types of adverse events and their frequency of occurrence will be measured.
Measured: under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
Use of medication for pain control during treatment
Information on the use of medication will be collected by directly asking the patient at every visit. Medication type, dose, and frequency will be recorded and assessed.
Measured: under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
Number of patients who received surgery
The number of patients who participated in the trial but finally received surgery during the study period will be counted.
Measured: 12 weeks from the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Feb 2016
- Primary completion19 Dec 2016
- Study completion19 Dec 2016
Why it stopped: Low recruit rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korean Medicine Hospital of Pusan National University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kun Hyung Kim, PhD, Principal investigator, Korean Medicine Hospital of Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359941
- Sponsor's protocol ID
- N2015002
- Status last verified
- Nov 2017
- First submitted
- 10 Dec 2015
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Treatment for Pain Relief and Functional Recovery in Patients With Vertebral Compression Fracture
- ClinicalTrials.gov ID
- NCT03359941
- Acronym / sponsor ID
- N2015002
- Conditions
- Spinal Fracture, Compression Fracture, Fractures, Bone
- Keywords
- Integrative Treatments, Korean Traditional medicine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruit rate
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Korean Medicine Hospital of Pusan National UniversityUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 19 Dec 2016 (actual)
- Study completion
- 19 Dec 2016 (actual)
- First posted
- 2 Dec 2017 (actual)
- 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.
Patients with vertebral compression fractures (VCF) may experience pain, limitation of daily activities, and various complications (e.g., insomnia, constipation, urinary infection, depression, diminished quality of life).
Objective:
This study aims to evaluate the effectiveness, safety and feasibility of acupuncture treatments to achieve pain relief and functional recovery in patients with VCF.
Detailed description
Patients who have subacute or chronic vertebral compression fracture in one or more thoracic/lumbar vertebral body are eligible. Patients who have willingness to participate and provide written informed consents will be treated to the Pusan National University Korean Medicine Hospital with once to three times per weak for six weeks approximately. (total 12-18 sessions)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Integrative Treatments | Experimental | Procedure: acupunctureThis study's arm is single, so all participants will receive acupuncture treatments. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Is at least 19 years of age
- Radiographic confirmation of one more subacute or chronic stable vertebral compression fractures (x-ray, computerized tomography, or magnetic resonance imaging)
- Patient-reported pain intensity equal or greater than 4 points on 0 to 10 VAS scale at baseline
- Willingness to participate in the study and provide written informed consent
- Is able to give written consent independently or with a supporter's help
Key exclusion criteria (8 listed)
- Pathological fracture (malignancy, myeloma, metabolic disease, etc.)
- Spine malformation
- Pregnancy, infection, impaired cognitive function
- Hypersensitive reaction to acupuncture treatment
- Need for surgical treatment
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: Examples of acupuncture points to be used include BL23 (Sinsu, bilateral), BL24(Gihaesu, bilateral), BL25(Daejangsu, bilateral), BL40(Wijung, bilateral), BL60(Gollyun, bilateral), BL65(Sokgol, bilateral), LI11(Gokji, bilateral), LI4(Hapgok, bilateral), ST36(Joksamni, bilateral), GB41(Jogimeup, bilateral), LR3(Taechung, bilateral). Electrical stimulation with alternating frequency of 2-100 Hz will be applied to the selected points (e.g., BL 23-25, bilateral). Treatments will be provided by qualified Korean traditional medicine doctors with more than 2 years of clinical experience. | Procedure or surgery | Integrative Treatments |
Primary outcome
Pain intensity on the Visual Analog Scale (VAS)
Time frame: 6 weeks from the first treatment
VAS will be used to assess pain intensity reflecting average patient-perceived pain during the previous 24 hours. The scale ranges from 0 (no pain) to 10 (the worst pain imaginable).
7 secondary outcomes
Patient's satisfaction with treatment using the Patient Global Assessment(PGA)
Time frame: 6 weeks from the first treatment
Back-specific dysfunction using the Oswestry Disability Index (ODI)
Time frame: baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
Quality of life using the Quality-of-Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO)
Time frame: baseline, 6 weeks from the first treatment, 12 weeks from the first treatment
Physical function using Time Up and Go (TUG)
Time frame: baseline, 6 weeks from the first treatment
Adverse events related to integrative treatments as a measure of safety
Time frame: under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
Use of medication for pain control during treatment
Time frame: under treatment, 6 weeks from the first treatment, 12 weeks from the first treatment
Number of patients who received surgery
Time frame: 12 weeks from the first treatment
Results and safety
The study was stopped early (reason given: Low recruit rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Kun Hyung Kim, PhD principal investigator
Korean Medicine Hospital of Pusan National University
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 in people with Spinal Fracture and Compression Fracture, 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 5 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: stopped early, as of the sponsor's last update on 2 Dec 2017. 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 recruit rate). 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?
Pain intensity on the Visual Analog Scale (VAS) (time frame: 6 weeks from the first treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2017.