Chronic Low Back PainEARPIBNCT01995279
Ear Acupuncture Reducing Pain and Improving Balance
A study testing French ear acupuncture in people with Chronic Low Back Pain, run by Universidade Cruzeiro do Sul at 1 site in Brazil.
Trial summary
The aim of the present project is to examine the effects of single session of French ear acupuncture on pain sensation and on postural control in individuals with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- French ear acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Complaints of back pain lasting more than 12 weeks
- Pain referred larger than 4 according to the 11-points pain scale
Who cannot join
- No other musculoskeletal injury,
- Individuals diagnosed with structural damage
- Individuals who performed a spine surgery
- Individuals who have sensory abnormalities or dizziness.
- Individuals may not be in physical therapy for reducing low back pain.
- Painkillers or anti-inflammatories use 24 hours before the experimental procedure.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratório de Análise do Movimento, Universidade Cruzeiro do Sul
São Paulo, São Paulo, 01506-000
Paulo B de Freitas, PhD, +55(11)3385-3103, deFreitasPB@gmail.com
Bianca P Cunha, PT, MSc
About this study
Official title: The Effects of a Single Session of Ear Acupuncture in Pain Sensation and Body Balance
The aim of the present project is to examine the effects of single session of French ear acupuncture on pain sensation and on postural control in individuals with chronic low back pain.
We hypothesize that:
Read more
- The application of French ear acupuncture at specific points to reduce low back pain would decrease pain intensity in patients with chronic low back pain.
II) The pain reduction would be greater for those individuals with low back pain who receive application of French ear acupuncture at specific points to reduce low back pain compared with patients who receive placebo treatment.
III) The application of French ear acupuncture at specific points to reduce back pain will have positive effect on the performance of the postural control system.
- Conditions
- Chronic Low Back Pain
- Being tested
- French ear acupuncture, Sham Ultrasound
- Keywords
- low back pain, French Auriculotherapy, postural control, balance, posture
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
French ear acupunctureDevice
Also called Auriculotherapy
Single session (20 minutes) of French ear acupuncture at specific location used to reduce low back pain.
Sham UltrasoundOther
Also called Ultrasound
Ultrasound turned off.
| Study group | Role | What they receive |
|---|---|---|
| French ear acupuncture | Experimental | Application of single session of French ear acupuncture at specific points used to reduce low back pain. Receives: Device: French ear acupuncture |
| Sham Ultrasound | Placebo comparator | Sham ultrasound will be applied at lumbar spine. Receives: Other: Sham Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
11-point Short Pain Scale (SPS-11)
Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound
Measured: 20 minute
Secondary outcomes (1)
Center of pressure sway area
Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound
Measured: 20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Cruzeiro do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Barbosa de Freitas Junior, Universidade Cruzeiro do Sul
- Investigators
- Paulo B de Freitas, PhD, Principal investigator, Associate Professor, Universidade Cruzeiro do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995279
- Sponsor's protocol ID
- UCS_EA
- Acronym
- EARPIB
- Status last verified
- Nov 2013
- First submitted
- 21 Nov 2013
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ushinohama A, Cunha BP, Costa LO, Barela AM, Freitas PB. Effect of a single session of ear acupuncture on pain intensity and postural control in individuals with chronic low back pain: a randomized controlled trial. Braz J Phys Ther. 2016 Jul-Aug;20(4):328-35. doi: 10.1590/bjpt-rbf.2014.0158. Epub 2016 Jun 16.
PubMed 27556389
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Single Session of Ear Acupuncture in Pain Sensation and Body Balance
- ClinicalTrials.gov ID
- NCT01995279
- Acronym / sponsor ID
- EARPIB / UCS_EA
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, French Auriculotherapy, postural control, balance, posture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidade Cruzeiro do SulUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 26 Nov 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.
The aim of the present project is to examine the effects of single session of French ear acupuncture on pain sensation and on postural control in individuals with chronic low back pain.
We hypothesize that:
- The application of French ear acupuncture at specific points to reduce low back pain would decrease pain intensity in patients with chronic low back pain.
II) The pain reduction would be greater for those individuals with low back pain who receive application of French ear acupuncture at specific points to reduce low back pain compared with patients who receive placebo treatment.
III) The application of French ear acupuncture at specific points to reduce back pain will have positive effect on the performance of the postural control system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| French ear acupuncture | Experimental | Device: French ear acupunctureApplication of single session of French ear acupuncture at specific points used to reduce low back pain. |
| Sham Ultrasound | Placebo comparator | Other: Sham UltrasoundSham ultrasound will be applied at lumbar spine. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Complaints of back pain lasting more than 12 weeks
- Pain referred larger than 4 according to the 11-points pain scale
Key exclusion criteria (6 listed)
- No other musculoskeletal injury,
- Individuals diagnosed with structural damage
- Individuals who performed a spine surgery
- Individuals who have sensory abnormalities or dizziness.
- Individuals may not be in physical therapy for reducing low back pain.
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 |
|---|---|---|
| French ear acupunctureAlso: AuriculotherapySingle session (20 minutes) of French ear acupuncture at specific location used to reduce low back pain. | Device | French ear acupuncture |
| Sham UltrasoundAlso: UltrasoundUltrasound turned off. | Other | Sham Ultrasound |
Primary outcome
11-point Short Pain Scale (SPS-11)
Time frame: 20 minute
Treatment: single session of French ear acupuncture. Placebo: 20 minute application of sham ultrasound
1 secondary outcome
Center of pressure sway area
Time frame: 20 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
- Derived from this study: PubMed 27556389Ushinohama A, Cunha BP, Costa LO, Barela AM, Freitas PB. Effect of a single session of ear acupuncture on pain intensity and postural control in individuals with chronic low back pain: a randomized controlled trial. Braz J Phys Ther. 2016 Jul-Aug;20(4):328-35. doi: 10.1590/bjpt-rbf.2014.0158. Epub 2016 Jun 16.
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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.
Laboratório de Análise do Movimento, Universidade Cruzeiro do Sul
São Paulo, Brazil
Paulo B de Freitas, PhD principal investigator
Associate Professor, Universidade Cruzeiro do Sul
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing French ear acupuncture in people with Chronic Low Back Pain, run by Universidade Cruzeiro do Sul at 1 site in Brazil.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Nov 2013. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
11-point Short Pain Scale (SPS-11) (time frame: 20 minute). 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 NCT01995279, which also lists 1 linked publication.
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 26 Nov 2013.