Back PainNCT01869140
the Hypoalgesic Effect of Spinal Manual Therapy
A study testing spinal manual therapy in people with Back Pain, run by Institut Franco Europeen de Chiropratique at 1 site in Australia.
Trial summary
To study the immediate effect of spinal manual therapy on pain perception in normal subjects Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- spinal manual therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2013to May 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Students who volunteer from Murdoch University
- -
Who cannot join
- contraindication to spinal manual therapy
Trial locations and contacts
1 site in 1 country.
Australia1 site
Murdoch University
Perth, Western Australia
Bruce Walker, PhD MPH, 0033677500657, B.walker@murdoch.edu.au
Bruce Walker, PhD, MPH
About this study
Official title: the Hypoalgesic Effect of Spinal Manual Therapy on an Healthy Population: a Randomized Clinical Trial
To study the immediate effect of spinal manual therapy on pain perception in normal subjects
Read the detailed description
Is this effect only local or is it also noticed away from the stimulated area? How long does it last? Is there a dose/response phenomenon?
- Conditions
- Back Pain
- Being tested
- spinal manual therapy
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal manual therapyDevice
Also called activator
spinal manipulation either manual or instrumental (activator)
| Study group | Role | What they receive |
|---|---|---|
| sham spinal manual therapy | Sham comparator | activator set to zero Receives: Device: spinal manual therapy |
| percussive spinal manual therapy | Experimental | activator set to the maximum force Receives: Device: spinal manual therapy |
| Firm thoracic spinal manual therapy | Experimental | Firm thoracic manipulation Receives: Device: spinal manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Pressure pain threshold in KPa/Cm2 will be measure with an Algometer (SOMEDIC)
Measured: the pressure pain threshold will be measure immediately after intervention and every 15 minutes during 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Franco Europeen de Chiropratique
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audo, Institut Franco Europeen de Chiropratique
- Investigators
- yannick audo, PhD student, Principal investigator, Institut Franco Europeen de Chiropratique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869140
- Sponsor's protocol ID
- IFEC-001
- Status last verified
- Oct 2013
- First submitted
- 17 May 2013
- Last updated
- 8 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Hypoalgesic Effect of Spinal Manual Therapy on an Healthy Population: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01869140
- Acronym / sponsor ID
- IFEC-001
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Institut Franco Europeen de ChiropratiqueUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 5 Jun 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.
To study the immediate effect of spinal manual therapy on pain perception in normal subjects
Detailed description
Is this effect only local or is it also noticed away from the stimulated area? How long does it last? Is there a dose/response phenomenon?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sham spinal manual therapy | Sham comparator | Device: spinal manual therapyactivator set to zero |
| percussive spinal manual therapy | Experimental | Device: spinal manual therapyactivator set to the maximum force |
| Firm thoracic spinal manual therapy | Experimental | Device: spinal manual therapyFirm thoracic manipulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Students who volunteer from Murdoch University
- -
Key exclusion criteria (1 listed)
- contraindication to spinal manual therapy
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 |
|---|---|---|
| spinal manual therapyAlso: activatorspinal manipulation either manual or instrumental (activator) | Device | Firm thoracic spinal manual therapy, percussive spinal manual therapy, sham spinal manual therapy |
Primary outcome
the Pressure pain threshold in KPa/Cm2 will be measure with an Algometer (SOMEDIC)
Time frame: the pressure pain threshold will be measure immediately after intervention and every 15 minutes during 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2013.
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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.
yannick audo, PhD student principal investigator
Institut Franco Europeen de Chiropratique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal manual therapy in people with Back Pain, run by Institut Franco Europeen de Chiropratique at 1 site in Australia.
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 1 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 8 Oct 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 Australia. 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?
the Pressure pain threshold in KPa/Cm2 will be measure with an Algometer (SOMEDIC) (time frame: the pressure pain threshold will be measure immediately after intervention and every 15 minutes during 1 hour). 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 8 Oct 2013.