Pain in Leg, UnspecifiedNCT01449994
Efficacy of Instrumental Chiropractic Treatment Using Activator Methods for Pain and Dysfunction in Juvenile Athletes
A study testing Activator IV (Activator Methods Int. Phoenix, Arizona) in people with Pain in Leg, Unspecified and Knee Sprain, run by Medical University of Graz at 1 site in Austria.
Trial summary
The goal of the study is to prove efficacy of instrumental chiropractic treatment for leg pain in juvenile athletes. A randomized placebo controlled clinical trial including juvenile athletes with functional impairment and pain in thigh, leg or foot is performed. Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain in Leg, Unspecified, Knee Sprain
- What is being tested?
- Activator IV (Activator Methods Int. Phoenix, Arizona)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteAustria
- Study dates
- Jul 2010to Feb 2012
- 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 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- functional problems in the lower extremities
Who cannot join
- severe pathology that requires different treatment
Trial locations and contacts
1 site in 1 country.
Austria1 site
MedUni Graz Pediatric Surgery and Ped. Orthopedics
Graz, Styria, 8036
About this study
Official title: Efficacy of Instrumental Chiropractic Treatment Using Activator Methods for Pain and Dysfunction.A Randomized Placebo-controlled Clinical Study on Juvenile Athletes With Leg Pain
The goal of the study is to prove efficacy of instrumental chiropractic treatment for leg pain in juvenile athletes.
A randomized placebo controlled clinical trial including juvenile athletes with functional impairment and pain in thigh, leg or foot is performed.
Hypothesis: Instrumental chiropractic treatment with the "activator instrument "following the "activator methods" diagnostic evaluation should lead to significant improvement of complaints and functional impairment compared to the control group treated by a deactivated instrument following a sham evaluation protocol.
Read the detailed description
Pain and functional impairment may force young athletes to interrupt training plans and/or even stay away from competition. Usually elite athletes run through an abundance of tests and diagnostic features-too often these high cost diagnostics don´t provide useful information for treatment. Treating the symptoms in the first place (after ruling out severe pathology) will reduce the need for extensive diagnostic routines and bring athletes back to competition earlier.
In our outpatient department of young elite sportsmen chiropractic instrumental treatment is performed routinely- mostly a pain reduction of 3-4 levels in VAS is achieved within the first session of treatment.
The following study is thought to prove the efficacy of the Chiropractic Instrumental Treatment performed at our sports-medicine outpatient department.
- Conditions
- Pain in Leg, Unspecified, Knee Sprain
- Being tested
- Activator IV (Activator Methods Int. Phoenix, Arizona)
- Keywords
- knee, hip, ankle, foot, pain, lower limb, activator, instrumental, chiropractic, Painful functional conditions of the lower extremity
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Activator IV (Activator Methods Int. Phoenix, Arizona)Device
Also called Chiropractic adjusting instrument
Instruments gives a defined impulse on specified areas of the body
| Study group | Role | What they receive |
|---|---|---|
| Placebo-Activator | Placebo comparator | Treatment with Placebo Activator IV Receives: Device: Activator IV (Activator Methods Int. Phoenix, Arizona) |
| Activator | Active comparator | Treatment with Activator IV adjusting instrument Receives: Device: Activator IV (Activator Methods Int. Phoenix, Arizona) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of Pain
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startJul 2010
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain in Leg, UnspecifiedStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frank Schneider, MD, Medical University of Graz
- Investigators
- Frank J Schneider, MD, Principal investigator, Meical University Graz Department of pediatric orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449994
- Sponsor's protocol ID
- Activator in Austria
- Status last verified
- Feb 2012
- First submitted
- 20 Jul 2011
- Last updated
- 8 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Instrumental Chiropractic Treatment Using Activator Methods for Pain and Dysfunction.A Randomized Placebo-controlled Clinical Study on Juvenile Athletes With Leg Pain
- ClinicalTrials.gov ID
- NCT01449994
- Acronym / sponsor ID
- Activator in Austria
- Conditions
- Pain in Leg, Unspecified, Knee Sprain
- Keywords
- knee, hip, ankle, foot, pain, lower limb, activator, instrumental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Oct 2011 (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 goal of the study is to prove efficacy of instrumental chiropractic treatment for leg pain in juvenile athletes.
A randomized placebo controlled clinical trial including juvenile athletes with functional impairment and pain in thigh, leg or foot is performed.
Hypothesis: Instrumental chiropractic treatment with the "activator instrument "following the "activator methods" diagnostic evaluation should lead to significant improvement of complaints and functional impairment compared to the control group treated by a deactivated instrument following a sham evaluation protocol.
Detailed description
Pain and functional impairment may force young athletes to interrupt training plans and/or even stay away from competition. Usually elite athletes run through an abundance of tests and diagnostic features-too often these high cost diagnostics don´t provide useful information for treatment. Treating the symptoms in the first place (after ruling out severe pathology) will reduce the need for extensive diagnostic routines and bring athletes back to competition earlier.
In our outpatient department of young elite sportsmen chiropractic instrumental treatment is performed routinely- mostly a pain reduction of 3-4 levels in VAS is achieved within the first session of treatment.
The following study is thought to prove the efficacy of the Chiropractic Instrumental Treatment performed at our sports-medicine outpatient department.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo-Activator | Placebo comparator | Device: Activator IV (Activator Methods Int. Phoenix, Arizona)Treatment with Placebo Activator IV |
| Activator | Active comparator | Device: Activator IV (Activator Methods Int. Phoenix, Arizona)Treatment with Activator IV adjusting instrument |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- functional problems in the lower extremities
Key exclusion criteria (1 listed)
- severe pathology that requires different 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 |
|---|---|---|
| Activator IV (Activator Methods Int. Phoenix, Arizona)Also: Chiropractic adjusting instrumentInstruments gives a defined impulse on specified areas of the body | Device | Activator, Placebo-Activator |
Primary outcome
Reduction of Pain
Time frame: 1 week
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 8 Feb 2012.
Related trials for Pain in Leg, Unspecified
Not yet recruiting
Mulligan Mobilization Techniques for Non-Specific Low Back Pain
Non-specific Low Back Pain (NSLBP)
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.
Frank J Schneider, MD principal investigator
Meical University Graz Department of pediatric orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Activator IV (Activator Methods Int. Phoenix, Arizona) in people with Pain in Leg, Unspecified and Knee Sprain, run by Medical University of Graz at 1 site in Austria.
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 1 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: finished, as of the sponsor's last update on 8 Feb 2012. 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 Austria. 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?
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?
Reduction of Pain (time frame: 1 week). 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 Feb 2012.