TorticollisPhase 1NCT01041157
Botulinum Toxin Injection Efficiency
A Phase 1 study testing Resistance training in people with Torticollis and Muscle Spasticity, run by Jyväskylä Central Hospital at 1 site in Finland.
Trial summary
The purpose of the study is to examine the effect of the botulinum toxin injection into muscle tone, strength and mobility with and without muscle exercise effect. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Torticollis, Muscle Spasticity
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2008to Dec 2011
- Phase
- Phase 1
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of cervical dystonia
- Spasticity in splenius capitis muscle
- Regular treatment with botulinum toxin injection
Who cannot join
- Don't want to take part the Trial
- Very long distance from home to Jyväskylä Central Hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Botulinum Toxin Injection After Exercising Splenius Capitis Muscle in Patients With Cervical Dystonia
The purpose of the study is to examine the effect of the botulinum toxin injection into muscle tone, strength and mobility with and without muscle exercise effect.
Read the detailed description
The purpose is also to find out patients subjective symptoms between injections. Hypothesis: Efficiency of the botulinum toxin is more powerful with the muscle exercise before injection.
- Conditions
- Torticollis, Muscle Spasticity
- Being tested
- Resistance training
- Keywords
- Torticollis, Botulinum Toxins
- Medical subject headings
- Torticollis, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Neck muscle trainings effect on botulinum toxin efficiency
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | resistance training Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle tone in splenius capitis muscle
Measured: five months
Secondary outcomes (3)
Pain in the neck
Measured: five months
Mobility in the neck
Measured: five months
Neck muscle strength
Measured: five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TorticollisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jyväskylä Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eurostars
- Investigators
- Jari Ylinen, MD, PhD, Study director, Senior physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041157
- Sponsor's protocol ID
- KSKS
- Status last verified
- Dec 2009
- First submitted
- 8 Dec 2009
- Last updated
- 31 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Botulinum Toxin Injection After Exercising Splenius Capitis Muscle in Patients With Cervical Dystonia
- ClinicalTrials.gov ID
- NCT01041157
- Acronym / sponsor ID
- KSKS
- Conditions
- Torticollis, Muscle Spasticity
- Keywords
- Torticollis, Botulinum Toxins
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Jyväskylä Central HospitalUniversity, hospital or other
- Collaborators
- Eurostars
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 31 Dec 2009 (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 purpose of the study is to examine the effect of the botulinum toxin injection into muscle tone, strength and mobility with and without muscle exercise effect.
Detailed description
The purpose is also to find out patients subjective symptoms between injections. Hypothesis: Efficiency of the botulinum toxin is more powerful with the muscle exercise before injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Resistance trainingresistance training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of cervical dystonia
- Spasticity in splenius capitis muscle
- Regular treatment with botulinum toxin injection
Key exclusion criteria (2 listed)
- Don't want to take part the Trial
- Very long distance from home to Jyväskylä Central Hospital
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 |
|---|---|---|
| Resistance trainingNeck muscle trainings effect on botulinum toxin efficiency | Other | 1 |
Primary outcome
Muscle tone in splenius capitis muscle
Time frame: five months
3 secondary outcomes
Pain in the neck
Time frame: five months
Mobility in the neck
Time frame: five months
Neck muscle strength
Time frame: five months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2009.
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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.
Jari Ylinen, MD, PhD study director
Senior physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Resistance training in people with Torticollis and Muscle Spasticity, run by Jyväskylä Central Hospital at 1 site in Finland.
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 3 inclusion and 2 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 31 Dec 2009. 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 Finland. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Muscle tone in splenius capitis muscle (time frame: five months). 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 31 Dec 2009.