Botulinum Toxin Injection Efficiency | NCT01041157

Studies
Botulinum Toxin Injection Efficiency

NCT01041157

Sponsor

Jyväskylä Central Hospital

Status

Unknown status

Last Update Posted

Dec 31, 2009Estimated

Enrollment

22Estimated

Phase

Phase 1

Conditions

Torticollis
Muscle Spasticity

Interventions

Resistance training

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Dec 8, 2009

First Submission Date that Met QC Criteria

Dec 30, 2009

First Posted Date

Dec 31, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2009

Last Update Posted Date

Dec 31, 2009Estimated

Name	Class
Eurostars	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	resistance training	Other: Resistance training

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Resistance training	Other	Neck muscle trainings effect on botulinum toxin efficiency	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle tone in splenius capitis muscle		five months

Secondary Outcomes

Measure	Description	Time Frame
Pain in the neck		five months
Mobility in the neck		five months
Neck muscle strength

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of cervical dystonia
Spasticity in splenius capitis muscle
Regular treatment with botulinum toxin injection

Exclusion Criteria:

Don't want to take part the Trial
Very long distance from home to Jyväskylä Central Hospital

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jari Ylinen, MD, PhD	Senior physician	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Finland Helth Care District		Jyväskylä			Finland

Condition Browse Module

MeSH Terms

ID	Term
D014103	Torticollis
D009128	Muscle Spasticity

Ancestor Terms

ID	Term
D004421	Dystonia
D020820	Dyskinesias
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D055070	Resistance Training

Ancestor Terms

ID	Term
D005081	Exercise Therapy
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided