SpasticityTOXINECHONCT02566837
Use of Ultrasound in Injections of Botulinum Toxin
A study testing Ultrasound and electrical stimulation in people with Spasticity, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Intramuscular injections of botulinum toxin are currently the best focal treatment of spasticity, with clearly defined indications and role. French and European recommendations focus on the toxin's mode of administration, which must be as precise as possible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spasticity
- What is being tested?
- Ultrasound and electrical stimulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Feb 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with a spasticity associated with a central neurological lesion caused by vascular hemiplegia, head trauma, sequelae of cerebral anoxia, multiple sclerosis, spinal cord injury, or cerebral palsy.
- Patient with a spasticity with an indication for a focal treatment with intramuscular injections of botulinum toxin, and associated with:
- Functional discomfort
- Tardieu score ≥1 for one or several muscles in the upper and/or lower limbs
- Patient naive to intramuscular botulinum toxin injections, and in whom the physician wishes to use the Speywood botulinum toxin (Dysport).
- Patient able to self-evaluate the pain on a VAS and understand three successive instructions, such as those used in the Mini Mental Status(MMS).
Show all 9Show fewer
- Patient able to give his/her consent to participate.
- Patients able to provide a signed informed consent freely for the study protocol and data collection.
- Patient with a recognised Long-Term Illness, and thus necessarily covered by the social security.
Who cannot join
- General contra-indications of botulinum toxin:
- History of myasthenia or Lambert-Eaton syndrome
- History of neuromuscular disease
- Previous surgery with curarization less than a month ago
- Treatment with aminosides, aminoquinoleines or cyclosporine
- Progressive neurological disease at the time of inclusion
Show all 9Show fewer
- Anticoagulant treatment: heparin administered with an electrical syringe or anticoagulant therapy with effective doses
- Legal incompetence (judicial protection, guardianship)
- Subject participating in another study, with an exclusion period on-going at the time of the screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guidance to Alleviate the Pain Associated With Intramuscular Injections of Botulinum Toxin in Spastic Patients
Intramuscular injections of botulinum toxin are currently the best focal treatment of spasticity, with clearly defined indications and role. French and European recommendations focus on the toxin's mode of administration, which must be as precise as possible. The toxin's specific action on motor endplates (blocking the release of acetylcholine) shows the importance of targeted injections within the muscle belly. The pain caused by these injections is due partly the number of injections (up to 30 in a single session), and partly to the use of electrical stimulation guidance. Prevention and alleviation of the pain caused by these injections have become a regulatory obligation since the law of 4 March 2002 relating to the rights of patients and the quality of the health system (" Any person has the right to receive relief from pain, which must, under all circumstances, be prevented, evaluated, taken into account and treated … ").
Read the detailed description
Electrical stimulation guidance is generally used nowadays, and is recommended over the use of palpation and anatomical landmarks. However, electrical stimulation has its limits. It is sometimes poorly tolerated by patients as it causes pain, which is greater in muscles less responsive to such stimulation and requiring a stronger electrical current. The pain also increases with the number of injections performed in a single session. Electrical stimulation does not guarantee for certain that the needle is placed within the muscle, as a stimulation of the aponeurosis may cause the muscle to contract through the excitation of motor branches entering the muscle. The injection of botulinum toxin in the aponeurosis does not provide a satisfactory effect and may render the injection ineffective. In some patients, the muscle to inject may present some degree of retraction with fat degeneration, which reduces its sensitivity to electrical stimulation. Individual patients may also respond poorly or not at all to electrical stimulation, which causes technical and treatment problems. Finally, certain muscles are difficult to locate by electrical stimulation because their contraction produces only weak mechanical effects (e.g. short muscles such as the interossei muscles). All these factors explain why ultrasound imaging provides an interesting alternative guidance technique for botulinum toxin injections. In most cases, it can replace electrical stimulation altogether, and thus avoid the pain it causes. Ultrasound guidance is already recommended in pediatric patients to improve their comfort during the injections. In our study, the patient's comfort during the injection was chosen as the main endpoint because it has already been demonstrated in children and because the investigators feel it is an essential aspect of our routine practice. Moreover, ultrasound imaging helps locate accurately the muscle to be injected. Once the tip of the needle has been located, it can be tracked during the injection, and guided to the muscle belly. Previous studies have already shown that this technique improves the efficacy of the injections. Ultrasound imaging is also interesting when the muscles to be injected are located in a deep plane or close to vital structures, such as nerves, arteries, or veins (e.g. piriformis or psoas). All these considerations have been studied in children and should be validated in adult spastic patients as well.
Therefore, the investigators will compare ultrasound guidance to electrical stimulation guidance in routine clinical practice. This study will be carried out in adult spastic patients who may receive botulinum toxin injections in the Service of Physical Medicine and Rehabilitation of University Teaching Hospital. The aim is to analyse the advantages of this injection technique under current practice conditions.
The evaluating physician (blinded) will conduct a clinical examination of the patients before the injections, and 6 to 8 weeks after the injection of botulinum toxin. The pain associated with the toxin injections will be evaluated after the injections and during the follow-up visit, using the vertical indexed VAS and the Face Pain Scale. The spasticity will be evaluated on the Tardieu scale before the injections and during the follow-up visit. The duration of the botulinum toxin injections will be measured. Finally, functional objectives will be determined prior to the injections. The GAS (Goal Attainment Scaling) methodology will be used during the follow-up visit to determine whether these objectives have been met or not.
- Conditions
- Spasticity
- Being tested
- Ultrasound, electrical stimulation
- Keywords
- ultrasound, Electrical stimulation guidance, botulinum toxin
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
ultrasound imaging to guide the intramuscular injections of botulinum toxin : Ultrasound is used to identify the target muscle, and for guiding the insertion of the needle in the muscle. Once the needle is positioned, the botulinum toxin is injected
electrical stimulationProcedure or surgery
electrical stimulation (reference technique currently recommended over muscle palpation and anatomical landmarks) to guide intramuscular injections of botulinum toxin. Intramuscular injection is carried out in register with the zone where is located the theoretically target muscle. Electrical stimulation (mediated by the tip of the needle) used to verify the correct position of the needle, and reposition it if necessary. Once the needle is correctly positioned, the botulinum toxin is injected.
| Study group | Role | What they receive |
|---|---|---|
| ELEC | Active comparator | electrical stimulation guidance Receives: Procedure: electrical stimulation |
| ECHO | Experimental | ultrasound guidance Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain caused by the injections
pain evaluated by vertical visual analogue scale indexed
Measured: inclusion
Secondary outcomes (5)
Compare the pain felt by the patient
pain evaluated by vertical visual analogue scale indexed
Measured: 7 weeks after inclusion
Compare the pain felt by the patient
pain evaluated by the Face Pain Scale
Measured: 7 weeks after inclusion
reduction of spasticity
using Tardieu scale
Measured: 6-8 weeks after inclusion
Compare the time required to perform the injections of botulinum toxin under ultrasound guidance and under electrical guidance.
Time to perform the injections will be notified in minutes
Measured: inclusion
Compare the efficacy of the injections of botulinum toxin in terms of functional gain.
efficacy was evaluated by Goal Attainment Scaling (GAS)
Measured: 6-8 weeks after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startFeb 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpasticityStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David GASQ, MD, Principal investigator, Service d'explorations fonctionnelles - Hôpital Rangueil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566837
- Sponsor's protocol ID
- 11 425 03
- Other IDs
- 2012-A00004-39
- Acronym
- TOXINECHO
- Status last verified
- Sep 2015
- First submitted
- 18 Aug 2015
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guidance to Alleviate the Pain Associated With Intramuscular Injections of Botulinum Toxin in Spastic Patients
- ClinicalTrials.gov ID
- NCT02566837
- Acronym / sponsor ID
- TOXINECHO / 11 425 03
- Conditions
- Spasticity
- Keywords
- ultrasound, Electrical stimulation guidance, botulinum toxin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 2 Oct 2015 (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.
Intramuscular injections of botulinum toxin are currently the best focal treatment of spasticity, with clearly defined indications and role. French and European recommendations focus on the toxin's mode of administration, which must be as precise as possible. The toxin's specific action on motor endplates (blocking the release of acetylcholine) shows the importance of targeted injections within the muscle belly. The pain caused by these injections is due partly the number of injections (up to 30 in a single session), and partly to the use of electrical stimulation guidance. Prevention and alleviation of the pain caused by these injections have become a regulatory obligation since the law of 4 March 2002 relating to the rights of patients and the quality of the health system (" Any person has the right to receive relief from pain, which must, under all circumstances, be prevented, evaluated, taken into account and treated … ").
Detailed description
Electrical stimulation guidance is generally used nowadays, and is recommended over the use of palpation and anatomical landmarks. However, electrical stimulation has its limits. It is sometimes poorly tolerated by patients as it causes pain, which is greater in muscles less responsive to such stimulation and requiring a stronger electrical current. The pain also increases with the number of injections performed in a single session. Electrical stimulation does not guarantee for certain that the needle is placed within the muscle, as a stimulation of the aponeurosis may cause the muscle to contract through the excitation of motor branches entering the muscle. The injection of botulinum toxin in the aponeurosis does not provide a satisfactory effect and may render the injection ineffective. In some patients, the muscle to inject may present some degree of retraction with fat degeneration, which reduces its sensitivity to electrical stimulation. Individual patients may also respond poorly or not at all to electrical stimulation, which causes technical and treatment problems. Finally, certain muscles are difficult to locate by electrical stimulation because their contraction produces only weak mechanical effects (e.g. short muscles such as the interossei muscles). All these factors explain why ultrasound imaging provides an interesting alternative guidance technique for botulinum toxin injections. In most cases, it can replace electrical stimulation altogether, and thus avoid the pain it causes. Ultrasound guidance is already recommended in pediatric patients to improve their comfort during the injections. In our study, the patient's comfort during the injection was chosen as the main endpoint because it has already been demonstrated in children and because the investigators feel it is an essential aspect of our routine practice. Moreover, ultrasound imaging helps locate accurately the muscle to be injected. Once the tip of the needle has been located, it can be tracked during the injection, and guided to the muscle belly. Previous studies have already shown that this technique improves the efficacy of the injections. Ultrasound imaging is also interesting when the muscles to be injected are located in a deep plane or close to vital structures, such as nerves, arteries, or veins (e.g. piriformis or psoas). All these considerations have been studied in children and should be validated in adult spastic patients as well.
Therefore, the investigators will compare ultrasound guidance to electrical stimulation guidance in routine clinical practice. This study will be carried out in adult spastic patients who may receive botulinum toxin injections in the Service of Physical Medicine and Rehabilitation of University Teaching Hospital. The aim is to analyse the advantages of this injection technique under current practice conditions.
The evaluating physician (blinded) will conduct a clinical examination of the patients before the injections, and 6 to 8 weeks after the injection of botulinum toxin. The pain associated with the toxin injections will be evaluated after the injections and during the follow-up visit, using the vertical indexed VAS and the Face Pain Scale. The spasticity will be evaluated on the Tardieu scale before the injections and during the follow-up visit. The duration of the botulinum toxin injections will be measured. Finally, functional objectives will be determined prior to the injections. The GAS (Goal Attainment Scaling) methodology will be used during the follow-up visit to determine whether these objectives have been met or not.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELEC | Active comparator | Procedure: electrical stimulationelectrical stimulation guidance |
| ECHO | Experimental | Procedure: Ultrasoundultrasound guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient with a spasticity associated with a central neurological lesion caused by vascular hemiplegia, head trauma, sequelae of cerebral anoxia, multiple sclerosis, spinal cord injury, or cerebral palsy.
- Patient with a spasticity with an indication for a focal treatment with intramuscular injections of botulinum toxin, and associated with:
- Functional discomfort
- Tardieu score ≥1 for one or several muscles in the upper and/or lower limbs
- Patient naive to intramuscular botulinum toxin injections, and in whom the physician wishes to use the Speywood botulinum toxin (Dysport).
Key exclusion criteria (9 listed)
- General contra-indications of botulinum toxin:
- Progressive neurological disease at the time of inclusion
- Anticoagulant treatment: heparin administered with an electrical syringe or anticoagulant therapy with effective doses
- Legal incompetence (judicial protection, guardianship)
- Subject participating in another study, with an exclusion period on-going at the time of the screening visit
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 |
|---|---|---|
| Ultrasoundultrasound imaging to guide the intramuscular injections of botulinum toxin : Ultrasound is used to identify the target muscle, and for guiding the insertion of the needle in the muscle. Once the needle is positioned, the botulinum toxin is injected | Procedure or surgery | ECHO |
| electrical stimulationelectrical stimulation (reference technique currently recommended over muscle palpation and anatomical landmarks) to guide intramuscular injections of botulinum toxin. Intramuscular injection is carried out in register with the zone where is located the theoretically target muscle. Electrical stimulation (mediated by the tip of the needle) used to verify the correct position of the needle, and reposition it if necessary. Once the needle is correctly positioned, the botulinum toxin is injected. | Procedure or surgery | ELEC |
Primary outcome
pain caused by the injections
Time frame: inclusion
pain evaluated by vertical visual analogue scale indexed
5 secondary outcomes
Compare the pain felt by the patient
Time frame: 7 weeks after inclusion
Compare the pain felt by the patient
Time frame: 7 weeks after inclusion
reduction of spasticity
Time frame: 6-8 weeks after inclusion
Compare the time required to perform the injections of botulinum toxin under ultrasound guidance and under electrical guidance.
Time frame: inclusion
Compare the efficacy of the injections of botulinum toxin in terms of functional gain.
Time frame: 6-8 weeks after inclusion
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 2 Oct 2015.
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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.
David GASQ, MD principal investigator
Service d'explorations fonctionnelles - Hôpital Rangueil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and electrical stimulation in people with Spasticity, run by University Hospital, Toulouse at 1 site in France.
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 9 inclusion and 9 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 2 Oct 2015. 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 France. 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.
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?
pain caused by the injections (time frame: inclusion). 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 2 Oct 2015.