Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
WITHDRAWN
Clinical Phase
PHASE2
Study Classification
INTERVENTIONAL
Study Start Date
2022-11-30
Study Completion Date
2024-06-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Background Digital vasospasm as part of frostbite sequelae is comparable to the vasospastic disorders found in Raynaud's phenomenon which has been successfully treated with Botulinum toxin type A injections in the palm of the hands.
Aim of this pilot study To investigate the effect of Botulinum toxin type A for frostbite sequelae in the fingers.
Hypothesis The null hypothesis which is that all study-subjects will have equal distribution of symptoms and measurements after treatment, regardless of injection with Botulinum toxin type A or placebo.
Methodology A randomized, double-blind, placebo-controlled study design, The study population consists of four patients with frostbite sequelae. The patients are randomized to either treatment with Botulinum toxin type A or placebo Two patients in the primary treatment group will receive Botulinum toxin type A at their first injection at inclusion, while the two patients in the secondary treatment group will receive normal saline (placebo) as their first injection at inclusion. At 6 weeks follow up, the primary treatment group will receive their second injection of Botulinum toxin type A and the secondary treatment group now will receive their second injection, but this will be their first injection of Botulinum toxin type A.
By using the described study-design, all participating soldiers will get treatment. However, the secondary treatment group will have a delayed onset of treatment with Botulinum toxin type A and serves as a control for the primary treatment group during the initial 6 weeks observation.
Botulinum toxin A and placed will be injected near the neurovascular bundle at the A1 pulley in the palm of the hand using a total dosage 100 U per hand (concentration 50 U per ml), 8-12 U/ injection site.
The effect of Botulinum toxin type A on subjective symptoms will be measured by Patients Subjective Symptom Score (PSSS) The effect of Botulinum toxin type A on peripheral microcirculation will be evaluated with dynamic infrared thermography (DIRT) of the dorsal side of the hands. Quantitative sensory testing will be used to evaluate the effect of Botulinum toxin type A on peripheral nerve function. Both DIRT and QST will be performed prior to the treatment with Botulinum toxin type A and placebo at the start of the pilot study, at 6 weeks as well as 6 weeks after the last injections.
Statistical methods and data analysis will be performed according to the EMA guidelines for biostatistics. Statistical analysis will be performed according to the null hypothesis.
Aim of this pilot study To investigate the effect of Botulinum toxin type A for frostbite sequelae in the fingers.
Hypothesis The null hypothesis which is that all study-subjects will have equal distribution of symptoms and measurements after treatment, regardless of injection with Botulinum toxin type A or placebo.
Methodology A randomized, double-blind, placebo-controlled study design, The study population consists of four patients with frostbite sequelae. The patients are randomized to either treatment with Botulinum toxin type A or placebo Two patients in the primary treatment group will receive Botulinum toxin type A at their first injection at inclusion, while the two patients in the secondary treatment group will receive normal saline (placebo) as their first injection at inclusion. At 6 weeks follow up, the primary treatment group will receive their second injection of Botulinum toxin type A and the secondary treatment group now will receive their second injection, but this will be their first injection of Botulinum toxin type A.
By using the described study-design, all participating soldiers will get treatment. However, the secondary treatment group will have a delayed onset of treatment with Botulinum toxin type A and serves as a control for the primary treatment group during the initial 6 weeks observation.
Botulinum toxin A and placed will be injected near the neurovascular bundle at the A1 pulley in the palm of the hand using a total dosage 100 U per hand (concentration 50 U per ml), 8-12 U/ injection site.
The effect of Botulinum toxin type A on subjective symptoms will be measured by Patients Subjective Symptom Score (PSSS) The effect of Botulinum toxin type A on peripheral microcirculation will be evaluated with dynamic infrared thermography (DIRT) of the dorsal side of the hands. Quantitative sensory testing will be used to evaluate the effect of Botulinum toxin type A on peripheral nerve function. Both DIRT and QST will be performed prior to the treatment with Botulinum toxin type A and placebo at the start of the pilot study, at 6 weeks as well as 6 weeks after the last injections.
Statistical methods and data analysis will be performed according to the EMA guidelines for biostatistics. Statistical analysis will be performed according to the null hypothesis.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Botulinum Toxin in the Treatment of Raynaud's
NCT01233999
Raynaud's Syndrome
COMPLETED
NA
Botulinum Toxin Type A for Cold Intolerance Secondary to Digital Amputations and Replantations: A Pilot Study
NCT04917731
Cold Intolerance
UNKNOWN
PHASE1
Evaluation of Botulinum TOXin Type a in the Treatment of Buerger's Disease
NCT05698979
Buerger Disease
Raynaud Syndrome
NOT_YET_RECRUITING
PHASE3
A Two-Part Study of BOTOX® Therapy for Ischemic Digits
NCT01309802
Raynaud's Disease
COMPLETED
PHASE2
Botulinum Toxin A for Treatment of Catocholamine Induced Finger Necrosis
NCT01500668
Catocholamine Induced Finger Necrosis
UNKNOWN
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background Frostbite sequelae can have a significant negative impact on quality of life. Depending on the type of frostbite, sequelae such as cold hypersensitivity, sensory loss, chronic pain, hyperhidrosis, growth plate disturbances and osteoarthritis may develop. Long-term paraesthesia with occasional electric shock-type sensations have also been repored. The pathophysiology of these sequelae is still poorly understood although peripheral neurovascular dysfunction plays an important role. This may result in a vasospastic disorder similar as in Raynaud's phenomenon.
Recently, the use of Botulinum toxin type A (BTX-A) for the treatment of vasospastic disorders of the hand has shown to result in great benefits for the patients by reducing the severity and number of vasospastic disorders. BTX-A injections are targeting the neurovascular bundle at or slightly proximal to the A1 pulley in the palm of the hand.
A case history has described the off-label use of BTX-A to treat a Norwegian soldier who suffered from long-term sequelae of frostbite to his hands after a military exercise. He was successfully treated with BTX-A injections in each palm of the hand. At follow up, the patient reported less pain, warmer hands and improved sensory function. Dynamic Infrared thermography (DIRT) showed improved rewarming of all fingers compared to the pre-treatment examination, while Quantattive sensory testing (QST) showed a normalization of sensory function.
Aim of this pilot study To investigate the effect of Botulinum toxin type A for frostbite sequelae in fingers.
Hypothesis The null hypothesis is that all study-subjects will have equal distribution of symptoms and measurements after treatment, regardless of injection with Botulinum toxin type A or placebo.
Methodology A two armed, randomized, double-blind, placebo-controlled study design, performed at one single centre will be used. The study population consists of four soldiers with frostbite sequelae who will be recruited from the Norwegian Armed Forces Health Registry. These four soldiers are randomized to either treatment with Botulinum toxin type A or placebo according to computer-generated random numbers provided by the research unit at the University Hospital of North Norway. Two soldiers in the primary treatment group will receive Botulinum toxin type A at their first injection at inclusion, while the two soldires in the secondary treatment group will receive normal saline (placebo) as their first injection at inclusion. At 6 weeks follow up, the primary treatment group will receive their second injection of Botulinum toxin type A and the secondary treatment group now will receive their second injection, but this will be their first injection of Botulinum toxin type A.
By using the described study-design, all participating soldiers will get treatment. However, the secondary treatment group will have a delayed onset of treatment with Botulinum toxin type A and serves as a control for the primary treatment group during the initial 6 weeks observation.
Botulinum toxin A and placed will be injected near the neurovascular bundle at the A1 pulley in the palm of the hand using a total dosage 100 U per hand (concentration 50 U per ml), 8-12 U/ injection site.
The effect of BTX- A on peripheral microcirculation will be evaluated with dynamic infrared thermography (DIRT) of the dorsal side of the hands. DIRT of the dorsal side of the hands encompass a pre-cooling phase (T1), a cooling phase of one minute (T2), and a four-minute recovery phase (T3, T4, T5 and T6). The pre-cooling phase include baseline measurements before the DIRT takes place and includes also the time from the initial image (T1) until the hands are immersed in water.
The DIRT procedure follows international standards and recommendations involving a cold challenge followed by a rewarming phase with both hands were positioned palms down on a grid made of thin nylon netting strung on a plastic frame. The nylon grid is positioned 7 cm (+/- 0.5 cm) above a uniformly heated base plate (40 +/-2°C) to ensure a thermally uniform background for the thermal imaging.
Quantitative sensory testing will be used to evaluate the effect of BTX- A on peripheral nerve function. Thermal tests will be performed with a device TSA (Medoc, Israel) attaching a thermode to the investigated body part. Thermal tests include detection thresholds for warm and cold sensation, sensory limen (i.e., perception of changing temperatures, pain thresholds for heat and cold pain as well paradoxical cold or heat sensation. It is important to notice, that the maximum temperatures produced by the device are 0° or 50° for cold and warm, respectively. The test system automatically cancels the run, when the participant did not respond with pain up to these temperatures. Mechanical tests include also detection thresholds and pain thresholds. Mechanical detection is evaluated by von Frey hairs (pressure) and a standardized tuning fork (vibration). Pain thresholds are assessed by pin prick stimulation, pressure algometry. Additional tests for allodynia are included as well. Finally, there is a test to assess temporary summation using wind-up ratio to a repeated stimulation with pinprick (10 stimuli with 1/s).
Both DIRT and QST will be performed prior to the treatment with BTX- A and placebo at the start of the pilot study, at 6 weeks as well as 6 weeks after the last injections. At 6 months follow up after the first injection DIRT and QST will be repeated again.
The patient's subjective symptoms are monitored by comparing Patient-Subjective-Symptom-Score (PSSS) after 6 weeks with the baseline values for each patient.
Statistical methods and data analysis will be performed according to the EMA guidelines for biostatistics. Statistical analysis will be performed according to the null hypothesis.
Recently, the use of Botulinum toxin type A (BTX-A) for the treatment of vasospastic disorders of the hand has shown to result in great benefits for the patients by reducing the severity and number of vasospastic disorders. BTX-A injections are targeting the neurovascular bundle at or slightly proximal to the A1 pulley in the palm of the hand.
A case history has described the off-label use of BTX-A to treat a Norwegian soldier who suffered from long-term sequelae of frostbite to his hands after a military exercise. He was successfully treated with BTX-A injections in each palm of the hand. At follow up, the patient reported less pain, warmer hands and improved sensory function. Dynamic Infrared thermography (DIRT) showed improved rewarming of all fingers compared to the pre-treatment examination, while Quantattive sensory testing (QST) showed a normalization of sensory function.
Aim of this pilot study To investigate the effect of Botulinum toxin type A for frostbite sequelae in fingers.
Hypothesis The null hypothesis is that all study-subjects will have equal distribution of symptoms and measurements after treatment, regardless of injection with Botulinum toxin type A or placebo.
Methodology A two armed, randomized, double-blind, placebo-controlled study design, performed at one single centre will be used. The study population consists of four soldiers with frostbite sequelae who will be recruited from the Norwegian Armed Forces Health Registry. These four soldiers are randomized to either treatment with Botulinum toxin type A or placebo according to computer-generated random numbers provided by the research unit at the University Hospital of North Norway. Two soldiers in the primary treatment group will receive Botulinum toxin type A at their first injection at inclusion, while the two soldires in the secondary treatment group will receive normal saline (placebo) as their first injection at inclusion. At 6 weeks follow up, the primary treatment group will receive their second injection of Botulinum toxin type A and the secondary treatment group now will receive their second injection, but this will be their first injection of Botulinum toxin type A.
By using the described study-design, all participating soldiers will get treatment. However, the secondary treatment group will have a delayed onset of treatment with Botulinum toxin type A and serves as a control for the primary treatment group during the initial 6 weeks observation.
Botulinum toxin A and placed will be injected near the neurovascular bundle at the A1 pulley in the palm of the hand using a total dosage 100 U per hand (concentration 50 U per ml), 8-12 U/ injection site.
The effect of BTX- A on peripheral microcirculation will be evaluated with dynamic infrared thermography (DIRT) of the dorsal side of the hands. DIRT of the dorsal side of the hands encompass a pre-cooling phase (T1), a cooling phase of one minute (T2), and a four-minute recovery phase (T3, T4, T5 and T6). The pre-cooling phase include baseline measurements before the DIRT takes place and includes also the time from the initial image (T1) until the hands are immersed in water.
The DIRT procedure follows international standards and recommendations involving a cold challenge followed by a rewarming phase with both hands were positioned palms down on a grid made of thin nylon netting strung on a plastic frame. The nylon grid is positioned 7 cm (+/- 0.5 cm) above a uniformly heated base plate (40 +/-2°C) to ensure a thermally uniform background for the thermal imaging.
Quantitative sensory testing will be used to evaluate the effect of BTX- A on peripheral nerve function. Thermal tests will be performed with a device TSA (Medoc, Israel) attaching a thermode to the investigated body part. Thermal tests include detection thresholds for warm and cold sensation, sensory limen (i.e., perception of changing temperatures, pain thresholds for heat and cold pain as well paradoxical cold or heat sensation. It is important to notice, that the maximum temperatures produced by the device are 0° or 50° for cold and warm, respectively. The test system automatically cancels the run, when the participant did not respond with pain up to these temperatures. Mechanical tests include also detection thresholds and pain thresholds. Mechanical detection is evaluated by von Frey hairs (pressure) and a standardized tuning fork (vibration). Pain thresholds are assessed by pin prick stimulation, pressure algometry. Additional tests for allodynia are included as well. Finally, there is a test to assess temporary summation using wind-up ratio to a repeated stimulation with pinprick (10 stimuli with 1/s).
Both DIRT and QST will be performed prior to the treatment with BTX- A and placebo at the start of the pilot study, at 6 weeks as well as 6 weeks after the last injections. At 6 months follow up after the first injection DIRT and QST will be repeated again.
The patient's subjective symptoms are monitored by comparing Patient-Subjective-Symptom-Score (PSSS) after 6 weeks with the baseline values for each patient.
Statistical methods and data analysis will be performed according to the EMA guidelines for biostatistics. Statistical analysis will be performed according to the null hypothesis.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Cold Hypersensitivity
Vascular System Injuries
Vibration; Disorder
Sensory Disorders
Pain, Nerve
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
The methodology uses a two armed, randomized, double-blind, placebo-controlled studydesign, . All participating soldiers will get two injections, one first injection at inclusion and a second injection after 6 weeks. The injections contain either BTX
-A or an inert placebo. Both patient and treating doctor is blinded to content of the injection.
The two patients in the primary treatment group will receive Botox at their first injection at inclusion, while the two patients in the secondary group will receive placebo as their first injection at inclusion. At 6 weeks follow up, the patients in the primary treatment group will receive their second injection of botox. The patients in the secondary treatment group now will receive their second injection, but this will be their first injection of Botox, given at their 6 weeks follow-up.
-A or an inert placebo. Both patient and treating doctor is blinded to content of the injection.
The two patients in the primary treatment group will receive Botox at their first injection at inclusion, while the two patients in the secondary group will receive placebo as their first injection at inclusion. At 6 weeks follow up, the patients in the primary treatment group will receive their second injection of botox. The patients in the secondary treatment group now will receive their second injection, but this will be their first injection of Botox, given at their 6 weeks follow-up.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
double blind
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Botulinum toxin
100 IU botulinum toxin injection in the palm of the hand
Group Type
ACTIVE_COMPARATOR
Botuinum toxin
Intervention Type
DRUG
Injection of botulinum toxin in the palm of the hand
Placebo
Saline injection in the palm of the hand
Group Type
PLACEBO_COMPARATOR
Botuinum toxin
Intervention Type
DRUG
Injection of botulinum toxin in the palm of the hand
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Botuinum toxin
Injection of botulinum toxin in the palm of the hand
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Botox
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Entering the Norwegian Armed Forces Health Registry (NAFHR) between 01.01.2010-31.12.2014
* Still suffering from sequelae related to frostbite injury in their fingers at least four years after their initial frostbite
* Have agreed on receiving a request to participate in the NAFHR quality assurance study.
* Still suffering from sequelae related to frostbite injury in their fingers at least four years after their initial frostbite
* Have agreed on receiving a request to participate in the NAFHR quality assurance study.
Exclusion Criteria
* Patients who cannot read Norwegian information or answer questions in the study
* Patients who are unable to comply the examination and treatment procedures
* Patients who are unable to travel to University Hospital North Norway in Tromsø for examination and treatment
* Patients who have undergone/is undergoing surgical treatment of hands/fingers
* Patients with known allergy/anaphylaxis in relation to the injection of BTX-A
* Patients who have used/are using drugs that interact with BTX-A injection (anticoagulants)
* Patients who are pregnant before start of the trial and/or during the trial
* Patients who are unable to comply the examination and treatment procedures
* Patients who are unable to travel to University Hospital North Norway in Tromsø for examination and treatment
* Patients who have undergone/is undergoing surgical treatment of hands/fingers
* Patients with known allergy/anaphylaxis in relation to the injection of BTX-A
* Patients who have used/are using drugs that interact with BTX-A injection (anticoagulants)
* Patients who are pregnant before start of the trial and/or during the trial
Minimum Eligible Age
20 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital of North Norway
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Arne J Norheim, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of North Norway
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital of North Norway
Tromsø, , Norway
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Norway
References
Explore related publications, articles, or registry entries linked to this study.
Schaefer G, Huguet J, Zhu SY, Plassmann P, Ring F. Adopting the DICOM standard for medical infrared images. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:236-9. doi: 10.1109/IEMBS.2006.259523.
Reference Type
BACKGROUND
Iorio ML, Masden DL, Higgins JP. Botulinum toxin A treatment of Raynaud's phenomenon: a review. Semin Arthritis Rheum. 2012 Feb;41(4):599-603. doi: 10.1016/j.semarthrit.2011.07.006. Epub 2011 Aug 24.
Reference Type
RESULT
Imray C, Grieve A, Dhillon S; Caudwell Xtreme Everest Research Group. Cold damage to the extremities: frostbite and non-freezing cold injuries. Postgrad Med J. 2009 Sep;85(1007):481-8. doi: 10.1136/pgmj.2008.068635.
Reference Type
RESULT
Fabregat G, De Andres J, Villanueva-Perez VL, Asensio-Samper JM. Subcutaneous and perineural botulinum toxin type a for neuropathic pain: a descriptive review. Clin J Pain. 2013 Nov;29(11):1006-12. doi: 10.1097/AJP.0b013e31827eafff.
Reference Type
RESULT
Norheim AJ, Mercer J, Musial F, de Weerd L. A new treatment for frostbite sequelae; Botulinum toxin. Int J Circumpolar Health. 2017;76(1):1273677. doi: 10.1080/22423982.2016.1273677.
Reference Type
RESULT
Segreto F, Marangi GF, Cerbone V, Persichetti P. The Role of Botulinum Toxin A in the Treatment of Raynaud Phenomenon. Ann Plast Surg. 2016 Sep;77(3):318-23. doi: 10.1097/SAP.0000000000000715.
Reference Type
RESULT
Arnold PB, Campbell CA, Rodeheaver G, Merritt W, Morgan RF, Drake DB. Modification of blood vessel diameter following perivascular application of botulinum toxin-A. Hand (N Y). 2009 Sep;4(3):302-7. doi: 10.1007/s11552-009-9169-8. Epub 2009 Feb 5.
Reference Type
RESULT
Ring EF, Ammer K. Infrared thermal imaging in medicine. Physiol Meas. 2012 Mar;33(3):R33-46. doi: 10.1088/0967-3334/33/3/R33. Epub 2012 Feb 28.
Reference Type
RESULT
Moreira DG, Costello JT, Brito CJ, Adamczyk JG, Ammer K, Bach AJE, Costa CMA, Eglin C, Fernandes AA, Fernandez-Cuevas I, Ferreira JJA, Formenti D, Fournet D, Havenith G, Howell K, Jung A, Kenny GP, Kolosovas-Machuca ES, Maley MJ, Merla A, Pascoe DD, Priego Quesada JI, Schwartz RG, Seixas ARD, Selfe J, Vainer BG, Sillero-Quintana M. Thermographic imaging in sports and exercise medicine: A Delphi study and consensus statement on the measurement of human skin temperature. J Therm Biol. 2017 Oct;69:155-162. doi: 10.1016/j.jtherbio.2017.07.006. Epub 2017 Jul 18.
Reference Type
RESULT
Maier C, Baron R, Tolle TR, Binder A, Birbaumer N, Birklein F, Gierthmuhlen J, Flor H, Geber C, Huge V, Krumova EK, Landwehrmeyer GB, Magerl W, Maihofner C, Richter H, Rolke R, Scherens A, Schwarz A, Sommer C, Tronnier V, Uceyler N, Valet M, Wasner G, Treede DR. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): somatosensory abnormalities in 1236 patients with different neuropathic pain syndromes. Pain. 2010 Sep;150(3):439-450. doi: 10.1016/j.pain.2010.05.002.
Reference Type
RESULT
Aru RG, Songcharoen SJ, Seals SR, Arnold PB, Hester RL. Microcirculatory Effects of Botulinum Toxin A in the Rat: Acute and Chronic Vasodilation. Ann Plast Surg. 2017 Jul;79(1):82-85. doi: 10.1097/SAP.0000000000001054.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018/1961(REK)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Efficacy of Botulinum Toxin A in Adult Subjects With Raynaud Phenomenon Secondary to Systemic Sclerosis
NCT03717961
COMPLETED
PHASE3
Radial Diffusion of the Botulinum Toxin Type A (Botox®): Electromyographic Evaluation of the Frontal Muscle
NCT01297634
COMPLETED
PHASE4
Effect of Blood Flow by Botulinum Toxin Injection for Severe Peripheral Artery Occlusive Disease
NCT06878482
RECRUITING
PHASE4
Botulinum Toxin for Carpal Tunnel Syndrome
NCT00701233
WITHDRAWN
PHASE2
Botulinum Toxin Injections by Ultrasounds Guidance and Stretching Exercise in Spastic Toe Clawing
NCT02586142
COMPLETED
PHASE3
Study of a New Generation Botulinum Toxin A2NTX to Treat Spasticity After Stroke
NCT01910363
UNKNOWN
PHASE2/PHASE3
Treatment of Gastrocnemius Tightness and Subsequent Chronic Plantar Fasciitis with Botulinum Toxin a
NCT05218785
RECRUITING
CLINICAL EFFECT OF BOTULINUM TOXIN TYPE A IN TREATMENT OF SPASTICITY
NCT04673240
UNKNOWN
Safety Study of Botulinum Toxin Type A for the Treatment of Focal Upper Limb Poststroke Spasticity
NCT00651729
COMPLETED
PHASE2
Trial Comparing Two Commercial Formulations of Botulinum Toxin Type A in the Treatment of Spasticity
NCT00819065
COMPLETED
PHASE3
Botulinum Toxin A to Treat Arm Tremor
NCT02207946
COMPLETED
PHASE2
Comparative Study Between Botulinum Toxin-A Injection and Shock Waves on Hypertrophic Scars in Hand-burned Children
NCT06174155
COMPLETED
NA
The Effect of Extracorporeal Shock Wave Therapy After Botulinum Toxin Type A Injection for Post-stroke Spasticity
NCT05889026
COMPLETED
NA
A Dosage-dependent Manner of Botulinum Toxin Type A on the Prevention of Postoperative Scars of Various Anatomic Regions of the Body
NCT06349733
COMPLETED
EARLY_PHASE1
Impact Of Physiotherapy And Botox In Improving Functional Outcomes Among Post Stroke Focal Dystonia Patients
NCT03664375
COMPLETED
NA
The Effect of Subcutaneous Injection of Botulinum Toxin A on Chronic Wound Pain in Lower Extremities
NCT05426161
COMPLETED
PHASE4
Effectiveness of Botulinum Toxin A in Preventing Scar Formation and Initial Exploration of "Optimal Concentration"
NCT06437912
COMPLETED
EARLY_PHASE1
Unicentric Comparing Study of Suction Curettage With Standard BOTOX Injection in the Treatment of Patients With Essential Axillar Hyperhidrosis: Comparing of Efficacy, Duration of Effectiveness, and Adverse Events.
NCT00669474
TERMINATED
PHASE4
Factors Determining the Efficacy of Botulinum Toxin for Arm Tremor in Dystonia
NCT06411028
RECRUITING
PHASE4
IncobotulinumtoxinA (Xeomin) for Upper Limb Spasticity
NCT00465738
COMPLETED
PHASE3
Study of Botulinum Toxin and Recovery of Hand Function After Stroke
NCT01422161
COMPLETED
PHASE3
Comparing Upper Limb Surgery and Botulinum Toxin for Spasticity: A Paired Design Study
NCT06733025
RECRUITING
NA
Long-term Efficacy of Spasticity-correcting Surgery and Botulinum Toxin Injections for Upper Limb Spasticity Treatment
NCT03910101
COMPLETED
NA
Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
NCT02460107
TERMINATED
EARLY_PHASE1
Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity
NCT06296082
RECRUITING
PHASE2/PHASE3