Shock Wave Therapy for Management of Spasticity in Patients With Cerebral Palsy

NCT05702606 | Completed DMC

• 1 other identifier: ASP_Shock_MT
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

Spasticity is the most common motor disorder in cerebral palsy (CP). The objectives of his therapeutic approach include; reducing pain, ease of use of orthopedic aids, improving posture, minimizing contractures and deformity, and facilitating mobility and dexterity, with the ultimate goal of maximizing the potential of the patient and promoting their independence and quality of life. The approach to spasticity in CP is complex and presents itself as a great challenge for the rehabilitation team. Radial extracorporeal shock wave therapy (rESWT) has been established in recent years as an effective, non-invasive alternative with hardly any side effects (small bruises or discomfort during the application) for the management of spasticity in patients with CP. rESWT is a relatively new therapy in the field of neurology, in 2010 was published the first clinical trial where shock waves were applied for the management of spasticity in patients with CP. Currently, few works have studied the efficacy of rESWT in patients with CP. In all of them, the results demonstrated the treatment's effectiveness in reducing spasticity locally in people with CP up to 3 months after the application. The group most studied muscle has been the Triceps Surae, and there is a great disparity regarding the doses of treatment applied in each study, especially regarding the number of sessions and the time interval between sessions. The most widely used protocol is 3 rESWT sessions with a time interval of 1 week between session; This protocol was established as the most effective in the treatment of trauma pathology. Despite all the variability in the administration of the dose, we have been able to observe that none of them has studied the effect of rESWT by lengthening the time interval between sessions beyond one week to check whether the therapeutic effects on spasticity can be prolonged over time by applying the same dose. Most of the studies conclude that future research should be aimed at studying the most optimal dose of treatment as well as evaluating the long-term results.

Conditions

Cerebral Palsy; Spasticity, Muscle; Extracorporeal Shock Wave Therapy

Outcome Measures

Primary Outcomes (2)

• Change in passive range of movement and the stretching reflex in ankle dorsiflexion. Tardieu Scale

  Assess the change in degrees of passive range of motion and the ankle dorsiflexion stretch reflex measured with an inclinometer

  Base line,3,5,9,12 and 24 weeks

• Change in goal attainment scale (GAS)

  Goal attainment scale: Definition of an individual goal at the start. Will be assess the achievement or not of an objective and evaluates the expectations of improvement in each of the goals with a numerical scale from -2 to +2: (-2) Result much lower than expected (-1) Lower than expected result (0) Expected result (+1) Result higher than expected (+2) Result much higher than expected

  Setting of goal(s) at start (base line), assesment al 3,5,9,12 and 24 weeks

Secondary Outcomes (3)

• Pain secondary to spasticity assessed by the visual analog scale

  Base line,3,5,9,12 and 24 weeks

• Satisfaction with the therapy assessed by the visual analog scale

  Base line,3,5,9,12 and 24 weeks

• Adverse effects by Data collection notebook

  Base line,3,5,9,12 and 24 weeks

Study Arms (3)

Control Group

ACTIVE COMPARATOR

3 rESWT sessions with a time interval of 1 week between each session.

Other: Radial extracorporeal shock wave therapy (rESWT)

Experimental Group A

EXPERIMENTAL

3 rESTW sessions with a time interval of 2 weeks between each session.

Other: Radial extracorporeal shock wave therapy (rESWT)

Experimental Group B

EXPERIMENTAL

3 rESTW sessions with a time interval of 4 weeks between each session.

Other: Radial extracorporeal shock wave therapy (rESWT)

Interventions

Radial extracorporeal shock wave therapy (rESWT) OTHER

Radial shock waves are ballistic waves generated by injection of compressed air inside an applicator that fires a projectile into the itself and impacts against the application head

Control Group; Experimental Group A; Experimental Group B

Eligibility Criteria

• Age: 4 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with CP.
• With a CP classified as spastic.
• Spasticity in the Triceps Surae muscle.
• Who have a Gross Motor Classification (GMFCS) level between l and ll
• Having signed the informed consent by the participant or your legal guardian

You may not qualify if:

• Have received treatment with shock waves in the Triceps Surae or any other muscle of the lower extremity in the 6 months before the study.
• Have received treatment with botulinum toxin and/or treatment focal intramuscular injection with phenol or alcohol in the Triceps Surae or some other lower extremity muscle in the 6 months before the study.
• Patients who have undergone surgery for deformities foot orthotics in the last year.
• Fixed deformities in the ankle joint.
• Clinical signs of myopathy and neuropathy.
• Infection or tumor at the site of application of the therapy\*.
• Severe blood dyscrasia\*.
• Blood coagulation disorders\*.
• Treatment with oral anticoagulants\*
• Contraindications of radial extracorporeal shock wave therapy.

Sponsors & Collaborators

• Fundacio Aspace Catalunya: lead

Study Sites (1)

Fundació Aspace Catalunya

Barcelona, 08038, Spain

Location

Related Publications (13)

• Oskoui M, Coutinho F, Dykeman J, Jette N, Pringsheim T. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013 Jun;55(6):509-19. doi: 10.1111/dmcn.12080. Epub 2013 Jan 24.

  PMID: 23346889 BACKGROUND

• Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society; Delgado MR, Hirtz D, Aisen M, Ashwal S, Fehlings DL, McLaughlin J, Morrison LA, Shrader MW, Tilton A, Vargus-Adams J. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2010 Jan 26;74(4):336-43. doi: 10.1212/WNL.0b013e3181cbcd2f.

  PMID: 20101040 BACKGROUND

• National Collaborating Centre for Women's and Children's Health (UK). Spasticity in Children and Young People with Non-Progressive Brain Disorders: Management of Spasticity and Co-Existing Motor Disorders and Their Early Musculoskeletal Complications. London: RCOG Press; 2012 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK116583/

  PMID: 23346608 BACKGROUND

• Ramstad K, Jahnsen R, Skjeldal OH, Diseth TH. Characteristics of recurrent musculoskeletal pain in children with cerebral palsy aged 8 to 18 years. Dev Med Child Neurol. 2011 Nov;53(11):1013-8. doi: 10.1111/j.1469-8749.2011.04070.x.

  PMID: 22014321 BACKGROUND

• Benini R, Shevell MI. Updates in the treatment of spasticity associated with cerebral palsy. Curr Treat Options Neurol. 2012 Dec;14(6):650-9. doi: 10.1007/s11940-012-0192-7.

  PMID: 22851256 BACKGROUND

• Ogden JA, Alvarez RG, Levitt R, Marlow M. Shock wave therapy (Orthotripsy) in musculoskeletal disorders. Clin Orthop Relat Res. 2001 Jun;(387):22-40. doi: 10.1097/00003086-200106000-00005.

  PMID: 11400888 BACKGROUND

• Schmitz C, Csaszar NB, Milz S, Schieker M, Maffulli N, Rompe JD, Furia JP. Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions: a systematic review on studies listed in the PEDro database. Br Med Bull. 2015;116(1):115-38. doi: 10.1093/bmb/ldv047. Epub 2015 Nov 18.

  PMID: 26585999 BACKGROUND

• Mattyasovszky SG, Langendorf EK, Ritz U, Schmitz C, Schmidtmann I, Nowak TE, Wagner D, Hofmann A, Rommens PM, Drees P. Exposure to radial extracorporeal shock waves modulates viability and gene expression of human skeletal muscle cells: a controlled in vitro study. J Orthop Surg Res. 2018 Apr 6;13(1):75. doi: 10.1186/s13018-018-0779-0.

  PMID: 29625618 BACKGROUND

• Manganotti P, Amelio E. Long-term effect of shock wave therapy on upper limb hypertonia in patients affected by stroke. Stroke. 2005 Sep;36(9):1967-71. doi: 10.1161/01.STR.0000177880.06663.5c. Epub 2005 Aug 18.

  PMID: 16109905 BACKGROUND

• Amelio E, Manganotti P. Effect of shock wave stimulation on hypertonic plantar flexor muscles in patients with cerebral palsy: a placebo-controlled study. J Rehabil Med. 2010 Apr;42(4):339-43. doi: 10.2340/16501977-0522.

  PMID: 20358168 BACKGROUND

• Vidal X, Morral A, Costa L, Tur M. Radial extracorporeal shock wave therapy (rESWT) in the treatment of spasticity in cerebral palsy: a randomized, placebo-controlled clinical trial. NeuroRehabilitation. 2011;29(4):413-9. doi: 10.3233/NRE-2011-0720.

  PMID: 22207070 BACKGROUND

• Vidal X, Marti-Fabregas J, Canet O, Roque M, Morral A, Tur M, Schmitz C, Sitja-Rabert M. Efficacy of radial extracorporeal shock wave therapy compared with botulinum toxin type A injection in treatment of lower extremity spasticity in subjects with cerebral palsy: A randomized, controlled, cross-over study. J Rehabil Med. 2020 Jun 30;52(6):jrm00076. doi: 10.2340/16501977-2703.

  PMID: 32556354 BACKGROUND

• Tur Segura M, Gimeno Esteve F, Biedermann Villagra T, Jimenez Redondo J, Garcia Rodriguez N, Mila Villarroel R. Radial extracorporeal shock wave therapy for the management of spasticity in cerebral palsy: study protocol for a randomized controlled trial. Front Neurol. 2024 Jun 13;15:1402452. doi: 10.3389/fneur.2024.1402452. eCollection 2024.

  PMID: 38957349 DERIVED

MeSH Terms

Conditions

Cerebral Palsy; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Míriam Tur Segura, First

  Fundació Aspace Catalunya

  PRINCIPAL INVESTIGATOR

• Raimon Milà Villarroel, third

  Facultat de Ciències de la Salut Blanquerna - Universitat Ramon Llull

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2022
• First Posted: January 27, 2023
• Study Start: June 10, 2021
• Primary Completion: October 3, 2022
• Study Completion: October 3, 2022
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)