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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05702606
• Other study ID #: ASP_Shock_MT
• Status: Completed
• Phase: N/A
• Start date: June 10, 2021
• Est. completion date: October 3, 2022

Study information

• Verified date: January 2023
• Source: Fundacio Aspace Catalunya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Shock
• Spasticity, Muscle

Intervention

Other:
• Radial extracorporeal shock wave therapy (rESWT)
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

Locations

Country	Name	City	State
Spain	Fundació Aspace Catalunya	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Fundacio Aspace Catalunya

Country where clinical trial is conducted

Spain, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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/ — View Citation

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. — View Citation

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. Erratum In: Dev Med Child Neurol. 2016 Mar;58(3):316. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Pain secondary to spasticity assessed by the visual analog scale	If the patient presents pain secondary to spasticity, evaluate the degree of improvement after therapy using the visual analog scale where the value 0 is no pain and 10 is the worst possible pain.	Base line,3,5,9,12 and 24 weeks
Secondary	Satisfaction with the therapy assessed by the visual analog scale	Evaluate the degree of improvement perceived by the patient in relation to the therapy using the visual analog scale where the value 0 is no perceived improvement and 10 is the maximum expected improvement	Base line,3,5,9,12 and 24 weeks
Secondary	Adverse effects by Data collection notebook	Possible adverse effects secondary to treatment such as small bruises, petechiae, or muscle fatigue will be recorded in the data collection notebook	Base line,3,5,9,12 and 24 weeks