NCT05923957

Brief Summary

To present an evidence-based case report on the prognosis of a pediatric patient with right sciatica and painful leg. A 5-year-old girl with limping gait, presented with right-sided buttock and lower extremity pain and numbness. There has been a history of trauma prior to this 18-month ago. Following clinical examination, she was found to have numbness along the entire length of her right leg, in addition to a little sensory disturbance, accompanied by weakening in that leg. There was a generalized loss in sensation to pinprick as well as light touch, but it was most noticeable above the right knee joint. The remaining of the clinical exam was normal. High frequency electrical stimulation was done for thirty minutes per day for five days a week for four consecutive weeks. The stimulator provides a biphasic current of 100 Hz frequency. The pulse duration was 200 msec with an (on-off). Stimulus mode (20sec stimulation, 20 sec pause). The maximal stimulation amplitude was 40 - 60 mA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 28, 2023

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 9, 2023

Last Update Submit

June 20, 2023

Conditions

Keywords

High frequency electrical stimulationlumber spinesciatic nervepainful leggait trainingchiropractic

Outcome Measures

Primary Outcomes (1)

  • Nerve conduction velocity

    Motor conduction studies were carried out for both common peroneal, tibial and right main trunk of the right sciatic nerve.

    4 weeks

Study Arms (1)

Intervention

High frequency electrical stimulation was done for thirty minutes per day for five days a week for four consecutive weeks. The stimulator provides a biphasic current of 100 Hz frequency. The pulse duration was 200 msec with an (on-off). Stimulus mode (20sec stimulation, 20 sec pause). The maximal stimulation amplitude was 40 - 60 mA

Other: TENS and Exercise

Interventions

High frequency electrical stimulation was done for thirty minutes per day for five days a week for four consecutive weeks. The stimulator provides a biphasic current of 100 Hz frequency. The pulse duration was 200 msec with an (on-off). Stimulus mode (20sec stimulation, 20 sec pause). The maximal stimulation amplitude was 40 - 60 mA

Intervention

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with sciatica nerve pain

You may qualify if:

  • Sciatica nerve pain
  • Able to attend 20 sessions
  • Children age 5-10 years

You may not qualify if:

  • Chronic pain
  • Pain in the spine other than Sciatica

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy

Qina, Qena Governorate, 83523, Egypt

Location

Related Publications (18)

  • Vance CG, Rakel BA, Blodgett NP, DeSantana JM, Amendola A, Zimmerman MB, Walsh DM, Sluka KA. Effects of transcutaneous electrical nerve stimulation on pain, pain sensitivity, and function in people with knee osteoarthritis: a randomized controlled trial. Phys Ther. 2012 Jul;92(7):898-910. doi: 10.2522/ptj.20110183. Epub 2012 Mar 30.

    PMID: 22466027BACKGROUND
  • Gordon T, Sulaiman O, Boyd JG. Experimental strategies to promote functional recovery after peripheral nerve injuries. J Peripher Nerv Syst. 2003 Dec;8(4):236-50. doi: 10.1111/j.1085-9489.2003.03029.x.

    PMID: 14641648BACKGROUND
  • Kao CH, Chen JJ, Hsu YM, Bau DT, Yao CH, Chen YS. High-frequency electrical stimulation can be a complementary therapy to promote nerve regeneration in diabetic rats. PLoS One. 2013 Nov 12;8(11):e79078. doi: 10.1371/journal.pone.0079078. eCollection 2013.

    PMID: 24265744BACKGROUND
  • Willand MP. Electrical Stimulation Enhances Reinnervation After Nerve Injury. Eur J Transl Myol. 2015 Aug 24;25(4):243-8. doi: 10.4081/ejtm.2015.5243. eCollection 2015 Aug 24.

    PMID: 26913163BACKGROUND
  • Su HL, Chiang CY, Lu ZH, Cheng FC, Chen CJ, Sheu ML, Sheehan J, Pan HC. Late administration of high-frequency electrical stimulation increases nerve regeneration without aggravating neuropathic pain in a nerve crush injury. BMC Neurosci. 2018 Jun 25;19(1):37. doi: 10.1186/s12868-018-0437-9.

    PMID: 29940857BACKGROUND
  • Baptista AF, Gomes JR, Oliveira JT, Santos SM, Vannier-Santos MA, Martinez AM. High- and low-frequency transcutaneous electrical nerve stimulation delay sciatic nerve regeneration after crush lesion in the mouse. J Peripher Nerv Syst. 2008 Mar;13(1):71-80. doi: 10.1111/j.1529-8027.2008.00160.x.

    PMID: 18346233BACKGROUND
  • Alrashdan MS, Park JC, Sung MA, Yoo SB, Jahng JW, Lee TH, Kim SJ, Lee JH. Thirty minutes of low intensity electrical stimulation promotes nerve regeneration after sciatic nerve crush injury in a rat model. Acta Neurol Belg. 2010 Jun;110(2):168-79.

    PMID: 20873447BACKGROUND
  • Teodori RM, Silva AM, Silva MT, Oliveira LS, Polacow ML, Guirro EC. High-voltage electrical stimulation improves nerve regeneration after sciatic crush injury. Rev Bras Fisioter. 2011 Aug-Sep;15(4):325-31. doi: 10.1590/s1413-35552011005000008. Epub 2011 Aug 5.

    PMID: 21975682BACKGROUND
  • Foecking EM, Fargo KN, Coughlin LM, Kim JT, Marzo SJ, Jones KJ. Single session of brief electrical stimulation immediately following crush injury enhances functional recovery of rat facial nerve. J Rehabil Res Dev. 2012;49(3):451-8. doi: 10.1682/jrrd.2011.03.0033.

    PMID: 22773203BACKGROUND
  • Bowman BR, McNeal DR. Response of single alpha motoneurons to high-frequency pulse trains. Firing behavior and conduction block phenomenon. Appl Neurophysiol. 1986;49(3):121-38. doi: 10.1159/000100137.

    PMID: 3827239BACKGROUND
  • WOO MY, CAMPBELL B. ASYNCHRONOUS FIRING AND BLOCK OF PERIPHERAL NERVE CONDUCTION BY 20 KC ALTERNATING CURRENT. Bull Los Angel Neuro Soc. 1964 Jun;29:87-94. No abstract available.

    PMID: 14169956BACKGROUND
  • TANNER JA. Reversible blocking of nerve conduction by alternating-current excitation. Nature. 1962 Aug 18;195:712-3. doi: 10.1038/195712b0. No abstract available.

    PMID: 13919574BACKGROUND
  • Porcino A, Solomonian L, Zylich S, Gluvic B, Doucet C, Vohra S. Pediatric training and practice of Canadian chiropractic and naturopathic doctors: a 2004-2014 comparative study. BMC Complement Altern Med. 2017 Dec 1;17(1):512. doi: 10.1186/s12906-017-2024-5.

    PMID: 29191235BACKGROUND
  • Donnelly C, Stegmuller J, Blazevich AJ, Crettaz von Roten F, Kayser B, Neyroud D, Place N. Modulation of torque evoked by wide-pulse, high-frequency neuromuscular electrical stimulation and the potential implications for rehabilitation and training. Sci Rep. 2021 Mar 18;11(1):6399. doi: 10.1038/s41598-021-85645-0.

    PMID: 33737664BACKGROUND
  • Kilgore KL, Bhadra N. Nerve conduction block utilising high-frequency alternating current. Med Biol Eng Comput. 2004 May;42(3):394-406. doi: 10.1007/BF02344716.

    PMID: 15191086BACKGROUND
  • Egginton S, Hudlicka O. Early changes in performance, blood flow and capillary fine structure in rat fast muscles induced by electrical stimulation. J Physiol. 1999 Feb 15;515 ( Pt 1)(Pt 1):265-75. doi: 10.1111/j.1469-7793.1999.265ad.x.

    PMID: 9925896BACKGROUND
  • 2. Katirji B, editor. 2002. Compressive and entrapment neuropathies of the lower extremity in Neuromuscular Disorders in Clinical Practice. Boston: Butterworth Heinemann;. p. 787-96.

    BACKGROUND
  • Distad BJ, Weiss MD. Clinical and electrodiagnostic features of sciatic neuropathies. Phys Med Rehabil Clin N Am. 2013 Feb;24(1):107-20. doi: 10.1016/j.pmr.2012.08.023. Epub 2012 Oct 31.

    PMID: 23177034BACKGROUND

MeSH Terms

Interventions

Transcutaneous Electric Nerve StimulationExercise

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 9, 2023

First Posted

June 28, 2023

Study Start

February 2, 2023

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

June 28, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Only IPD used in the publication will be shared.

Shared Documents
CSR
Time Frame
01/07/2023 - 01/07/2024
Access Criteria
Team researchers

Locations