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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05923957
Other study ID # P.T-IMG-02/2023/507
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2, 2023
Est. completion date May 1, 2023

Study information

Verified date June 2023
Source Prince Sattam Bin Abdulaziz University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

A 5-year-old girl with limping gait, presented with right-sided buttock and lower extremity pain and numbness. There was a history of trauma preceding this eighteen months ago. There was diffuse decreased sensation to pinprick and light touch but mainly from above the right knee joint. The rest of the clinical examination was normal. The patient attended 20 sessions, which were structured to include High-frequency transcutaneous neuromuscular electrical nerve stimulation (TENS), chiropractic care, strengthening exercise for hamstring and back muscle and gait training (figure 1). Electrical stimulation was performed for 30 min /day for five days a week for four consecutive weeks, 100 Hz frequency with pulse duration 200 m sec with an (on-off) (20 sec stimulation, 20 sec pause) and maximum amplitude 40 - 60 mA. Two electrodes were placed on the back at the level of L5, S1 lumber spine and the other two electrodes were placed along the course of sciatic nerve on the back of the thigh. Chiropractic treatment sessions (manual manipulation refers to a high-velocity, short lever arm thrust that is applied to abnormal vertebra with the goal of improving functionality, reducing nerve irritability and restoring range of motion in the back) were scheduled for one month with frequency 5 sessions per week. strengthening program was three sets, ten repetitions and rest period of 1-2 minutes for low intensity or low repetition activity started by 2-3 days a week, then increase to 3-5 days a week as the strength progresses, amount of resistance 40%-60% of one-repetition maximum (1 RM). Mirror imaging and verbal promoting, Balance training and coordination to encourage normal gait. EMG examination using concentric needle electrodes was carried bilaterally for the vastus medialis, tibialis anterior, extensor digitorum brevis and abductor halluces muscles and the right biceps femoris muscle. Motor conduction studies were carried out for both common peroneal, tibial and right main trunk of the right sciatic nerve.


Recruitment information / eligibility

Status Completed
Enrollment 1
Est. completion date May 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender All
Age group 5 Years to 10 Years
Eligibility Inclusion Criteria: - Sciatica nerve pain - Able to attend 20 sessions - Children age 5-10 years Exclusion Criteria: - Chronic pain - Pain in the spine other than Sciatica

Study Design


Related Conditions & MeSH terms


Intervention

Other:
TENS and Exercise
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

Locations

Country Name City State
Egypt Faculty of physical therapy Qina Qena

Sponsors (1)

Lead Sponsor Collaborator
Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Egypt, 

References & Publications (18)

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03663842 - Effectiveness of a Novel Neural Tissue Management to Improve Short-term Pain and Disability in Patients With Sciatica N/A