Sciatica PainNCT05923957
The Impact of High Frequency Electrical Nerve Stimulation and Chiropractic Care on Sciatic Axonal Lesion Presenting as Painful Leg: Case Report
An observational study of Sciatica Pain, run by Prince Sattam Bin Abdulaziz University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Sciatica Pain
- What is being tested?
- TENS and Exercise
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2023to 1 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with sciatica nerve pain
Who may be able to join
- Sciatica nerve pain
- Able to attend 20 sessions
- Children age 5-10 years
Who cannot join
- Chronic pain
- Pain in the spine other than Sciatica
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Sciatica Pain
- Being tested
- TENS and Exercise
- Keywords
- High frequency electrical stimulation, lumber spine, sciatic nerve, painful leg, gait training, chiropractic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS and ExerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: TENS and Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve conduction velocity
Motor conduction studies were carried out for both common peroneal, tibial and right main trunk of the right sciatic nerve.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start2 Feb 2023
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Sciatica PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sattam Bin Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mshari Saleh Alghadier, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923957
- Sponsor's protocol ID
- P.T-IMG-02/2023/507
- Status last verified
- Jun 2023
- First submitted
- 9 Jun 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the publication will be shared.
Publications
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.
PubMed 22466027Gordon 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.
PubMed 14641648Kao 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.
PubMed 24265744Willand 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.
PubMed 26913163Su 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.
PubMed 29940857Baptista 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.
PubMed 18346233Alrashdan 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.
PubMed 20873447Teodori 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.
PubMed 21975682Foecking 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.
PubMed 22773203Bowman 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.
PubMed 3827239WOO 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.
PubMed 14169956TANNER JA. Reversible blocking of nerve conduction by alternating-current excitation. Nature. 1962 Aug 18;195:712-3. doi: 10.1038/195712b0. No abstract available.
PubMed 13919574Porcino 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.
PubMed 29191235Donnelly 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.
PubMed 33737664Kilgore 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.
PubMed 15191086
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of High Frequency Electrical Nerve Stimulation and Chiropractic Care on Sciatic Axonal Lesion Presenting as Painful Leg: Case Report
- ClinicalTrials.gov ID
- NCT05923957
- Acronym / sponsor ID
- P.T-IMG-02/2023/507
- Conditions
- Sciatica Pain
- Keywords
- High frequency electrical stimulation, lumber spine, sciatic nerve, painful leg, gait training, chiropractic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Prince Sattam Bin Abdulaziz UniversityUniversity, hospital or other
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Other: TENS and ExerciseHigh 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 |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with sciatica nerve pain
Key inclusion criteria (3 listed)
- Sciatica nerve pain
- Able to attend 20 sessions
- Children age 5-10 years
Key exclusion criteria (2 listed)
- Chronic pain
- Pain in the spine other than Sciatica
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENS and ExerciseHigh 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 | Intervention |
Primary outcome
Nerve conduction velocity
Time frame: 4 weeks
Motor conduction studies were carried out for both common peroneal, tibial and right main trunk of the right sciatic nerve.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Background: PubMed 22466027Vance 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.
- Background: PubMed 14641648Gordon 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.
- Background: PubMed 24265744Kao 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.
- Background: PubMed 26913163Willand 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.
- Background: PubMed 29940857Su 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.
- Background: PubMed 18346233Baptista 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.
- Background: PubMed 20873447Alrashdan 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.
- Background: PubMed 21975682Teodori 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.
- Background: PubMed 22773203Foecking 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.
- Background: PubMed 3827239Bowman 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.
- Background: PubMed 14169956WOO 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.
- Background: PubMed 13919574TANNER JA. Reversible blocking of nerve conduction by alternating-current excitation. Nature. 1962 Aug 18;195:712-3. doi: 10.1038/195712b0. No abstract available.
- Individual participant dataSharing planned: Yes. Only IPD used in the publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sciatica Pain, run by Prince Sattam Bin Abdulaziz University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nerve conduction velocity (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05923957, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.