- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07841405
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Effect of Capacitive and Resistive Energy Transfer on Pain, Functional Outcome and Electrophysiological Parameters in Patients With Chronic Discogenic Sciatica
The goal of this clinical trial is to evaluate the effect of Transfer of Energy Capacitive and Resistive (TECAR) on pain, functional disability and electrophysiological parameters in adults with chronic discogenic sciatica . The main questions it aims to answer are:
• Is there significant effect of TECAR therapy on pain, functional disability and Electrophysiological parameters (H-reflex latency and amplitude) ? Researchers will compare effect of adding TECAR therapy to conventional physical therapy program (TENS, hot pack, stretching exercises and core stability exercises) Vs conventional physical therapy program alone to see if there is a beneficial effect of adding TECAR therapy to physical therapy program Participants in study group will receive TECAR therapy in addition to conventional PT program while participants in control group will receive conventional PT program
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: OMAR ABDELAZIZ MOSTAFA, bachelor
- Telefonnummer: +201063019924
- E-post: omarabdelaziz708@gmail.com
Studieorter
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-
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Giza, Egypten
- Rekrytering
- Faculty of Physical Therapy Cairo University
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Kontakt:
- Shaimaa Mohamed Abdelmageed, Assistant Professor
- Telefonnummer: 0201028202856
- E-post: shaimaa.abdelmageed@pt.cu.edu.eg
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Age between 30-50 years
- Unilateral chronic discogenic sciatica at L5-S1, MRI confirmed
- Symptom duration more than 3 months
- Pain score ≥ 4 on the Visual Analogue Scale (VAS)
- Ability to participate in outpatient physiotherapy
Exclusion Criteria:
- Previous lumbar spine surgery
- Pacemaker or metallic implants
- Peripheral neuropathy or systemic neurological disorders
- Severe sensory loss
- Skin lesions at the treatment site
- Recent corticosteroid injection (< 3 weeks)
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Study (TECAR) Group
|
Andra namn:
conventional physical therapy program will include TENS, hot pack, stretching exercises and core stabilization exercises for 3 sessions per week for four weeks. |
|
Aktiv komparator: Control (Conventional treatment) Group
|
conventional physical therapy program will include TENS, hot pack, stretching exercises and core stabilization exercises for 3 sessions per week for four weeks. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain intensity
Tidsram: from enrollment to the end of treatment at 4 weeks
|
lower back pain will be assessed though Visual Analogue Scale (VAS) which is used to measure the severity of pain. It is a straight line with one end representing no pain and the other end representing the worst imaginable pain. The subject will mark a point on the line that corresponds to the current level of pain he or she experiences. Higher values indicate higher levels of pain while lower values indicate lower levels of pain |
from enrollment to the end of treatment at 4 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Hoffmann reflex (H-reflex)
Tidsram: from enrollment to the end of treatment at 4 weeks
|
H-reflex has been measured in the soleus muscle by stimulating the tibial nerve with a one-millisecond pulse at 0.2pps of H-max. The peak-to-peak amplitude of the highest recorded H-reflex and the latencies of four spaced traces for both lower extremities will be averaged for each participant. lower amplitudes and delayed latencies indicate more damage to nerve root, while higher amplitudes and shorter latencies indicate less damage |
from enrollment to the end of treatment at 4 weeks
|
|
functional disability
Tidsram: from enrollment to the end of treatment at 4 weeks
|
Functional disability will be evaluated using the Oswestry Disability Index (ODI), which is considered the gold standard for assessing disability in low back pain and radiculopathy. The ODI consists of 10 sections evaluating daily activities such as lifting, walking, sitting, and personal care. It is scored from 0% to 100%, where higher percentages represent more severe functional impairment |
from enrollment to the end of treatment at 4 weeks
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P.T.REC/012/006312
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