- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07695181
Effectiveness of Pain Neuroscience Education Along With Neural Mobilization Versus Neural Mobilization Alone on Pain, Functional Disability And Quality of Life In Patients With Diabetic Neuropathic Pain
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Roshan Farman, MSPT
- Telefonnummer: +923188108470
- E-post: 5012324032@student.iiui.edu.pk
Studer Kontakt Backup
- Navn: Somiya Naz, PhD scholar
- Telefonnummer: +923315163093
- E-post: somiyanaz@uipt.iiui.edu.pk
Studiesteder
-
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Punjab Province
-
Rawalpindi, Punjab Province, Pakistan, 46000
- Positive Solution Clinic, Wah Cantt
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Ta kontakt med:
- Mahjabeen Farooqui, MSPT
- Telefonnummer: 3313666898
- E-post: mahafarooqui0@gmail.com
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Ta kontakt med:
- Somiya Asif, MSPT
- Telefonnummer: 3435322291
- E-post: sumaiya.asif92@gmail.com
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Hovedetterforsker:
- Roshan Farman, MSPT
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Age ≥ 40 years (WHO 2016 criteria) Diagnosed Type II diabetes mellitus Lower limb neuropathic pain ≥ 3 months Pain intensity ≥ 4/10 on NPRS Able to walk independently and follow instructions
Exclusion Criteria:
Neurological disorders (e.g. stroke, Guillain-Barré) Lumbar disc herniation with radiculopathy Lower limb surgery or spinal fracture within 6 months Active diabetic foot ulcer Diagnosed cognitive impairment or severe infection
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Group A - Pain Neurosciences Education combined with Neural Mobilization
Pain neuroscience education (PNE) will be delivered through structured educational sessions focusing on pain physiology, neural sensitization, and pain modulation.
PNE: 20-30 min (weeks 1-2) → 10 min reinforcement (weeks 3-6) Methods: Simple diagrams, patient-friendly metaphors, video demonstrations.
Neural mobilization techniques will be applied following standardized neurodynamic principles and patients' tolerance.
Target nerves: Sciatic, tibial & common peroneal Technique: Slider neurodynamic mobilization Dosage: 10-15 reps × 2-3 sets | Rest: 30-60 sec between sets Session duration: 15-20 minutes
|
In Group A pain neuroscience Education will be given in adjunct with neural mobilization techniques Target nerves: Sciatic, tibial & common peroneal Technique: Slider neurodynamic mobilization Dosage: 10-15 reps × 2-3 sets | Rest: 30-60 sec between sets Session duration: 15-20 minutes PNE: 20-30 min (weeks 1-2) → 10 min reinforcement (weeks 3-6) Methods: Simple diagrams, patient-friendly metaphors, video demonstrations
|
|
Aktiv komparator: Group B - Neural Mobilization Alone
Neural mobilization techniques will be applied following standardized neurodynamic principles and patients' tolerance.
Target nerves: Sciatic, tibial & common peroneal Technique: Slider neurodynamic mobilization Dosage: 10-15 reps × 2-3 sets | Rest: 30-60 sec between sets Session duration: 15-20 minutes
|
In Group A pain neuroscience Education will be given in adjunct with neural mobilization techniques Target nerves: Sciatic, tibial & common peroneal Technique: Slider neurodynamic mobilization Dosage: 10-15 reps × 2-3 sets | Rest: 30-60 sec between sets Session duration: 15-20 minutes PNE: 20-30 min (weeks 1-2) → 10 min reinforcement (weeks 3-6) Methods: Simple diagrams, patient-friendly metaphors, video demonstrations
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pain intensity
Tidsramme: Baseline to week 6
|
Pain intensity will be evaluated using Numeric Pain Rating Scale
|
Baseline to week 6
|
|
Functional disability
Tidsramme: Baseline to week 6
|
Functional disability will be evaluated using Urdu version of Lower Extremity Functional Scale (LEFS)
|
Baseline to week 6
|
|
Quality of life
Tidsramme: Baseline to week 6
|
Quality of life will be evaluated by World Health Organization Quality Of Life-BREF
|
Baseline to week 6
|
|
Central sensitization
Tidsramme: Baseline to week 6
|
Central sensitization will be evaluated using Central Sensitization Inventory
|
Baseline to week 6
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- IIUI/RERC/ADT/2026/05/265
Legemiddel- og utstyrsinformasjon, studiedokumenter
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