- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Roshan Farman, MSPT
- Telefonnummer: +923188108470
- E-mail: 5012324032@student.iiui.edu.pk
Undersøgelse Kontakt Backup
- Navn: Somiya Naz, PhD scholar
- Telefonnummer: +923315163093
- E-mail: somiyanaz@uipt.iiui.edu.pk
Studiesteder
-
-
Punjab Province
-
Rawalpindi, Punjab Province, Pakistan, 46000
- Positive Solution Clinic, Wah Cantt
-
Kontakt:
- Mahjabeen Farooqui, MSPT
- Telefonnummer: 3313666898
- E-mail: mahafarooqui0@gmail.com
-
Kontakt:
- Somiya Asif, MSPT
- Telefonnummer: 3435322291
- E-mail: sumaiya.asif92@gmail.com
-
Ledende efterforsker:
- Roshan Farman, MSPT
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde 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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- IIUI/RERC/ADT/2026/05/265
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .