Intraneural Facilitation and Otago Exercise for Diabetic Peripheral Neuropathy
Combined Effect Of Intraneural Facilitation Therapy And Otago Exercise On Pain, Balance And Quality Of Life In Patients With Diabetic Peripheral Neuropathy
This study will test whether intraneural facilitation, the Otago exercise program, or a combination of both can improve balance, reduce neuropathic pain, and improve quality of life for people aged 50–75 with diabetic peripheral neuropathy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | All |
| Sponsor | Riphah International University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07274735 on ClinicalTrials.gov |
What this trial studies
Adults aged 50–75 with type 2 diabetes and symptomatic diabetic peripheral neuropathy (DN4 ≥ 4) who can walk at least 10 meters and complete the TUG in under 15 seconds will be enrolled at Rasheed Hospital in Lahore. Participants will receive intraneural facilitation (manual techniques aimed at improving nerve blood flow), the Otago Exercise Program (a structured strength and balance regimen), or both combined, delivered in person. Outcomes will include measures of balance, timed-up-and-go, neuropathic pain scores, and quality-of-life measures collected before and after the intervention period. The trial compares these approaches directly to identify which strategy most effectively reduces fall risk and neuropathic symptoms.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults aged 50–75 with type 2 diabetes and symptomatic diabetic peripheral neuropathy (DN4 ≥ 4) who can walk at least 10 meters and complete the Timed Up-and-Go in under 15 seconds.
Not a fit: Patients with major systemic comorbidities, active inflammatory or non-diabetic neuropathies, lower-limb amputations, morbid obesity, pregnancy, substance misuse, or who are non-ambulatory are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, participants could have better balance, less neuropathic pain, fewer falls, and improved daily functioning without adding new medications.
How similar studies have performed: The Otago Exercise Program has strong evidence for reducing falls and improving balance in older adults, whereas intraneural facilitation has limited controlled evidence specifically in diabetic peripheral neuropathy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 50-75years * Both male and female patients will be included in the study * Patient with type 2 diabetes mellitus (diagnosed by the physician) * Patients with a score ≥ 4 on DN4 scale * Patients have a score on the Timed Up-and-Go (TUG) test of less than 15 s * Able to walk at least 10 meters long Exclusion Criteria: * Patient with presence of any other systemic disease rather than diabetes such as end-stage renal failure, uncontrolled hypertension, severe dyslipidemia, chronic liver disease, autoimmune disease, advanced chronic obstructive pulmonary disease etc * Patients with documented active alcohol or drug misuse * Patient with total or partial amputation of lower extremities * Participants will be also excluded if they were morbidly obese or if pregnant (self-reported) * Patient with active inflammations or other inflammatory neuropathies including chronic inflammatory demyelinating polyneuropathy, proximal diabetic neuropathy, chemotherapy-induced peripheral neuropathy, autonomic neuropathies, or other neuropathies not associated with DM such as B12 deficiency
Where this trial is running
Lahore, Punjab Province
- Rasheed Hospital — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Aruba Saeed, PhD — Riphah International University
- Study coordinator: Imran Amjad, PhD
- Email: imran.amjad@riphah.edu.pk
- Phone: 03324390125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.