Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
All Genders
ID07274735

Combined Effect of Intraneural Facilitation Therapy and Otago Exercise on Pain, Balance, and Quality of Life in Patients with Diabetic Peripheral Neuropathy

Led by Riphah International University · Updated on 2025-12-10

65

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying diabetic peripheral neuropathy (DPN), a condition that often causes balance problems, sensory loss, and chronic pain, affecting daily life and independence. The trial compares intraneural facilitation (INF) therapy and the Otago Exercise Program (OEP) to identify which approach better improves balance, reduces pain, and enhances quality of life for people with DPN. This study aims to fill a knowledge gap by directly comparing these two therapies in DPN patients. The trial involves three groups receiving different interventions over eight weeks. One group receives intraneural facilitation therapy with 24 sessions, three times weekly, each lasting 50-60 minutes. Another group participates in Otago exercise training three times a week for 50 minutes per session, including warm-up, cool-down, strengthening, and balance exercises. The third group combines both therapies with sessions three times a week, mixing 20-30 minutes of OEP and 20-30 minutes of INF therapy per session. Effects are measured at the start, after four weeks, and after eight weeks. Participants will be assessed using various tests such as the DN4 pain scale, Mini BESTest for balance, and quality of life questionnaires specific to diabetic neuropathy at the 8-week point. Additional measures include pain rating scales, Timed Up-and-Go test, and ankle brachial index. The study includes monitoring of balance, pain, and quality of life improvements. Total participation lasts eight weeks with evaluations at baseline, mid, and end points to track progress and effects of the therapies.

CONDITIONS

Brief Title

Combined Effects of INF and OEP in Patients With Diabetic Peripheral Neuropathy

Who Can Participate

Age: 50Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 50 and 75 years
  • Male or female patients
  • Diagnosed with type 2 diabetes mellitus by a physician
  • DN4 pain score of 4 or greater
  • Timed Up-and-Go (TUG) test score less than 15 seconds
  • Able to walk at least 10 meters
Not Eligible

You will not qualify if you...

  • Presence of systemic diseases other than diabetes, such as end-stage renal failure, uncontrolled hypertension, severe dyslipidemia, chronic liver disease, autoimmune disease, or advanced chronic obstructive pulmonary disease
  • Documented active alcohol or drug misuse
  • Total or partial amputation of lower extremities
  • Morbid obesity or pregnancy (self-reported)
  • Active inflammations or other inflammatory neuropathies, including chronic inflammatory demyelinating polyneuropathy, proximal diabetic neuropathy, chemotherapy-induced peripheral neuropathy, autonomic neuropathies, or neuropathies not associated with diabetes such as B12 deficiency

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants receive one of three interventions involving intraneural facilitation therapy, Otago exercise program, or a combination of both. Sessions occur three times per week for eight weeks, with each session lasting 50 to 60 minutes.

3 visits per week for 8 weeks

Trial Site Locations

Total: 1 location

1

Rasheed Hospital

Lahore, Punjab Province, Pakistan, 54800

Actively Recruiting

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Research Team

I

Imran Amjad, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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The development and validation of the Norfolk QOL-DN, a new measure of patients' perception of the effects of diabetes and diabetic neuropathy.

Etta J Vinik, Risa P Hayes, Alan Oglesby...

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The Mini-Balance Evaluation Systems Test (Mini-BESTest) Demonstrates Higher Accuracy in Identifying Older Adult Participants With History of Falls Than Do the BESTest, Berg Balance Scale, or Timed Up and Go Test.

Anyamanee Yingyongyudha, Vitoon Saengsirisuwan, Wanvisa Panichaporn...

https://pubmed.ncbi.nlm.nih.gov/25794308