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NCT Number: NCT07274735

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

DPN often leads to balance issues, sensory deficits, and chronic pain, which can severely impact daily functioning and independence. INF therapy aims to improve nerve blood flow and alleviate neuropathic symptoms through manual techniques, while the Otago Exercise Program focuses on enhancing strength and balance to reduce fall risk. By comparing these two interventions, this study seeks to identify effective strategies that can improve balance, reduce pain, and enhance the quality of life for individuals suffering from DPN

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rasheed Hospital

Lahore, Punjab Province, 54800, Pakistan

Location status: Recruiting

Location contact

Aruba Saeed, PhD

CONTACT

[email protected]

+923344399403

Rameen Shahzad, MSNMPT

PRINCIPAL_INVESTIGATOR

About this study

This study addresses a gap in existing literature by comparing the effects of intraneural facilitation therapy and Otago exercise in improving balance, pain and QOL among DPN patients. While both Intraneural Facilitation (INF) therapy and the Otago Exercise Program have been acknowledged for their individual benefits, their comparative effectiveness in the context of diabetic peripheral neuropathy (DPN) has not been adequately explored. This study aims to bridge this gap by examining which intervention more effectively improves quality of life, reduces pain, and enhances balance in DPN patients, thus providing essential insights for optimizing treatment approaches.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraneural facilitation therapy

Other

The intervention will consist of 24 sessions delivered three times per week over eight weeks, with each session lasting 50-60 minutes. Effects will be measured at baseline (before treatment), after the 4th week and after 8th week (post treatment)

Otago Exercise Program

Other

Otago exercise training was conducted 3 times a week for a total of 50 min per session, including 5 min of warm-up and 5 min of cool-down. Effects will be measured at baseline, at 4th weeks and at 8th week. The exercises consisted of the following strengthening exercises: knee extensors, knee flexors, hip abductors, ankle plantar flexors, and ankle dorsiflexors. The balance retraining exercises consisted of the following: knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel toe walking backwards, and sit to stand

Intraneural facilitation therapy with Otago exercise program

Other

The exercise intervention will be an 8 week, 3xweek, and 50-60 min class following the 20-30min OEP curriculum with 20-30 min /sessions of intraneural facilitation therapy per week. Effects will be measured at baseline, at 4th weeks and at 8th week

Primary outcomes

  1. DN4

    Time frame: 8th week

    The DN4 Questionnaire is a screening tool for neuropathic pain consisting of 10 interview questions (DN4-interview) and physical tests which has been validated for the diagnosis of diabetic peripheral neuropathy in western populations. The DN4 questionnaire is used to screen for the presence of neuropathic pain. This questionnaire consisted of 4 sections; 3 sections concerned with symptoms review and associated symptoms and the 4th section reserved for physical examination.

  2. Mini BESTest scale

    Time frame: 8th week

    The Mini-BESTest has 14 items, scored from 0-2, so the maximum score is 28

  3. Quality of Life- Diabetic Neuropathy Questionnaire

    Time frame: 8th week

    It is an extensive and validated 35-item questionnaire that has been developed to encompass the complete range of Diabetic Neuropathy (DN) symptoms associated with small fiber, large fiber, and autonomic neuropathy. It is composed of two sections: one focusing on the symptoms experienced by diabetic patients and the other on how the patient's neuropathy affects their activities of daily living (ADLs).

Secondary outcomes

  1. Numeric Pain Rating Scale

    Time frame: 8th week

    Numeric Pain Rating Scale is a subjective measure 11 point (0-10) numerical scale which is a commonly used outcome measure to assess pain intensity, including in patients with diabetic peripheral neuropathy. Its score ranges from 0 indicating no pain at all to 10 indicating worst pain

  2. TUG test

    Time frame: 8th week

    In this test, participants are asked to stand up from a chair, walk 3 m, turn, walk 3 m back and sit down again. The time taken to perform this task indicates high or low falls risk. The cut-off scores reported in the articles varied from 10.9 s to 13 s.

  3. Ankle brachial index (ABI)

    Time frame: 8th week

    ABI (Osc-ABI) during the first measurement by the first observer were 89.1%, 94.4%, 94.1%, 91.8%, and 92.4%, sensitivity and specificity respectively normal value will be 0.9-1.4, higher: greater than 1.4, typically indicative of vessel stiffening. Low: less than 0.9 means narrowing of vessels, non-measurable: unable to occlude blood vessel at 300mmHG of pressure application

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, PhD

CONTACT

[email protected]

03324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effect Of Intraneural Facilitation Therapy And Otago Exercise On Pain, Balance And Quality Of Life In Patients With Diabetic Peripheral Neuropathy

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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