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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorRiphah International University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraneural facilitation therapy

    Other intervention

    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 intervention

    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 intervention

    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

Treatment groups

65 Participants
are divided into 3 treatment groups
Group A: Intraneural facilitation therapyExperimental treatment 1 intervention
Group B: Otago exercise programExperimental treatment 1 intervention
Group C: Intraneural facilitation therapy with Otago exercise programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DN4

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.

Time frame
8th week
2

Mini BESTest scale

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

Time frame
8th week
3

Quality of Life- Diabetic Neuropathy Questionnaire

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).

Time frame
8th week

Secondary outcomes

1

Numeric Pain Rating Scale

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

Time frame
8th week
2

TUG test

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.

Time frame
8th week
3

Ankle brachial index (ABI)

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

Time frame
8th week

Other outcomes

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