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

Riphah International University

Status: Enrolling

Conditions: Diabetic Peripheral Neuropathy

Treatments: Other: Otago exercise program; Other: Intraneural facilitation therapy with Otago exercise program; Other: Intraneural facilitation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07274735

REC/0269 Rameen Shahzad

Details and patient eligibility

About

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

Full description

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.

Enrollment: 65 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 3 patient groups

Intraneural facilitation therapy

Experimental group

Description:

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)

Treatment:

Other: Intraneural facilitation therapy

Otago exercise program

Experimental group

Description:

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

Treatment:

Other: Otago exercise program

Intraneural facilitation therapy with Otago exercise program

Experimental group

Description:

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:

Other: Intraneural facilitation therapy with Otago exercise program