Combined Effect Of Intraneural Facilitation Therapy And Otago Exercise On Pain, Balance And Quality Of Life In Patients With Diabetic Peripheral Neuropathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 65
- Locations
- 2
- Primary Endpoint
- DN4
Study Overview
Brief Summary
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
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Mini BESTest scale
Time Frame: 8th week
The Mini-BESTest has 14 items, scored from 0-2, so the maximum score is 28
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
- Numeric Pain Rating Scale(8th week)
- TUG test(8th week)
- Ankle brachial index (ABI)(8th week)