Diabetic Peripheral Neuropathy
Conditions
Keywords
Diabetic Nephropathies, Exercise, Musculoskeletal Manipulations, Peripheral Neuropathy, Quality of Life
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.
Interventions
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)
OTHEROtago exercise program
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
OTHERIntraneural facilitation therapy with Otago exercise program
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
Sponsors
Riphah International University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DN4 | 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 | 8th week | The Mini-BESTest has 14 items, scored from 0-2, so the maximum score is 28 |
| Quality of Life- Diabetic Neuropathy Questionnaire | 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
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale | 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 |
| TUG test | 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. |
| Ankle brachial index (ABI) | 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 |
Countries
Pakistan
Contacts
Primary ContactImran Amjad, PhD
Outcome results
None listed