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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое Intraneural facilitation therapy
  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)
• Другое Otago 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 walkin
• Другое Intraneural 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

Первичные конечные точки

• DN4 [Срок оценки: 8th week]
• Mini BESTest scale [Срок оценки: 8th week]
• Quality of Life- Diabetic Neuropathy Questionnaire [Срок оценки: 8th week]

Вторичные конечные точки (3)

• Numeric Pain Rating Scale [Срок оценки: 8th week]
• TUG test [Срок оценки: 8th week]
• Ankle brachial index (ABI) [Срок оценки: 8th week]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Rasheed Hospital — Lahore

Публикации

• Baker NA, Vuong D, Bussell M, Gharibvand L, Lee S, Tsao B. Prospective, Randomized, Double-Blinded, Sham-Controlled Pilot Study of Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome. Arch Rehabil Res Clin Transl. 2022 Mar 29;4(2):100193. doi: 10.1016/j.arrct.2022.100193. eCollection 2022 Jun. PMID 35756982
• Alnajafi KZ-S. The Impact of Intraneural Facilitation Therapy on Diabetic Peripheral Neuropathy. 2021.
• Kadir MI, Hardiyanty N, Adliah F. A pilot study of the effect of otago exercise program on fall risk and quality of life of older women. Physical Therapy Journal of Indonesia. 2021;2(1):1-4.
• Jahanpeyma P, Kayhan Kocak FO, Yildirim Y, Sahin S, Senuzun Aykar F. Effects of the Otago exercise program on falls, balance, and physical performance in older nursing home residents with high fall risk: a randomized controlled trial. Eur Geriatr Med. 2021 Feb;12(1):107-115. doi: 10.1007/s41999-020-00403-1. Epub 2020 Nov 25. PMID 33237565
• Brown JJ, Colberg SR, Pribesh S, Baskette KG, Vinik AI. A comparison of neuropathy quality of life tools: Norfolk QOL-DN, PN-QOL-97, and NeuroQOL-28. Medical Research Archives. 2021;9(11)
• Agoons BB, Tchapmi D, Boli AO, Katte J-C. Clinical utility of the DN4 questionnaire in the assessment of neuropathic pain in patients with type 2 diabetes: Experience from a newly-created diabetes clinic in Cameroon. PAMJ-Clinical Medicine. 2020;3(165).
• Lytras D, Sykaras E, Iakovidis P, Komisopoulos C, Chasapis G, Mouratidou C. Effects of a modified Otago exercise program delivered through outpatient physical therapy to community-dwelling older adult fallers in Greece during the COVID-19 pandemic: a controlled, randomized, multicenter trial. Eur Geriatr Med. 2022 Aug;13(4):893-906. doi: 10.1007/s41999-022-00656-y. Epub 2022 May 24. PMID 35606677
• Spallone V, Morganti R, D'Amato C, Greco C, Cacciotti L, Marfia GA. Validation of DN4 as a screening tool for neuropathic pain in painful diabetic polyneuropathy. Diabet Med. 2012 May;29(5):578-85. doi: 10.1111/j.1464-5491.2011.03500.x. PMID 22023377

Идентификаторы

NCT: NCT07274735 · REC/0269 Rameen Shahzad

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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