Intraneural Facilitation Therapy and Nerve Flossing Technique in Patients With Diabetic Peripheral Neuropathy

Официальное название

Comparative Effects of Intraneural Facilitation Therapy and Nerve Flossing Technique on Pain, Balance, Gait, and Quality of Life in Patients With Diabetic Peripheral Neuropathy

Обзор

The aim of this study is to determine the comparative effects of intraneural facilitation therapy and nerve flossing technique on pain, balance, gait, and quality of life in Diabetic peripheral neuropathy.

Подробное описание

Intraneural Facilitation Therapy is a novel manual therapy technique that seeks to enhance endoneurial capillary circulation, bias blood flow into the neural fascicle, and reverse intrafascicular ischemia. To redirect blood to the ischemic nerves, this passive approach involves tractioning skin, distending visceral tissues, stretching muscles, mobilizing joints, and stretching blood vessels. The Nerve Flossing Technique is an emerging treatment approach that aims to improve neurodynamic, range of motion, and quality of life. Intraneural Facilitation and Nerve Flossing Techniques address diabetic peripheral neuropathy, and their effectiveness in improving pain, balance, gait, and quality of life remains un-compared.

This randomized clinical trial will be conducted at Social Security Hospital, and Siddique Family Hospital, Gujranwala. 44 Participants who meet the inclusion criteria will be selected through a non-probability convenience sampling technique and randomly allocated into two groups using an online randomizer tool. Participants will be included in Groups A (Intraneural Facilitation Therapy) and Group B (Nerve Flossing Technique). A total of 24 sessions (3x/week for 8 weeks) will be conducted, lasting 60 minutes each.. A Numeric Pain Rating scale will be used to assess pain, the Berg Balance Scale (BBS) to assess balance, a 4-item Dynamic Gait Index to assess Gait, and the Quality of Life-Diabetic Neuropathy (QOL-DN) for quality of life. Assessment will be carried out at baseline (before treatment), after the 8th week (post-intervention), and at a 2-month follow-up. The data will be entered and analyzed using the IBM SPSS Statistics 27.0 version. Statistical significance will be set at p ≤0.05.

Вмешательства

• Другое Intraneural Facilitation Therapy
  * The initial hold, known as the facilitation hold, involves placing the contralateral joint in a maximal loose-pack position that will be comfortable for the patient. An illustration of this would be positioning the ankle joint on the contralateral side in full plantar flexion and inversion. Throughout the entire session, this position will be maintained using a stretch strap. It is crucial to emphasize that there is no muscle engagement in the joint where the facilitation takes place, only a s
• Другое Nerve Flossing Technique
  Tibial Nerve: 1. Passively flex the hip while dorsiflexing and everting the ankle to create tension; flex the knee to unload, then extend and plantarflex to reload. 2. Flex the hip, extend the knee, and dorsiflex and evert the ankle to induce tension; flex the hip to unload, then extend and plantarflex to reload. 3. Lift the leg, flex the hip, and extend the knee; dorsiflex and evert the ankle to induce tension, then plantarflex to unload. Common Peroneal Nerve: 1. Passively flex the hip and

Первичные конечные точки

• Numeric Pain Rating Scale [Срок оценки: 8 week]
• Michigan Neuropathy Screening Instrument [Срок оценки: 8 week]
• Quality of Life- Diabetic Neuropathy Questionnaire [Срок оценки: 8 week]
• BERG BALANCE SCALE [Срок оценки: 8 week]
• 4-Item Dynamic Gait Index [Срок оценки: 8 week]

Критерии участия

Критерии включения

• Type 2 diabetes mellitus (diagnosed by the physician)
• Score >3 on Michigan Neuropathy Screening Instrument-Questionnaire and score >2 on MNSI-Physical Examination
• Diabetic peripheral neuropathy symptoms below the ankle (numbness, tingling, burning, sharp pain, increased sensitivity, etc.)

Критерии исключения

• 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.
• Diabetic ulcer in either foot
• Total or partial amputation of lower extremities
• 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
• History of fracture, strain, history of trauma leading to nerve injuries in the last year.

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 · 2 центра

• Siddique Family Hospital — Gujranwala
• Social Security Hospital — Gujranwala

Публикации

• Topp KS, Boyd BS. Structure and biomechanics of peripheral nerves: nerve responses to physical stresses and implications for physical therapist practice. Phys Ther. 2006 Jan;86(1):92-109. doi: 10.1093/ptj/86.1.92. PMID 16386065
• Intraneural Facilitation MR Bussell - US Patent App. 13/371,103, 2012
• Alnajafi KZ-S. The Impact of Intraneural Facilitation Therapy on Diabetic Peripheral Neuropathy Loma Linda University Electronic Theses, Dissertations & Projects 2021.
• BASUDEO RAJBHOR AG, SAURABH KUMAR. Comparison of Kinesio Taping and Nerve Flossing Technique on Balance, Gait and Ankle Flexibility in Diabetic Neuropathy. 2022.
• Dan Ran Castillo WJJ, Carvy Floyd Lucero, Mark Bussell, Ron Coleman, Karla Pieters, Jamie Hankins, Annette Boggs, Salem Dehom, Lorena Garcia, Ellen D'Errico, and Gayathri Nagaraj. A pilot study of intraneural facilitation versus standard physical therapy for prevention ofchemotherapy-induced peripheral neuropathy. Journal of Clinical Oncology. May31,2023.
• G.Tharani DJP, Dr. Jagatheesan Alagesan,Dr. Harikrishnan. N Exploring the Effectiveness of Peroneal Nerve Flossing in Alleviating Diabetic Peripheral Neuropathy Symptoms. Journal for Re Attach Therapy and Developmental Diversities. August6,2023
• Alshahrani A, Bussell M, Johnson E, Tsao B, Bahjri K. Effects of a Novel Therapeutic Intervention in Patients With Diabetic Peripheral Neuropathy. Arch Phys Med Rehabil. 2016 May;97(5):733-8. doi: 10.1016/j.apmr.2015.12.026. Epub 2016 Jan 22. PMID 26808781
• Goyat M, Saxena A, Goyal M. Study Protocol titled as "Effectiveness of neural mobilization in improving the ankle ROM and plantar pressure distribution in patients with diabetic peripheral neuropathy: A single group, pre post, quasi experimental study protocol". J Diabetes Metab Disord. 2022 Aug 15;21(2):2035-2041. doi: 10.1007/s40200-022-01106-z. eCollection 2022 Dec. PMID 36404825

Идентификаторы

NCT: NCT06663670 · REC/RCR&AHS/24/0256

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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