NCT06663670

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Riphah International University · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetic Peripheral Neuropathy

Interventions

Type	Name	Description
OTHER	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 slight stretch. * Once the pressure elevation occurs, the subsequent phase known as the secondary hold will be initiated to direct the augmented flow of epineurial blood toward the transperineurial vessels connecting the epiperineum and the endoneurial capillaries of the target area. * The final maneuver, the sub hold, leverages Bernoulli's principle to augment blood flow through the ischemic endoneurial capillaries experiencing heightened transmural pressure.
OTHER	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 plantarflex and invert the ankle to induce tension; flex the knee to unload, then extend and dorsiflex to reload. 2. Flex the hip, extend the knee, and plantarflex and invert the ankle to induce tension; flex the hip to unload, then extend and dorsiflex to reload. 3. Lift the leg, flex the hip, and extend the knee; plantarflex and invert the ankle to induce tension, then dorsiflex to unload.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-10-29
• Last updated: 2024-11-26

Locations

2 sites across 1 country: Pakistan