Study protocol for a double-blinded randomized clinical trial evaluating effectiveness of neurodynamic approach in lower limb for diabetic peripheral sensory neuropathy

Abstract

Background Diabetic peripheral sensory neuropathy (DPSN) presents with pain or neuropathy symptoms and disturbances in lower limb sensory functions, leading to complicated diabetic foot conditions and declining quality of life. There is a research gap on the non-pharmacological conservative approach to this disabling condition. The objective of this study is to evaluate the effectiveness of the neurodynamic approach, along with electrophysical stimulation, in reducing the severity of neuropathic symptoms and improving the quality of life in patients with DPSN. Methods An assessor and patient-blinded randomized clinical trial (RCT) on 90 DPSN cases through hospital-based simple random sampling. Participants will be randomly assigned equally to either the Neurodynamic approach or the Sham neurodynamic approach group by concealed allocation between April and August 2025 at the Nurul Islam Diabetic Center in Jashore, Bangladesh. The experimental group will receive the Neurodynamic approach, and the control group will receive the sham approach; however, both groups will receive transcutaneous electrical nerve stimulation (TENS) and home exercises for 12 sessions over 4 weeks. A pretest will be taken at baseline, a posttest after 4 weeks, and a follow-up evaluation after 12 weeks. In addition to outcome measures, manageable and fatal adverse events will be documented and reported. Discussion This trial will be implemented in the non-pharmacological management of prevalent cases with DPSN and diabetic foot, sparing the burden of polypharmacy in people living with diabetes. Moreover, a positive result may guide clinicians toward an alternative in evidence-based practice, especially in a low-resource country like Bangladesh. This single-center trial may be limited by a lack of external generalizability, but it will lead to multicenter, large-sample studies in the future. Trial registration Registered from Clinical Trial Registry of India CTRI/2025/01/079801 [Registered on: 30/01/2025] Trial Registered Prospectively.