A study protocol on nerve mobilization induced diffusion tensor imaging values in posterior tibial nerve in healthy controls and in patients with diabetic neuropathy-multigroup pretest posttest design

BACKGROUND: Diabetic neuropathy is the commonest chronic disabling complication of diabetes which may lead to amputation and compromising patient’s quality of life. It is characterized by pain, sensation loss associated with neural edema. Diffusion tensor imaging parameter i.e. fraction anisotropy determines the free water proton diffusion in the healthy nerve. Since the diabetes leads to altered mechanosensitivity of the posterior tibial nerve thereby, might interferes with the water molecules movement. Therefore the present clinical trial will provide the evidence of improving the diffusion tensor imaging in the diabetic neuropathy directly by targeting the nerve through nerve mobilization treatment. METHODS: Participants with Type II Diabetes Mellitus induced peripheral neuropathy will be selected randomly on the basis of eligibility criteria and informed consent will be taken. Participants will be recruited into three groups. Group A (experimental group A) will receive neural mobilization technique, Group B (experimental group B) will receive conventional therapy and Group C (control group) will receive sham treatment for 3 weeks. MRI technique, Visual analogue scale and neuropathy specific quality of life questionnaire will be used as assessment tools. Assessment will be taken at baseline and post intervention. CONCLUSION: this clinical trial will provide the evidence of efficacy of nerve mobilization in determining the diffusion tensor imaging (DTI) changes in the posterior tibial nerve in patients with diabetic neuropathy. This trial will also be the first one in itself to look at the treatment induced DTI changes in the peripheral nerve. TRIAL REGISTRATION: Clinical Trial Registry of India (CTRI/2019/06/019552).