Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosed Diabetes Mellitus with atleast 7 years of duration treated by diet, oral hypoglycemics or insulin therapy. 2.BMI (Body mass index) between 18 and 29.9 kg/m2 . 3.NDS (Neuropathy Disability score) more than 3. 4.Distal symmetrical or asymmetrical polyneuropathy with pain in the lower extremity for =6 months. 5.LANSS score (Leeds assessment of neuropathic symptoms and signs) =12. 6. Patients who can stand on both of their feet independently or using walking aids
Exclusion criteria
Exclusion criteria: 1.History or evidence of neurological disorders other than peripheral neuropathy associated with Diabetes mellitus. 2. Evidence of musculoskeletal dysfunctions like scoliosis, lumbar disc prolapse and lumbar spine associated radiculopathy. 3.History of any low back surgeries and lower limb surgeries. 4.History or evidence of plantar/foot ulcers. 5.History of Diabetic complications like severe nephropathy, severe retinopathy, severe hepatic disorders and significant cardiovascular impairment. 6. Receiving any other physiotherapy treatment for lower limb pain and other symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Nerve Conduction Studies (NCS)-NCS will be done by a skilled technician to perform bilateral nerve conduction investigations for the Tibial, Peroneal, and Sural nerves. 2.Quantitative Sensory Testing (QST) 3.Ankle Proprioception 4.Pain- The Neuropathic Pain Scale (NPS) & Leeds Assessment of Neuropathic Symptoms and Signs Scale (LANSS Scale) will be used to quantify and discriminate the different types of pain.Timepoint: Two measurement points -At the baseline and at the end of the eight-week intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life: Quality of life will be measured by Neuropathy specific Quality of life Questionnaire. This is a reliable and valid questionnaire that measures physical and emotional aspect related to quality of life of PDPN patient. Timepoint: Two measurement points -At the baseline and at the end of the eight-week intervention;Psychological Status: Pain catastrophising scale and Pain Self efficacy questionnaire will be used to assess the patients’ psychological status. The 13-item Pain catastrophising scale is designed to assess the feelings associated with feelings of helplessness, rumination and magnification caused by pain whereas the 10-item Pain Self efficacy questionnaire assesses that how well patient is coping with pain without medications in performing different functional activities. Timepoint: Two measurement points -At the baseline and at the end of the eight-week intervention;3. Neuropathy Disability Score-It measures the severity of neuropathy.Timepoint: Two measurement points-At the baseline and at the end of eight week intervention | — |
Countries
India
Contacts
Sarvodaya hospital and Research Centre