About this trial
The current study aims to investigate the effects of hydrotherapy compared to land-based training on patients with diabetic peripheral neuropathy. It will evaluate hydrotherapy's impact on pain relief, sensation improvement, balance, and overall quality of life for these patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of diabetic peripheral neuropathy due to type 2 diabetes mellitus of both sex Patients must have confirmed diagnosis of diabetic peripheral neuropathy based on clinical symptoms (E.G, numbness, tingling and burning pain) and diagnostic test such as nerve conduction studies
Chronicity of type 2 diabetes mellitus more than 10 years
Age range: between 40-65years old
Stable Blood Glucose Levels HbA1c (≤5.7)
Disqualifiers
Severe Renal Impairment.
Uncontrolled cardiovascular diseases
Pregnancy
Neurological or musculoskeletal conditions
Trial design
Parallel
Treatments tested in this trial
Hydrotherapy training
Other interventionThe patients will participate in hydrotherapy sessions three days per week for 12 weeks in a heated swimming pool maintained at 32°C. Each session will include a sequence of activities: relaxation and breath control, balance exercises, gait training, and hydrotherapy cycling.
Land training
Other interventionThe patients do the same exercise of the experimental group on land three days per week for 12 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Toronto Clinical Neuropathy Score
The Toronto Clinical Neuropathy Score (TCNS) is a validated tool for diagnosing and monitoring diabetic sensorimotor peripheral neuropathy (DSPN). It ranges from 0 to 19 points, comprising six points from symptom scores, eight points from lower limb reflexes, and five points from sensory examinations at the toes. The total score categorizes neuropathy severity as follows: 0-5 indicates no neuropathy, 6-8 mild neuropathy, 9-11 moderate neuropathy, and 12 or more indicates severe neuropathy. This scoring system helps clinicians accurately assess neuropathy progression and guide patient management.
McGill pain assessment questionnaire
The McGill Pain Questionnaire is a tool used to assess and quantify the severity and characteristics of neuropathic pain, which results from nerve damage or dysfunction. It evaluates pain intensity on a 0-10 scale, where 0 means "no pain" and 10 is the worst possible pain. Patients describe their pain quality using terms like burning, stabbing, electric shock-like, tingling, numbness, and itching. The scoring reflects pain severity, with higher scores indicating more intense pain. This multidimensional tool helps clinicians understand pain characteristics and guide treatment decisions effectively.
Berg balance scale
The Berg Balance Scale (BBS) is a widely recognized tool for assessing balance, consisting of 14 items scored on an ordinal scale from 0 to 4, with a total score of 56. Lower scores indicate higher fall risk, where 0 represents the lowest function and 4 the highest. The test typically takes about 20 minutes. Functional levels based on scores include 0-20 indicating ability to walk with a walking aid, 21-40 suggesting walking with assistance, and 41-56 indicating independent walking. The BBS is also used as a fall risk predictor: scores of 41-56 indicate low risk, 21-40 medium risk, and 0-20 high risk.
Secondary outcomes
Diabetes self-Care Activities measurement
The Self-Care Activities (SDSCA) scale, developed by Wan Qiaoqin of Peking University, China, will be used to measure the self-care level of patients with diabetic peripheral neuropathy. This scale includes 11 items across six dimensions: general diet, special diet, exercise, blood glucose monitoring, foot care, and medication adherence. Each item will be scored on an eight-point scale from 0 to 7, reflecting the frequency of self-care activities performed by the patients.
Sponsors and contacts
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