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Effect of Hydrotherapy On Pain, Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy

NCT07260214 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-12-01
Last updated
2025-12-03

Condition(s) studied

Diabetic Peripheral Neuropathy

Investigational drug(s) / intervention(s)

Hydrotherapy trainingLand training

Hydrotherapy training: The 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: The patients do the same exercise of the experimental group on land three days per week for 12 weeks.

Study summary

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

Sex
ALL
Min age
40 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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) * No active infections or wound Exclusion Criteria: * Severe Renal Impairment. * Uncontrolled cardiovascular diseases * Pregnancy * Neurological or musculoskeletal conditions * Inability to safely enter or exit the pool * Uncontrolled infections * Vitamin B12 deficiency. * Postural hypotension

Primary outcome measure(s)

  • Toronto Clinical Neuropathy Score — 12 weeks
    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 — 12 weeks
    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 — 12 weeks
    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.

Trial sites (1)

FacilityCityRegionStatus
Beni-Suef university hospital Banī Suwayf Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07260214 on ClinicalTrials.gov ↗ ← All trials in Egypt