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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-65
SponsorBeni-Suef University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Hydrotherapy training

    Other intervention

    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

    Other intervention

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

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Hydrotherapy trainingExperimental treatment 1 intervention
Group B: Land trainingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 weeks
2

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.

Time frame
12 weeks
3

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.

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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