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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Other: Hydrotherapy training; Other: Land training

Detailed Description

Hydrotherapy training is a rehabilitative approach proposed for different medical conditions, the hydrotherapy environment facilitates patients with functional limitations, who feel a safer setting and are consequently more motivated to the training. The physical properties of water help to improve patient stability and to allow limbs movements by offloading the body weight and Exerting resistance against the body segments and giving proprioceptive inputs.

Moreover, the warmth of hydrotherapy pool helps muscle relaxation and seems to reduce pain perception, aiming to improve blood circulation so that nutrients can be distributed more smoothly to body tissues, strengthen small muscles, calves, and thighs, as well as address joint mobility limitations often experienced by diabetes mellitus patients.

Several authors evaluated hydrotherapy therapy as possible gait and balance training of neurological patients and demonstrated beneficial effects mostly in Parkinson's disease and stroke. Limited number of studies, even if affected by small sample sizes, made a comparison between hydrotherapy training and on land training. Showing best balance results of the former for the same diseases.

• Study Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aya Yasser Saber Mahmoud, B.Sc; Phone Number: +201559406122; Email: Ayayassersaber@gmail.com
• Study Contact Backup: Name: Tamer Ibrahim Abo Elyazed, PhD

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • Beni-suef university Hospital
    • Contact: Aya Yasser Saber Mahmoud, B.Sc; Phone Number: +201559406122; Email: Ayayassersaber@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydrotherapy training; This group will consist of seventeen diabetic peripheral neuropathy patients will perform hydrotherapy training for 12 weeks.	Other: 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.
Active Comparator: Land training; This group will consist of seventeen diabetic peripheral neuropathy patients will do land training for 12 weeks.	Other: Land training; The patients do the same exercise of the experimental group on land three days per week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
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.	12 weeks
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.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Study Chair: Tamer Ibrahim Abo Elyazed, PhD, Assistant Professor, Beni-Suef University; Study Director: Reham Ali Mohamed Ali, PhD, Lecturer, Beni-Suef University; Study Director: Ahmed Moheyeldien Hamed, PhD, Lecturer, Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Estimated): December 3, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 21, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: FPTBSUREC/0305/2325

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No