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

NCT07260214 | Not Yet Recruiting

• 1 other identifier: FPTBSUREC/0305/2325
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Diabetes self-Care Activities measurement

  12 weeks

Study Arms (2)

Hydrotherapy training

EXPERIMENTAL

This group will consist of seventeen diabetic peripheral neuropathy patients will perform hydrotherapy training for 12 weeks.

Other: Hydrotherapy training

Land training

ACTIVE COMPARATOR

This group will consist of seventeen diabetic peripheral neuropathy patients will do land training for 12 weeks.

Other: Land training

Interventions

Hydrotherapy training OTHER

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.

Hydrotherapy training

Land training OTHER

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

Land training

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Beni-Suef university hospital

Banī Suwayf, Egypt

Location

Study Officials

• Tamer Ibrahim Abo Elyazed, PhD

  Assistant Professor, Beni-Suef University

  STUDY CHAIR

• Reham Ali Mohamed Ali, PhD

  Lecturer, Beni-Suef University

  STUDY DIRECTOR

• Ahmed Moheyeldien Hamed, PhD

  Lecturer, Beni-Suef University

  STUDY DIRECTOR

Central Study Contacts

Aya Yasser Saber Mahmoud, B.Sc

CONTACT

+201559406122; Ayayassersaber@gmail.com

Tamer Ibrahim Abo Elyazed, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

EG (1)