Additional Effects of Neural Mobilization on Pain, Balance and Quality of Life in Diabetic Neuropathy

Not Applicable

Recruiting

• Conditions: Diabetic Neuropathy; Postural Balance; Pain

• Registration Number: NCT07210203
• Lead Sponsor: Foundation University Islamabad

Brief Summary

Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes, affecting up to 50% of patients and causing pain, numbness, and balance impairments, which increase the risk of falls, ulcers, and reduced quality of life. Current treatments mainly manage symptoms, highlighting the need for adjunctive approaches. This randomized controlled trial will evaluate the additional effects of Neural Mobilization (NM) on pain, balance, and quality of life in DPN. Thirty-two patients with type 2 diabetes and DPN will be recruited at Fauji Foundation Hospital and screened using the Michigan Neuropathy Screening Instrument (MNSI). Participants will be randomized into two groups: (1) NM plus Balance Training with standard care and (2) Balance Training alone, each for six weeks (two 30-minute sessions/week). Pain will be assessed using the Numeric Pain Rating Scale (NPRS), balance using the Berg Balance Scale, and quality of life using the Norfolk QOL-DN questionnaire. Outcome measures will be recorded at baseline and post-intervention. Ethical approval will be obtained from FUMC ERC, and data will be analyzed using SPSS v.22.

Detailed Description

Diabetic Peripheral Neuropathy (DPN) is a common and debilitating complication of diabetes, affecting nearly 50% of individuals with the condition during their lifetime. It is characterized by nerve damage that leads to symptoms such as pain, numbness, and balance impairments, significantly impacting patients' daily functioning and overall quality of life. The prevalence of DPN is associated with increased risks of falls, foot ulcers, and other serious complications. Current treatment options often focus on managing symptoms but may fall short in addressing the multifactorial nature of the condition. This highlights the urgent need for effective adjunctive therapies that can improve both physical function and quality of life. This study aims to investigate the additional effects of Neural Mobilization (NM) on pain reduction, balance and quality of life improvement, in Diabetic Peripheral Neuropathy (DPN).A randomized controlled trial will be conducted with participants diagnosed with DPN . This study will be a single-blinded, randomized controlled trial with two groups: the intervention group, which will receive Neural Mobilization and Balance Training in addition to standard care, and the control group, which will receive Balance Training alone. The intervention will last for six weeks, with participants attending two 30-minute sessions per week. A total of 32 individuals with type 2 diabetes mellitus and Peripheral Diabetic Neuropathy will be recruited and randomly assigned to one of the two groups. The Michigan Neuropathy Screening Instrument (MNSI) will be used to screen for neuropathy. Quality of life will be measured using the Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) questionnaire, and pain will be assessed using the Numeric Pain Rating Scale (NPRS). Balance will be assessed by using berg balance scale. The study will be conducted over a period of 1 year at Fauji Foundation Hospital. Ethical approval will be obtained from FUMC ERC. Recruited participants will be allocated to either group through a convenient sampling method. Outcome measurements will be taken at baseline and again after the 6-week intervention period. Individuals meeting the inclusion criteria will be selected, and written informed consent will be obtained after explaining the study's purpose. Data will be entered and analyzed on SPSS v. 22.

Study Timeline

• Study Start: 2024-09-13
• Status Verified: 2025-09
• Study First Submitted: 2025-09-29
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Primary Completion: 2025-12-10
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Both genders.
• Diagnosed cases of Diabetic Peripheral Neuropathy
• Age 50-75 years.
• Patients having history of type 2 Diabetes for at least 5 years.
• Presence of neuropathic symptoms (pain, numbness, tingling, balance issues).
• Patient having mild to moderate pain according to NPRS

Exclusion Criteria

• Patients with Neurological Disorders like Stroke, multiple sclerosis, Parkinson's disease.
• Chronic Pain Conditions or Conditions unrelated to DPN (e.g., fibromyalgia, osteoarthritis).
• Foot Ulcers/Infection: Active ulcers or infections on lower limbs.
• Uncontrolled Diabetes
• Severe Balance Impairment Individuals unable to perform basic balance tests (e.g., unable to stand unaided for a few seconds).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain in Diabetic Neuropathy	6 weeks	Numeric Pain Rating Scale (NPRS): 0-10 scale where 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.
Balance	6 weeks	Berg Balance Scale (BBS): A 14-item, 0-56 point test of static and dynamic balance where 41-56 = low fall risk, 21-40 = medium fall risk, and 0-20 = high fall risk, with higher scores reflecting better balance and independence.
Quality of life in Diabetic Neuropathy	6 weeks	Norfolk QOL-DN total score ranges from -4 to 136. Lower scores reflect better quality of life / fewer neuropathy symptoms, whereas higher scores indicate poorer quality of life

Trial Locations

Locations (1)

Foundation University College of Physical Therapy; 🇵🇰 Islamabad, Pakistan