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

NCT07210203 | Recruiting

• 1 other identifier: FUI/CTR/2025/03
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathy; Postural Balance; Pain

Keywords

Balance; Diabetic Peripheral Neuropathy; Postural Pain; Quality of life

Outcome Measures

Primary Outcomes (3)

• Pain in Diabetic Neuropathy

  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.

  6 weeks

• Balance

  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.

  6 weeks

• Quality of life in Diabetic Neuropathy

  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

  6 weeks

Study Arms (2)

Neural moblization with Balance traning

EXPERIMENTAL

Neural Moblization Includes the following protocol: Hot Pack 10 mins TENS 10 mins Upper limb and lower limb sliding techniques . (10 reps) Upper limb lower limb tentioning technique (10 reps) Tibial Nerve sliding,Siatic Nerve Sliding,Median nerve Sliding, (10 reps) Combine sliding plue Tensioning,(10 reps) Balance Traning Include:Sitting to standing (10 reps × 2 sets) Standing unsupported (Hold 30s × 3) Standing to sitting (10 reps × 2 sets) Transfers ( 10 reps) Standing with eyes closed( Hold 10-20s ×3) Standing with feet together (Hold 10-20s × 5) Reaching forward with outstretched arm (10 reps) Retrieving object from floor (8-10 reps) Turning to look behind (10 reps each side) Turning 360 degrees (3 reps each) Placing alternate foot on stool(10 reps each) Standing with one foot in front (Hold 15-30s × 3) Standing on one foot( Hold 15-30s × 3) Repetitions will increase gradually week wise

Procedure: Neural mobilization with Balance training with conventional physical Therapy

Balance traning

ACTIVE COMPARATOR

Hot pack 10 mins TENS 10 mins Sitting to standing (10 reps × 2 sets) Standing unsupported (Hold 30s × 3) Standing to sitting (10 reps × 2 sets) Transfers ( 10 reps) Standing with eyes closed( Hold 10-20s ×3) Standing with feet together (Hold 10-20s × 5) Reaching forward with outstretched arm (10 reps) Retrieving object from floor (8-10 reps) Turning to look behind (10 reps each side) Turning 360 degrees (3 reps each) Placing alternate foot on stool(10 reps each) Standing with one foot in front (Hold 15-30s × 3) Standing on one foot( Hold 15-30s × 3) Repetitions will increase gradually week wise

Procedure: Balance Training only with conventional physical therapy

Interventions

Neural mobilization with Balance training with conventional physical Therapy PROCEDURE

( HOT pack 10 mins + TENS 10 mins) Neural Moblization Includes the following protocol: Hot Pack 10 mins TENS 10 mins Upper limb and lower limb sliding techniques . (10 reps) Upper limb lower limb tentioning technique (10 reps) Tibial Nerve sliding,Siatic Nerve Sliding,Median nerve Sliding, (10 reps) Combine sliding plue Tensioning,(10 reps) Balance Training Sitting to standing (10 reps × 2 sets) Standing unsupported (Hold 30s × 3) Standing to sitting (10 reps × 2 sets) Transfers ( 10 reps) Standing with eyes closed( Hold 10-20s ×3) Standing with feet together (Hold 10-20s × 5) Reaching forward with outstretched arm (10 reps) Retrieving object from floor (8-10 reps) Turning to look behind (10 reps each side) Turning 360 degrees (3 reps each) Placing alternate foot on stool(10 reps each) Standing with one foot in front (Hold 15-30s × 3) Standing on one foot( Hold 15-30s × 3) Repetitions will increase gradually week wise

Neural moblization with Balance traning

Balance Training only with conventional physical therapy PROCEDURE

balance training program combines conventional physical therapy with hot pack (10 min) and TENS (10 min), delivered over 4-6 weeks, 3-4 sessions per week, 30-40 minutes each. Training begins with easier Berg Balance Scale (BBS) tasks and progresses as the patient improves. In Weeks 1-2, basic static and supported tasks are practiced, including sit-to-stand, standing unsupported (wide to narrow base), supervised transfers, reaching forward, and standing with eyes closed. Weeks 3-4 focus on dynamic stability with picking objects from the floor, head/torso turns, 360° turns, step-ups, and heel-to-toe stance. Weeks 5-6 progress to advanced functional tasks such as alternating foot placement on a stool, tandem stance, one-leg standing, gentle perturbations, and walking 5-10 m with head turns.

Balance traning

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 46000, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maria Ghulam Fareed, DPT

CONTACT

+92 3458353129; mariafareed@000gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: September 13, 2024
• Primary Completion: December 10, 2025
• Study Completion: January 10, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-09

Locations

PA (1)