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NCT Number: NCT07210203

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

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.

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Key information

Conditions

Diabetic Neuropathy Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Postural Balance Signs and Symptoms

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University College of Physical Therapy

Islamabad, 46000, Pakistan

Location status: Recruiting

Location contact

Nida Mushtaq Kayani, MS-NMPT

CONTACT

[email protected]

+92 3330418548

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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.

Primary outcomes

  1. Pain in Diabetic Neuropathy

    Time frame: 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.

  2. Balance

    Time frame: 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.

  3. Quality of life in Diabetic Neuropathy

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Ghulam Fareed, DPT

CONTACT

[email protected]

+92 3458353129

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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