Diabetic NeuropathyNCT07210203
Additional Effects of Neural Mobilization on Pain, Balance and Quality of Life in Diabetic Neuropathy
A study testing Neural mobilization with Balance training with conventional physical Therapy and Balance Training only with conventional physical therapy in people with Diabetic Neuropathy and Postural Balance, run by Foundation University Islamabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Diabetic Neuropathy, Postural Balance, Pain
- What is being tested?
- Neural mobilization with Balance training with conventional physical Therapy and Balance Training only with conventional physical therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Sep 2024to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Islamabad, 46000
Nida Mushtaq Kayani, MS-NMPT, +92 3330418548, nida.mushtaq@fui.edu.pk
About this study
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.
Read the 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.
- Conditions
- Diabetic Neuropathy, Postural Balance, Pain
- Being tested
- Neural mobilization with Balance training with conventional physical Therapy, Balance Training only with conventional physical therapy
- Keywords
- Balance, Diabetic Peripheral Neuropathy, Postural Pain, Quality of life
- Medical subject headings
- Diabetic Neuropathies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neural mobilization with Balance training with conventional physical TherapyProcedure or surgery
( 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 therapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Balance Training only with conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start13 Sep 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NeuropathyStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210203
- Sponsor's protocol ID
- FUI/CTR/2025/03
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effects of Neural Mobilization on Pain, Balance and Quality of Life in Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT07210203
- Acronym / sponsor ID
- FUI/CTR/2025/03
- Conditions
- Diabetic Neuropathy, Postural Balance, Pain
- Keywords
- Balance, Diabetic Peripheral Neuropathy, Postural Pain, Quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 10 Jan 2026 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neural moblization with Balance traning | Experimental | Procedure: Neural mobilization with Balance training with conventional physical TherapyNeural 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 |
| Balance traning | Active comparator | Procedure: Balance Training only with conventional physical therapyHot 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 |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neural mobilization with Balance training with conventional physical Therapy( 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 | Procedure or surgery | Neural moblization with Balance traning |
| Balance Training only with conventional physical therapybalance 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. | Procedure or surgery | Balance traning |
Primary outcome
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.
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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neural mobilization with Balance training with conventional physical Therapy and Balance Training only with conventional physical therapy in people with Diabetic Neuropathy and Postural Balance, run by Foundation University Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Ghulam Fareed, DPT (+92 3458353129, mariafareed@000gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain in Diabetic Neuropathy (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.