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NeuropathyRCTNCT07141992

Comparison of Active vs Passive Neural Mobilizations Effects in Improving Burning Pain, Muscular Strength, and Range of Motion in Patients With Diabetic Neuropathy

A study testing Active Neural Mobilzations and Passive Neural Mobilzations in people with Neuropathy and Diabete Mellitus, run by Dow University of Health Sciences at 1 site in Pakistan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Randomized controlled trial evaluating active and passive neurodynamic techniques for diabetic neuropathy. Sample size: 60 patients (30 per group), aged 40 to 65 years, diagnosed with diabetes mellitus. Exclusion criteria: Systemic diseases, pregnancy, fractures, foot ulceration, amputation, osteoarthritis. Read more about this study

Who is it for?
Ages 40 to 65 years
Conditions the study is for
Neuropathy, Diabete Mellitus, Diabetic Neuropathy
What is being tested?
Active Neural Mobilzations and Passive Neural Mobilzations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 sitePakistan
Study dates
4 Jun 2025to 1 Sep 2025
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 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Both male and female individuals
  • Aged between 40 and 65 years
  • Diagnosed with Diabetes Mellitus (Type I and Type II)
  • Diagnosis confirmed by a physician

Who cannot join

  • One with any systemic disease
  • Medical conditions (neurological disorders, fractures, acute inflammatory conditions, recent surgeries)
  • Foot Ulceration
  • Amputation
  • OA of Ankle or Knee Joint

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
  • Dow University of Health Sciences / Baqai Institute of Diabetology and Endocrinology

    Karachi, Sindh, 75280

Other trials in Pakistan

About this study

Official title: Comparison of Active vs Passive Neural Mobilizations Effects in Improving Burning Pain, Muscular Strength, and Range of Motion in Patients With Diabetic Neuropathy: A Randomized Control Trial

  • Randomized controlled trial evaluating active and passive neurodynamic techniques for diabetic neuropathy.
  • Sample size: 60 patients (30 per group), aged 40 to 65 years, diagnosed with diabetes mellitus.
  • Exclusion criteria: Systemic diseases, pregnancy, fractures, foot ulceration, amputation, osteoarthritis.
  • Study will be conducted at physiotherapy OPDs of Dow Ojha Hospital, DIPMR,NIDE and Baqai Institute of Diabetology and Endocrinology.
  • Participants randomly assigned into two groups using a computer-generated randomization sheet.

Group A: Active neurodynamics (neural flossing) - patient-controlled nerve gliding movements.

Read more

Group B: Passive neurodynamics (tensioners) - therapist-applied nerve stretches.

  • Standard treatment includes gait training, lower limb strengthening exercised, and stationary bike sessions.
  • Treatment: 12 sessions over 4 weeks (3 sessions per week, 30 minutes each session).
  • Assessments will be done at baseline and post-intervention by a blinded physical therapist.
  • Outcome measures: DN-4 (pain), MMT (muscle strength), Goniometry (ROM), LLTT (nerve mobility).
  • Data were analyzed using SPSS Version 27. A one-way ANOVA was performed to compare the results before and after the intervention.
  • Study duration: 9 months, including approval, pilot study, data collection, and final presentation.
  • Study aims to determine the most effective neurodynamic technique for pain relief, mobility, and muscle strength.
  • Findings will guide better rehabilitation strategies for improved patient outcomes and quality of life.
Read the detailed description

Diabetic neuropathy is a common complication of diabetes mellitus that presents with neuropathic pain, muscle weakness, and restricted mobility in the lower limbs. These impairments negatively affect quality of life and increase the risk of falls, foot ulcers, and amputations. Pharmacological treatments are available but frequently provide incomplete symptom relief and may cause adverse effects, creating the need for effective non-pharmacological interventions.

Neural mobilization techniques have been reported to improve nerve mobility and decrease pain sensitivity. Two forms will be applied in this trial: active neural mobilization (neural flossing) and passive neural mobilization (tensioners). Both approaches aim to restore normal neural dynamics but differ in their application principles.

This randomized controlled trial will be conducted in the physiotherapy outpatient departments of Dow Ojha Hospital, the National Institute of Diabetology and Endocrinology (NIDE), and the Baqai Institute of Diabetology and Endocrinology (BIDE). A total of 60 participants with clinically diagnosed diabetic neuropathy, aged 40-65 years, will be recruited and randomly assigned to either an active neural mobilization group or a passive neural mobilization group.

Each group will receive 12 treatment sessions over a 4-week period. Both groups will additionally perform conventional physiotherapy, including gait training, strengthening exercises, and stationary cycling. Outcomes will be assessed at baseline and post-intervention. Measures will include:

Neuropathic pain using the DN-4 questionnaire

Muscle strength using manual muscle testing (MMT)

Joint range of motion using goniometry

The primary objective of the study will be to compare the effectiveness of active versus passive neural mobilization in reducing neuropathic pain and improving muscle strength and joint mobility. Secondary objectives will include determining clinical applicability and the potential role of these interventions in rehabilitation protocols for diabetic neuropathy.

Limitations of the trial will include the inability to blind participants, possible variability in treatment adherence, and potential influence of external factors such as concurrent analgesic use. Randomization and standardized intervention protocols will be employed to minimize bias.

Being tested
Active Neural Mobilzations, Passive Neural Mobilzations
Keywords
Active Neural mobilizations, Passive Neural mobilizations, diabetic neuropathy, neuropathic pain, muscle strength improvement, ROM improvement, pain reduction
Medical subject headings
Diabetes Mellitus, Diabetic Neuropathies, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Active Neural MobilzationsOther

    Participants in this group will receive active neural mobilization in the form of neural flossing techniques. These involve controlled, repeated movements performed actively by the patient to mobilize peripheral nerves without placing them under excessive tension. The goal is to restore neural mobility, reduce mechanosensitivity, and relieve neuropathic symptoms such as burning pain.

  • Passive Neural MobilzationsOther

    Participants in this group will receive passive neural mobilization using neural tensioning techniques. These techniques involve therapist-applied passive limb movements that place a controlled tensile load on the neural structures. The objective is to improve neural gliding, reduce nerve compression, and decrease neuropathic pain, particularly in cases of restricted neural tissue mobility.

Study groups in NCT07141992
Study groupRoleWhat they receive
Effect of Active Neural Mobilization on Pain, Strength, and ROM in Diabetic NeuropathyExperimentalParticipants in the active neural mobilization group will receive neural flossing techniques, aimed at improving nerve mobility and reducing neuropathic symptoms. Along with neural mobilization, participants will follow a standardized physiotherapy protocol, including: Gait training on both smooth and rough surfaces Strengthening exercises: leg press, ankle press, isometric exercises for knee and ankle extensors, bridging, and pelvic rolling All exercises will be performed in 3 sets of 12 repetitions, with 30 seconds of rest between sets Stationary cycling will be included as part of cardiovascular conditioning The intervention will be delivered over 12 sessions, scheduled three times per week for four weeks. This program aims to reduce burning pain, and enhance muscle strength and range of motion in patients with diabetic neuropathy.
Receives: Other: Active Neural Mobilzations
Effect of Passive Neural Mobilization on Pain, Strength, and ROM in Diabetic NeuropathyExperimentalParticipants in the passive neural mobilization group will receive neural tensioning techniques, which involve therapist-guided passive movements to mobilize the neural structures. In addition to passive mobilization, participants will undergo the same standardized physiotherapy protocol, which includes: Gait training on both smooth and rough surfaces Strengthening exercises: leg press, ankle press, isometric exercises for knee and ankle extensors, bridging, and pelvic rolling Exercises will be performed in 3 sets of 12 repetitions, with 30 seconds of rest between sets Stationary cycling will be used for cardiovascular conditioning This group will also receive 12 treatment sessions, conducted three times per week over four weeks, with the goal of improving pain, strength, and mobility in individuals with diabetic neuropathy.
Receives: Other: Passive Neural Mobilzations

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lower Limb Tension Test

    Lower Limb Tension Test (LLTT) Purpose: Assess neural mechanosensitivity of lower limb nerves, especially sciatic, tibial, and peroneal nerves.

    Also Known As: Straight Leg Raise (SLR), Slump Test, Prone Knee Bend Test, etc.

    Indications:

    Radiating leg pain Suspected lumbar radiculopathy Neural tension syndromes

    Procedure Includes:

    Hip flexion, knee extension, ankle dorsiflexion, and/or foot inversion/eversion based on nerve bias

    Positive Sign:

    Reproduction of neuropathic symptoms (burning, tingling, shooting pain) Symptoms change with sensitizing maneuvers

    Used In:

    Neuropathy Sciatica Disc herniation Piriformis syndrome

    Measured: 12 sessions for 4 weeks

  2. DN-4 (Douleur Neuropathique en 4 questions)

    DN-4 Questionnaire (Douleur Neuropathique en 4 questions) Purpose: To screen for neuropathic pain and distinguish it from nociceptive pain.

    Total Items: 10 7 sensory descriptors (e.g., burning, electric shocks, tingling, numbness) 3 clinical examination findings (e.g., hypoesthesia to touch or pinprick, pain on brushing)

    Scoring:

    Each "yes" = 1 point Total Score Range: 0 to 10 Score ≥ 4 indicates likely neuropathic pain Time Required: Less than 5 minutes

    Advantages:

    Quick and easy to administer Non-invasive High sensitivity and specificity

    Used In:

    Diabetic neuropathy Post-stroke pain

    Sciatica

    Postherpetic neuralgia

    Measured: 12 sessions in 4 weeks

  3. Goniometery (Joint Range of Motion)

    Goniometry Purpose: Measure joint range of motion (ROM) accurately Instrument: Goniometer (standard)

    Components:

    Axis: Placed over the joint Stationary arm: Aligned with proximal segment Moving arm: Aligned with distal segment

    Procedure:

    Explain to patient → Proper positioning → Stabilize proximal joint → Move limb through ROM → Read measurement

    Used To Assess:

    Joint mobility limitations Effectiveness of treatment Progress tracking in rehabilitation Common Areas: Knee, hip, ankle, shoulder, elbow, wrist, cervical spine

    Measured: 12 sessions for 4 weeks

  4. Manual Muscle Testing

    Manual Muscle Testing (MMT) Purpose: Evaluate muscle strength manually

    Grading Scale (0-5):

    0 = No contraction

    1. = Flicker/trace of contraction
    2. = Full ROM in gravity-eliminated position
    3. = Full ROM against gravity
    4. = Full ROM with some resistance
    5. = Full ROM with maximum resistance (normal)

    Procedure:

    Proper positioning → Isolate target muscle → Apply resistance gradually → Grade based on performance

    Used In:

    Neuromuscular conditions Orthopedic rehab Stroke, SCI, peripheral nerve injuries

    Advantages:

    Quick and cost-effective Useful in baseline assessment and progress monitoring

    Measured: 12 sessions in 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2025
  2. Study start4 Jun 2025
  3. Primary completion23 Aug 2025 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07141992
Sponsor's protocol ID
IRB No. 3966
Acronym
RCT
Status last verified
Aug 2025
First submitted
19 Aug 2025
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data (IPD) will not be shared due to confidentiality concerns. Protecting the privacy and anonymity of participants is a top priority, and sharing IPD may risk breaching this confidentiality. Additionally, the data is securely stored and intended solely for use within the scope of this study; therefore, it will not be shared with other researchers.

Publications

  • Goyat M, Saxena A, Goyal M. Study Protocol titled as "Effectiveness of neural mobilization in improving the ankle ROM and plantar pressure distribution in patients with diabetic peripheral neuropathy: A single group, pre post, quasi experimental study protocol". J Diabetes Metab Disord. 2022 Aug 15;21(2):2035-2041. doi: 10.1007/s40200-022-01106-z. eCollection 2022 Dec.

    PubMed 36404825

Questions about this trial

What is this clinical trial studying?

A study testing Active Neural Mobilzations and Passive Neural Mobilzations in people with Neuropathy and Diabete Mellitus, run by Dow University of Health Sciences 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 4 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: enrolling by invitation, as of the sponsor's last update on 3 Sep 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lower Limb Tension Test (time frame: 12 sessions for 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07141992, which also lists 1 linked publication.

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 3 Sep 2025.

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