Intraneural Facilitation Therapy and Nerve Flossing Technique in Patients With Diabetic Peripheral Neuropathy

November 25, 2024 updated by: Riphah International University

Comparative Effects of Intraneural Facilitation Therapy and Nerve Flossing Technique on Pain, Balance, Gait, and Quality of Life in Patients With Diabetic Peripheral Neuropathy

The aim of this study is to determine the comparative effects of intraneural facilitation therapy and nerve flossing technique on pain, balance, gait, and quality of life in Diabetic peripheral neuropathy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Intraneural Facilitation Therapy is a novel manual therapy technique that seeks to enhance endoneurial capillary circulation, bias blood flow into the neural fascicle, and reverse intrafascicular ischemia. To redirect blood to the ischemic nerves, this passive approach involves tractioning skin, distending visceral tissues, stretching muscles, mobilizing joints, and stretching blood vessels. The Nerve Flossing Technique is an emerging treatment approach that aims to improve neurodynamic, range of motion, and quality of life. Intraneural Facilitation and Nerve Flossing Techniques address diabetic peripheral neuropathy, and their effectiveness in improving pain, balance, gait, and quality of life remains un-compared.

This randomized clinical trial will be conducted at Social Security Hospital, and Siddique Family Hospital, Gujranwala. 44 Participants who meet the inclusion criteria will be selected through a non-probability convenience sampling technique and randomly allocated into two groups using an online randomizer tool. Participants will be included in Groups A (Intraneural Facilitation Therapy) and Group B (Nerve Flossing Technique). A total of 24 sessions (3x/week for 8 weeks) will be conducted, lasting 60 minutes each.. A Numeric Pain Rating scale will be used to assess pain, the Berg Balance Scale (BBS) to assess balance, a 4-item Dynamic Gait Index to assess Gait, and the Quality of Life-Diabetic Neuropathy (QOL-DN) for quality of life. Assessment will be carried out at baseline (before treatment), after the 8th week (post-intervention), and at a 2-month follow-up. The data will be entered and analyzed using the IBM SPSS Statistics 27.0 version. Statistical significance will be set at p ≤0.05.

Study Type

Interventional

Enrollment (Estimated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Gujranwala, Punjab, Pakistan, 05228
        • Siddique Family Hospital
        • Contact:
        • Principal Investigator:
          • Amina Nazir, DPT
      • Gujranwala, Punjab, Pakistan, 05228
        • Social Security Hospital
        • Contact:
        • Principal Investigator:
          • Amina Nazir, DPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus (diagnosed by the physician)
  • Score >3 on Michigan Neuropathy Screening Instrument-Questionnaire and score >2 on MNSI-Physical Examination
  • Diabetic peripheral neuropathy symptoms below the ankle (numbness, tingling, burning, sharp pain, increased sensitivity, etc.)

Exclusion Criteria:

  • Presence of any other systemic disease rather than diabetes such as end-stage renal failure, uncontrolled hypertension, severe dyslipidemia, chronic liver disease, autoimmune disease, advanced chronic obstructive pulmonary disease, etc.
  • Diabetic ulcer in either foot
  • Total or partial amputation of lower extremities
  • Active inflammations or other inflammatory neuropathies including chronic inflammatory demyelinating polyneuropathy, proximal diabetic neuropathy, chemotherapy-induced peripheral neuropathy, autonomic neuropathies, or other neuropathies not associated with DM such as B12 deficiency
  • History of fracture, strain, history of trauma leading to nerve injuries in the last year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GROUP A Intraneural Facilitation Therapy along with Home care plan
Group A will receive 24 sessions of Intraneural Facilitation therapy, delivered three times weekly for eight weeks, each session lasting 60 minutes. Effects will be measured at baseline, post-intervention (after 8 weeks), and at a 2-months follow-up.
Other: Intraneural Facilitation Therapy
  • The initial hold, known as the facilitation hold, involves placing the contralateral joint in a maximal loose-pack position that will be comfortable for the patient. An illustration of this would be positioning the ankle joint on the contralateral side in full plantar flexion and inversion. Throughout the entire session, this position will be maintained using a stretch strap. It is crucial to emphasize that there is no muscle engagement in the joint where the facilitation takes place, only a slight stretch.
  • Once the pressure elevation occurs, the subsequent phase known as the secondary hold will be initiated to direct the augmented flow of epineurial blood toward the transperineurial vessels connecting the epiperineum and the endoneurial capillaries of the target area.
  • The final maneuver, the sub hold, leverages Bernoulli's principle to augment blood flow through the ischemic endoneurial capillaries experiencing heightened transmural pressure.
Experimental: Group B Nerve Flossing Technique along with Home care plan
Group B will receive the nerve flossing technique for about 3 sets of 10 repetitions with an interval of 1 minutes between sets. A total of 24 sessions (3x/week for 8 weeks) will be conducted, lasting 50-60 minutes each. The effects will be measured at baseline (pre-treatment), after week 8 (post-intervention), and at 2-month follow-up.
Other: Nerve Flossing Technique

Tibial Nerve:

  1. Passively flex the hip while dorsiflexing and everting the ankle to create tension; flex the knee to unload, then extend and plantarflex to reload.
  2. Flex the hip, extend the knee, and dorsiflex and evert the ankle to induce tension; flex the hip to unload, then extend and plantarflex to reload.
  3. Lift the leg, flex the hip, and extend the knee; dorsiflex and evert the ankle to induce tension, then plantarflex to unload.

Common Peroneal Nerve:

  1. Passively flex the hip and plantarflex and invert the ankle to induce tension; flex the knee to unload, then extend and dorsiflex to reload.
  2. Flex the hip, extend the knee, and plantarflex and invert the ankle to induce tension; flex the hip to unload, then extend and dorsiflex to reload.
  3. Lift the leg, flex the hip, and extend the knee; plantarflex and invert the ankle to induce tension, then dorsiflex to unload.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life- Diabetic Neuropathy Questionnaire
Time Frame: 8 week
The Norfolk QOL-DN is an extensive and validated 47-item questionnaire that has been developed to encompass the complete range of Diabetic Neuropathy (DN) symptoms associated with small fiber, large fiber, and autonomic neuropathy. It is composed of two sections: one focusing on the symptoms experienced by diabetic patients and the other on how the patient's neuropathy affects their activities of daily living (ADLs). The questionnaire items are divided into six different domains, namely overall quality of life, symptoms, ADLs, physical functioning/large fiber, small fiber, and autonomic neuropathy. The symptom domain (items 1-7) will allocated a score of 1 or 0, denoting the presence or absence of the specified symptoms. Apart from items 31 and 32, the remaining items were evaluated using a 5-point scale (0-4, ranging from "No Problem" to "Severe Problem").A score range of 2-9 classified the neuropathy as mild, 10-19 as moderate, and greater than or equal to 20 as severe.
8 week
BERG BALANCE SCALE
Time Frame: 8 week
The BBS is a postural balance scale containing 14 items including standing and sitting unsupported, reaching forward, and placing the alternating foot on a stool. Administering the BBS takes approximately 15 min. Each of the 14 items is scored on a 5-level ordinal scale from 0 ("unable to perform or requiring help") to 4 ("normal performance"), thus providing a potential maximum score of 56 points.
8 week
4-Item Dynamic Gait Index
Time Frame: 8 week
It is a shortened version of the Dynamic gait index. It consists of 4 items of Dynamic gait index such as horizontal head turns, vertical head turns, gait on level surfaces, and changes in gait speed. Each of the four items is scored on an ordinal scale from 0-3 with higher numbers indicating better performance of the specified task. Additionally, each item has specific criteria that must be met to be granted a specific score number. The test has a total score of 12.
8 week
Numeric Pain Rating Scale
Time Frame: 8 week
Numeric Pain Rating Scale is a subjective measure 11 point (0-10) numerical scale which is a commonly used outcome measure to assess pain intensity, including in patients with diabetic peripheral neuropathy. Its score ranges from 0 indicating no pain at all to 10 indicating worst pain. In NPRS, 0 for No pain, 1-3 range for Mild pain, 4-6 range for Moderate pain, and 7-10 indicates Severe pain.
8 week
Michigan Neuropathy Screening Instrument
Time Frame: 8 week
Michigan Neuropathy Screening Instrument (MNSI) is a simple, non-invasive, and valid tool for screening DPN in diabetic patients. The initial section of the assessment tool comprises a self-administered questionnaire (15 yes-or-no questions) focusing on foot sensation, including aspects like discomfort, numbness, and temperature sensitivity. The subsequent segment involves a brief physical examination such as visual inspection of the feet, testing ankle reflexes using a tendon hammer, assessing vibration perception utilizing a 128 Hz tuning fork, and evaluating tactile sensation through the application of a 10 gm Semmes-Weinstein Monofilament (SWM). A score greater than 3 on the MNSI-Q and greater than 2 on the MNSI-PE suggests diabetic peripheral neuropathy.
8 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Study Chair: Hira Jabeen, MS-NMPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 29, 2024

Study Record Updates

Last Update Posted (Estimated)

November 26, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR&AHS/24/0256

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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