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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-75
SponsorRiphah International University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intraneural Facilitation Therapy

    Other intervention

    * 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.

  • Nerve Flossing Technique

    Other intervention

    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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: GROUP A Intraneural Facilitation Therapy along with Home care planExperimental treatment 1 intervention
Group B: Group B Nerve Flossing Technique along with Home care planExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Numeric Pain Rating Scale

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.

Time frame
8 week
2

Michigan Neuropathy Screening Instrument

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.

Time frame
8 week
3

Quality of Life- Diabetic Neuropathy Questionnaire

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.

Time frame
8 week
4

BERG BALANCE SCALE

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.

Time frame
8 week

Secondary outcomes

Other outcomes

Sponsors and contacts

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