Clinical trial NCT06663670: Intraneural Facilitation Therapy and Nerve Flossing Technique in Patients With Diabetic Peripheral Neuropathy
Official title: Comparative Effects of Intraneural Facilitation Therapy and Nerve Flossing Technique on Pain, Balance, Gait, and Quality of Life in Patients With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: Diabetes mellitus Type 2
Diabetic Neuropathy
Endoneurium
Epineurium
Gait
Pain
Peripheral Nerve
Quality of Life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 8 week
measure: Michigan Neuropathy Screening Instrument
timeFrame: 8 week
measure: Quality of Life- Diabetic Neuropathy Questionnaire
timeFrame: 8 week
measure: BERG BALANCE SCALE
timeFrame: 8 week
measure: 4-Item Dynamic Gait Index
timeFrame: 8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Gujranwala
country: Pakistan
facility: Siddique Family Hospital
state: Punjab
city: Gujranwala
country: Pakistan
facility: Social Security Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hira Jabeen, MS-NMPT
role: STUDY_CHAIR
References:
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