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

Riphah International University

Status: Not yet enrolling

Conditions: Diabetic Peripheral Neuropathy

Treatments: Other: Nerve Flossing Technique; Other: Intraneural Facilitation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06663670

REC/RCR&AHS/24/0256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

GROUP A Intraneural Facilitation Therapy along with Home care plan

Experimental group

Description:

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.

Treatment:

Other: Intraneural Facilitation Therapy

Group B Nerve Flossing Technique along with Home care plan

Experimental group

Description:

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.

Treatment:

Other: Nerve Flossing Technique