Diabetic Peripheral NeuropathyNCT06663670
Intraneural Facilitation Therapy and Nerve Flossing Technique in Patients With Diabetic Peripheral Neuropathy
A study testing Intraneural Facilitation Therapy and Nerve Flossing Technique in people with Diabetic Peripheral Neuropathy, run by Riphah International University at 2 sites in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Intraneural Facilitation Therapy and Nerve Flossing Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesPakistan
- Study dates
- Dec 2024to Aug 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites
Siddique Family Hospital
Gujranwala, Punjab Province, 05228
Hira Jabeen, 03234116506, hira.jabeen@riphah.edu.pk
Amina Nazir, DPT
Social Security Hospital
Gujranwala, Punjab Province, 05228
Hira Jabeen, MS-NMPT, 03234116506, hira.jabeen@riphah.edu.pk
Amina Nazir, DPT
About this study
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
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.
Read the 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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Intraneural Facilitation Therapy, Nerve Flossing Technique
- Keywords
- Diabetes mellitus Type 2, Diabetic Neuropathy, Endoneurium, Epineurium, Gait, Pain, Peripheral Nerve, Quality of Life
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Neuropathies, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraneural Facilitation TherapyOther
- 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 TechniqueOther
Tibial Nerve:
- Passively flex the hip while dorsiflexing and everting the ankle to create tension; flex the knee to unload, then extend and plantarflex to reload.
- 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.
- 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:
- Passively flex the hip and plantarflex and invert the ankle to induce tension; flex the knee to unload, then extend and dorsiflex to reload.
- 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.
- Lift the leg, flex the hip, and extend the knee; plantarflex and invert the ankle to induce tension, then dorsiflex to unload.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A Intraneural Facilitation Therapy along with Home care plan | Experimental | 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. Receives: Other: Intraneural Facilitation Therapy |
| Group B Nerve Flossing Technique along with Home care plan | Experimental | 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. Receives: Other: Nerve Flossing Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 week
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.
Measured: 8 week
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.
Measured: 8 week
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.
Measured: 8 week
4-Item Dynamic Gait Index
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.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study startDec 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hira Jabeen, MS-NMPT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663670
- Sponsor's protocol ID
- REC/RCR&AHS/24/0256
- Status last verified
- Nov 2024
- First submitted
- 28 Oct 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Topp KS, Boyd BS. Structure and biomechanics of peripheral nerves: nerve responses to physical stresses and implications for physical therapist practice. Phys Ther. 2006 Jan;86(1):92-109. doi: 10.1093/ptj/86.1.92.
PubMed 16386065Intraneural Facilitation MR Bussell - US Patent App. 13/371,103, 2012
Alnajafi KZ-S. The Impact of Intraneural Facilitation Therapy on Diabetic Peripheral Neuropathy Loma Linda University Electronic Theses, Dissertations & Projects 2021.
BASUDEO RAJBHOR AG, SAURABH KUMAR. Comparison of Kinesio Taping and Nerve Flossing Technique on Balance, Gait and Ankle Flexibility in Diabetic Neuropathy. 2022.
Dan Ran Castillo WJJ, Carvy Floyd Lucero, Mark Bussell, Ron Coleman, Karla Pieters, Jamie Hankins, Annette Boggs, Salem Dehom, Lorena Garcia, Ellen D'Errico, and Gayathri Nagaraj. A pilot study of intraneural facilitation versus standard physical therapy for prevention ofchemotherapy-induced peripheral neuropathy. Journal of Clinical Oncology. May31,2023.
G.Tharani DJP, Dr. Jagatheesan Alagesan,Dr. Harikrishnan. N Exploring the Effectiveness of Peroneal Nerve Flossing in Alleviating Diabetic Peripheral Neuropathy Symptoms. Journal for Re Attach Therapy and Developmental Diversities. August6,2023
Alshahrani A, Bussell M, Johnson E, Tsao B, Bahjri K. Effects of a Novel Therapeutic Intervention in Patients With Diabetic Peripheral Neuropathy. Arch Phys Med Rehabil. 2016 May;97(5):733-8. doi: 10.1016/j.apmr.2015.12.026. Epub 2016 Jan 22.
PubMed 26808781Goyat 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 36404825Sahba K, Berk L, Bussell M, Lohman E, Zamora F, Gharibvand L. Treating peripheral neuropathy in individuals with type 2 diabetes mellitus with intraneural facilitation: a single blind randomized control trial. J Int Med Res. 2022 Aug;50(8):3000605221109390. doi: 10.1177/03000605221109390.
PubMed 35922961Baker NA, Vuong D, Bussell M, Gharibvand L, Lee S, Tsao B. Prospective, Randomized, Double-Blinded, Sham-Controlled Pilot Study of Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome. Arch Rehabil Res Clin Transl. 2022 Mar 29;4(2):100193. doi: 10.1016/j.arrct.2022.100193. eCollection 2022 Jun.
PubMed 35756982
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06663670
- Acronym / sponsor ID
- REC/RCR&AHS/24/0256
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Diabetes mellitus Type 2, Diabetic Neuropathy, Endoneurium, Epineurium, Gait, Pain, Peripheral Nerve, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A Intraneural Facilitation Therapy along with Home care plan | Experimental | Other: Intraneural Facilitation TherapyGroup 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. |
| Group B Nerve Flossing Technique along with Home care plan | Experimental | Other: Nerve Flossing TechniqueGroup 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | GROUP A Intraneural Facilitation Therapy along with Home care plan |
| Nerve Flossing TechniqueTibial 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. | Other | Group B Nerve Flossing Technique along with Home care plan |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Background: PubMed 16386065Topp KS, Boyd BS. Structure and biomechanics of peripheral nerves: nerve responses to physical stresses and implications for physical therapist practice. Phys Ther. 2006 Jan;86(1):92-109. doi: 10.1093/ptj/86.1.92.
- BackgroundIntraneural Facilitation MR Bussell - US Patent App. 13/371,103, 2012
- BackgroundAlnajafi KZ-S. The Impact of Intraneural Facilitation Therapy on Diabetic Peripheral Neuropathy Loma Linda University Electronic Theses, Dissertations & Projects 2021.
- BackgroundBASUDEO RAJBHOR AG, SAURABH KUMAR. Comparison of Kinesio Taping and Nerve Flossing Technique on Balance, Gait and Ankle Flexibility in Diabetic Neuropathy. 2022.
- BackgroundDan Ran Castillo WJJ, Carvy Floyd Lucero, Mark Bussell, Ron Coleman, Karla Pieters, Jamie Hankins, Annette Boggs, Salem Dehom, Lorena Garcia, Ellen D'Errico, and Gayathri Nagaraj. A pilot study of intraneural facilitation versus standard physical therapy for prevention ofchemotherapy-induced peripheral neuropathy. Journal of Clinical Oncology. May31,2023.
- BackgroundG.Tharani DJP, Dr. Jagatheesan Alagesan,Dr. Harikrishnan. N Exploring the Effectiveness of Peroneal Nerve Flossing in Alleviating Diabetic Peripheral Neuropathy Symptoms. Journal for Re Attach Therapy and Developmental Diversities. August6,2023
- Background: PubMed 26808781Alshahrani A, Bussell M, Johnson E, Tsao B, Bahjri K. Effects of a Novel Therapeutic Intervention in Patients With Diabetic Peripheral Neuropathy. Arch Phys Med Rehabil. 2016 May;97(5):733-8. doi: 10.1016/j.apmr.2015.12.026. Epub 2016 Jan 22.
- Background: PubMed 36404825Goyat 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.
- Background: PubMed 35922961Sahba K, Berk L, Bussell M, Lohman E, Zamora F, Gharibvand L. Treating peripheral neuropathy in individuals with type 2 diabetes mellitus with intraneural facilitation: a single blind randomized control trial. J Int Med Res. 2022 Aug;50(8):3000605221109390. doi: 10.1177/03000605221109390.
- Background: PubMed 35756982Baker NA, Vuong D, Bussell M, Gharibvand L, Lee S, Tsao B. Prospective, Randomized, Double-Blinded, Sham-Controlled Pilot Study of Intraneural Facilitation as a Treatment for Carpal Tunnel Syndrome. Arch Rehabil Res Clin Transl. 2022 Mar 29;4(2):100193. doi: 10.1016/j.arrct.2022.100193. eCollection 2022 Jun.
- Individual participant dataSharing planned: No
Related trials for Diabetic Peripheral Neuropathy
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects Of Sensory Reweighting And Proprioceptive Facilitation Training On Balance And Fall Risk In Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Not yet recruiting
Adaptive Gamified Sensory Training on Sensory Function and Limb-Specific Functional Performance in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hira Jabeen, MS-NMPT study chair
Riphah International University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraneural Facilitation Therapy and Nerve Flossing Technique in people with Diabetic Peripheral Neuropathy, run by Riphah International University at 2 sites 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 3 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: opening soon, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Hira Jabeen, MS-NMPT (03234116506, hira.jabeen@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 8 week). The study lists 5 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 NCT06663670, which also lists 10 linked publications.
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 26 Nov 2024.