Combined Effects of INF and OEP in Patients With Diabetic Peripheral Neuropathy

NCT07274735 | Recruiting

• 1 other identifier: REC/0269 Rameen Shahzad
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

DPN often leads to balance issues, sensory deficits, and chronic pain, which can severely impact daily functioning and independence. INF therapy aims to improve nerve blood flow and alleviate neuropathic symptoms through manual techniques, while the Otago Exercise Program focuses on enhancing strength and balance to reduce fall risk. By comparing these two interventions, this study seeks to identify effective strategies that can improve balance, reduce pain, and enhance the quality of life for individuals suffering from DPN

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetic Nephropathies; Exercise; Musculoskeletal Manipulations; Peripheral Neuropathy; Quality of Life

Outcome Measures

Primary Outcomes (3)

• DN4

  The DN4 Questionnaire is a screening tool for neuropathic pain consisting of 10 interview questions (DN4-interview) and physical tests which has been validated for the diagnosis of diabetic peripheral neuropathy in western populations. The DN4 questionnaire is used to screen for the presence of neuropathic pain. This questionnaire consisted of 4 sections; 3 sections concerned with symptoms review and associated symptoms and the 4th section reserved for physical examination.

  8th week

• Mini BESTest scale

  The Mini-BESTest has 14 items, scored from 0-2, so the maximum score is 28

  8th week

• Quality of Life- Diabetic Neuropathy Questionnaire

  It is an extensive and validated 35-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).

  8th week

Secondary Outcomes (3)

• Numeric Pain Rating Scale

  8th week

• TUG test

  8th week

• Ankle brachial index (ABI)

  8th week

Study Arms (3)

Intraneural facilitation therapy

EXPERIMENTAL

The intervention will consist of 24 sessions delivered three times per week over eight weeks, with each session lasting 50-60 minutes. Effects will be measured at baseline (before treatment), after the 4th week and after 8th week (post treatment)

Other: Intraneural facilitation therapy

Otago exercise program

EXPERIMENTAL

Otago exercise training was conducted 3 times a week for a total of 50 min per session, including 5 min of warm-up and 5 min of cool-down. Effects will be measured at baseline, at 4th weeks and at 8th week. The exercises consisted of the following strengthening exercises: knee extensors, knee flexors, hip abductors, ankle plantar flexors, and ankle dorsiflexors. The balance retraining exercises consisted of the following: knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel toe walking backwards, and sit to stand

Other: Otago exercise program

Intraneural facilitation therapy with Otago exercise program

EXPERIMENTAL

The exercise intervention will be an 8 week, 3xweek, and 50-60 min class following the 20-30min OEP curriculum with 20-30 min /sessions of intraneural facilitation therapy per week. Effects will be measured at baseline, at 4th weeks and at 8th week

Other: Intraneural facilitation therapy with Otago exercise program

Interventions

Intraneural facilitation therapy OTHER

The intervention will consist of 24 sessions delivered three times per week over eight weeks, with each session lasting 50-60 minutes. Effects will be measured at baseline (before treatment), after the 4th week and after 8th week (post treatment)

Intraneural facilitation therapy

Otago exercise program OTHER

Otago exercise training was conducted 3 times a week for a total of 50 min per session, including 5 min of warm-up and 5 min of cool-down. Effects will be measured at baseline, at 4th weeks and at 8th week. The exercises consisted of the following strengthening exercises: knee extensors, knee flexors, hip abductors, ankle plantar flexors, and ankle dorsiflexors. The balance retraining exercises consisted of the following: knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel toe walking backwards, and sit to stand

Otago exercise program

Intraneural facilitation therapy with Otago exercise program OTHER

The exercise intervention will be an 8 week, 3xweek, and 50-60 min class following the 20-30min OEP curriculum with 20-30 min /sessions of intraneural facilitation therapy per week. Effects will be measured at baseline, at 4th weeks and at 8th week

Intraneural facilitation therapy with Otago exercise program

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-75years
• Both male and female patients will be included in the study
• Patient with type 2 diabetes mellitus (diagnosed by the physician)
• Patients with a score ≥ 4 on DN4 scale
• Patients have a score on the Timed Up-and-Go (TUG) test of less than 15 s
• Able to walk at least 10 meters long

You may not qualify if:

• Patient with 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
• Patients with documented active alcohol or drug misuse
• Patient with total or partial amputation of lower extremities
• Participants will be also excluded if they were morbidly obese or if pregnant (self-reported)
• Patient with 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Rasheed Hospital

Lahore, Punjab Province, 54800, Pakistan

RECRUITING

Related Publications (18)

• Baker 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.

  PMID: 35756982 BACKGROUND

• Alnajafi KZ-S. The Impact of Intraneural Facilitation Therapy on Diabetic Peripheral Neuropathy. 2021.

  BACKGROUND

• Kadir MI, Hardiyanty N, Adliah F. A pilot study of the effect of otago exercise program on fall risk and quality of life of older women. Physical Therapy Journal of Indonesia. 2021;2(1):1-4.

  BACKGROUND

• Jahanpeyma P, Kayhan Kocak FO, Yildirim Y, Sahin S, Senuzun Aykar F. Effects of the Otago exercise program on falls, balance, and physical performance in older nursing home residents with high fall risk: a randomized controlled trial. Eur Geriatr Med. 2021 Feb;12(1):107-115. doi: 10.1007/s41999-020-00403-1. Epub 2020 Nov 25.

  PMID: 33237565 BACKGROUND

• Brown JJ, Colberg SR, Pribesh S, Baskette KG, Vinik AI. A comparison of neuropathy quality of life tools: Norfolk QOL-DN, PN-QOL-97, and NeuroQOL-28. Medical Research Archives. 2021;9(11)

  BACKGROUND

• Agoons BB, Tchapmi D, Boli AO, Katte J-C. Clinical utility of the DN4 questionnaire in the assessment of neuropathic pain in patients with type 2 diabetes: Experience from a newly-created diabetes clinic in Cameroon. PAMJ-Clinical Medicine. 2020;3(165).

  BACKGROUND

• Lytras D, Sykaras E, Iakovidis P, Komisopoulos C, Chasapis G, Mouratidou C. Effects of a modified Otago exercise program delivered through outpatient physical therapy to community-dwelling older adult fallers in Greece during the COVID-19 pandemic: a controlled, randomized, multicenter trial. Eur Geriatr Med. 2022 Aug;13(4):893-906. doi: 10.1007/s41999-022-00656-y. Epub 2022 May 24.

  PMID: 35606677 BACKGROUND

• Spallone V, Morganti R, D'Amato C, Greco C, Cacciotti L, Marfia GA. Validation of DN4 as a screening tool for neuropathic pain in painful diabetic polyneuropathy. Diabet Med. 2012 May;29(5):578-85. doi: 10.1111/j.1464-5491.2011.03500.x.

  PMID: 22023377 BACKGROUND

• Shakya BM, Shrestha A, Poudyal AK, Shrestha N, Acharya B, Gurung R, et al. Nepalese version of Douleur Neuropathique 4 (DN4) questionnaire for Assessment of Neuropathic pain: A Validation Study. medRxiv. 2021:2021.09. 17.21263734.

  BACKGROUND

• Zielinski J, Morawska-Kochman M, Zatonski T. Pain assessment and management in children in the postoperative period: A review of the most commonly used postoperative pain assessment tools, new diagnostic methods and the latest guidelines for postoperative pain therapy in children. Adv Clin Exp Med. 2020 Mar;29(3):365-374. doi: 10.17219/acem/112600.

  PMID: 32129952 BACKGROUND

• Vinik EJ, Hayes RP, Oglesby A, Bastyr E, Barlow P, Ford-Molvik SL, Vinik AI. The development and validation of the Norfolk QOL-DN, a new measure of patients' perception of the effects of diabetes and diabetic neuropathy. Diabetes Technol Ther. 2005 Jun;7(3):497-508. doi: 10.1089/dia.2005.7.497.

  PMID: 15929681 BACKGROUND

• Alghamdi M, Owolabi LF, Adamu B, Taura MG, Jibo A, Almansour M, Alaklabi SN, Alghamdi MA, Imam IA, Abdelrazak R, Rafaat A, Aliyu MH. Disease-specific quality of life in patients with diabetic neuropathy. Saudi Med J. 2022 Apr;43(4):408-417. doi: 10.15537/smj.2022.43.4.20210861.

  PMID: 35414620 BACKGROUND

• Smith SC, Lamping DL, Maclaine GD. Measuring health-related quality of life in diabetic peripheral neuropathy: a systematic review. Diabetes Res Clin Pract. 2012 Jun;96(3):261-70. doi: 10.1016/j.diabres.2011.11.013. Epub 2011 Dec 10.

  PMID: 22154463 BACKGROUND

• King L, Horak F. On the mini-BESTest: scoring and the reporting of total scores. Phys Ther. 2013 Apr;93(4):571-5. doi: 10.2522/ptj.2013.93.4.571. No abstract available.

  PMID: 23547173 BACKGROUND

• Yingyongyudha A, Saengsirisuwan V, Panichaporn W, Boonsinsukh R. The Mini-Balance Evaluation Systems Test (Mini-BESTest) Demonstrates Higher Accuracy in Identifying Older Adult Participants With History of Falls Than Do the BESTest, Berg Balance Scale, or Timed Up and Go Test. J Geriatr Phys Ther. 2016 Apr-Jun;39(2):64-70. doi: 10.1519/JPT.0000000000000050.

  PMID: 25794308 BACKGROUND

• Meekes WM, Korevaar JC, Leemrijse CJ, van de Goor IA. Practical and validated tool to assess falls risk in the primary care setting: a systematic review. BMJ Open. 2021 Sep 29;11(9):e045431. doi: 10.1136/bmjopen-2020-045431.

  PMID: 34588228 BACKGROUND

• Ichihashi S, Desormais I, Hashimoto T, Magne J, Kichikawa K, Aboyans V. Accuracy and Reliability of the Ankle Brachial Index Measurement Using a Multicuff Oscillometric Device Versus the Doppler Method. Eur J Vasc Endovasc Surg. 2020 Sep;60(3):462-468. doi: 10.1016/j.ejvs.2020.06.013. Epub 2020 Aug 3.

  PMID: 32763120 BACKGROUND

• Leem SH, Kim JH, Lee BH. Effects of Otago exercise combined with action observation training on balance and gait in the old people. J Exerc Rehabil. 2019 Dec 31;15(6):848-854. doi: 10.12965/jer.1938720.360. eCollection 2019 Dec.

  PMID: 31938708 BACKGROUND

MeSH Terms

Conditions

Diabetic Nephropathies; Motor Activity; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Behavior; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Aruba Saeed, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 10, 2025
• Study Start: October 17, 2024
• Primary Completion: January 17, 2026
• Study Completion: January 17, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)