Slider Versus Tensioner Neural Mobilization in Diabetic Peripheral Neuropathy

NCT05349357 | Completed

• 1 other identifier: REC01253 Aaseya Syed
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Neurodynamics, i.e., the mobilization of the peripheral nervous system, is a physical approach to the treatment of pain; the method relies on influencing pain physiology via mechanical treatment of neural tissues and the non-neural structures surrounding the nervous system. Neural mobilization (NM) is used to treat various disorders of the nervous system concerning the length and mobility of peripheral nerves, as the nerve mobilizing refers to techniques that help to reestablish motion between a nerve and its surrounding soft tissues, thus to treat the nerves that have become entangled within the soft tissue, as it leads to tension release on a nerve by stretching and pulling one end of the nerve during keeping the other end in a relaxed state.

Conditions

Diabetic Peripheral Neuropathic Pain

Outcome Measures

Primary Outcomes (2)

• Michigan neuropathy screening instrument

  For screening the neuropathy; The MNSI questionnaire is self-administered. Responses are added to obtain a total score. 'Yes' responses to questions 1-3, 5-6, 8-9, 11-12, 14-15 are each counted as one point. 'No' responses to questions 7 and 13 each count as one point. Question 4 was considered to be a measure of impaired circulation and question 10 a measure of general asthenia and were not included in the published scoring algorithm. A score of ≥ 7 was considered abnormal. All 15 questions were included in the new scoring algorithms.

  3 weeks

• Numerical Pain Rating Scale

  Quantify the pain ranging from 0 to 10 in which zero means no pain and 10 severe pain

  3 weeks

Secondary Outcomes (1)

• Quality of Life SF-36

  3 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

TENS, Stretching exercises, ROM exercises Sliding neural mobilization to femoral, sciatic, tibial nerve

Other: Sliding Neural mobilization; Other: Stretching exercises; Device: TENS

Group B

ACTIVE COMPARATOR

TENS, Stretching exercises, ROM exercises Tensioner neural mobilization to femoral, sciatic, tibial nerve

Other: Tensioner Neural mobilization; Other: Stretching exercises; Device: TENS

Interventions

Sliding Neural mobilization OTHER

Sliding neural mobilization to femoral, sciatic and tibial nerve

Group A

Tensioner Neural mobilization OTHER

Tensioner neural mobilization to femoral, sciatic and tibial nerve

Group B

Stretching exercises OTHER

Stretching exercises

Group A; Group B

TENS DEVICE

TENS

Group A; Group B

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient having≥12score on Self report Leads Assessment of Neuropathic Symptoms and Sign
• Patients with lower limb pain ≥4 to ≤7 on NPRS

You may not qualify if:

• Diabetic foot ulcer
• Complex regional pain syndrome
• Infection in lower limb
• Lower extremity amputation
• Discogenic pain
• Restricted joint deformity
• Dependency on chemical or drugs
• Pregnancy

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

DHQ Hospital

Mianwali, Punjab Province, Pakistan

Location

Related Publications (4)

• Pop-Busui R, Boulton AJ, Feldman EL, Bril V, Freeman R, Malik RA, Sosenko JM, Ziegler D. Diabetic Neuropathy: A Position Statement by the American Diabetes Association. Diabetes Care. 2017 Jan;40(1):136-154. doi: 10.2337/dc16-2042. No abstract available.

  PMID: 27999003 BACKGROUND

• Iqbal Z, Azmi S, Yadav R, Ferdousi M, Kumar M, Cuthbertson DJ, Lim J, Malik RA, Alam U. Diabetic Peripheral Neuropathy: Epidemiology, Diagnosis, and Pharmacotherapy. Clin Ther. 2018 Jun;40(6):828-849. doi: 10.1016/j.clinthera.2018.04.001. Epub 2018 Apr 30.

  PMID: 29709457 BACKGROUND

• Feldman EL, Nave KA, Jensen TS, Bennett DLH. New Horizons in Diabetic Neuropathy: Mechanisms, Bioenergetics, and Pain. Neuron. 2017 Mar 22;93(6):1296-1313. doi: 10.1016/j.neuron.2017.02.005.

  PMID: 28334605 BACKGROUND

• Cho NH, Shaw JE, Karuranga S, Huang Y, da Rocha Fernandes JD, Ohlrogge AW, Malanda B. IDF Diabetes Atlas: Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018 Apr;138:271-281. doi: 10.1016/j.diabres.2018.02.023. Epub 2018 Feb 26.

  PMID: 29496507 BACKGROUND

MeSH Terms

Interventions

Muscle Stretching Exercises; Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Electric Stimulation Therapy; Analgesia; Anesthesia and Analgesia

Study Officials

• Mirza Obaid Baig, MSPT(NMR)

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 27, 2022
• Study Start: June 25, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 9, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)