Slider Versus Tensioner Neural Mobilization in Diabetic Peripheral Neuropathy

Diabetic Peripheral Neuropathic Pain Clinical Trial

Official title:

Compare the Effects of Sliding With Tensioner Technique of Neural Mobilization in Diabetic Peripheral Neuropathy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05349357
• Other study ID #: REC01253 Aaseya Syed
• Status: Completed
• Phase: N/A
• Start date: June 25, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The neurodynamic technique both sliders and tensioners results in changes of the mechanical or physiological function of nerve tissues along with the interface; restoring pressure gradients, relieving hypoxia and pain resulting in reducing associated symptoms.

Through clinical reasoning the nervous system seems to be the logical place for treatment and explanations and previous descriptions of this method have clarified the overall impact on quality of life in diabetic peripheral neuropathy but it doesn't discuss which technique of neural mobilization is more effective and its effects on diabetic peripheral neuropathic population. Within this reasoning it is important to determine which neurodynamic technique is more effective in improving quality of life and reduce pain in patients with diabetic peripheral neuropathy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient having=12score on Self report Leads Assessment of Neuropathic Symptoms and Sign

• Patients with lower limb pain =4 to =7 on NPRS

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetic Peripheral Neuropathic Pain
• Neuralgia
• Peripheral Nervous System Diseases

Intervention

Other:
• Sliding Neural mobilization
Sliding neural mobilization to femoral, sciatic and tibial nerve
• Tensioner Neural mobilization
Tensioner neural mobilization to femoral, sciatic and tibial nerve
• Stretching exercises
Stretching exercises

Device:
• TENS
TENS

Locations

Country	Name	City	State
Pakistan	DHQ Hospital	Mianwali	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Quality of Life SF-36	to assess the quality of life, SF-36 ; Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.	3 weeks