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Slider Versus Tensioner Neural Mobilization in Diabetic Peripheral Neuropathy

Primary Purpose

Diabetic Peripheral Neuropathic Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Sliding Neural mobilization
Tensioner Neural mobilization
Stretching exercises
TENS
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Peripheral Neuropathic Pain

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DHQ Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A

Group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Numerical Pain Rating Scale
Quantify the pain ranging from 0 to 10 in which zero means no pain and 10 severe pain

Secondary Outcome Measures

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.

Full Information

First Posted
April 15, 2022
Last Updated
March 7, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05349357
Brief Title
Slider Versus Tensioner Neural Mobilization in Diabetic Peripheral Neuropathy
Official Title
Compare the Effects of Sliding With Tensioner Technique of Neural Mobilization in Diabetic Peripheral Neuropathy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 25, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
February 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Peripheral Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
TENS, Stretching exercises, ROM exercises Sliding neural mobilization to femoral, sciatic, tibial nerve
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
TENS, Stretching exercises, ROM exercises Tensioner neural mobilization to femoral, sciatic, tibial nerve
Intervention Type
Other
Intervention Name(s)
Sliding Neural mobilization
Intervention Description
Sliding neural mobilization to femoral, sciatic and tibial nerve
Intervention Type
Other
Intervention Name(s)
Tensioner Neural mobilization
Intervention Description
Tensioner neural mobilization to femoral, sciatic and tibial nerve
Intervention Type
Other
Intervention Name(s)
Stretching exercises
Intervention Description
Stretching exercises
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
TENS
Primary Outcome Measure Information:
Title
Michigan neuropathy screening instrument
Description
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.
Time Frame
3 weeks
Title
Numerical Pain Rating Scale
Description
Quantify the pain ranging from 0 to 10 in which zero means no pain and 10 severe pain
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Quality of Life SF-36
Description
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.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mirza Obaid Baig, MSPT(NMR)
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
DHQ Hospital
City
Mianwali
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27999003
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.
Results Reference
background
PubMed Identifier
29709457
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.
Results Reference
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PubMed Identifier
28334605
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.
Results Reference
background
PubMed Identifier
29496507
Citation
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.
Results Reference
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Slider Versus Tensioner Neural Mobilization in Diabetic Peripheral Neuropathy

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