Slider Versus Tensioner Neural Mobilization in Diabetic Peripheral Neuropathy

March 7, 2023 updated by: Riphah International University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Mianwali, Punjab, Pakistan
        • DHQ Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
TENS, Stretching exercises, ROM exercises Sliding neural mobilization to femoral, sciatic, tibial nerve
Other: Sliding Neural mobilization
Sliding neural mobilization to femoral, sciatic and tibial nerve
Other: Stretching exercises
Stretching exercises
Device: TENS
TENS
Active Comparator: Group B
TENS, Stretching exercises, ROM exercises Tensioner neural mobilization to femoral, sciatic, tibial nerve
Other: Stretching exercises
Stretching exercises
Device: TENS
TENS
Other: Tensioner Neural mobilization
Tensioner neural mobilization to femoral, sciatic and tibial nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Michigan neuropathy screening instrument
Time Frame: 3 weeks
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
Time Frame: 3 weeks
Quantify the pain ranging from 0 to 10 in which zero means no pain and 10 severe pain
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life SF-36
Time Frame: 3 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Mirza Obaid Baig, MSPT(NMR), Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 25, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

April 15, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

April 27, 2022

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC01253 Aaseya Syed

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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