Slider Versus Tensioner Neural Mobilization in Diabetic Peripheral Neuropathy

Sponsor
Riphah International University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05349357
Collaborator
(none)
32
2
8.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Sliding Neural mobilization
  • Other: Tensioner Neural mobilization
  • Other: Stretching exercises
  • Device: TENS
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Compare the Effects of Sliding With Tensioner Technique of Neural Mobilization in Diabetic Peripheral Neuropathy Patients
Anticipated Study Start Date :
Jun 25, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

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: Tensioner Neural mobilization
Tensioner neural mobilization to femoral, sciatic and tibial nerve

Other: Stretching exercises
Stretching exercises

Device: TENS
TENS

Outcome Measures

Primary Outcome Measures

  1. Michigan neuropathy screening instrument [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.

  2. Numerical Pain Rating Scale [3 weeks]

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

Secondary Outcome Measures

  1. SF-36 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Riphah International University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05349357
Other Study ID Numbers:
  • REC01253 Aaseya Syed
First Posted:
Apr 27, 2022
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2022