A study protocol on nerve mobilization induced diffusion tensor imaging values in posterior tibial nerve in healthy controls and in patients with diabetic neuropathy-multigroup pretest posttest design.
Anisotropy
Diabetic neuropathy
Diffusion tensor imaging
Edema
Nerve mobilization
Protons
Tibial nerve
Journal
Contemporary clinical trials communications
ISSN: 2451-8654
Titre abrégé: Contemp Clin Trials Commun
Pays: Netherlands
ID NLM: 101671157
Informations de publication
Date de publication:
Dec 2019
Dec 2019
Historique:
received:
20
06
2019
revised:
27
08
2019
accepted:
14
09
2019
entrez:
26
10
2019
pubmed:
28
10
2019
medline:
28
10
2019
Statut:
epublish
Résumé
Diabetic neuropathy is the commonest chronic disabling complication of diabetes which may lead to amputation and compromising patient's quality of life. It is characterized by pain, sensation loss associated with neural edema. Diffusion tensor imaging parameter i.e. fraction anisotropy determines the free water proton diffusion in the healthy nerve. Since the diabetes leads to altered mechanosensitivity of the posterior tibial nerve thereby, might interferes with the water molecules movement. Therefore the present clinical trial will provide the evidence of improving the diffusion tensor imaging in the diabetic neuropathy directly by targeting the nerve through nerve mobilization treatment. Participants with Type II Diabetes Mellitus induced peripheral neuropathy will be selected randomly on the basis of eligibility criteria and informed consent will be taken. Participants will be recruited into three groups. Group A (experimental group A) will receive neural mobilization technique, Group B (experimental group B) will receive conventional therapy and Group C (control group) will receive sham treatment for 3 weeks. MRI technique, Visual analogue scale and neuropathy specific quality of life questionnaire will be used as assessment tools. Assessment will be taken at baseline and post intervention. this clinical trial will provide the evidence of efficacy of nerve mobilization in determining the diffusion tensor imaging (DTI) changes in the posterior tibial nerve in patients with diabetic neuropathy. This trial will also be the first one in itself to look at the treatment induced DTI changes in the peripheral nerve. Clinical Trial Registry of India (CTRI/2019/06/019552).
Sections du résumé
BACKGROUND
BACKGROUND
Diabetic neuropathy is the commonest chronic disabling complication of diabetes which may lead to amputation and compromising patient's quality of life. It is characterized by pain, sensation loss associated with neural edema. Diffusion tensor imaging parameter i.e. fraction anisotropy determines the free water proton diffusion in the healthy nerve. Since the diabetes leads to altered mechanosensitivity of the posterior tibial nerve thereby, might interferes with the water molecules movement. Therefore the present clinical trial will provide the evidence of improving the diffusion tensor imaging in the diabetic neuropathy directly by targeting the nerve through nerve mobilization treatment.
METHODS
METHODS
Participants with Type II Diabetes Mellitus induced peripheral neuropathy will be selected randomly on the basis of eligibility criteria and informed consent will be taken. Participants will be recruited into three groups. Group A (experimental group A) will receive neural mobilization technique, Group B (experimental group B) will receive conventional therapy and Group C (control group) will receive sham treatment for 3 weeks. MRI technique, Visual analogue scale and neuropathy specific quality of life questionnaire will be used as assessment tools. Assessment will be taken at baseline and post intervention.
CONCLUSION
CONCLUSIONS
this clinical trial will provide the evidence of efficacy of nerve mobilization in determining the diffusion tensor imaging (DTI) changes in the posterior tibial nerve in patients with diabetic neuropathy. This trial will also be the first one in itself to look at the treatment induced DTI changes in the peripheral nerve.
TRIAL REGISTRATION
BACKGROUND
Clinical Trial Registry of India (CTRI/2019/06/019552).
Identifiants
pubmed: 31650071
doi: 10.1016/j.conctc.2019.100451
pii: S2451-8654(19)30213-3
pii: 100451
pmc: PMC6804550
doi:
Types de publication
Journal Article
Langues
eng
Pagination
100451Informations de copyright
© 2019 Published by Elsevier Inc.
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