Protocol summary
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Study aim
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To evaluate the effect of perineural and acupoints hypertonic saline5% injection in diabetic neuropathy
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Design
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A double blinded randomized controlled clinical trial with a parallel group design of 30 patients. Randomization sequence was created by the computer with the block size of six.
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Settings and conduct
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In this study, 30 patients with diabetic neuropathy who are eligible for entering the study will be randomly divided into two groups of 15, in the first group heypertonic saline is injected perineural and in the second group at the site of acupoints.Both the patients and analyzer are blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Diabetic patients with neuropathic pain in the past 3 months, ages between 30-60 years
Exclusion criteria: any infection, tumor or cutaneous lesions at or near sites of injection, significant foot deformity, history of chemotherapy, pregnancy, lumbosacral canal stenosis, discopathy, trauma, collagen vascular disease, nerve injury or other types of neuropathy, history of coagulopathy or bleeding tendency and allergy to the medication used in trial
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Intervention groups
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The first group will receive hypertonic saline injection near the nerves of Sural, Peroneal and Tibial. In the second group hypertonic saline will be injected at the site of acupoints(St-44, ST41, GB-40 )
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Main outcome variables
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Main outcome measures include neuropathy and the score of Douleur Neuropathique 4 questionnaire(DN4)
General information
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Reason for update
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We encountered an unexpected problem in publishing the manuscript due to error in recording the dates.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170517034008N1
Registration date:
2019-04-07, 1398/01/18
Registration timing:
prospective
Last update:
2021-06-06, 1400/03/16
Update count:
1
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Registration date
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2019-04-07, 1398/01/18
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-04-09, 1398/01/20
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Expected recruitment end date
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2019-11-11, 1398/08/20
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Actual recruitment start date
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2019-04-09, 1398/01/20
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Actual recruitment end date
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2020-01-29, 1398/11/09
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Trial completion date
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2020-02-19, 1398/11/30
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Scientific title
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Efficacy of perineural hypertonic saline injection versus acupoints of foot in the management of diabetic neuropathy: a randomized clinical trial
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Public title
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Effect of hypertonic saline injection in diabetic neuropathy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Presence of pain, paresthesia and sympoms of diabetic neuropathy over the past month
Ages between 30-60
Complete and sign written consent
Exclusion criteria:
Infection, tumor or any skin lesions at the site of intervention
Severe foot deformity
History of chemotherapy
Pregnancy
Lumbosacral canal stenosis or discopathy
Trauma
Rheumatologic and collagen vascular disease(CVD)
Spinal cord injury(SCI)
Traumatic brain injury(TBI)
Cerebrovascular accident(CVA)
Other nerve injuries and neuropathies
History of coagulopathy disorders
History of allergy to the drugs being used in the study
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Age
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From 30 years old to 60 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Data analyser
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Sample size
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Target sample size:
30
Actual sample size reached:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Thirty eligible patients will be randomly allocated to two parallel groups (Perineural injection group or G1 and acupoints injection group or G2). Randomization sequence is created using Excel 2007 (Microsoft) with a random block size of six.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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We will perform a double blinded study. In both groups there are equal volume and appearance of the drug and the patients have no ideas about injection sites of the groups. Also the analyst does not have any knowledge about the type of intervention in each group.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-06-18, 1397/03/28
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Ethics committee reference number
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IR.SUMS.MED.REC.1397.132
Health conditions studied
1
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Description of health condition studied
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Diabetic neuropathy
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ICD-10 code
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E08.40
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ICD-10 code description
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Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified
Primary outcomes
1
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Description
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The primary outcome is an assessment tool for neuropathic pain, called Douleur Neuropathique 4 questionnaire(DN4) score.
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Timepoint
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For each subject, the Douleur Neuropathique 4 questionnaire outcome measure is completed at baseline, first, second and 8th week after treatment.
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Method of measurement
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Douleur Neuropathique 4 questionnaire to assess neuropathic pain.
Intervention groups
1
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Description
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Intervention group 1: The study solution consisted of 5 mL sodium chloride hypertonic 5% and 1 mL lidocaine 2% (Pasteur institute of Iran) was injected with a 27-gauge needle near the tibial, saphenous and sural nerves (based on anatomical landmarks) under sterile condition.(Two milliliters of the study solution were injected in each point.)
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Category
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Rehabilitation
2
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Description
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Intervention group 2: we defined three acupuncture points based on the relevant literature, including ST-41, ST-44 and GB-40.The study solution consisted of 5 mL sodium chloride hypertonic 5% and 1 mL lidocaine 2% (Pasteur institute of Iran) was injected with a 27-gauge needle and two milliliters in each point.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available