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IRCT20210309050642N1 IRCT 2021-03-30 Shiraz University of Medical Sciences The effect of prolotherapy injection in the treatment of neuropathy The effect of prolotherapy in perineural points and lower extremity acupoints on neuropathic pain in patients with neuropathy 2021-04-09 anticipated 48 Complete https://irct.ir/trial/54897 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The total number of eligible patients is 48. This number is randomly divided by computer into three groups: perineural, acupuncture and control, each group of 16 people. Random allocation is done with 6 blocks, Blinding description: The study is performed in double blind method. The type and volume of drug injected and its appearance are the same in all groups. Patients do not know the injection site in other groups. Also, the data analyzer is not aware of the interventions made in the groups. 3 Neuropathy. Intervention 1: Intervention group 1: after sterilizing the injection site with betadine, injection of 5 cc of 5% dextrose solution construction of Pasteur Institute with 1 cc of 2% lidocaine solution construction of Pasteur Institute around 3 peripheral nerves, tibial sural and saphenous, in the ankle area based on anatomical landmarks, 2 cc each point, subcutaneous with an angle of 45 degrees and a depth of 4 mm, with needle gage 25. Weekly injections for 3 consecutive weeks, number of patients in this group is 16. Oral pregabalin 75 mg twice daily for all patients. Intervention 2: Intervention group 2: after sterilizing the injection site with betadine, injection of 5 cc of 5% dextrose solution construction of Pasteur Institute with 1 cc of 2% lidocaine solution construction of Pasteur Institute around 3 foot acupuncture points, ST41, ST44 and GB40 points, 2 cc each point, subcutaneous with an angle of 45 degrees and a depth of 4 mm, with needle gage 25. Weekly injections for 3 consecutive weeks, number of patients in this group is 16. Oral pregabalin 75 mg twice daily for all patients. Intervention 3: Control group: oral pregabalin 75 mg twice daily, without injection in the foot. Number of patients in this group is 16. Yes - There is a plan to make this available What will be shared: All data in this study will be shared without mentioning patients' identities, including patient grouping, injection methods, data obtained, and data analysis methods. When: Data will be available 3 months after approval To whom: The data will be accessible to physician colleagues in all disciplines as well as to patients Conditions: Access to the data in this study will not require special conditions Where to obtain: sharareh.roshanzamir@gmail.com How to obtain: An email request is sufficient Comments:
public Sharareh Roshanzamir
Physical Medicine and Rehabilitation Department, Faghihi hospital, Zand Blvd, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3231 9040 sharareh.roshanzamir@gmail.com Shiraz University of Medical Sciences scientific Sharareh Roshanzamir
Physical Medicine and Rehabilitation Department, Faghihi hospital, Zand Blvd, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134844119 +98 71 3231 9040 sharareh.roshanzamir@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Clinical signs of lower limb neuropathy in the last three months No response to conventional treatments Age 30-60 years Complete and sign the consent form 30 years 60 years Both any tumor, infection, or skin lesion at the target site Pregnancy Bleeding disorders History of allergies to the drugs used G62.9 Polyneuropathy, unspecified Rehabilitation Rehabilitation Rehabilitation Intervention group 1: after sterilizing the injection site with betadine, injection of 5 cc of 5% dextrose solution construction of Pasteur Institute with 1 cc of 2% lidocaine solution construction of Pasteur Institute around 3 peripheral nerves, tibial sural and saphenous, in the ankle area based on anatomical landmarks, 2 cc each point, subcutaneous with an angle of 45 degrees and a depth of 4 mm, with needle gage 25. Weekly injections for 3 consecutive weeks, number of patients in this group is 16. Oral pregabalin 75 mg twice daily for all patients Intervention group 2: after sterilizing the injection site with betadine, injection of 5 cc of 5% dextrose solution construction of Pasteur Institute with 1 cc of 2% lidocaine solution construction of Pasteur Institute around 3 foot acupuncture points, ST41, ST44 and GB40 points, 2 cc each point, subcutaneous with an angle of 45 degrees and a depth of 4 mm, with needle gage 25. Weekly injections for 3 consecutive weeks, number of patients in this group is 16. Oral pregabalin 75 mg twice daily for all patients Control group: oral pregabalin 75 mg twice daily, without injection in the foot. Number of patients in this group is 16 Douleur Neuropathique 4 questionnaire (DN4) score. Timepoint: For all patients, Douleur Neuropathique 4 questionnaire is filled out before injection and then in the first, second and eighth weeks after injection. Method of measurement: Completion of Douleur Neuropathique 4 Questionnaire. Overall Neuropathy Limitations Scale (ONLS) score. Timepoint: For all patients, Overall Neuropathy Limitations Scale (ONLS) is filled out before injection and then in the first, second and eighth weeks after injection. Method of measurement: Completion of Overall Neuropathy Limitations Scale (ONLS) Questionnaire. Shiraz University of Medical Sciences Approved 2019-09-16 Ethics Committee of Shiraz University of Medical Sciences Ethics Committee in Medical Research, Vice Chancellor for Research, 7th Floor, Central Building of Shiraz University of Medical Science, Zand St., Shiraz, Iran Shiraz Fars Iran (Islamic Republic of)