Evaluating effects of Acupuncture versus Mesotherapy with Calcitonin in Patients with Lumbar Spinal Canal stenosis( randomized controlled clinical trial)

Study of the effect of acupuncture and calcitonin mesotherapy compared to the control group (exercise therapy) in patients with lumbar spinal stenosis

Randomized clinical trial with control group,parallel-group,double-blind,60patients

Calcitonin injections:3sessions, 1session/week.Acupuncture:10sessions, at a frequency of 3sessions/week. evaluated before treatment, and then again at 4 and 8 weeks after the intervention through clinical visits and standardized questionnaires. The study site:Imam Reza Clinic. clinical supervisor and the outcome assessor will be blinded

Inclusion Criteria: Age40_75 years;Completion of the consent form;Confirmation of diagnosis of lumbar spinal canal stenosis through radiography,MRI,or electromyography;At least 6 months of lumbar spinal canal stenosis symptoms(low back pain,claudication,radicular pain in the lower limbs.) Exclusion Criteria: Pregnancy;breastfeeding;systemic or localized infection;Uncontrolled DM;Rheumatoid,collagen vascular diseases,cancer;severe liver,kidney,heart,or respiratory diseases;bleeding disorders;use of anticoagulant drugs;Brucellosis;spinal canal surgery;diabetic neuropathy or radiculopathy;BMI>42 allergic reaction to drug used in the study;Inability to complete the questionnaire;acupuncture or calcitonin injection in the last 3months;symptoms of cauda equina syndrome(perineal numbness, urinary or fecal incontinence);Muscle weakness with MMT less than 4/5

A)Mesotherapy with Calcitonin & Therapeutic exercise B)Acupuncture & Therapeutic exercise C)Therapeutic exercise

Pain intensity;Functional performance;Weight-bearing ability

In this study, the random allocation method will be 6-block randomization, as follows: Group A represents individuals receiving the intervention of mesotherapy with calcitonin and therapeutic exercise. Group B represents individuals receiving acupuncture and therapeutic exercise. Group C represents individuals receiving therapeutic exercise only. Next, using a random number table and assigning numbers from 0 to 9 to each possible permutation, a randomized list of 60 participants will be generated. This list will include 10 blocks of 6 participants each (6*10 = 60 total participants), and the allocation of each method to each participant will be determined. Each participant's group allocation will be assigned through the sealed envelope method, and the analyst will be blinded to the group assignments to prevent bias in the analysis.

To ensure concealment, the random sequence method is placed in sealed envelopes in the possession of another person who is unaware of the research process, and the questionnaires are completed by an individual unaware of the group assignment. Clinical caregiver: We train the person who is responsible for the care and follow-up of patients on how to complete the questionnaire. This person has no knowledge of the type of intervention the patient received. Outcome assessor: The completed questionnaires are given to a person who is unaware of the interventions performed and is asked to determine the degree of pain reduction and increase in function and weight-bearing ability and balance in each individual, according to the questionnaire.