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IRCT20250511065690N1 IRCT 2025-06-12 Shiraz University of Medical Sciences Effects of Acupuncture in lumbar spinal canal stenosis ; Effects of Mesotherapy with calcitonin in lumbar spinal canal stenosis Evaluating effects of Acupuncture versus Mesotherapy with Calcitonin in Patients with Lumbar Spinal Canal stenosis( randomized controlled clinical trial) 2025-08-23 anticipated 60 Complete https://irct.ir/trial/83518 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 LUMBAR SPINAL CANAL STENOSIS. Intervention 1: Intervention group: A)mesotherapy with calcitonine and exercises in the form of three injection sessions (two 50-unit ampoules of calcitonin + 4 cc of 2% lidocaine per session) with an interval of one week. Using sterile disposable 10cc syringes with a 12mm*0.27mm needle and one cc injection at each point. Calcitonin and lidocaine manufacturer: Caspian Tamin. Intervention 2: Intervention group: B)acupuncture and exercise For acupuncture, 25 x 25 needles are inserted bilaterally at BL-23, BL-25, BL-26, BL-37, BL-40, BL-54, BL-57, LI-4, BL-60, DU-3, DU-4 to a depth of 2.5 cm in the muscles, and DU-20 is inserted intradermally and remains in the patient's body for 30 minutes / Acupuncture needle manufacturer: Huanqiu. Intervention 3: Control group: (c) Exercise therapy . Therapeutic exercises include isometric gluteal muscle exercises, hamstring and calf muscle stretching, and knee bending to the chest. The duration of each exercise is 15 to 30 seconds and is repeated 30 time per day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is NO information
public Nazanin Rashidirezvan
no19, ghasrodasht street, Shiraz
Shiraz Iran (Islamic Republic of) 7133844311 009871 Nazaninrashidi4872@gmail.com Shiraz University of Medical Sciences scientific Nazanin Rashidirezvan
no19, ghasrodasht street, Shiraz
Shiraz Iran (Islamic Republic of) 7133844311 009871 Nazaninrashidi4872@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Age between 40-75 years old confirmation of the diagnosis of lumbar spinal canal stenosis by radiography, MRI, or Electrodiagnosis study. ATleast 6 months should have passed since the onset of symptoms of lumbar spinal canal stenosis ( such as low back pain, claudication, radicular leg pain, etc.) 40 years 75 years Both pregnancy breastfeeding critical systemic or local infection uncontrolled diabetes Rheumatic and collagen vascular diseases cancer history of severe hepatic, renal, cardiac, or pulmonary disease bleeding disorders use of anticoagulants Brucellosis history of spinal canal surgery Diabetic neuropathy Concurrent radiculopathy BMI over 42 history of allergic reaction to the drug used in the study presence of cauda equina syndrome symptoms(perineal numbness, urinary and fecal incontinence) muscle weakness with manual muscle test score less than 4 out of 5 inability to communicate and complete the questionnaire history of acupuncture or calcitonin injection in thepast three months M48.06 Spinal stenosis, lumbar region Treatment - Drugs Treatment - Other Rehabilitation Intervention group: A)mesotherapy with calcitonine and exercises in the form of three injection sessions (two 50-unit ampoules of calcitonin + 4 cc of 2% lidocaine per session) with an interval of one week. Using sterile disposable 10cc syringes with a 12mm*0.27mm needle and one cc injection at each point. Calcitonin and lidocaine manufacturer: Caspian Tamin Intervention group: B)acupuncture and exercise For acupuncture, 25 x 25 needles are inserted bilaterally at BL-23, BL-25, BL-26, BL-37, BL-40, BL-54, BL-57, LI-4, BL-60, DU-3, DU-4 to a depth of 2.5 cm in the muscles, and DU-20 is inserted intradermally and remains in the patient's body for 30 minutes / Acupuncture needle manufacturer: Huanqiu Control group: (c) Exercise therapy . Therapeutic exercises include isometric gluteal muscle exercises, hamstring and calf muscle stretching, and knee bending to the chest. The duration of each exercise is 15 to 30 seconds and is repeated 30 time per day. Pain Intensity. Timepoint: Before treatment, 4 and 8 weeks after start treatment. Method of measurement: VAS(Visual)analoge scale. Function. Timepoint: Before treatment, 4 and 8 weeks after start treatment. Method of measurement: health Shortform_(survey(SF_36 Quebec scale(QBPDS disability pain(back. Ability to hop on one leg for 5 steps. Timepoint: Before treatment, 4 and 8 weeks after start treatment. Method of measurement: hopping standard scale (SHS ). Shiraz University of Medical Sciences Approved 2025-04-22 Ethics committee of Shiraz University of Medical Sciences Shiraz Medical School, Imam Hossein Square, Zand Street, Shiraz Shiraz Fars Iran (Islamic Republic of)