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IRCT20121216011763N64 IRCT 2024-06-15 Esfahan University of Medical Sciences The effects of curcumin piperine supplementation along with manual therapy on Frozen Shoulder Patients The Effect of Combined Manual Therapy and Curcumin Piperine Supplementation on Metabolic Factors, Inflammatory Markers, Oxidative Stress, Clinical Symptoms, and Electromyography in Patients with Frozen Shoulder: A Randomized, Placebo-Controlled Clinical Trial. 2024-07-22 anticipated 60 Complete https://irct.ir/trial/76286 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done through the official website https://www.sealedenvelope.com/simple-randomiser/v1/list. The participants will be randomly (classified by randomized block method) in one of the two curcumin piperine supplement groups along with manual therapy and manual therapy plus placebo, as the control group. In order to distribute patients into intervention and control groups, first, people will be classified by age and divided using blocks of four. Randomization is done inside each block based on the random chain that will be extracted from the site, Blinding description: In this study, participants, therapists, and assessors will be blinded to the receipt of curcumin-piperine or placebo. 3 Frozen Shoulder. Intervention 1: Daily intake of one capsule containing curcumin-piperine (with 500 mg of curcumin extract and 5 mg of piperine) alongside manual therapy (3 sessions per week) for 14 days. Manual Therapy Protocol: Manual therapy followed a fixed 30-minute protocol per session, including soft tissue techniques, specific joint mobilizations (Maitland), and passive stretching, delivered by trained physiotherapists. Intervention 2: Daily intake of one placebo capsule alongside manual therapy (3 sessions per week) for 14 days. Manual Therapy Protocol: Manual therapy followed a fixed 30-minute protocol per session, including soft tissue techniques, specific joint mobilizations (Maitland), and passive stretching, delivered by trained physiotherapists. 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 There is no further information

public Dr. Gholamreza Askari

Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan

Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3060 Askari@mui.ac.ir Esfahan University of Medical Sciences scientific Dr. Gholamreza Askari

Deputy of Research & Technology of Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan

Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3060 Askari@mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Agreement for participation in the study Age of 20 to 65 years old Diagnosis of frozen shoulder syndrome patients by an orthopedic specialist Duration of symptoms between 1 and 12 months 20 years 65 years Male Unwillingness or inability to provide informed consent or adhere to the study protocol. Consumption of less than 80% of the prescribed supplement/placebo (verified by pill count). Voluntary withdrawal from the study or being lost to follow-up Occurrence of any allergic reaction or serious adverse event related to manual therapy or the supplement that makes continuation unsafe. Significant worsening of pain or functional limitation requiring additional intervention (e.g., corticosteroid injection or surgery) Systemic Inflammatory Diseases: Rheumatoid arthritis, ankylosing spondylitis, lupus, active gout, or other inflammatory arthropathies. Neuromuscular Disorders: Severe peripheral neuropathy, cervical radiculopathy, thoracic outlet syndrome, or stroke with residual upper limb impairment affecting function. Severe Uncontrolled Systemic Diseases: Renal or hepatic failure, active malignancy, bleeding disorders, active peptic ulcer disease, inflammatory bowel disease, cholelithiasis, or bile duct obstruction. Use of any supplement containing curcumin, turmeric, or other potent herbal anti-inflammatory agents within the past 4 weeks. Smoking Current participation in any other clinical trial. Other Shoulder Pathologies:* Diagnosis of impingement syndrome or full-thickness rotator cuff tear.* Symptomatic glenohumeral osteoarthritis.* Shoulder instability, prior dislocation, or history of surgery on the affected shoulder.* Cervical radiculopathy or other neurogenic causes of shoulder pain (confirmed by neurological examination).* Secondary frozen shoulder (due to diabetes, thyroid disorder, stroke, Parkinson's disease, trauma). M75.0 Adhesive capsulitis of shoulder Treatment - Drugs Placebo Daily intake of one capsule containing curcumin-piperine (with 500 mg of curcumin extract and 5 mg of piperine) alongside manual therapy (3 sessions per week) for 14 days. Manual Therapy Protocol: Manual therapy followed a fixed 30-minute protocol per session, including soft tissue techniques, specific joint mobilizations (Maitland), and passive stretching, delivered by trained physiotherapists. Daily intake of one placebo capsule alongside manual therapy (3 sessions per week) for 14 days. Manual Therapy Protocol: Manual therapy followed a fixed 30-minute protocol per session, including soft tissue techniques, specific joint mobilizations (Maitland), and passive stretching, delivered by trained physiotherapists. Evaluation of shoulder function, range of motion, pain, and disability in patients with frozen shoulder. Timepoint: At baseline and after 14 days. Method of measurement: Questionnaire. Serum level of High sensitive C reactive protein. Timepoint: At baseline and after 14 days. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. Total antioxidant capacity. Timepoint: At baseline and after 14 days. Method of measurement: Biochemical kit of KiaZist Co. Total oxidant status. Timepoint: At baseline and after 14 days. Method of measurement: Biochemical kit of KiaZist Co. Muscle nerve band. Timepoint: At baseline and after 14 days. Method of measurement: Electromyography. Malondialdehyde. Timepoint: At baseline and after 14 days. Method of measurement: Biochemical kit of KiaZist Co. Serum concentration of glutathione. Timepoint: At baseline and after 14 days. Method of measurement: Biochemical kit of KiaZist Co. Superoxide dismutase activity. Timepoint: At baseline and after 14 days. Method of measurement: Biochemical kit of KiaZist Co. Serum level of vascular cell adhesion molecule-1. Timepoint: At baseline and after 14 days. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. Erythrocyte sedimentation rate (ESR). Timepoint: At baseline and after 14 days. Method of measurement: Biochemical kit of KiaZist Co. Serum level of IL-6. Timepoint: At baseline and after 14 days. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. Serum level of TNF-a. Timepoint: At baseline and after 14 days. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. Serum level of TGF. Timepoint: At baseline and after 14 days. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. Serum level of IL-1β. Timepoint: At baseline and after 14 days. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. Serum level of IL-8. Timepoint: At baseline and after 14 days. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits. The average level of (total cholesterol, HDL, LDL, TG) in the intervention and control groups. Timepoint: Before and after intervention. Method of measurement: Kiazist biochemical kit. The mean level of fasting blood sugar (FBS) among the intervention and control groups. Timepoint: Before and after intervention. Method of measurement: Kiazist biochemical kit. Quality of Life. Timepoint: Before and after intervention. Method of measurement: Quality of life questionnaire. Assessment of mental health status. Timepoint: Before and after intervention. Method of measurement: Depression, Anxiety, and Stress Scale (DASS-21). Esfahan University of Medical Sciences, Research and Technology Vice-Chancellor Approved 2024-03-19 Research Ethics Committees of Schools of Pharmacy and Nutrition, Isfahan University of Medical Scien Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)