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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.

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20121216011763N64
Enrollment
60
Registered
2024-06-15
Start date
2024-07-22
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frozen Shoulder. Adhesive capsulitis of shoulder

Interventions

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 Thera

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
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-1ß. 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 im

Secondary

MeasureTime frame
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).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Gholamreza Askari

Esfahan University of Medical Sciences

Askari@mui.ac.ir+98 31 3792 3060

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026