The effect of the Boswellia serrata, Apium graveolens, Zingiber officinale, and Curcuma longa supplementation on pain intensity, physical function, and shoulder joint range of motion in patients shoulder tendinitis: A randomized controlled trial

To determine the effect of the Boswellia serrata, Apium graveolens, Zingiber officinale, and Curcuma longa supplementation on pain intensity, physical function, and range of motion in shoulder tendinitis patients

A clinical trial with a control group, with parallel groups, randomized, phase 2-3 on 30 patients. Random Allocation Software (RAS) will be used for randomization.

Patients attending outpatient clinics of Imam Reza General Hospital of Tabriz University diagnosed with shoulder tendinitis will be invited to an initial assessment to determine if they meet the eligibility criteria. Then the patients will be randomly assigned to receive either the Arthrodin or the placebo supplement for 8 weeks.

Inclusion criteria: Recent shoulder pain for at least three months, pain in the proximal lateral part of the arm which is exacerbated by abduction, no restrictions in the passive range of motion, pain on Full Can Test and/or Resisted External Rotation Test, positive Hawkins-Kennedy test or Neer's test, and shoulder radiography with no evidence of fracture or bone disorders Exclusion criteria: Pain due to severe radiculopathy, corticosteroid injection in the last six months, pregnancy, breastfeeding, and people taking antidepressants, antiplatelet drugs, low molecular weight heparin, and thrombolytic agents.

Intervention group 1: Arthrodin herbal tablet (concentrated extract equivalent to 1900 mg of Boswellia serrata oleoresin, extract equivalent to 1000 mg of Apium graveolens celery seed, extract equivalent to 300 mg of ginger rhizome Zingiber officinale and extract equivalent to 2000 mg of rhizome Curcuma longa standardized turmeric based on 4.70 mg of total curcuminoids, once daily for 8 weeks Intervention group 2 (control): placebo tablet once daily for 8 weeks

Pain intensity, shoulder physical function, shoulder range of motion

A block randomization method will be used to allocate participants to the groups with a 1:1 allocation using random allocation software (RAS) with block sizes of 2 and 4. Blocking will be performed by the non-involved person in data sampling and analysis. To conceal the assignment, the type of intervention will be written on a sheet of paper coding using the letters A and B and placed inside matted, consecutively numbered envelopes. The envelopes will be arranged according to the participants' entry to the intervention, and the type of group will be revealed.

Intervention and placebo supplements will be prepared in exactly the same way in terms of shape, color, and odor, and will be placed in a small envelope containing 14 tablets for each participant for two-week consumption. The envelopes will be opened in the order in which the participants enter this stage from number 1, and an envelope containing the supplement will be provided to the participant for two weeks. Outcome assessors, the person responsible for statistical analysis of the data, and the respondents will be blinded to the type of supplement received until the end of the study.