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IRCT20161221031506N3 IRCT 2019-02-27 Mashhad University of Medical Sciences The Comparison of two approach of drug transition in shoulder impingement patients The Comparative Effect of Phonophoresis and Injection of Triamcinolone with lidocain on Pain, Disability, Quality of Life and Effectiveness of Treatments in Shoulder Impingement Patients 2018-12-06 anticipated 24 Complete https://irct.ir/trial/35447 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants choose to pick one of the sealed envelopes. Another physiotherapist who does not know how to group and do the study will evaluate the patients. N/A Shoulder Impingement Syndrome. Intervention 1: Intervention group#1 (Injection): The triamcinolone (Cortiran, Iran hormone, Tehran, Iran) and lidocaine (Caspian, Iran tamin, Tehran, Iran) will be injected by the orthopedic physician in subacromial space. Then, the patients were requested to return to orthopedic ward for completing all questionnaires again.The drug dosage that were used for injection include two milliliter triamcinolone ampule and 0.5 cc lidocaine 2%, and 1 cc distilled water. Intervention 2: Intervention group#2 (phonophoresis): The phonophoresis treatment will be done in 5 sessions with one day interval. In these patients, the phonophoresis of triamcinolone 1% (Cortiran, Iran hormone, Tehran, Iran) plus lidocaine (Caspian, Iran tamin, Tehran, Iran) will be done in semi-recumbent position (60 degrees) when the arm place in extenstion and medial rotation. The ultrasound current will be pulse, frequency 3 MHz , and intensity 1.5 Wcm-2. The assessment will be done after five sessions. The topical cream ,produced by Pharmaceutics department of the pharmacy school of the Mashhad University of Medical Sciences, Mashhad, Iran, that were used for phonophoresis include 80 milligram triamcinolone and 0.5 cc lidocaine 2%. Intervention 3: Control group: placebo tablets. Before and after 10 days placebo treatment (#placebo) will be performed by the prescription of placebo tablet (vitamin C) and giving educational pamphlet. 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 Mohammadreza Mazaheri Tehrani
Mashhad- Azadi Square- East door of Ferdowsi University of Mashhad- University campus- Faculty of Paramedical Sciences
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3869 8719 mtmazaheri@outlook.com Mashhad University of Medical Sciences scientific Mohamadreza Mazaheri Tehrani
Mashhad- Azadi Square- East door of Ferdowsi University of Mashhad- University campus- Faculty of Paramedical Sciences
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3869 8719 mtmazaheri@outlook.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Pain less than 3 month Pain in the upper, outer arm especially when lifting of arm Aged 18-65 years Signs of shoulder impingement syndrome : Presence of at least two of the following 1) Painful arch movement during flexion or abduction of the shoulder 2) Positive Neer or Hawkins-Kennedy test 3) Painful resisted external rotation, abduction or painful jobe (empty can) test 18 years 65 years Both Existence of type 3 acromion Existence of frozen shoulder ( the loss in passive shoulder range of motion greater than 50% as compared to the uninvolved side in at least 2 shoulder movements) Existence of neck radiculopathy Existence of Complete rupture of rotator cuff muscles (MRI findings) Existence of shoulder joint instability (Positive tests of sulcus or apprehension) Use of corticosteroid drugs in last 3 months History of RSD History of any neurological diseases History of rheumatoid diseases and shoulder osteoarthritis History of fracture or dislocation or surgery in the shoulder complex m75.4 Impingement syndrome of shoulder Treatment - Drugs Treatment - Drugs Placebo Intervention group#1 (Injection): The triamcinolone (Cortiran, Iran hormone, Tehran, Iran) and lidocaine (Caspian, Iran tamin, Tehran, Iran) will be injected by the orthopedic physician in subacromial space. Then, the patients were requested to return to orthopedic ward for completing all questionnaires again.The drug dosage that were used for injection include two milliliter triamcinolone ampule and 0.5 cc lidocaine 2%, and 1 cc distilled water. Intervention group#2 (phonophoresis): The phonophoresis treatment will be done in 5 sessions with one day interval. In these patients, the phonophoresis of triamcinolone 1% (Cortiran, Iran hormone, Tehran, Iran) plus lidocaine (Caspian, Iran tamin, Tehran, Iran) will be done in semi-recumbent position (60 degrees) when the arm place in extenstion and medial rotation. The ultrasound current will be pulse, frequency 3 MHz , and intensity 1.5 Wcm-2. The assessment will be done after five sessions. The topical cream ,produced by Pharmaceutics department of the pharmacy school of the Mashhad University of Medical Sciences, Mashhad, Iran, that were used for phonophoresis include 80 milligram triamcinolone and 0.5 cc lidocaine 2%. Control group: placebo tablets. Before and after 10 days placebo treatment (#placebo) will be performed by the prescription of placebo tablet (vitamin C) and giving educational pamphlet. Pain. Timepoint: visit time- after 10 days placebo intervention- after 10 days treatment period. Method of measurement: visual analog scale. Disability. Timepoint: visit time- after 10 days placebo intervention- after 10 days treatment period. Method of measurement: by SPADI questionnaire. Quality of life. Timepoint: visit time- after 10 days placebo intervention- after 10 days treatment period. Method of measurement: by WORC questionnaire. Treatment effect. Timepoint: discharge time. Method of measurement: by Global Rating Scale. Mashhad University of Medical Sciences Approved 2019-01-09 The Ethics Committee of Mashhad University of Medical Sciences Opposite University Street 18, University street Mashhad Razavi Khorasan Iran (Islamic Republic of)