Protocol summary
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Study aim
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The purpose of this study was to compare the effect of two methods of injection and phonophoresis of triamcinolone 1% with lidocaine on pain and disability in patients with shoulder impingement syndrome.
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Design
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Patients are transmitted into two groups based on simple randomization with closed envelopes in which numbers 1-44 are transmitted so that the even numbers enter into the injection group and the odd numbers into the phonophoresis group.
Based on the mean and standard deviation of the SPADI questionnaire score in similar articles, 22 individuals in each group, with a 10% drop is considered.
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Settings and conduct
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Physical Therapy clinic of Qaem Hospital
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Participants/Inclusion and exclusion criteria
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Individuals with shoulder impingement syndrome included by orthopedic physician. Patients are divided randomly into two groups of injections and phonophoresis after being evaluated based on inclusion and exclusion criteria .
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Intervention groups
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In the first group, phonophoresis treatment will be performed in 5 sessions, 3 times a week. The phonophoresis group received 10 minutes of phonophoresis (1% triamcinolone with lidocaine) in the supraspinatus and biceps tendons while the patient is half asleep at a 60° angle and shoulder in the extension and internal rotation position with the frequency of ultrasound 3MHz and the intensity of 1.5 W / Cm2 . After performing the phonophoresis, the patient will be asked to remove gauze after 2 hours and remove the cream. The amount of triamcinolone that each patient uses is equivalent to 16 mg, receiving a total 80 mg during 5 treatment sessions.
The second group, after evaluating the outcomes, will be given by the orthopedic surgeon to administer the triamcinolone with lidocaine in the subacromal region.
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Main outcome variables
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VAS
SPADI questionnaire
WORC questionnaire
GRC
General information
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Reason for update
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Decrease sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20161221031506N3
Registration date:
2019-02-27, 1397/12/08
Registration timing:
prospective
Last update:
2021-12-13, 1400/09/22
Update count:
1
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Registration date
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2019-02-27, 1397/12/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-12-06, 1397/09/15
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Expected recruitment end date
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2019-05-19, 1398/02/29
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Actual recruitment start date
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2019-05-24, 1398/03/03
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Actual recruitment end date
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2019-09-16, 1398/06/25
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Trial completion date
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2019-09-16, 1398/06/25
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Scientific title
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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
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Public title
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The Comparison of two approach of drug transition in shoulder impingement patients
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
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
Exclusion criteria:
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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
24
Actual sample size reached:
24
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-09, 1397/10/19
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Ethics committee reference number
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IR.MUMS.REC.1397.251
Health conditions studied
1
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Description of health condition studied
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Shoulder Impingement Syndrome
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ICD-10 code
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m75.4
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ICD-10 code description
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Impingement syndrome of shoulder
Primary outcomes
1
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Description
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pain
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Timepoint
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visit time- after 10 days placebo intervention- after 10 days treatment period
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Method of measurement
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visual analog scale
2
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Description
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Disability
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Timepoint
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visit time- after 10 days placebo intervention- after 10 days treatment period
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Method of measurement
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by SPADI questionnaire
3
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Description
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quality of life
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Timepoint
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visit time- after 10 days placebo intervention- after 10 days treatment period
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Method of measurement
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by WORC questionnaire
4
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Description
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treatment effect
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Timepoint
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discharge time
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Method of measurement
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by Global Rating Scale
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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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%.
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Category
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Treatment - Drugs
3
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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ersonal Grant (Dr Salman Nazary-Moghadam)
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All reports will be reported in one research paper. Raw data will be delivered to researchers for meta analysis.
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When the data will become available and for how long
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Starting 6 months after publication
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To whom data/document is available
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For researchers
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Under which criteria data/document could be used
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فقط برای متاآنالیز
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From where data/document is obtainable
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Nazary_salman@yahoo.com
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What processes are involved for a request to access data/document
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The response will be sent 3 months after considering the researcher's request.
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Comments
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