Protocol summary
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Study aim
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The Comparative Effect of Comprehensive Physical therapy with Focus on Scapula and Glenohumeral Joint versus Common Physical Therapy in treatment of shoulder impingement syndrome
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Design
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Clinical trial, randomized grouping of individuals with sealed envelopes into intervention and control groups, blind assessment of variables by the evaluator
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Settings and conduct
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Place of study: Physical Therapy Clinic of Ghaem Hospital
Evaluator: The other physiotherapist will evaluate the patients.
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Participants/Inclusion and exclusion criteria
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inclusion criteria:
.aged 18-65 years/pain more than 6 weeks/ pain in the upper,outer arm especially when lifting of arm/ 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 test
exclusion criteria:
1.Existence of type 3 acromion
2. Existence of frozen shoulder
3. Existence of neck radiculopathy
4.Existence of Complete rupture of rotator-cuff muscles
5.Existence of shoulder joint instability
6.History of fracture or dislocation or surgery in the shoulder complex
7.Use of Corticosteroids drugs in last 3 months
8.History of Reflex Sympathetic Dystrophy
9.History of any neurological diseases
10.History of rheumatoid diseases and shoulder osteoarthritis
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Intervention groups
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In the intervention group, a comprehensive physiotherapy focusing on scapula and shoulder joint, and in the control group a common physiotherapy in the shoulder joint will be performed.
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Main outcome variables
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Pain with VAS scale; functional level with Shoulder pain and disability index and Quick DASH questionnaires; quality of life with WORC questionnaire; effectiveness of treatment with GRC
General information
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Reason for update
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This update is done to inform the completion of treatment, increase the sample size as well as increase the evaluation time to six months after treatment.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20161221031506N2
Registration date:
2018-06-29, 1397/04/08
Registration timing:
registered_while_recruiting
Last update:
2021-07-11, 1400/04/20
Update count:
1
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Registration date
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2018-06-29, 1397/04/08
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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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2018-06-05, 1397/03/15
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Expected recruitment end date
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2019-09-06, 1398/06/15
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Actual recruitment start date
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2018-06-05, 1397/03/15
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Actual recruitment end date
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2019-08-05, 1398/05/14
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Trial completion date
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2019-09-21, 1398/06/30
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Scientific title
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The Comparative Effect of Comprehensive Physical therapy with Focus on Scapula and Glenohumeral Joint versus Common Physical Therapy on Pain, Range of motion, Disability Level, Quality of Life and the Effectiveness of Treatment Parameters in Patients with Shoulder Impingement Syndrome
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Public title
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The comparative effect of two physiotherapy methods in patients with shoulder impingement syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Aged 18-65 years
Pain more than 6 weeks
Pain in the upper, outer arm especially when lifting of arm
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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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
32
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Convenient sampling
Randomization Tool: Sealed envelopes include paired and odd numbers (from one to 40)
allocation concealment will be done randomly.
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Blinding (investigator's opinion)
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Double blinded
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Blinding 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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Placebo
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Not 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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2018-05-19, 1397/02/29
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Ethics committee reference number
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IR.MUMS.REC.1397.056
Health conditions studied
1
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Description of health condition studied
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impingement syndrome of shoulder
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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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functional level
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Timepoint
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Before the start of the treatment plan / after the completion of the treatment plan / one month after the completion of the treatment plan/ Six month after the completion of the treatment plan
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Method of measurement
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Shoulder pain and disability index questionnaire
Secondary outcomes
1
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Description
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pain
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Timepoint
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Before the start of the treatment plan / after the completion of the treatment plan / one month after the completion of the treatment plan/ six month after the completion of the treatment plan
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Method of measurement
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visual analogue scale
2
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Description
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functional level
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Timepoint
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Before the start of the treatment plan / after the completion of the treatment plan / one month after the completion of the treatment plan/ six month after the completion of the treatment plan
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Method of measurement
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Quick The Disabilities of the Arm, Shoulder and Hand Score questionnaire
3
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Description
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quality of life
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Timepoint
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Before the start of the treatment plan / after the completion of the treatment plan / one month after the completion of the treatment plan/ six month after the completion of the treatment plan
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Method of measurement
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Western ontario rotator cuff questionnaire
4
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Description
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The effectiveness of the treatment
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Timepoint
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Before the start of the treatment plan / after the completion of the treatment plan / one month after the completion of the treatment plan/ six month after the completion of the treatment plan
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Method of measurement
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global rating of change scale
Intervention groups
1
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Description
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Intervention group: One-month Physical therapy program with focus on scapula and glenohumeral joint (shoulder) for twelve sessions
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Category
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Rehabilitation
2
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Description
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Control group: One-Months Physical Therapy Program at the shoulder joint for twelve sessions
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Personal Grant (Dr Salman Nazary-Moghadam)
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Grant code / Reference number
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961343
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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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Vice chancellor for research, 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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Undecided - It is not yet known if there will be 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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Only for metaanalysis
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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 request.
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Comments
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