Comparison of the Efficacy of Manual Treatment According to Fascial Distortion Model Versus Joint Mobilization in Pain Reduction of Patients With Shoulder Impingement Syndrome Who Refer to Pirouzi Physiotherapy Clinic
Comparison of Manual Treatment According to Fascial Distortion Model Versus Joint Mobilization in Reducing Pain, Increasing Range of Motion and Improving Function of Patients With Shoulder Impingement Syndrome
Design
Single-blinded randomized clinical trial with parallel groups and phase 3 on 26 patients. Randomization is carried out by coin toss method.
Settings and conduct
Study population are patients with shoulder impingement syndrome that are referred to Pirouzi physiotherapy clinic in Mashhad.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: pain by arm elevation with Intensity of ≥3 on VAS and positive Neer & Hawkins-Kennedy tests. Exclusion criteria are: stroke, rheumatoid arthritis, full-thickness rotator cuff tear; trauma; surgery or freezing of the shoulder; osteoporosis or malignancy.
Intervention groups
In FDM group, the diagnosis is based on body language, subjective complaints, objective findings and mechanism of injury.
In mobilization group, related accessory movements in glenohumeral, scapulothoracic, acromioclavicular and sternoclavicular joints are assessed in regard to the presence of pain and/or restriction. Treatment includes oscillatory movements with Maitland grading and frequency of two times per second that first is done in comfortable position and progressively toward painful position. Grades I-II and III-IV are used for pain and restriction respectively.
Main outcome variables
Pain intensity (VAS); pain-free abduction ROM (Goniometry); function (SPADI); patient satisfaction with treatment (Likert Scale)
General information
Reason for update
Acronym
FDM (Fascial Distortion Model)
IRCT registration information
IRCT registration number:IRCT20200922048803N1
Registration date:2021-04-20, 1400/01/31
Registration timing:registered_while_recruiting
Last update:2021-04-20, 1400/01/31
Update count:0
Registration date
2021-04-20, 1400/01/31
Registrant information
Name
Mahmood Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3851 6396
Email address
m.moradi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-01, 1398/10/11
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Efficacy of Manual Treatment According to Fascial Distortion Model Versus Joint Mobilization in Pain Reduction of Patients With Shoulder Impingement Syndrome Who Refer to Pirouzi Physiotherapy Clinic
Public title
Comparison of the Efficacy of Manual Treatment according to Fascial Distortion Model Versus Joint Mobilization in Patients With Shoulder Impingement Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain By Arm Elevation With Intensity of ≥3 on VAS
Positive Neer & Hawkins-Kennedy Tests
Exclusion criteria:
Stroke
Rheumatoid Arthritis
Full-thickness Rotator Cuff Tear
Trauma
Surgery of the Shoulder
Freezing of the Shoulder
Osteoporosis
Malignancy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization would be carried out by coin toss method for patients with odd number, and the patients with even number would receive the other treatment. Heads side is indicative of FDM treatment and tails side is indicative of joint mobilization.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients would be blinded in respect to allocation in either of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
School of Rehabilitation of Tehran University of Medical Sciences, Piche Shemiran, Enghelab Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1148956111
Approval date
2020-02-05, 1398/11/16
Ethics committee reference number
IR.TUMS.VCR.REC.1398.880
Health conditions studied
1
Description of health condition studied
Shoulder Impingement Syndrome
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder
Primary outcomes
1
Description
Pain Intensity
Timepoint
Before and after every treatment session and after a 2 week follow up
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Pain-free Abduction ROM
Timepoint
Before and after every treatment session and after a two week follow up
Method of measurement
Goniometry
2
Description
Function
Timepoint
Before the first treatment session, after the last session and after a two week follow up
Method of measurement
Persian Version of SPADI
3
Description
Patient Satisfaction With Treatment
Timepoint
After a two week follow up
Method of measurement
Likert Scale
Intervention groups
1
Description
Intervention group: Three Sessions of Manual Treatment according to Fascial Distortion Model (Including Triggerband, Herniated Triggerpoint, Continuum, Folding, Cylinder And Tectonic) Every Other Day And Each Session Lasting 30 Minutes
Category
Rehabilitation
2
Description
Intervention group: Three Sessions of Joint Mobilization (Including Oscillatory Movements With Maitland Grading and a Frequency of Two Times per Second Which Are Done Initially in Resting Position and Progressively Into Painful Position of the Patient) Every Other Day and Each Session Lasting 30 Minutes
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Pirouzi Physiotherapy Clinic
Full name of responsible person
Mahmood Moradi
Street address
No. 536, Between 16 & 18, Pirouzi Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177969855
Phone
+98 51 3878 3213
Email
m.moradi@razi.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Qods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
02166706141
Phone
+98 21 8898 7381
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmood Moradi
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Enqelab St., Between Sadi St. & Darvazeh Shemiran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
rehabilitation@tums.ac.ir
Web page address
https://rehab.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmood Moradi
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Enqelab St., Between Sadi St. & Darvazeh Shemiran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
rehabilitation@tums.ac.ir
Web page address
https://rehab.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmood Moradi
Position
Master of Science Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Enqelab St., Between Sadi St. & Darvazeh Shemiran
City
Tehran
Province
Tehran
Postal code
1148956111
Phone
+98 21 7753 3939
Fax
+98 21 7753 4133
Email
rehabilitation@tums.ac.ir
Web page address
https://rehab.tums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available