Investigating the effect of joint mobilization and proprioceptive neuromuscular facilitation (PNF) on pain, range of motion and function of the patients with shoulder adhesive capsulitis; a randomized clinical trial
To determine the additional effect of combined joint mobilization and PNF on pain, function, and range of motion in patients with shoulder adhesive capsulitis
Design
Randomized, superiority, parallel-group trial with blinded outcome assessment. Randomization was centralized and computerized with concealed randomization sequence carried out at an external site
Settings and conduct
Sports medicine clinic of Imam khomeini hospital
Participants/Inclusion and exclusion criteria
Inclusion:
Age between 40 & 70;
Diagnosed unilateral shoulder adhesive capsulitis, as pain, stiffness and limitation of passive movement compared with the opposite side;
More than 3 months after the start of symptoms.
Exclusion:
Other pathologic conditions in shoulder or neck;
Severe trauma or fracture;
Infection;
Pregnancy;
Cardiologic, psychiatric, and any other severe diseases impairing the active participation in the study;
Any type of manual therapies or intraarticular injections in the course of disease before inclusion in study.
Intervention groups
Intervention group: Intraarticular corticosteroid injection + general exercises + 5 sessions of joint mobilization and PNF
Control group: Intraarticular corticosteroid injection + general exercises
Main outcome variables
Pain
Function
Range of motion in flexion, external rotation, abduction, and internal rotation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111116008117N5
Registration date:2021-12-22, 1400/10/01
Registration timing:registered_while_recruiting
Last update:2021-12-22, 1400/10/01
Update count:0
Registration date
2021-12-22, 1400/10/01
Registrant information
Name
Farzin Halabchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2282
Email address
fhalabchi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of joint mobilization and proprioceptive neuromuscular facilitation (PNF) on pain, range of motion and function of the patients with shoulder adhesive capsulitis; a randomized clinical trial
Public title
Investigating the effect of joint mobilization and PNF on shoulder adhesive capsulitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 & 70
Diagnosed unilateral shoulder adhesive capsulitis (idiopathic or diabetes-related) as pain, stiffness and more than 50% limitation of passive movement in one or more movements of external rotation, abduction and internal rotation compared with the opposite side
More than 3 months after start of symptoms
Exclusion criteria:
Other pathologic conditions in shoulder or neck
Severe trauma or fracture
Infection
Pregnancy
Cardiologic, psychiatric, and any other severe diseases impairing the active participation in the study
Any type of manual therapies or intraarticular injections in the course of disease before inclusion in study
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization in sizes of 2, 4 and 6
Randomization unit: Individual
Randomization tool: Random digits tables
The researcher who will assess the outcomes is not aware of the patient allocation.
Blinding (investigator's opinion)
Single blinded
Blinding description
Because the interventions are performed as manual therapies and special exercises, blinding of the participants and care provider is not possible, but the outcome assessors and data analyzers will be blind to the allocation of participants to intervention or control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committee of Imam Khomeini Hospital Complex,, Tehran University of Medical Sciences
Street address
Department Sports and Exercise Medicine, Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2021-12-01, 1400/09/10
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.362
Health conditions studied
1
Description of health condition studied
Adhesive capsulitis of shoulder
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Pain
Timepoint
before & immediately after intervention period
Method of measurement
VAS score
2
Description
Function
Timepoint
before & immediately after intervention period
Method of measurement
SPADI (Shoulder Pain And Disability Index) score: A 13 items questionnaire to assess function and disability of shoulder with reported good validity and reliability.
Secondary outcomes
1
Description
Range of motion - abduction
Timepoint
Before and immediately after intervention
Method of measurement
Goniometric measurement
Intervention groups
1
Description
Intervention group: Joint mobilization (5X20minutes joint mobilization sessions including PNF D1 & D2 patterns)+ usual care (Intraarticular corticosteroid injection plus home exercises)
Category
Rehabilitation
2
Description
Control group: Usual care (Intraarticular corticosteroid injection plus home exercises)
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports medicine clinic, Imam Khomeini hospital, Tehran university of medical sciences
Full name of responsible person
Farzin Halabchi
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2282
Fax
+98 21 6658 1637
Email
fhalabchi@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotoohi, Vice Chancellor of research Tehran University of Medical Sciences
Street address
Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1476737831
Phone
+98 21 6119 2282
Fax
+98 21 6658 1637
Email
fhalabchi@tums.ac.ir
Grant name
Vice Chancellor of research - Tehran University of Medical Sciences
Grant code / Reference number
1400-2-101-54488
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
Farzin Halabchi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1476737831
Phone
+98 21 6119 2282
Fax
+98 21 6658 1637
Email
fhalabchi@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzin Halabchi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1476737831
Phone
+98 21 6119 2282
Fax
+98 21 6658 1637
Email
fhalabchi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzin Halabchi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Imam Khomeini Hospital, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1476737831
Phone
+98 21 6119 2282
Fax
Email
fhalabchi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deidentified data
When the data will become available and for how long
12 months after publication
To whom data/document is available
Only for people working in academic institutions
Under which criteria data/document could be used
No specific criteria
From where data/document is obtainable
email of the corresponding person fhalabchi@tums.ac.ir
clinic contact phone: +982161192282
What processes are involved for a request to access data/document
All de-identified data will be provided 1 month after request.