The aim of the study is:
To find the effects of Stabilization exercises with or without mobilization on pain, range
of motion and quality of life among patients with frozen shoulder.
Design
Randomized clinical trial
Settings and conduct
Arif Memorial Teaching Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients diagnosed with frozen shoulder and stiff frozen
shoulder
Symptom duration >3months
Patients with shoulder pain and restriction in ROM
Exclusion criteria:
Shoulder stiffness due to severe trauma, post fracture, immobilization and surgical
release of capsules
History of cortisone injection in effected area in previous 6 weeks
Patients with joint infection
Intervention groups
Group (A): stabilization exercise without mobilization
Group (B): stabilization with mobilization
Main outcome variables
pain
range of motion
quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220701055331N1
Registration date:2022-12-24, 1401/10/03
Registration timing:prospective
Last update:2022-12-24, 1401/10/03
Update count:0
Registration date
2022-12-24, 1401/10/03
Registrant information
Name
Ifra Zulqarnain Awan
Name of organization / entity
Rashid Latif Medical College
Country
Pakistan
Phone
+92 333 4975431
Email address
ifra.awan@rlmc.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-26, 1401/10/05
Expected recruitment end date
2023-05-26, 1402/03/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of stabilization exercises with and without mobilization on frozen shoulder
Public title
Effects of stabilization exercises with and without mobilization on Pain, range of motion and Quality of life among patients with frozen shoulder: A Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with frozen shoulder and stiff frozen shoulder
Symptom duration >3months
Patients with shoulder pain and restriction in ROM
Exclusion criteria:
Shoulder stiffness due to severe trauma, post fracture, immobilization and surgical release of capsules
History of cortisone injection in effected area in previous 6 weeks
Patients with joint infection
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were allocated in two groups (i.e, Group A and Group B, by lottery method). Lottery method is a type of simple random sampling. In lottery method 42 cards were put in a glass bowl. and randomly pick cards from bowl and allocate these cards randomly in two groups. 16 cards were allocated randomly in group A and 16 cards were allocated randomly in group B.
Blinding (investigator's opinion)
Single blinded
Blinding description
In single blinding study, participant is concealed so that they are not aware of which group a participant is allocated to after random allocation occurs. This is done to avoid biasness.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board of Rashid Latif Medical College, Lahore.
Street address
35-KM Ferozepur Road Lahore
City
Lahore
Postal code
54000
Approval date
2022-10-05, 1401/07/13
Ethics committee reference number
IRB/2022/050
Health conditions studied
1
Description of health condition studied
Adhesive Capsulitis
ICD-10 code
M75.00
ICD-10 code description
Adhesive capsulitis of unspecified shoulder
Primary outcomes
1
Description
Pain
Timepoint
Pre-intervention and 4 weeks post-intervention
Method of measurement
Numeric Pain Rating Scale (NPRS)
2
Description
Range Of Motion
Timepoint
Pre-intervention and 4 weeks post-intervention
Method of measurement
Goniometer
3
Description
Quality Of Life
Timepoint
Pre-intervention and 4 weeks post-intervention
Method of measurement
SF-36 Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group A: Patients will be treated with stabilization exercises. Stabilization exercises
Category
Rehabilitation
2
Description
Intervention Group B: Patients will be treated with stabilization exercises and mobilization
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Arif memorial teaching hospital
Full name of responsible person
Sonia
Street address
35-km ferozepur road, lahore
City
lahore
Postal code
54000
Phone
+92 306 9706895
Email
soniashah724@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid latif medical college
Full name of responsible person
Ifra Zulqarnain Awan
Street address
35-km ferozepur road lahore
City
lahore
Postal code
54000
Phone
+92 333 4975431
Email
ifra.awan@rlmc.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rashid latif medical college
Proportion provided by this source
100
Public or private sector
Private
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
Rashid latif medical college
Full name of responsible person
Sonia
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-km ferozepur road lahore
City
lahore
Province
punjab
Postal code
54000
Phone
+92 306 9706895
Email
soniashah724@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid latif medical college
Full name of responsible person
Ifra Zulqarnain Awan
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-km ferozepur road lahore
City
lahore
Province
punjab
Postal code
54000
Phone
+92 333 4975431
Email
ifra.awan@rlmc.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Rashid latif medical college
Full name of responsible person
Ifra zulqarnain awan
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
35-km ferozepur road lahore
City
lahore
Province
punjab
Postal code
54000
Phone
+92 333 4975431
Email
ifra.awan@rlmc.edu.pk
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