The purpose of the present study is find the association in integrated patient education and routine physical therapy in patient of sub acromial pain syndrome.
Design
randomized control trial
Settings and conduct
Muhmmad rehabilitation center multan
Participants/Inclusion and exclusion criteria
• . Inclusion Criteria
Both Male and Female
• Age ≥40(9)
• Primary complaint of shoulder with or without referral in the upper limb for ≥ 3 months
• Shoulder pain provoked with resisted abduction and lateral rotation contraction
• Limitation to the range of motion of glenohumeral joint in the comparison to the contralateral side
Exclusion Criteria
• Shoulder pain in the last 6 months.
• Known systemic inflammatory disorder.
• Cervical repeated movement testing affecting shoulder pain and range of movement.
• Severe depressive symptoms, suicidal inclination or psychotic illness.
Intervention groups
2 group are included in which 1 group have 10 patients with light weight exercise and educate the routine physical activity and 2 group have 11 patients with mobilization and educate the routine physical activity
Main outcome variables
We are expecting that the patient education and routine physical therapy decrease the sub acromial pain syndrome.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230718058826N1
Registration date:2023-08-22, 1402/05/31
Registration timing:prospective
Last update:2023-08-22, 1402/05/31
Update count:0
Registration date
2023-08-22, 1402/05/31
Registrant information
Name
Perwasha Perwasha
Name of organization / entity
Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan.
Country
Pakistan
Phone
+92 310 6562039
Email address
perwashanaseer123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2023-11-01, 1402/08/10
Actual recruitment start date
2023-09-01, 1402/06/10
Actual recruitment end date
2023-11-01, 1402/08/10
Trial completion date
2023-11-01, 1402/08/10
Scientific title
INTEGRATED PATIENT EDUCATION AND ROUTINE PHYSICAL THERAPY IN PATIENTS WITH SUBACROMIAL PAIN SYNDROME
Public title
INTEGRATED PATIENT EDUCATION AND ROUTINE PHYSICAL THERAPY IN PATIENTS WITH SUBACROMIAL PAIN SYNDROME
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
• Both Male and Female• Age ≥40(9)•
Primary complaint of shoulder with or without referral in the upper limb for ≥ 3 months•
Shoulder pain provoked with resisted abduction and lateral rotation contraction •
Limitation to the range of motion of glenohumeral joint in the comparison to the contralateral side.
Exclusion criteria:
• Shoulder pain in the last 6 months.
• Known systemic inflammatory disorder
• Cervical repeated movement testing affecting shoulder pain and range of movement
• Severe depressive symptoms, suicidal inclination or psychotic illness.
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
21
Actual sample size reached:
21
Randomization (investigator's opinion)
Randomized
Randomization description
randomized control trial with 21 sample size which divided in two groups. Group 1 have 10 patients and group 2 have 11 patients
Blinding (investigator's opinion)
Triple blinded
Blinding description
participant allocated randomly . investigator allocated randomly .Data analyser blindingly apply the state on both intervention group
Placebo
Not used
Assignment
Parallel
Other design features
sample size contain 2 group in which 1 group have 11 patients and 2 group have10 patient . The group 1 have light weight strengthening exercise and educate the routine physical activity and the group 2 have mobilization and routine physical activity.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Muhmmad institute of medical and allied sciences multan
Street address
HBL street near sbzazar metro station bosan road Multan
City
Multan
Postal code
66000
Approval date
2023-09-01, 1402/06/10
Ethics committee reference number
MIMAS/IRB/24/08
Health conditions studied
1
Description of health condition studied
Diseases of the musculoskeletal system and connective tissue
ICD-10 code
(M00-M99)
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
We are expecting that the patient education and routine physical therapy decrease the sub acromial pain syndrome.
Timepoint
> 3month
Method of measurement
SPADI,PCS,NPRS, Quick DASH,SF.12 and shoulder mobilization, light weight exercise and educate the routine physical activity.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group have sample size 21 in which group 1 have 10 patient and group 2 have 11 patients. The intervention for the group 1 is the shoulder mobilization with education the patient daily living activity and the group2 have the intervention of light weight strengthening exercise and education of patients.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Muhmmad rehabilitation center Multan
Full name of responsible person
Dr. Farah zahid
Street address
HBL street near sabzazar metro station bosan road Multan
City
Multan
Postal code
66000
Phone
+92 61 6221111
Email
perwashanaseer123@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mimas
Full name of responsible person
Imran Durrani
Street address
Bosan road multan
City
Multan
Postal code
66000
Phone
+92 333 6120602
Email
imranahmadkhandurrani@gmail.com
Grant name
research scholarship
Grant code / Reference number
45632
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mimas
Proportion provided by this source
80
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
MIMAS
Full name of responsible person
Perwasha
Position
Med.Dr
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Bosan road multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 310 6562039
Email
perwashanaseer123@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mimas
Full name of responsible person
Shahid Ishaq
Position
AP
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Bosan road multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 61 6221111
Email
shahidishaq53@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mimas
Full name of responsible person
Perwasha
Position
Med. doc
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Bosan road multan
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 61 6221111
Email
perwashanaseer123@gmail.com
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
INTEGRATED PATIENT EDUCATION AND ROUTINE PHYSICAL
THERAPY IN PATIENTS WITH SUBACROMIAL PAIN SYNDROME
When the data will become available and for how long
After 3 month
To whom data/document is available
supervisor
Under which criteria data/document could be used
ethical consedration
From where data/document is obtainable
supervisor
What processes are involved for a request to access data/document