The study aims to assess the comparative effect of METs and (muscle energy techniques) with and without scapular mobilization in patients with adhesive capsulitis. This study will help to highlight various physiological effects for managing adhesive capsulitis. To study the effect of Muscle Energy Technique on pain in patient with adhesive capsulitis.
Design
Pragmatic, community based, parallel group, double blinded, randomized controlled trial. Total 377 patients will be enrolled. Patients who met our inclusion criteria will be randomized into two groups.
Settings and conduct
Muhammad physical therapy & rehabilitation center Multan
Participants/Inclusion and exclusion criteria
Inclusion:
1. Age range (e.g 30-60 y)
2. Patients who have completed their conservative treatment for a minimum of 6 Week
3. Patients with pain and Restricted range of motion in the affected shoulder joint
5. Patients who can understand exercise programe
6. Both genders
Exclusion:
1. Patients with any other pathological disease related to the
shoulder
2. Patients with neurological and rheumatological disorders
3. Patients with systemic diseases affecting the musculoskeletal
system
4. Patients who may be limited in their capacity to exercise due to
cardiovascular, respiratory, or metabolic issues
5. Pregnant or breastfeeding ladies
6. Fractures/dislocations
7. History of acute trauma or previous surgery in the affected shoulder
8. Patients treated with corticoid injection in the affected shoulder in the last 12 months (25, 26).
Intervention groups
Group A 188 (who will receive METs with combination of scapular mobilization) and Group B 188 (who will receive METs without scapular mobilization).
Main outcome variables
joint range of motion, joint stiffness, adhesions, independency and quality of life in adhesive capsulitis patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241220064105N1
Registration date:2024-12-26, 1403/10/06
Registration timing:prospective
Last update:2024-12-26, 1403/10/06
Update count:0
Registration date
2024-12-26, 1403/10/06
Registrant information
Name
Komal Ammar Bukhari
Name of organization / entity
Muhammad Institute of Medical Sciences, Multan
Country
Pakistan
Phone
+92 314 6361728
Email address
komalbukhari608@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-12, 1403/10/23
Expected recruitment end date
2025-04-12, 1404/01/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of METs With and Without Scapular Mobilization in Treating Patients with Adhesive Capsulitis
Public title
METs With and Without Scapular Mobilization in Treating Patients with Adhesive Capsulitis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age range (e.g 30-60 y)
Patients who have completed their conservative treatment for a minimum of 6 Week
Restricted range of motion of the affected shoulder joint
Patients with pain (e.g visual analogue score > 4) in the affected shoulder joint
Patients who can understand exercise programm and co-operate with therapist
Both genders
Exclusion criteria:
1. Patients with any other pathological disease related to the shoulder (e. g. “rotator cuff tear, impingement syndrome”)
Patients with neurological and rheumatological disordersaffecting the shoulder joint
Patients with a history of shoulder surgery or trauma
Patients with systemic diseases affecting the musculoskeletal system (e. g., osteoarthritis, rheumatoid arthritis)
Patients who may be limited in their capacity to exercise due to cardiovascular, respiratory, or metabolic issues
Patients who are pregnant or breastfeeding
Fractures/dislocations8. History of acute trauma or previous surgery in the affected shoulder
Patients treated with corticoid injection in the affected shoulder in the last 12 months
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
377
Randomization (investigator's opinion)
Randomized
Randomization description
This randomization will be done by Lottery method to ensure fairness. Medications will be given in numbered white boxes, each with a unique medication number. The treatment codes will be kept by the principal investigator.
Blinding (investigator's opinion)
Double blinded
Blinding description
Statistical analyser and outcome assessor will be kept blind so that the result obtained will be without biasness.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences
Street address
Bosan Road
City
Multan
Postal code
66000
Approval date
2024-12-12, 1403/09/22
Ethics committee reference number
MIMAS/19/01/Komal
Health conditions studied
1
Description of health condition studied
Adhesive capsulitis
ICD-10 code
M75.0
ICD-10 code description
Adhesive capsulitis of shoulder
Primary outcomes
1
Description
Range of motion
Timepoint
12weeks
Method of measurement
Goniometer Scale
2
Description
Shoulder Disability
Timepoint
12weeks
Method of measurement
SPADI Scale
3
Description
pain
Timepoint
12weeks
Method of measurement
NPRS(Numerical pain rating scale)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will receive METs with combination of scapular mobilization scapular exercises • scapular wall angles• scapular protraction and retraction with Quadruped exercises • scapular dips• scapular punches• scapular cat camel stretch . Muscle Energy Techniques MET for Glenohumeral Joint Restricted Flexion , Abduction and External Rotation, Treatment regime distributed in 12 weeks period, 5 days a week, with 30 repititions per set and sessions lasting 30 min per day
Category
Rehabilitation
2
Description
Control group: will receive METs without scapular mobilization , MET for Glenohumeral Joint Restricted Flexion MET for Glenohumeral Joint Restricted Abduction MET for Glenohumeral Joint Restricted External Rotation, Treatment regime distributed in 12 weeks period, 5 days a week, with 30 repititions per set and sessions lasting 30 min per day
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Muhammad physical therapy & rehabilitation center Multan
Full name of responsible person
Maliha Khalid Khan
Street address
Bosan Road
City
Multan
Postal code
66000
Phone
+92 314 6361728
Email
malihatareen1997@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Muhammad Instituite of Rehabilitation Sciences, Multan
Full name of responsible person
Qurat ul Ain
Street address
Bosan Road
City
Multan
Postal code
66000
Phone
+92 312 6862130
Email
qain0635@gmail.com
Grant name
Student fund
Grant code / Reference number
MIMAS/6/2/Rabia
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Muhammad Instituite of Rehabilitation Sciences, Multan
Proportion provided by this source
70
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
Muhammad Instituite of Medical and Allied Sciences, Multan
Full name of responsible person
Maliha Khalid Khan
Position
Lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 312 6862130
Email
malihatareen1997@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Muhammad Institute of Medical Sciences and Rehabilitation center, Multan
Full name of responsible person
Komal Ammar Bukhari
Position
Lecturer
Latest degree
Medical doctor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 314 6361728
Email
komalbukhari608@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Muhammad Instituite of Medical and Allied Sciences, Multan
Full name of responsible person
Rabia Abbas
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Bosan Road
City
Multan
Province
Punjab
Postal code
66000
Phone
+92 319 6826592
Email
rabiahabbas12@gmail.com
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