To compare the effects of Spencer muscle energy techniques and Bowen therapy on pain,
Range of motion and disability in patients with Adhesive capsulitis.
Design
Single blinded randomized clinical trial with parallel assignment of 32 participants to two groups equally.
Settings and conduct
The study will be conducted at Arif memorial teaching hospital. Outcome assessor will be kept blind in it.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Both male and female patients between age of 40 - 60 years.
Patients with positive capsular pattern.
Patients experiencing pain, stiffness, and limited range of motion in the affected shoulder.
Patients who have not undergone shoulder surgery or received corticosteroid injections in the past three months.
Exclusion Criteria:
Patients with a history of shoulder fractures, dislocations, or other significant shoulder injuries.
Patients with fracture in and around shoulder.
Patients with any neurological disorder
Intervention groups
Group A: Spencer muscle energy technique
Group B: Bowen Therapy
Main outcome variables
Pain measured by numeric pain rating scale
ROM measured by universal goniometer
Disability measured by shoulder pain and disability index Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220701055331N3
Registration date:2024-06-13, 1403/03/24
Registration timing:prospective
Last update:2024-06-13, 1403/03/24
Update count:0
Registration date
2024-06-13, 1403/03/24
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
2024-06-25, 1403/04/05
Expected recruitment end date
2024-11-25, 1403/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effects of Spencer Muscle Energy Technique and Bowen Therapy on Pain, Range of motion and Disability in Patients with Adhesive Capsulitis
Public title
Comparative effects of Spencer Muscle Energy Technique and Bowen Therapy on Pain, Range of motion and Disability in Patients with Adhesive Capsulitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female patients between age of 40 - 60 years.
Patients with positive capsular pattern
Patients experiencing pain, stiffness, and limited range of motion in the affected shoulder.
Patients who have not undergone shoulder surgery or received corticosteroid injections in the past three months.
Exclusion criteria:
Patients with a history of shoulder fractures, dislocations, or other significant shoulder injuries
Patients with any neurological disorder
Patients with fracture in and around shoulder
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by random computer number generator. Assign unique identification numbers to participants, then use a reliable software tool to generate a list of random numbers. Match these numbers to participant IDs and allocate individuals to different study groups based on the sorted random numbers. Ensure that the randomization process is concealed and documented for transparency and integrity.
Blinding (investigator's opinion)
Single blinded
Blinding description
This will be a Single blinded study. It involves keeping the outcome assessor blind to the intervention received by the participants. This helps to minimize bias in assessing the study outcomes. To achieve single blinding, the outcome assessor is not informed about the treatment allocation of the participants and remains unaware of which group received the intervention being studied.
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
54600
Approval date
2023-12-28, 1402/10/07
Ethics committee reference number
IRB/2023/138
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
Pain
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Numeric pain rating scale
2
Description
Range of motion
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Universal Goniometer
3
Description
Disability
Timepoint
Before intervention and 4 weeks after intervention
Method of measurement
Shoulder pain and disability index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group A: Spencer muscle energy technique: Patients of group A received Spencer muscle energy technique 3 times a week for 4 weeks.
Category
Rehabilitation
2
Description
Intervention group B: Participants of group B received Bowen therapy 3 times a week for 4 weeks
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Arif Memorial Teaching Hospital
Full name of responsible person
Dr. Ifra Zulqarnain Awan
Street address
35-km ferozepur road Lahore
City
Lahore
Postal code
54600
Phone
+92 333 4975431
Email
ifra.awan@rlmc.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Dr. Ifra Zulqarnain Awan
Street address
35-km ferozepur road Lahore
City
Lahore
Postal code
54600
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
Umm-ul-wara
Position
Physiotherapist
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Rashid Latif Medical College 35-km Ferozpur Road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 333 4975431
Fax
Email
ifra.awan@rlmc.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rashid Latif Medical College
Full name of responsible person
Dr. Ifra Zulqarnain Awan
Position
Lecturer/Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Rashid Latif Medical College 35-km Ferozpur Road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 333 4975431
Fax
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
Dr. Ifra Zulqarnain Awan
Position
Lecturer/Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Rashid Latif Medical College 35-km Ferozpur Road Lahore
City
Lahore
Province
Punjab
Postal code
54600
Phone
+92 333 4975431
Fax
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