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Effect of Myofascial Release of Subscapularis Along With Shoulder Mobilization in Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis of Shoulder

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Myofascial release of subscapularis
Maitland mobilization
Stretching exercises
Cold pack
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adhesive Capsulitis of Shoulder focused on measuring Adhesive capsulitis, Muscle stretching exercise, Myofascial trigger point, Range of motion, Pain

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged between 40-65 years
  • Diagnosed with sub-acute adhesive capsulitis
  • Pain range of 3 to 8 on NPRS
  • SPADI score of >40
  • Presence of myofascial trigger point in subscapularis muscle

Exclusion Criteria:

  • History of fracture
  • Rheumatoid arthritis
  • Shoulder osteoarthritis
  • Any malignancy
  • Shoulder dislocation
  • Subacute adhesive capsulitis with impingement syndrome

Sites / Locations

  • Sindh Institute Physical Medicine and RehabilitationRecruiting
  • Dow University Hospital Ojha CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Maitland mobilization with myofascial trigger point release group

Maitland mobilization alone group

Arm Description

Maitland technique: caudal, anteroposterior (AP), and posteroanterior (PA) glides 5 sets of 2-3 glides per second of Grade III and IV for 30 seconds with a rest interval of 30 second between sets. Ischemic Compression technique: on subscapularis trigger points for 90 secs thrice a week for 2 weeks. Stretching exercises in direction of abduction, external rotation (ER), internal rotation (IR), and flexion. 6 repetitions of each stretch for 10 seconds Cold pack for 20 mins

Maitland technique: caudal, anteroposterior (AP), and posteroanterior (PA) glides 5 sets of 2-3 glides per second of Grade III and IV for 30 seconds with a rest interval of 30 second between sets. Stretching exercises in direction of abduction, external rotation (ER), internal rotation (IR), and flexion. 6 repetitions of each stretch for 10 seconds Cold pack for 20 mins

Outcomes

Primary Outcome Measures

Change from baseline pain intensity on Numeric Pain Rating Scale in scores at 6th session (10 days)
It will be use to assess pain intensity. It will be administered by simply asking the intensity of pain experienced in last 24 hours. The response of 0 represent no pain rather the responses between 1-3, 4-6, and 7-9 represents mild, moderate, and severe pain respectively. While 10 is the worst possible pain ever experienced by the person
Change from baseline joint range of motion on universal goniometer in degrees at 6th session (10 days)
It will be assessed by using standard universal goniometer and measured in degrees
change from baseline shoulder disability on Shoulder pain and disability index in percentage at 6th session (10 days)
Shoulder pain and disability index is used to assess shoulder disability. It consist of 13 questions i .e. 5 to assess pain and 8 to assess disability. Results will be calculated in percentage and higher results indicate increased disability. lower the percentage better will be the outcome.
Change from baseline pain pressure threshold on algometer in kilogram/centimeter2 at 6th session (10 days)
assessed through algometer which provide sustained pressure from 0.05Newton/second to 20 Newton/second. Results will be recorded in kilogram/centimeter2 and higher values indicate decrease sensitivity of myofascial trigger points

Secondary Outcome Measures

Full Information

First Posted
March 28, 2022
Last Updated
February 15, 2023
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05325255
Brief Title
Effect of Myofascial Release of Subscapularis Along With Shoulder Mobilization in Adhesive Capsulitis
Official Title
Effect of Myofascial Release of Subscapularis Along With Shoulder Mobilization Versus Shoulder Mobilization Alone in Adhesive Capsulitis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized control trial aims to compare the effect of myofascial release of subscapularis along with shoulder mobilization VS mobilization alone among patients with adhesive capsulitis. The study will be conducted at physiotherapy outpatient department (OPD) of Sindh Institute of physical medicine and rehabilitation, and Dow University Ojha Campus, Karachi. According to study criteria, 70 patients with sub-acute adhesive capsulitis will be selected through a non-randomized purposive sampling technique by a consultant physician. After taking informed consent, participants will be randomly divided into 2 groups through the sealed envelope method. Both the groups will receive conventional treatment while Group 1 will be given an additional treatment of myofascial release of subscapularis through ischemic compression technique. Total 6 treatment sessions will be provided and assessment will be done at baseline and end of the 6th session.
Detailed Description
The sample size of 31 per group was determined using planning and specification software (PASS) version 15 software based on two independent sample t-test using 95%confidence interval and 80% power of the test. This sample was raised to 35 per group with 4 patients as drop out per group. Mean and standard deviation will be calculated for the quantitative variables while frequency and percentages will be calculated for qualitative variables. Inter-group comparison at baseline will be calculated using an independent sample t-test. The mean difference between both the techniques in terms of numeric pain rating scale (NPRS), range of motion (ROM), shoulder pain and disability index (SPADI), and pain pressure threshold(PPT) will be determined using Repeated measure 2-way ANOVA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis of Shoulder
Keywords
Adhesive capsulitis, Muscle stretching exercise, Myofascial trigger point, Range of motion, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maitland mobilization with myofascial trigger point release group
Arm Type
Experimental
Arm Description
Maitland technique: caudal, anteroposterior (AP), and posteroanterior (PA) glides 5 sets of 2-3 glides per second of Grade III and IV for 30 seconds with a rest interval of 30 second between sets. Ischemic Compression technique: on subscapularis trigger points for 90 secs thrice a week for 2 weeks. Stretching exercises in direction of abduction, external rotation (ER), internal rotation (IR), and flexion. 6 repetitions of each stretch for 10 seconds Cold pack for 20 mins
Arm Title
Maitland mobilization alone group
Arm Type
Active Comparator
Arm Description
Maitland technique: caudal, anteroposterior (AP), and posteroanterior (PA) glides 5 sets of 2-3 glides per second of Grade III and IV for 30 seconds with a rest interval of 30 second between sets. Stretching exercises in direction of abduction, external rotation (ER), internal rotation (IR), and flexion. 6 repetitions of each stretch for 10 seconds Cold pack for 20 mins
Intervention Type
Other
Intervention Name(s)
Myofascial release of subscapularis
Intervention Description
It is the application of manual pressure over myofascial trigger point that induces ischemia and causes release of trigger points
Intervention Type
Other
Intervention Name(s)
Maitland mobilization
Intervention Description
It is the type of mobilization technique that uses passive accessory mobilization to reduce pain and stiffness and increasing range of motion
Intervention Type
Other
Intervention Name(s)
Stretching exercises
Intervention Description
It is the technique use to increase flexibility and range of motion of short and hypomobile structures
Intervention Type
Other
Intervention Name(s)
Cold pack
Intervention Description
It is the application of cold to provide analgesic effects
Primary Outcome Measure Information:
Title
Change from baseline pain intensity on Numeric Pain Rating Scale in scores at 6th session (10 days)
Description
It will be use to assess pain intensity. It will be administered by simply asking the intensity of pain experienced in last 24 hours. The response of 0 represent no pain rather the responses between 1-3, 4-6, and 7-9 represents mild, moderate, and severe pain respectively. While 10 is the worst possible pain ever experienced by the person
Time Frame
At baseline and after 6 sessions (10 days)
Title
Change from baseline joint range of motion on universal goniometer in degrees at 6th session (10 days)
Description
It will be assessed by using standard universal goniometer and measured in degrees
Time Frame
At baseline and after 6 sessions (10 days)
Title
change from baseline shoulder disability on Shoulder pain and disability index in percentage at 6th session (10 days)
Description
Shoulder pain and disability index is used to assess shoulder disability. It consist of 13 questions i .e. 5 to assess pain and 8 to assess disability. Results will be calculated in percentage and higher results indicate increased disability. lower the percentage better will be the outcome.
Time Frame
At baseline and after 6 sessions (10 days)
Title
Change from baseline pain pressure threshold on algometer in kilogram/centimeter2 at 6th session (10 days)
Description
assessed through algometer which provide sustained pressure from 0.05Newton/second to 20 Newton/second. Results will be recorded in kilogram/centimeter2 and higher values indicate decrease sensitivity of myofascial trigger points
Time Frame
At baseline and after 6 sessions (10 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients aged between 40-65 years Diagnosed with sub-acute adhesive capsulitis Pain range of 3 to 8 on NPRS SPADI score of >40 Presence of myofascial trigger point in subscapularis muscle Exclusion Criteria: History of fracture Rheumatoid arthritis Shoulder osteoarthritis Any malignancy Shoulder dislocation Subacute adhesive capsulitis with impingement syndrome
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Umama Abbasi, DPT
Phone
+923122930340
Email
umamaabbasi42@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aftab Ahmed Mirza Baig, MSAPT
Phone
+923002739920
Email
ab.dptrm@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Umama Abbasi, DPT
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rabail R Soomro, PhD Scholar
Organizational Affiliation
Sindh Institute of Physical Medicine and Rehabilitation
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aftab Ahmed Mirza Baig, MSAPT
Organizational Affiliation
Sindh Institute of Physical Medicine and Rehabilitation
Official's Role
Study Director
Facility Information:
Facility Name
Sindh Institute Physical Medicine and Rehabilitation
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aftab Ahmed Mirza Baig, MSAPT
Phone
+923002739920
Email
ab.dptrm@gmail.com
First Name & Middle Initial & Last Name & Degree
Umama Abbasi, DPT
Facility Name
Dow University Hospital Ojha Campus
City
Karachi
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Umama Abbasi, PG student
Phone
+923122930340
Email
umamaabbasi42@gmail.com
First Name & Middle Initial & Last Name & Degree
Umama Abbasi, DPT

12. IPD Sharing Statement

Learn more about this trial

Effect of Myofascial Release of Subscapularis Along With Shoulder Mobilization in Adhesive Capsulitis

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