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

Adhesive Capsulitis of Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05325255
• Other study ID #: UAbbasi
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: February 2023
• Source: Dow University of Health Sciences
• Contact: Umama Abbasi, DPT
• Phone: +923122930340
• Email: umamaabbasi42[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis of Shoulder
• Bursitis

Intervention

Other:
• Myofascial release of subscapularis
It is the application of manual pressure over myofascial trigger point that induces ischemia and causes release of trigger points
• Maitland mobilization
It is the type of mobilization technique that uses passive accessory mobilization to reduce pain and stiffness and increasing range of motion
• Stretching exercises
It is the technique use to increase flexibility and range of motion of short and hypomobile structures
• Cold pack
It is the application of cold to provide analgesic effects

Locations

Country	Name	City	State
Pakistan	Dow University Hospital Ojha Campus	Karachi	Sindh
Pakistan	Sindh Institute Physical Medicine and Rehabilitation	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At baseline and after 6 sessions (10 days)
Primary	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	At baseline and after 6 sessions (10 days)
Primary	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.	At baseline and after 6 sessions (10 days)
Primary	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	At baseline and after 6 sessions (10 days)