Clinical trial NCT05325255: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Capsulitis of Shoulder
Keywords: Adhesive capsulitis
Muscle stretching exercise
Myofascial trigger point
Range of motion
Pain
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline pain intensity on Numeric Pain Rating Scale in scores at 6th session (10 days)
timeFrame: At baseline and after 6 sessions (10 days)
measure: Change from baseline joint range of motion on universal goniometer in degrees at 6th session (10 days)
timeFrame: At baseline and after 6 sessions (10 days)
measure: change from baseline shoulder disability on Shoulder pain and disability index in percentage at 6th session (10 days)
timeFrame: At baseline and after 6 sessions (10 days)
measure: Change from baseline pain pressure threshold on algometer in kilogram/centimeter2 at 6th session (10 days)
timeFrame: At baseline and after 6 sessions (10 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Sindh Institute Physical Medicine and Rehabilitation
state: Sindh
city: Karachi
country: Pakistan
facility: Dow University Hospital Ojha Campus
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Umama Abbasi, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Sindh Institute of Physical Medicine and Rehabilitation
name: Rabail R Soomro, PhD Scholar
role: STUDY_DIRECTOR
affiliation: Sindh Institute of Physical Medicine and Rehabilitation
name: Aftab Ahmed Mirza Baig, MSAPT
role: STUDY_DIRECTOR
References: