NCT05325255

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 13, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

April 26, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

February 16, 2023

Status Verified

February 1, 2023

Enrollment Period

1 year

First QC Date

March 28, 2022

Last Update Submit

February 15, 2023

Conditions

Keywords

Adhesive capsulitisMuscle stretching exerciseMyofascial trigger pointRange of motionPain

Outcome Measures

Primary Outcomes (4)

  • 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)

  • 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)

  • 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)

  • 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)

Study Arms (2)

Maitland mobilization with myofascial trigger point release group

EXPERIMENTAL

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

Other: Myofascial release of subscapularisOther: Maitland mobilizationOther: Stretching exercisesOther: Cold pack

Maitland mobilization alone group

ACTIVE COMPARATOR

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

Other: Maitland mobilizationOther: Stretching exercisesOther: Cold pack

Interventions

It is the application of manual pressure over myofascial trigger point that induces ischemia and causes release of trigger points

Maitland mobilization with myofascial trigger point release group

It is the type of mobilization technique that uses passive accessory mobilization to reduce pain and stiffness and increasing range of motion

Maitland mobilization alone groupMaitland mobilization with myofascial trigger point release group

It is the technique use to increase flexibility and range of motion of short and hypomobile structures

Maitland mobilization alone groupMaitland mobilization with myofascial trigger point release group

It is the application of cold to provide analgesic effects

Maitland mobilization alone groupMaitland mobilization with myofascial trigger point release group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sindh Institute Physical Medicine and Rehabilitation

Karachi, Sindh, 74200, Pakistan

RECRUITING

Dow University Hospital Ojha Campus

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

BursitisPain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Umama Abbasi, DPT

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Rabail R Soomro, PhD Scholar

    Sindh Institute of Physical Medicine and Rehabilitation

    STUDY DIRECTOR
  • Aftab Ahmed Mirza Baig, MSAPT

    Sindh Institute of Physical Medicine and Rehabilitation

    STUDY DIRECTOR

Central Study Contacts

Umama Abbasi, DPT

CONTACT

Aftab Ahmed Mirza Baig, MSAPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 28, 2022

First Posted

April 13, 2022

Study Start

April 26, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

February 16, 2023

Record last verified: 2023-02

Locations