NCT05450068

Brief Summary

This study will be a randomized control trial conducted on 44 patients diagnosed as adhesive capsulitis in headquarter hospital Gujar khan. Subjects will be divided equally into 4 groups (n=11 in each group) that are Group A, B, C and D by sealed envelope method. Pre-intervention assessment will be done by using data collection tools and then intervention will be applied. Group A will receive mobilization with movement (MWM) technique along with Spencer's muscle energy technique (MET) with conventional therapy. Group B will receive MWM along with conventional therapy. Group C will receive Spencer's MET along with conventional therapy. Group D will receive conventional therapy alone. All subjects will be given a home exercise plan. Assessment will be done after 1st session, 1st week, 2nd week, 3rd week and finally after 2 weeks on follow up using data collection tool. Data collection tools are semi-structured questionnaire (informed consent, demographic details, goniometric measurements), Visual analogue scale (VAS), shoulder pain and disability index (SPADI) and universal goniometer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

April 15, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 8, 2022

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

4 months

First QC Date

April 9, 2022

Last Update Submit

September 5, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analogue Scale

    A Visual Analogue Scale (VAS) is one of the pain rating scales used for measurement of pain intensity. The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain. It will be used at baseline, after first session and then every week up to 6th week.

    6th week.

  • Shoulder Pain and Disability Index

    The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with Activity of daily Livings requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items. It will be used at baseline, every week up to 4th week and then after 2 week follow up on 6th week

    6th week

  • Range of Motion

    Ranges of motions of all shoulder movements will be measured. These include Flexion, Abduction, Eternal and Internal Rotation. It will be measured at baseline, after first session, every week up to 4th week and then after 2 week follow up on 6th week.

    6th week.

Study Arms (4)

Group A-Combined Group

ACTIVE COMPARATOR

Participants in this group will receive both Mulligan's mobilization with movement and Spencer's muscle energy technique along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks.

Other: Mulligan's Mobilization with movementOther: Spencer's muscle energy techniqueOther: Conventional Therapy

Group B-Mulligan Group

ACTIVE COMPARATOR

Participants in this group will receive Mulligan's mobilization with movement along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks.

Other: Mulligan's Mobilization with movement

Group C-Spencer Group

ACTIVE COMPARATOR

Participants in this group will receive Spencer's muscle energy technique along with conventional therapy and home exercise plan. 3 sessions per week will be given for 4 weeks.

Other: Spencer's muscle energy technique

Group D-Conventional Group

ACTIVE COMPARATOR

Participants in this group will receive conventional therapy alone in hospital with home exercise plan. 3 sessions per week will be given for 4 weeks.

Other: Conventional Therapy

Interventions

The Mulligan's technique will be performed as described by Brian Mulligan. 3 sets of 10 repetitions with 1 minute rest between sets.

Group A-Combined GroupGroup B-Mulligan Group

Muscle energy technique that is composed of 7 stages repeated on after the other will be performed. Each movement will be repeated 10 times with 1 minute rest between each set.

Group A-Combined GroupGroup C-Spencer Group

Electrotherapy-Ultrasound (5-10 mins), Exercise therapy program (isometric, capsular stretching, pectoral stretch and scapular stabilization exercises)

Group A-Combined GroupGroup D-Conventional Group

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female
  • Age bracket is 30-70 years
  • Pain in the shoulder for at least three months
  • All active and passive shoulder movements restricted, with a reduction in external rotation of at least 50%.

You may not qualify if:

  • Patients with
  • Recent history of surgery on particular shoulder
  • Post-traumatic and rotator cuff rupture
  • Neurological deficits affecting shoulder function
  • Pain or disorders of cervical spine, elbow, wrist or hand
  • Tendon calcification
  • Rheumatoid arthritis
  • Osteoporosis
  • Malignancies
  • Pregnancy
  • Open wounds or skin infections
  • Recent steroid injection
  • Previous manipulation under anesthesia of affected shoulder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehsil headquarter hospital

Gujar Khān, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Bursitis

Interventions

Movement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maria Khalid, MSOMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Study is single-blinded as the participants are unaware of the treatment given to them.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2022

First Posted

July 8, 2022

Study Start

April 15, 2022

Primary Completion

July 31, 2022

Study Completion

August 30, 2022

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations