NCT05889065

Brief Summary

The term ''frozen shoulder'' is defined as a clinical condition with restricted active and passive range of motion (ROM) in all directions, including flexion, abduction, and rotation.The objective of the study is to determine the effects of Scapular proprioceptive neuromuscular facilitation and conventional physical therapy among patients with adhesive capsulitis.The study will be a randomized controlled trial (single-blinded parallel study), consisting of 2 groups- interventional group A and interventional group B.Group A will be given conventional physical therapy and group B will be given conventional physical therapy alongwith scapular PNF.Scapular PNF exercises are not included in our routine PT treatment programs and there is limited literature related to the PNF techniques. These techniques help develop muscular strength and endurance, joint stability, mobility, neuromuscular control and coordination all of which are aimed at improving the overall functional ability of patients.

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
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 5, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

May 25, 2023

Last Update Submit

June 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Shoulder Pain

    Shoulder Pain will be measured on the basis of visual analogue scale of 0-100mm. A higher score signifies greater pain.

    2 weeks

Secondary Outcomes (2)

  • Shoulder range of motion (ROM)

    2 weeks

  • Scapular mobility

    2 weeks

Study Arms (2)

Conventional PT Group

ACTIVE COMPARATOR

Conventional group will receive routine physical therapy including 10 ultrasound(1.5w/cm2 ,3 MHz continuous type, duration 10 minutes),hot packs (on affected region of shoulder for 10 minutes),shoulder ROM, stretching exercises, and joint mobilization five times per week for two weeks with 40 minutes duration of each session. Maitland mobilization will be given in supine position. · After giving glenohumeral joint distraction, caudal, dorsal, and ventral glides will be given at a rate of 2-3 oscillation/second for 1 to 2 minutes to patients. Grade I or II rhythmic oscillations will be applied in free range.

Procedure: Conventional Physical Therapy

Scapular PNF + Conventional PT Group

EXPERIMENTAL

This group will receive scapular PNF techniques along with routine physical therapy (same as above). In this group 20 repetitions of diagonal scapular pattern (anterior elevation and posterior depression, posterior elevation and anterior depression) with 20 seconds rest period will be given to subjects. PNF techniques of rhythmic initiation and repeated contractions will be used in all patterns, applied for 40 minutes.

Procedure: Conventional Physical TherapyProcedure: PNF techniques

Interventions

group A will receive conventional physical therapy including 10 ultrasound(1.5w/cm2 ,3 MHz continuous type, duration 10 minutes),hot packs (on affected region of shoulder for 10 minutes),shoulder ROM, stretching exercises, and joint mobilization five times per week for two weeks with 40 minutes duration of each session. Maitland mobilization will be given in supine position. · After giving glenohumeral joint distraction, caudal, dorsal, and ventral glides will be given at a rate of 2-3 oscillation/second for 1 to 2 minutes to patients. Grade I or II rhythmic oscillations will be applied in free range.

Conventional PT GroupScapular PNF + Conventional PT Group

In this group 20 repetitions of diagonal scapular pattern (anterior elevation and posterior depression, posterior elevation and anterior depression) with 20 seconds rest period will be given to subjects. PNF techniques of rhythmic initiation and repeated contractions will be used in all patterns, applied for 40 minutes.

Scapular PNF + Conventional PT Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases diagnosed with adhesive capsulitis, both primary and secondary origin.
  • Stage two and stage three of adhesive capsulitis.
  • Unilateral adhesive capsulitis.
  • Both males and females of the age group 40 years and above.

You may not qualify if:

  • History of shoulder surgery or manipulation under anesthesia,
  • Local corticosteroid injection administration to the affected shoulder within the last 3 months.
  • Severe musculoskeletal, neurological and cardiovascular conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 46000, Pakistan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Maryum Fatima

    Foundation University Islamabad

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will not be aware of which group the participant belongs to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a randomized controlled trial having two groups. One group will receive conventional physical therapy and the other group will receive scapular PNF with conventional physical therapy. Both groups will be recruited concurrently.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 5, 2023

Study Start

August 1, 2022

Primary Completion

June 15, 2023

Study Completion

July 1, 2023

Last Updated

June 5, 2023

Record last verified: 2023-05

Locations