NCT06763601

Brief Summary

the study is about intervention to patient with frozen shoulder to help patients improve function and shoulder disability , reduce pain and improve range of motion, the main aim of this study is to find out which treatment intervention SSMP , MWM and sham mobilization give effective results

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 11, 2024

Completed
21 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 8, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2025

Completed
Last Updated

January 8, 2025

Status Verified

December 1, 2024

Enrollment Period

3 months

First QC Date

December 11, 2024

Last Update Submit

January 7, 2025

Conditions

Keywords

SSMPMWMsham mobilizationfrozen shoulder

Outcome Measures

Primary Outcomes (2)

  • Shoulder Pain And Disability Index

    shoulder pain and disability index is use to measure shoulder pain and disability where 0 is the best score and 130 is the worst

    from enrollment to week 4,6,8

  • Numeric Pain Rating Scale

    numeric pain rating scale where 0 indicates no pain and 10 indicates worst pain

    from enrollment to 8 weeks

Secondary Outcomes (2)

  • Range Of Motion

    week 4,6,8

  • Patients' Global Impression of Change (PGIC) scale

    at enrollment and on 8th week

Study Arms (3)

SSMP

EXPERIMENTAL

SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional program

Procedure: SSMP, Isometric exercise, eccentric exercise, heavy slow resistance , functional program

MWM

EXPERIMENTAL

MWM procedure followed by Isometric exercise, eccentric exercise, heavy slow resistance , functional program

Procedure: MWM,Isometric exercise, eccentric exercise, heavy slow resistance , functional program

sham mobilization

PLACEBO COMPARATOR

Sham mobilization will be given for placebo effect followed by Isometric exercise, eccentric exercise, heavy slow resistance , functional program

Procedure: sham mobilization

Interventions

In this group the patients will be given symptom modification procedure in the first phase followed by isometric exercises in second phase, eccentrics and HSR in third phase and functional program in fourth phase

SSMP

in this mobilization with movement in first phase will be given followed by isometrics, eccentrics and heavy slow resistance exercise and finally the functional program

MWM

Sham mobilization followed by isometrics, eccentric training and heavy resistance training and finally the functional program .

sham mobilization

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of adhesive capsulitis confirmed by a healthcare professional.
  • Scores more than 2 in adhesive capsulitis scale
  • Range of motion affected in capsular pattern
  • Age between 40-65 years.
  • Willingness to participate by signing informed consent

You may not qualify if:

  • Having any history of shoulder dislocation
  • Humerus fractures or trauma
  • Diagnosed with any sort of cancer
  • History of cardiovascular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thumbay Physical Therapy and Rehabilitation Hospital

Ajman, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ayesha seemab, BPT

CONTACT

Watson Watson Arulsingh, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: each participant will be randomly allocated one group. there are three groups in total
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 11, 2024

First Posted

January 8, 2025

Study Start

January 1, 2025

Primary Completion

March 22, 2025

Study Completion

May 16, 2025

Last Updated

January 8, 2025

Record last verified: 2024-12

Locations