NCT06201468

Brief Summary

This study will be conducted to examine and compare the effects of SM versus SPNF on shoulder pain, ROM and functional disabilities in patients with frozen shoulder.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 29, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

January 10, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

December 29, 2023

Last Update Submit

July 2, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Shoulder disability

    Shoulder Pain and Disability Index (SPADI) The translated version of SPADI in the Arabic language showed excellent internal consistency and test-retest reliability. Validity was shown by substantial correlations between SPADI and Quick DASH, NRS, and active shoulder ROM. The Arabic SPADI is recommended for the evaluation of patients with shoulder dysfunction

    4 weeks

  • Shoulder range of motion

    A goniometer is a device used to measure the range of motion (in degrees) of joints for either active or passive range. Shoulder flexion, extension, abduction adduction, internal rotation and external rotation will be assessed by Goniometer

    4 weeks

Secondary Outcomes (2)

  • Scapular upward rotation

    4 weeks

  • Lateral scapular slide test

    4 weeks

Study Arms (2)

group A

EXPERIMENTAL

Group A (n = 21): will receive scapular mobilization combined with mobilization with movement (MWM) and capsular stretch for 4 weeks. Mulligan Mobilization with Movement for peripheral joints combines sustained manual application of 'gliding' force to a joint, with the aim of repositioning the positional faults with concurrent physiological motion of the joint, either performed actively by the subject or passively by the therapist

Other: Group A SCAPULAR MOBILIZATION

group B

EXPERIMENTAL

Group B (n = 21): will receive scapular proprioceptive neuromuscular facilitation combined with (MWM) and capsular stretch for 4 weeks. Scapular PNF incorporates functional or diagonal patterns (anterior elevation - posterior depression and posterior elevation - anterior depression) for performing the exercises and can be used to stretch or strengthen the muscles selectively. These techniques help the muscles to relearn the normal timing of recruitment and the amount of activation to sustain the balance between different groups of muscles

Other: Group A SCAPULAR MOBILIZATION

Interventions

Two treatment groups will receive interventions as follows: Group A (n = 21): will receive scapular mobilization combined with mobilization with movement (MWM) and capsular stretch for 4 weeks. Group B (n = 21): will receive scapular proprioceptive neuromuscular facilitation combined with (MWM) and capsular stretch for 4 weeks.

Also known as: GROUP B SCAPULAR PNF
group Agroup B

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- All the patients refferd from orthopaedic surgeon with diagnosis of adhesive capsulitis. Patients will be included in this study if they fulfil the following criteria
  • Case diagnosed with adhesive capsulitis, both primary and secondary.
  • Both males and females of the age group 40 to 60 years.
  • Limited active and passive movement of the shoulder joint movements, as well as difficulties with ADLs.
  • The onset of symptoms between 3 to 12 months. 5. Unilateral adhesive capsulitis.

You may not qualify if:

  • \. History of shoulder surgery or manipulation under anaesthesia, local corticosteroid injection administration to the affected shoulder within the last 6 months, 2. Neurological deficit affecting the shoulder function during daily activities, 3. Pathology of the shoulder joint other than adhesive capsulitis including rotator cuff tear, tendonitis at the shoulder and neck region, malignancies, history of trauma or accidental injuries of the upper limb.
  • Other pathological conditions including, a history of stroke, history of mastectomy and coronary artery bypass grafting (CABG).
  • \. Rheumatoid arthritis, osteoporosis, or disorders of the cervical spine, elbow, wrist or hand.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Mona M ibrahim

    Cairo University

    STUDY DIRECTOR
  • mahmoud alsehemy

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
triple-blinded clinical randomized trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two treatment groups will receive interventions as follows: Group A (n = 21): will receive scapular mobilization combined with mobilization with movement (MWM) and capsular stretch for 4 weeks. Group B (n = 21): will receive scapular proprioceptive neuromuscular facilitation combined with (MWM) and capsular stretch for 4 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 29, 2023

First Posted

January 11, 2024

Study Start

January 10, 2024

Primary Completion

October 10, 2024

Study Completion

December 1, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations