NCT06618443

Brief Summary

50 patients with shoulder adhesive capsulitis were admitted. the patients will receive scapular mobilization (downward or upward mobilization) associated with arm movements. The percentage of improvement in shoulder ROM of flexion, abduction, and external rotation; and decrease in shoulder pain and disability index (SPADI).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Status
not yet 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

September 26, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2025

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

September 26, 2024

Last Update Submit

September 30, 2024

Conditions

Keywords

scapular mobilization; arm movement; pain; range of motion; disability; older adults; adhesive capsulitis

Outcome Measures

Primary Outcomes (4)

  • Shoulder Pain and Disability Index (SPADI)

    The patient was asked to refer to the degree of their shoulder problems in the previous week by choosing a number on a scale from 0 (no pain or disability) to 10 (extreme pain and disability) for each question 13. The chosen number from each subscale was summed up and transformed into an out-of-100 score. The mean two scales were assigned a sum score out of 100. The higher the end score, the more shoulder pain, or disability.

    3 months

  • Shoulder range of motion of flexion, abduction, and external rotation

    For evaluating shoulder flexion and abduction, the goniometer was positioned on the distal arm. The patient sat in a vertical position on an elevated-backed chair. To restrain trunk unwanted motion, a belt was put around the patient\'s waist and chair. The patient was directed to lift the tested arm voluntarily with his palm facing the floor. For evaluating shoulder external rotation, the goniometer was positioned on the proximal forearm next to the wrist joint. The patient was asked to lie supine with flexed hips and knees 45 degrees. The tested arm was placed on the plinth with 90 degrees in shoulder abduction, 90 degrees in elbow flexed, and 0 degrees in wrist joint11. The patient was asked to turn the forearm up to externally rotate the arm.

    3 months

  • Scapular dyskinesis

    this test was conducted with grasping dumbbells following the bodyweight, 1.4 kg (3 lb) for patients with a weight of lower than 68.1 kg (150 lb), and 2.3 kg (5 lb) for patients with a weight of 68.1 kg or higher. If any patient was unable to carry these predetermined weights, the weight was decreased by 0.5 kg29. Then, the patient was instructed to instantaneously raise his arms overhead with thumbs-up as much as possible at a 3-second count and then lower the arms back to the same starting position at a 3-second count. This study used a caliper to develop an objective method to measure improved scapular dyskinesis. The height difference between the 2 scapulae was measured with a caliper to the nearest millimeters at the end of the available shoulder ROM. The height difference between the 2 scapulae was defined as the difference between the vertical positions of the 2 inferior angles of the 2 scapulae30. A distance of more than 75 mm between the 2 scapulae was c

    3 months

  • Electromyography

    Electromyographical analysis of Upper and Lower trapezius and Serratus anterior

    3 months

Study Arms (2)

Scapular mobilization with movement

EXPERIMENTAL

The treatment consisted of scapular mobilization with arm movement in all directions for 15 min/session for 3 sessions/week for 4 weeks. Scapular mobilization included scapular upward glide and downward glid. Scapular upward glide was performed with shoulder adduction and extension, while scapular downward glide was performed with shoulder abduction and flexion.

Other: Scapular mobilization with movement

Control

NO INTERVENTION

Interventions

The treatment consisted of scapular mobilization with arm movement in all directions for 15 min/session for 3 sessions/week for 4 weeks. Scapular mobilization included scapular upward glide and downward glid. Scapular upward glide was performed with shoulder adduction and extension, while scapular downward glide was performed with shoulder abduction and flexion.

Scapular mobilization with movement

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • The existence of unilateral adhesive capsulitis (stage II) with incapability of the participant to raise the arm more than 100 degrees in the plane of the scapula

You may not qualify if:

  • The presence of any shoulder problem contraindicated for performing exercises to the shoulder joint, such as active inflammatory disease, cancer, active infection, recent subluxations or dislocations, fractures, and surgeries near the shoulder region.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BursitisPain

Interventions

Movement

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ayman AM Mohamed, PhD, MPT, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 26, 2024

First Posted

October 1, 2024

Study Start

October 15, 2024

Primary Completion

January 31, 2025

Study Completion

February 15, 2025

Last Updated

October 1, 2024

Record last verified: 2024-09