NCT04369144

Brief Summary

OBJECTIVE: To study the effect of adding a continual vertical downward correction to dynamic scapular recognition exercise on scapular dyskinesis and shoulder pain and disability in patients with frozen shoulder. Design: A double-blinded randomized controlled study Setting: Out-patient clinic Subjects: Sixty-seven subjects with unilateral frozen shoulder Interventions: Participants were distributed into two groups. The intervention group performed the dynamic scapular recognition exercise and continual vertical downward correction using rigid taping with 50%-75% tension. The control group performed a similar dynamic scapular recognition exercise using a wireless biofeedback system and placebo taping. A scapular dyskinesis test with caliper was utilized to measure scapular dyskinesis, a digital inclinometer was utilized to evaluate the scapular upward rotation and shoulder ROMs, and the Shoulder Pain and Disability Index (SPADI) was utilized to evaluate the shoulder pain and disability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2018

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

7 months

First QC Date

April 21, 2020

Last Update Submit

May 5, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Scapular dyskinesis

    Firstly, the patient was requested to place his/her upper limbs at his/her side with shoulders in mid-rotation and elbows straight. To better observation of scapular dyskinesis, this test was done with grasping dumbbells following the bodyweight, 1.4 kg (3 lb) for patients weighting lower than 68.1 kg (150 lb) and 2.3 kg (5 lb) for patients weighting 68.1 kg or higher. If any patient was unable to carry these predetermined weights, the weight was decreased by 0.5 kg(20). 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 arms back to the same starting position at a 3-second count.

    2 months

  • Scapular Upward rotation

    Digital inclinometers are reliable and validated tools in assessing the improvement in scapular upward rotation. During the test, the tested arm was preserved at 80 degrees of shoulder abduction. The upward rotation of the scapula was calculated as the angle formed between the line drained among lateral and medial parts of the spine of the scapula and the horizontal line drained parallel to the ground.

    2 months

  • Shoulder Pain and disability index (SPADI)

    Before gathering information from the patients, a detailed clarification of the SPADI was provided to them. Then, patients were requested to represent the extent of their shoulder pain and disability by selecting one number on subscales from zero (no pain or disability) to ten (maximum pain and disability) for each item. The results of each subscale were summarized and converted to a score out of 100. The means of these two subscales were summarized to give a total score out of 100. The lower the final score, the better the shoulder pain, impairment or disability.

    2 Months

Secondary Outcomes (1)

  • Shoulder ROMs

    2 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The dynamic scapular recognition exercise + rigid taping with 50%-75% tension.

Other: Dynamic Scapular Recognition exercise

Control

PLACEBO COMPARATOR

The dynamic scapular recognition exercise + placebo taping

Other: Dynamic Scapular Recognition exercise

Interventions

The intervention group received continual vertical downward correction using a standardized rigid tape. A hypoallergenic tape (Hypafix; BSN Medical GmbH, Hamburg, Germany) was used with 50% to 75% tension. Two rigid tapes were applied; the first one is placed from just superior to the midpoint of the superior border of the scapula to the level of T12 and the second tapes were placed from just superior to the superior angle of the scapula to the level of T12. The level of T12 was used as the end of both taps to increase the lever arm of the applied force and to decrease the incidence of peeling off of the tape. No tape was applied from the lateral angle of the scapula because it might impair the upward rotation of the scapula. Both taps were performed after each session and removed immediately before the next session

Also known as: Rigid Taping
ControlIntervention group

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • The existence of a unilateral frozen shoulder with incapability of the participant to raise the arm more than 100 degrees in the plane of the scapula.
  • Aa restriction in both passive and active shoulder ROM
  • The existence of pain that affects performing activities of daily living\[19\]

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 nearby the shoulder region. Furthermore, the patient was excluded if he/she had no signs of scapular dyskinesis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

beni Suef University

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

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
Model Details: Double-blinded Randomized Controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 30, 2020

Study Start

November 15, 2018

Primary Completion

June 2, 2019

Study Completion

December 15, 2019

Last Updated

May 7, 2020

Record last verified: 2020-05

Locations