Adding Vertical Correction to Scapular Recognition on Patients With Frozen Shoulder
Effect of Adding Continual Vertical Downward Correction to Dynamic Scapular Recognition Exercise on Scapular Dyskinesis and Shoulder Pain and Disability in Patients With Frozen Shoulder: a Randomized Controlled Trial
1 other identifier
interventional
34
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2019
CompletedFirst Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 30, 2020
CompletedMay 7, 2020
May 1, 2020
7 months
April 21, 2020
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
EXPERIMENTALThe dynamic scapular recognition exercise + rigid taping with 50%-75% tension.
Control
PLACEBO COMPARATORThe dynamic scapular recognition exercise + placebo taping
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
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
- 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