Frozen ShoulderNCT04369144
Adding Vertical Correction to Scapular Recognition on Patients With Frozen Shoulder
A study testing Dynamic Scapular Recognition exercise in people with Frozen Shoulder, run by Beni-Suef University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Dynamic Scapular Recognition exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2018to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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]
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Frozen Shoulder
- Being tested
- Dynamic Scapular Recognition exercise
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic Scapular Recognition exerciseOther
Also called Rigid Taping
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The dynamic scapular recognition exercise + rigid taping with 50%-75% tension. Receives: Other: Dynamic Scapular Recognition exercise |
| Control | Placebo comparator | The dynamic scapular recognition exercise + placebo taping Receives: Other: Dynamic Scapular Recognition exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 2 Months
Secondary outcomes (1)
Shoulder ROMs
The assessment of shoulder ROMs was performed by the similar digital inclinometer utilized for assessing scapular upward rotation. Digital inclinometers are reliable tools for assessing shoulder ROMs. For more precise assessment, the inclinometer was re-calibrated to zero degrees in advance of each measurement
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2020
- Study start15 Nov 2018
- Primary completion2 Jun 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded Randomized Controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Mohamed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04369144
- Sponsor's protocol ID
- Scapula recognition and taping
- Status last verified
- May 2020
- First submitted
- 21 Apr 2020
- Last updated
- 7 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04369144
- Acronym / sponsor ID
- Scapula recognition and taping
- Conditions
- Frozen Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 2 Jun 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 30 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blinded Randomized Controlled study
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Dynamic Scapular Recognition exerciseThe dynamic scapular recognition exercise + rigid taping with 50%-75% tension. |
| Control | Placebo comparator | Other: Dynamic Scapular Recognition exerciseThe dynamic scapular recognition exercise + placebo taping |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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]
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dynamic Scapular Recognition exerciseAlso: Rigid TapingThe 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 | Other | Control, Intervention group |
Primary outcome
Scapular dyskinesis
Time frame: 2 months
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.
Scapular Upward rotation
Time frame: 2 months
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.
Shoulder Pain and disability index (SPADI)
Time frame: 2 Months
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.
1 secondary outcome
Shoulder ROMs
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic Scapular Recognition exercise in people with Frozen Shoulder, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scapular dyskinesis (time frame: 2 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.