Shoulder Adhesive CapsulitisNCT06618443
Scapular Mobilization With Arm Movement in Patients With Adhesive Capsulitis.
A study testing Scapular mobilization with movement in people with Shoulder Adhesive Capsulitis, run by Beni-Suef University.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Shoulder Adhesive Capsulitis
- What is being tested?
- Scapular mobilization with movement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 15 Feb 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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 near the shoulder region.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Scapular Mobilization With Arm Movement on Shoulder Pain and Range of Motion and Disability in Older Adults With Adhesive Capsulitis.
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).
- Conditions
- Shoulder Adhesive Capsulitis
- Being tested
- Scapular mobilization with movement
- Keywords
- scapular mobilization; arm movement; pain; range of motion; disability; older adults; adhesive capsulitis
- Medical subject headings
- Bursitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular mobilization with movementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Scapular mobilization with movement |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 3 months
Electromyography
Electromyographical analysis of Upper and Lower trapezius and Serratus anterior
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion15 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
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
- NCT06618443
- Sponsor's protocol ID
- BNS
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Scapular Mobilization With Arm Movement on Shoulder Pain and Range of Motion and Disability in Older Adults With Adhesive Capsulitis.
- ClinicalTrials.gov ID
- NCT06618443
- Acronym / sponsor ID
- BNS
- Conditions
- Shoulder Adhesive Capsulitis
- Keywords
- scapular mobilization; arm movement; pain; range of motion; disability; older adults; adhesive capsulitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 15 Feb 2025 (estimated)
- First posted
- 1 Oct 2024 (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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Scapular mobilization with movement | Experimental | Other: Scapular mobilization with movementThe 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. |
| Control | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
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 near the shoulder region.
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 |
|---|---|---|
| Scapular mobilization with movementThe 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 |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: 3 months
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.
Shoulder range of motion of flexion, abduction, and external rotation
Time frame: 3 months
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.
Scapular dyskinesis
Time frame: 3 months
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
Electromyography
Time frame: 3 months
Electromyographical analysis of Upper and Lower trapezius and Serratus anterior
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Scapular mobilization with movement in people with Shoulder Adhesive Capsulitis, run by Beni-Suef University.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayman AM Mohamed, PhD, MPT, DPT (+201141776364, dr_ayman_pt@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Disability Index (SPADI) (time frame: 3 months). The study lists 4 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 1 Oct 2024.