Oncologic ComplicationsNCT05529680
Impact of Scapular Mobilization And Strengthening Exercises on Shoulder Function Post Mastectomy
A study testing Scapular mobilization and Scapular strengthening exercises and Conventional physical therapy program in people with Oncologic Complications and Exercise Therapy, run by Cairo University at 1 site in Egypt.
Trial summary
The most common complications following mastectomy are pain, lymphedema of the upper limb ipsilateral to surgery, decreased range of motion (ROM), limited to 90° of flexion, abduction, and external rotation to 40° of the shoulder, and postural changes. Read more about this study
- Who is it for?
- Ages 40 to 55 years, women only
- Conditions the study is for
- Oncologic Complications, Exercise Therapy, Shoulder Pain
- What is being tested?
- Scapular mobilization and Scapular strengthening exercises and Conventional physical therapy program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 20 Jul 2022
- 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 40 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients with ages ranging from 40-55 years.
- All patients had shoulder dysfunction post-mastectomy (20° ≥ ROM limitation compared to the sound shoulder).
- Patients were 3 months to 6 months post-mastectomy.
- All enrolled patients signed the informed consent.
Who cannot join
- Disease such as rheumatoid arthritis.
- History of trauma or accidental injuries.
- Neurological involvement (stroke, Parkinsonism).
- History of surgery on the involved shoulder.
- Diabetic patient.
Trial locations and contacts
1 site in 1 country.
About this study
The most common complications following mastectomy are pain, lymphedema of the upper limb ipsilateral to surgery, decreased range of motion (ROM), limited to 90° of flexion, abduction, and external rotation to 40° of the shoulder, and postural changes. It was reported that 60% of breast cancer patients show a reduction in shoulder flexion and abduction at 1-month post-surgery and 10% of survivors show a persistent ROM reduction at 12 months. So, The purpose of the study was to evaluate the therapeutic impact of scapular mobilization and strengthening exercises on shoulder function post-mastectomy.
Read the detailed description
In this randomized controlled trial study (RCT), forty female patients "The patient's ages ranged from 40 to 55 years" suffering from post-mastectomy shoulder dysfunction ((20° ≥ ROM limitation compared to the sound shoulder \& 3 months to 6 months post mastectomy) were randomly assigned into two equal groups, each one had 20 patients.
Group A (study group): This group included 20 patients with shoulder dysfunction post-mastectomy who received scapular mobilization and strengthening exercise in addition to their conventional physical therapy program for four weeks, three sessions/week.
Group B (control group): This group included 20 patients with shoulder dysfunction who received conventional physical therapy programs in form of joint mobilization, posterior capsule stretching, and range of motion exercise (ROM) for four weeks, 3 sessions/week.
Equipment and tools:
- Measurement tools were (The shoulder Pain and Disability Index (SPADI): for measurement of shoulder disability and inclinometer: for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation), the measurements were recorded before and after the study.
- Therapeutic equipment and tools were (Thera Bands of different colors and resistance and dumbbells of different weights).
The potential participants were excluded if they met any of the following criteria: Diseases such as rheumatoid arthritis, history of trauma or accidental injuries, neurological involvement (stroke, Parkinsonism), history of surgery on the involved shoulder, and diabetic patient.
- Being tested
- Scapular mobilization and Scapular strengthening exercises, Conventional physical therapy program
- Keywords
- Scapular mobilization, Scapular strengthening exercises, Mastectomy, Shoulder function
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scapular mobilization and Scapular strengthening exercisesOther
The intervention was applied for four weeks, 3 sessions/week. and the Shoulder Pain and Disability Index (SPADI): for measurement of shoulder disability and the Inclinometer: for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation were used for shoulder assessment before and after the intervention for both groups.
Conventional physical therapy programOther
The intervention was applied for four weeks, 3 sessions/week. and the Shoulder Pain and Disability Index (SPADI): for measurement of shoulder disability and the Inclinometer: for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation were used for shoulder assessment before and after the intervention for both groups.
| Study group | Role | What they receive |
|---|---|---|
| Scapular mobilization and strengthening exercise | Experimental | Group A (study group):
This group included 20 patients with shoulder dysfunction post-mastectomy who received scapular mobilization and strengthening exercise in addition to their conventional physical therapy program in form of joint mobilization, posterior capsule stretching and range of motion exercise (ROM). Receives: Other: Scapular mobilization and Scapular strengthening exercises; Other: Conventional physical therapy program |
| Conventional physical therapy program | Active comparator | This group included 20 patients with shoulder dysfunction who received conventional physical therapy programs in form of joint mobilization, posterior capsule stretching, and range of motion exercise (ROM). Receives: Other: Conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Inclinometer reading before and after the treatment.
for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation
Measured: Baseline and four weeks after the intervention
Changes in Shoulder Pain and Disability Index (SPADI) before and after the treatment.
for measurement of shoulder disability
Measured: Baseline and four weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Jan 2022
- Primary completion28 Jun 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic ComplicationsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- Forty patients suffering from post-mastectomy shoulder dysfunction were randomly assigned into two equal groups each one has 20 patients. Group A (study group): Who received scapular mobilization and strengthening exercises in addition to their conventional physical therapy program. Group B (control group): Who received a conventional physical therapy program in form of joint mobilization, posterior capsule stretching, and range of motion exercise.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohamed Ahmed Elsayeh, Cairo University
- Investigators
- Shaimaa Elsayeh, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05529680
- Sponsor's protocol ID
- P.T.REC/012/003464
- Status last verified
- Sep 2022
- First submitted
- 2 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Scapular Mobilization And Strengthening Exercises on Shoulder Function Post Mastectomy
- ClinicalTrials.gov ID
- NCT05529680
- Acronym / sponsor ID
- P.T.REC/012/003464
- Keywords
- Scapular mobilization, Scapular strengthening exercises, Mastectomy, Shoulder function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 7 Sep 2022 (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.
The most common complications following mastectomy are pain, lymphedema of the upper limb ipsilateral to surgery, decreased range of motion (ROM), limited to 90° of flexion, abduction, and external rotation to 40° of the shoulder, and postural changes. It was reported that 60% of breast cancer patients show a reduction in shoulder flexion and abduction at 1-month post-surgery and 10% of survivors show a persistent ROM reduction at 12 months. So, The purpose of the study was to evaluate the therapeutic impact of scapular mobilization and strengthening exercises on shoulder function post-mastectomy.
Detailed description
In this randomized controlled trial study (RCT), forty female patients "The patient's ages ranged from 40 to 55 years" suffering from post-mastectomy shoulder dysfunction ((20° ≥ ROM limitation compared to the sound shoulder \& 3 months to 6 months post mastectomy) were randomly assigned into two equal groups, each one had 20 patients.
Group A (study group): This group included 20 patients with shoulder dysfunction post-mastectomy who received scapular mobilization and strengthening exercise in addition to their conventional physical therapy program for four weeks, three sessions/week.
Group B (control group): This group included 20 patients with shoulder dysfunction who received conventional physical therapy programs in form of joint mobilization, posterior capsule stretching, and range of motion exercise (ROM) for four weeks, 3 sessions/week.
Equipment and tools:
- Measurement tools were (The shoulder Pain and Disability Index (SPADI): for measurement of shoulder disability and inclinometer: for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation), the measurements were recorded before and after the study.
- Therapeutic equipment and tools were (Thera Bands of different colors and resistance and dumbbells of different weights).
The potential participants were excluded if they met any of the following criteria: Diseases such as rheumatoid arthritis, history of trauma or accidental injuries, neurological involvement (stroke, Parkinsonism), history of surgery on the involved shoulder, and diabetic patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Forty patients suffering from post-mastectomy shoulder dysfunction were randomly assigned into two equal groups each one has 20 patients. Group A (study group): Who received scapular mobilization and strengthening exercises in addition to their conventional physical therapy program. Group B (control group): Who received a conventional physical therapy program in form of joint mobilization, posterior capsule stretching, and range of motion exercise.
| Arm | Type | Receives |
|---|---|---|
| Scapular mobilization and strengthening exercise | Experimental | Other: Scapular mobilization and Scapular strengthening exercises, Other: Conventional physical therapy programGroup A (study group): This group included 20 patients with shoulder dysfunction post-mastectomy who received scapular mobilization and strengthening exercise in addition to their conventional physical therapy program in form of joint mobilization, posterior capsule stretching and range of motion exercise (ROM). |
| Conventional physical therapy program | Active comparator | Other: Conventional physical therapy programThis group included 20 patients with shoulder dysfunction who received conventional physical therapy programs in form of joint mobilization, posterior capsule stretching, and range of motion exercise (ROM). |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients with ages ranging from 40-55 years.
- All patients had shoulder dysfunction post-mastectomy (20° ≥ ROM limitation compared to the sound shoulder).
- Patients were 3 months to 6 months post-mastectomy.
- All enrolled patients signed the informed consent.
Key exclusion criteria (5 listed)
- Disease such as rheumatoid arthritis.
- History of trauma or accidental injuries.
- Neurological involvement (stroke, Parkinsonism).
- History of surgery on the involved shoulder.
- Diabetic patient.
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 and Scapular strengthening exercisesThe intervention was applied for four weeks, 3 sessions/week. and the Shoulder Pain and Disability Index (SPADI): for measurement of shoulder disability and the Inclinometer: for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation were used for shoulder assessment before and after the intervention for both groups. | Other | Scapular mobilization and strengthening exercise |
| Conventional physical therapy programThe intervention was applied for four weeks, 3 sessions/week. and the Shoulder Pain and Disability Index (SPADI): for measurement of shoulder disability and the Inclinometer: for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation were used for shoulder assessment before and after the intervention for both groups. | Other | Conventional physical therapy program, Scapular mobilization and strengthening exercise |
Primary outcome
Changes in Inclinometer reading before and after the treatment.
Time frame: Baseline and four weeks after the intervention
for measurement of shoulder flexion, abduction, external rotation, and scapular upward rotation
Changes in Shoulder Pain and Disability Index (SPADI) before and after the treatment.
Time frame: Baseline and four weeks after the intervention
for measurement of shoulder disability
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 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Shaimaa Elsayeh, PhD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scapular mobilization and Scapular strengthening exercises and Conventional physical therapy program in people with Oncologic Complications and Exercise Therapy, run by Cairo 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 4 inclusion and 5 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 Sep 2022. 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. 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?
Changes in Inclinometer reading before and after the treatment. (time frame: Baseline and four weeks after the intervention). The study lists 2 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 Sep 2022.