Mastectomy; LymphedemaNCT06914258
Effects of Inhibition Compression Versus Scapular Mobilization Technique on Shoulder in Patients With Mastectomy
A study testing Inhibition Compression and Scapular Mobilization Technique in people with Mastectomy; Lymphedema, run by Superior University at 1 site in Pakistan.
Trial summary
A mastectomy is a medical surgery in which the breast is removed whole or in part. Breast cancer is the second most prevalent cancer diagnosed in women. Rotator cuff dysfunction-related shoulder pain is a common symptom associated with mastectomy, reconstruction, and therapy for breast cancer.) Patients who get… Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Mastectomy; Lymphedema
- What is being tested?
- Inhibition Compression and Scapular Mobilization Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 75 years (42)
- unilateral breast cancer followed by chemotherapy or radiations. (27)
- modified radical mastectomy surgery (27)
- limited ROM of shoulder
- Female
Who cannot join
- Patients with recurrent breast cancer (42)
- History of ischemic heart disease
- History of high blood pressure
- History of other surgery
- Any neurological issue
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Gujranwala institute of nuclear medicine
Chak One Hundred Seventy-five Nine Left
About this study
A mastectomy is a medical surgery in which the breast is removed whole or in part. Breast cancer is the second most prevalent cancer diagnosed in women. Rotator cuff dysfunction-related shoulder pain is a common symptom associated with mastectomy, reconstruction, and therapy for breast cancer.) Patients who get treatment for breast cancer report reduced strength (prevalence 17-33%), loss of upper limb range of motion (prevalence 2-51%), and reduced ability to carry out daily life tasks.
Read the detailed description
The study aims to observe the effectiveness of inhibition compression therapy versus scapular mobilization on shoulder in patients with mastectomy. By investigating the effectiveness of inhibition compression therapy versus scapular mobilization, this study can contribute to improved pain management, enhanced quality of life, and reduced healthcare utilization for breast cancer survivors. It will be randomized control trial (RCT). The study will be conduct in Gujranwala institute of nuclear medicine. It will be non-probability convenience sampling technique. Duration of the study will be 6 months after the approval of synopsis
- Conditions
- Mastectomy; Lymphedema
- Being tested
- Inhibition Compression, Scapular Mobilization Technique
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhibition CompressionCombination product
Group A will receive conventional Physiotherapy treatment along with the scapular mobilization which will include;
- Electrotherapy (TENS and hot pack) for 10 min
- Active and passive ROMs for 5 min
- pectoral stretching for 5min
- shoulder joint mobilization. To mobilize the shoulder joint, distraction of the glenohumeral joint, posterior glide and caudal glide were performed to the patient in supine position at a frequency of two to three oscillations/second for one to two minutes. (10 min)
- Manual scapular mobilization will be done in sideline with their back towards the physiotherapist.
Scapular Mobilization TechniqueCombination product
Group B will receive the same baseline physiotherapy treatment as in group A along with the Inhibition compression therapy which is a (MET). MET was performed on shoulder. Patient position: supine lying position. Following are the steps involved in application of MET: (1) stretch the muscle to a felt 'barrier' or to their tolerance of stretching (2) create a voluntary contraction that is isometric of the muscle being stretched while being resisted with equal and regulated counterforce by the physiotherapist for 7-10 seconds. (3) a stretch is held for a set amount of time after the muscle relaxes (4) the physiotherapist "takes up the slack" once the muscle relaxes Duration of treatment was approximately 15-20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Inhibition Compression | Experimental | Not described Receives: Combination Product: Inhibition Compression |
| Scapular Mobilization Technique | Experimental | Not described Receives: Combination Product: Scapular Mobilization Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index (SPADI)
Patients complete the 13-item Shoulder discomfort and Disability Index (SPADI) to gauge their level of discomfort and degree of difficulty doing activities of daily living (ADLs) that require the use of their upper extremities. There are five items on the pain subscale and eight items on the disability subscale. The following patient demographics can benefit from SPADI use: pain in the shoulders Rotator cuff injury, Osteoarthritis, rheumatoid arthritis, Shoulder Frozen and Shoulder replacement.
Using the affected shoulder, the patient is asked to select the number that most accurately represents their degree of pain and difficulty. The sum of the disability and pain scales is 80 and 50, respectively. The percentage represents the overall SPADI score.
A score of 100 denotes the worst, while 0 denotes the finest. A higher score indicates greater disability
Measured: 12 Months
Constant-Murley Shoulder Outcome Score
The Constant-Murley score (CMS) is a scale of 100 points made up of several distinct characteristics. These factors determine the patient's degree of pain and capacity to perform everyday tasks. To assess functionality following shoulder injury treatment, the Constant-Murley score was developed. The test is broken down into four subscales: range of motion (forward elevation, external rotation, abduction, and internal rotation of the shoulder) (40 points), activities of daily life (20 points), and discomfort (15 points).
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy; LymphedemaStudies of the same condition, open and under way.
- More trials run by Superior 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914258
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/818
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inhibition Compression Versus Scapular Mobilization Technique on Shoulder in Patients With Mastectomy
- ClinicalTrials.gov ID
- NCT06914258
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/818
- Conditions
- Mastectomy; Lymphedema
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 2025 (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.
A mastectomy is a medical surgery in which the breast is removed whole or in part. Breast cancer is the second most prevalent cancer diagnosed in women. Rotator cuff dysfunction-related shoulder pain is a common symptom associated with mastectomy, reconstruction, and therapy for breast cancer.) Patients who get treatment for breast cancer report reduced strength (prevalence 17-33%), loss of upper limb range of motion (prevalence 2-51%), and reduced ability to carry out daily life tasks.
Detailed description
The study aims to observe the effectiveness of inhibition compression therapy versus scapular mobilization on shoulder in patients with mastectomy. By investigating the effectiveness of inhibition compression therapy versus scapular mobilization, this study can contribute to improved pain management, enhanced quality of life, and reduced healthcare utilization for breast cancer survivors. It will be randomized control trial (RCT). The study will be conduct in Gujranwala institute of nuclear medicine. It will be non-probability convenience sampling technique. Duration of the study will be 6 months after the approval of synopsis
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhibition Compression | Experimental | Combination Product: Inhibition Compression |
| Scapular Mobilization Technique | Experimental | Combination Product: Scapular Mobilization Technique |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 40 to 75 years (42)
- unilateral breast cancer followed by chemotherapy or radiations. (27)
- modified radical mastectomy surgery (27)
- limited ROM of shoulder
- Female
Key exclusion criteria (5 listed)
- Patients with recurrent breast cancer (42)
- History of ischemic heart disease
- History of high blood pressure
- History of other surgery
- Any neurological issue
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 |
|---|---|---|
| Inhibition CompressionGroup A will receive conventional Physiotherapy treatment along with the scapular mobilization which will include; * Electrotherapy (TENS and hot pack) for 10 min * Active and passive ROMs for 5 min * pectoral stretching for 5min * shoulder joint mobilization. To mobilize the shoulder joint, distraction of the glenohumeral joint, posterior glide and caudal glide were performed to the patient in supine position at a frequency of two to three oscillations/second for one to two minutes. (10 min) * Manual scapular mobilization will be done in sideline with their back towards the physiotherapist. | Combination product | Inhibition Compression |
| Scapular Mobilization TechniqueGroup B will receive the same baseline physiotherapy treatment as in group A along with the Inhibition compression therapy which is a (MET). MET was performed on shoulder. Patient position: supine lying position. Following are the steps involved in application of MET: (1) stretch the muscle to a felt 'barrier' or to their tolerance of stretching (2) create a voluntary contraction that is isometric of the muscle being stretched while being resisted with equal and regulated counterforce by the physiotherapist for 7-10 seconds. (3) a stretch is held for a set amount of time after the muscle relaxes (4) the physiotherapist "takes up the slack" once the muscle relaxes Duration of treatment was approximately 15-20 minutes. | Combination product | Scapular Mobilization Technique |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: 12 Months
Patients complete the 13-item Shoulder discomfort and Disability Index (SPADI) to gauge their level of discomfort and degree of difficulty doing activities of daily living (ADLs) that require the use of their upper extremities. There are five items on the pain subscale and eight items on the disability subscale. The following patient demographics can benefit from SPADI use: pain in the shoulders Rotator cuff injury, Osteoarthritis, rheumatoid arthritis, Shoulder Frozen and Shoulder replacement. Using the affected shoulder, the patient is asked to select the number that most accurately represents their degree of pain and difficulty. The sum of the disability and pain scales is 80 and 50, respectively. The percentage represents the overall SPADI score. A score of 100 denotes the worst, while 0 denotes the finest. A higher score indicates greater disability
Constant-Murley Shoulder Outcome Score
Time frame: 12 Months
The Constant-Murley score (CMS) is a scale of 100 points made up of several distinct characteristics. These factors determine the patient's degree of pain and capacity to perform everyday tasks. To assess functionality following shoulder injury treatment, the Constant-Murley score was developed. The test is broken down into four subscales: range of motion (forward elevation, external rotation, abduction, and internal rotation of the shoulder) (40 points), activities of daily life (20 points), and discomfort (15 points).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- 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.
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 Inhibition Compression and Scapular Mobilization Technique in people with Mastectomy; Lymphedema, run by Superior University at 1 site in Pakistan.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Shoulder Pain and Disability Index (SPADI) (time frame: 12 Months). 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 6 Apr 2025.