Women Following Unilateral MastectomyNCT07478718
Shoulder Exercise Training on Pain, Range of Motion, and Functional Limitations in Women Following Unilateral Mastectomy
A study testing Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • Conducted in people with Women Following Unilateral Mastectomy, run by South Valley University at 1 site in Jordan.
Trial summary
Shoulder pain, reduced mobility, and functional limitations are common complications following unilateral mastectomy, often leading to long-term disability and an increased risk of secondary shoulder-hand syndrome Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women Following Unilateral Mastectomy
- What is being tested?
- Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • Conducted
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteJordan
- Study dates
- 1 Apr 2026to 1 Aug 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 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Female adults between 30 and 65 years old.
- History of unilateral breast cancer managed with either:
- Modified radical mastectomy, or
- Breast-conserving surgery with axillary clearance.
- Postoperative interval between 4 and 12 weeks before enrollment.
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- Objective evidence of impaired shoulder mobility or function including:
- Reduction of ROM ≥ 15% compared to the contralateral side,
- VAS pain ≥ 3/10 during shoulder movement, or
- DASH functional score > 25.
- Ability to ambulate independently and follow therapist instructions.
- Willingness to commit to the full rehabilitation protocol for 8 weeks.
Who cannot join
- Participants will be excluded if they have:
- Previously diagnosed shoulder disorders (adhesive capsulitis, rotator cuff tear, fracture/dislocation).
- Active or untreated lymphedema Grade II-III.
- Ongoing chemotherapy-induced neuropathy causing shoulder dysfunction.
- History of neurological or rheumatological disorders affecting the upper limb.
- Metastatic disease or local recurrence.
Show all 9Show fewer
- Recent infection, seroma, or unhealed surgical wounds.
- Participation in another physical therapy or exercise program in the past 4 weeks.
- Cognitive impairment or psychiatric conditions interfering with adherence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site
Hany elgohary
Jerash, 22B
Hany Elgohary, Associate professor, +962797756592, hmielgohary@gmail.com
About this study
Official title: Effect of Targeted Scapular and Shoulder Exercise Training on Pain, Range of Motion, and Functional Limitations in Women Following Unilateral Mastectomy "Randomized Controlled Trial"
Shoulder pain, reduced mobility, and functional limitations are common complications following unilateral mastectomy, often leading to long-term disability and an increased risk of secondary shoulder-hand syndrome
Read the detailed description
Shoulder pain, reduced mobility, and functional limitations are common complications following unilateral mastectomy, often leading to long-term disability and an increased risk of secondary shoulder-hand syndrome. Conventional physiotherapy provides general postoperative rehabilitation but may not adequately address altered scapulothoracic mechanics or psychological factors that contribute to persistent dysfunction. Targeted scapular and shoulder exercises may enhance clinical recovery; however, high-quality evidence supporting their effectiveness remains limited
- Conditions
- Women Following Unilateral Mastectomy
- Being tested
- Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • Conducted
- Keywords
- Breast cancer, Shoulder rehabilitation, Scapular exercises, Women Following Unilateral Mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • ConductedProcedure or surgery
Interventions
- Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration
- 3 sessions/week
- 45-60 minutes per session
- Total duration: 8 weeks (24 sessions)
- Conducted by physiotherapists with ≥5 years of musculoskeletal oncology rehabilitation experience (10).
Exercise Components
The program consists of five progressive phases:
Phase 1: Mobility and Motor Control (Week 1-2)
- Pendulum exercises
- Active-assisted ROM using pulleys or wand
- Scapular clocks and gentle setting exercises
- Pectoralis minor and posterior capsule stretching
- Deep breathing and thoracic mobilization exercises Phase 2: Early Scapular Activation (Week 2-3)
- Scapular retraction with tactile cueing
- Serratus anterior low-load activation (wall slides, punches without resistance)
- Lower trapezius recruitment in prone position
- Active ROM to 120° flexion/abduction Phase 3: Functional Strengthening (Week 3-5)
- Resistance-band exercises (yellow to red):
- External rotation
- Flex
| Study group | Role | What they receive |
|---|---|---|
| Scapular-Shoulder Exercise Group | Experimental | Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration
* 3 sessions/week
* 45-60 minutes per session
* Total duration: 8 weeks (24 sessions)
* Conducted by physiotherapists with ≥5 years of musculoskeletal oncology rehabilitation experience
All participants will receive the standard physiotherapy protocol implemented at the center, including:
* Posture correction education
* Diaphragmatic breathing
* Scar mobilization
* Gentle ROM exercises
* Pain education
* Relaxation and edema-prevention strategies The control group will not receive scapular-specific strengthening or progression beyond basic mobility exercises. Receives: Procedure: Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • Conducted |
| Control Group | Active comparator | All participants will receive the standard physiotherapy protocol implemented at the center, including:
* Posture correction education
* Diaphragmatic breathing
* Scar mobilization
* Gentle ROM exercises
* Pain education
* Relaxation and edema-prevention strategies The control group will not receive scapular-specific strengthening or progression beyond basic mobility exercises. Receives: Procedure: Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • Conducted |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Function
Shoulder Function
- DASH (Disabilities of the Arm, Shoulder and Hand)
- Reliable in post-mastectomy populations.
- Range: 0 (best) to 100 (worst).
- Shoulder Range of Motion (ROM)
- Measured using a calibrated universal goniometer
- Movements: flexion, abduction, external and internal rotation
- Three trials averaged for analysis
Measured: 8 weeks
Secondary outcomes (1)
Secondary out come
Pain Intensity
- Visual Analog Scale (VAS, 0-10) at rest and during movement 2. Incidence of Secondary Shoulder-Hand Syndrome (SHS)
Diagnosis based on recognized clinical criteria:
- Continuous upper limb pain
- Diffuse edema of hand/fingers
- Stiffness of wrist/hand joints
- Trophic skin changes (temperature, sweating, glossy skin)
- Reduced grip strength
- Symptoms persisting > 2 weeks Diagnosis will be made by an oncologic rehabilitation specialist. 3. Muscle Strength
- Shoulder flexors, abductors, and external rotators
- Measured using portable hand-held dynamometry (HHD)
- Three trials with 1-minute rest 4. Quality of Life
- EORTC QLQ-BR23 (breast cancer-specific module) 5. Shoulder Mobility Patterns
- Observed scapulohumeral rhythm
- Documented using a standardized clinical checklist
Measured: 16weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Women Following Unilateral MastectomyStudies 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
- A randomized clinical trial was conducted involving 66 women who underwent unilateral mastectomy. Participants were randomly assigned to either a Scapular-Shoulder Exercise Group (SSEG; n = 33) or a Control Group receiving conventional physiotherapy (CG; n = 33). The intervention lasted 8 weeks and consisted of scapular stabilization, mobility, neuromuscular control, and shoulder strengthening exercises. Outcomes were measured at baseline, post-treatment, and 8 week follow-up, including pain intensity (VAS), upper-limb function (DASH), shoulder range of motion, kinesiophobia (TSK-11), self-efficacy, psychological well-being, and incidence of secondary shoulder-hand syndrome. Data were analyzed using mixed-model ANOVA with Bonferroni post-hoc tests, chi-square analysis, and partial eta squared (ηp²) for effect sizes.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Abuzaid, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478718
- Sponsor's protocol ID
- Badr University in Cairo
- Status last verified
- Mar 2026
- First submitted
- 7 Mar 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aboelnour NH, Kamel FH, Basha MA, Azab AR, Hewidy IM, Ezzat M, Kamel NM. Combined effect of graded Thera-Band and scapular stabilization exercises on shoulder adhesive capsulitis post-mastectomy. Support Care Cancer. 2023 Mar 16;31(4):215. doi: 10.1007/s00520-023-07641-6.
PubMed 36922413Pirincci CS, Dalyan M, Delialioglu SU, Celenay ST. Effects of scapulothoracic stabilization exercises on scapular function, posture, and balance in lymphedema after mastectomy: a randomized controlled trial. Women Health. 2023 Apr;63(4):251-265. doi: 10.1080/03630242.2023.2178836. Epub 2023 Feb 22.
PubMed 36814100
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Targeted Scapular and Shoulder Exercise Training on Pain, Range of Motion, and Functional Limitations in Women Following Unilateral Mastectomy "Randomized Controlled Trial"
- ClinicalTrials.gov ID
- NCT07478718
- Acronym / sponsor ID
- Badr University in Cairo
- Conditions
- Women Following Unilateral Mastectomy
- Keywords
- Breast cancer, Shoulder rehabilitation, Scapular exercises, Women Following Unilateral Mastectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 17 Mar 2026 (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.
Shoulder pain, reduced mobility, and functional limitations are common complications following unilateral mastectomy, often leading to long-term disability and an increased risk of secondary shoulder-hand syndrome
Detailed description
Shoulder pain, reduced mobility, and functional limitations are common complications following unilateral mastectomy, often leading to long-term disability and an increased risk of secondary shoulder-hand syndrome. Conventional physiotherapy provides general postoperative rehabilitation but may not adequately address altered scapulothoracic mechanics or psychological factors that contribute to persistent dysfunction. Targeted scapular and shoulder exercises may enhance clinical recovery; however, high-quality evidence supporting their effectiveness remains limited
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized clinical trial was conducted involving 66 women who underwent unilateral mastectomy. Participants were randomly assigned to either a Scapular-Shoulder Exercise Group (SSEG; n = 33) or a Control Group receiving conventional physiotherapy (CG; n = 33). The intervention lasted 8 weeks and consisted of scapular stabilization, mobility, neuromuscular control, and shoulder strengthening exercises. Outcomes were measured at baseline, post-treatment, and 8 week follow-up, including pain intensity (VAS), upper-limb function (DASH), shoulder range of motion, kinesiophobia (TSK-11), self-efficacy, psychological well-being, and incidence of secondary shoulder-hand syndrome. Data were analyzed using mixed-model ANOVA with Bonferroni post-hoc tests, chi-square analysis, and partial eta squared (ηp²) for effect sizes.
| Arm | Type | Receives |
|---|---|---|
| Scapular-Shoulder Exercise Group | Experimental | Procedure: Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • ConductedScapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration * 3 sessions/week * 45-60 minutes per session * Total duration: 8 weeks (24 sessions) * Conducted by physiotherapists with ≥5 years of musculoskeletal oncology rehabilitation experience All participants will receive the standard physiotherapy protocol implemented at the center, including: * Posture correction education * Diaphragmatic breathing * Scar mobilization * Gentle ROM exercises * Pain education * Relaxation and edema-prevention strategies The control group will not receive scapular-specific strengthening or progression beyond basic mobility exercises. |
| Control Group | Active comparator | Procedure: Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • ConductedAll participants will receive the standard physiotherapy protocol implemented at the center, including: * Posture correction education * Diaphragmatic breathing * Scar mobilization * Gentle ROM exercises * Pain education * Relaxation and edema-prevention strategies The control group will not receive scapular-specific strengthening or progression beyond basic mobility exercises. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants must meet all of the following criteria:
Key exclusion criteria (9 listed)
- Participants will be excluded if they have:
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 |
|---|---|---|
| Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • ConductedInterventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration * 3 sessions/week * 45-60 minutes per session * Total duration: 8 weeks (24 sessions) * Conducted by physiotherapists with ≥5 years of musculoskeletal oncology rehabilitation experience (10). Exercise Components The program consists of five progressive phases: Phase 1: Mobility and Motor Control (Week 1-2) * Pendulum exercises * Active-assisted ROM using pulleys or wand * Scapular clocks and gentle setting exercises * Pectoralis minor and posterior capsule stretching * Deep breathing and thoracic mobilization exercises Phase 2: Early Scapular Activation (Week 2-3) * Scapular retraction with tactile cueing * Serratus anterior low-load activation (wall slides, punches without resistance) * Lower trapezius recruitment in prone position * Active ROM to 120° flexion/abduction Phase 3: Functional Strengthening (Week 3-5) * Resistance-band exercises (yellow to red): * External rotation * Flex | Procedure or surgery | Control Group, Scapular-Shoulder Exercise Group |
Primary outcome
Shoulder Function
Time frame: 8 weeks
Shoulder Function 1. DASH (Disabilities of the Arm, Shoulder and Hand) * Reliable in post-mastectomy populations. * Range: 0 (best) to 100 (worst). 2. Shoulder Range of Motion (ROM) * Measured using a calibrated universal goniometer * Movements: flexion, abduction, external and internal rotation * Three trials averaged for analysis
1 secondary outcome
Secondary out come
Time frame: 16weeks
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 20 Mar 2026.
- Results publication: PubMed 36922413Aboelnour NH, Kamel FH, Basha MA, Azab AR, Hewidy IM, Ezzat M, Kamel NM. Combined effect of graded Thera-Band and scapular stabilization exercises on shoulder adhesive capsulitis post-mastectomy. Support Care Cancer. 2023 Mar 16;31(4):215. doi: 10.1007/s00520-023-07641-6.
- Results publication: PubMed 36814100Pirincci CS, Dalyan M, Delialioglu SU, Celenay ST. Effects of scapulothoracic stabilization exercises on scapular function, posture, and balance in lymphedema after mastectomy: a randomized controlled trial. Women Health. 2023 Apr;63(4):251-265. doi: 10.1080/03630242.2023.2178836. Epub 2023 Feb 22.
- Related InfoLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions 1. Scapular and Shoulder Exercise Program (Intervention Group) Supervision and Duration • 3 sessions/week • 45-60 minutes per session • Total duration: 8 weeks (24 sessions) • Conducted in people with Women Following Unilateral Mastectomy, run by South Valley University at 1 site in Jordan.
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 12 inclusion and 9 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: opening soon, as of the sponsor's last update on 20 Mar 2026. 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 Jordan. 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?
Contact ibrahim ismail Abuzaid, Assistant professor (797756592, ibrahim_ismail_2011@svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Function (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07478718, which also lists 2 linked publications.
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 20 Mar 2026.