NCT07181980

Brief Summary

the study is to evaluate the therapeutic efficacy of intercostal mulligan Mobilization in decreasing pain and improve ROM for shoulder dysfunction Patients post mastectomy.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Sep 2025Sep 2026

First Submitted

Initial submission to the registry

August 26, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

September 16, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2026

Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

August 26, 2025

Last Update Submit

September 16, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • range of motion of shoulder abducation Universal goniometer.

    Universal goniometer: maximum pain free shoulder abduction was investigated in an upright position .Normal range of active movement of the shoulder 180 degree Were recorded at baseline and at the end of 8 weeks of treatment.

Secondary Outcomes (1)

  • 1.4.a. Measuring shoulder function The Arabic version of DASH questionnaire

    The DASH was adapted into Arabic . contains 30 items , each item has five response choices that range from 1, ''without any difficulty or no symptoms exist'' to 5, ''.Were recorded at baseline and at the end of 8 weeks of treatment

Study Arms (2)

intercostal mulligan moblization

ACTIVE COMPARATOR
Other: Intercostal mulligan mobilization with shoulder abductionOther: Exercise

control group

ACTIVE COMPARATOR
Other: Exercise

Interventions

Intercostal mulligan mobilization with shoulder abduction: is mulligain technique where the patient was Side lying with affected side up and the therapist Therapist placed ulnar side of his hand along the intercostal space of affected rib in oblique direction on the patient's wall of chest. Therapist's other hand hold the patient's elevated arm close to his abdomen 3sets 10 reptations * Assistive range of motion exercises (AAROME): Two sets of 15 repetitions of each exercise were performed for AAROME . * Active stretching: Two sets of 10 repetitions with 15- sec hold and relax times were performed for active stretching. * Strengthening exercises for the shoulder joint: Two sets of 15 repetitions of each exercise . * Postural correction exercises: 3 sets of postural correction were performed with 3-5 repetitions per set. * Scapular strengthening exercises : two sets of ten repetitions * The Intervention protocol: 45 to 50 minutes sessions 3 days per week for 8 week

intercostal mulligan moblization

1.3.b. Therapeutic Exercise: * Therapeutic exercise included: (prior to 3 month post mastectomy). * Assistive range of motion exercises (AAROME): Two sets of 15 repetitions of each exercise were performed for AAROME . * Active stretching: Two sets of 10 repetitions with 15- sec hold and relax times were performed for active stretching. . * Strengthening exercises for the shoulder joint: Two sets of 15 repetitions of each exercise . * Postural correction exercises: 3 sets of postural correction were performed with 3-5 repetitions per set. . * Scapular strengthening exercises : Strengthening exercises performed using weights were initiated with two sets of ten repetitions, beginning with a weight of 0.5kg and progressed to 0.75 and then 1 kg. * The Intervention protocol: 45 to 50 minutes sessions 3 days per week for 8 week

control groupintercostal mulligan moblization

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients post modified radical mastectomy at least 3 months prior and had a limited ROM in abduction.
  • Patients post mastectomy with lateral chest wall pain.
  • Age ranges between 40-60 years.
  • All patients had informed written consent

You may not qualify if:

  • Receiving any previous rehabilitation programs for the upper extremities
  • The presence of any type of metastases
  • The presence of lymphedema
  • Bilateral breast cancer surgery
  • Locoregional recurrence
  • Withdrawal of the consent at any time during the study for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cario U

Cairo, Egypt

Location

Related Publications (2)

  • Salati SA, Alsulaim L, Alharbi MH, Alharbi NH, Alsenaid TM, Alaodah SA, Alsuhaibani AS, Albaqami KA. Postmastectomy Pain Syndrome: A Narrative Review. Cureus. 2023 Oct 20;15(10):e47384. doi: 10.7759/cureus.47384. eCollection 2023 Oct.

    PMID: 38021812BACKGROUND
  • Min J, Yeon S, Ryu J, Kim JY, Yang EJ, Il Kim S, Park S, Jeon JY. Shoulder function and health outcomes in newly diagnosed breast cancer patients receiving surgery: a prospective study. Clin Breast Cancer. 2023 Jun;23(4):e247-e258. doi: 10.1016/j.clbc.2023.03.001. Epub 2023 Mar 6.

    PMID: 36990840BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aya M Submitted In Partial Fulfilment of The Requirements For Master, B.Sc. of physical therapy

    Cairo universty

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amany R lecturer of physical therapy Cairo university, PHD physical therapy

CONTACT

Wafaa H professor in physical therapy, PHD n physical therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Submitted In Partial Fulfilment of The Requirements For Master Degree In Department of Physical Therapy for surgery Cairo university

Study Record Dates

First Submitted

August 26, 2025

First Posted

September 19, 2025

Study Start

September 16, 2025

Primary Completion (Estimated)

September 16, 2026

Study Completion (Estimated)

September 16, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations