NCT06914258

Brief 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 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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

March 29, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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).

    12 Months

Study Arms (2)

Inhibition Compression

EXPERIMENTAL
Combination Product: Inhibition Compression

Scapular Mobilization Technique

EXPERIMENTAL
Combination Product: Scapular Mobilization Technique

Interventions

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.

Inhibition Compression

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.

Scapular Mobilization Technique

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with recurrent breast cancer (42)
  • History of ischemic heart disease
  • History of high blood pressure
  • History of other surgery
  • Any neurological issue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gujranwala institute of nuclear medicine

Gujranwala, Pakistan

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 20, 2026

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations