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Effects Of Lymphatic Drainage on Axillary Web Syndrome

Primary Purpose

Axillary Web Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Stretching exercises
Soft tissue mobilization
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Axillary Web Syndrome focused on measuring Axillary web syndrome, Manual lymphatic drainage

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Breast cancer patients with pain over >3 points, 4 weeks after surgery using
  • Numeric Pain Rating scale on upper limb.
  • With visible and palpable cords in axilla, arm and breast after surgery.

Exclusion Criteria:

  • Acute Thrombosis, Musculoskeletal Disorders,Skin
  • Problems: Infections, Osteoarthritis, Rheumatoid Arthritis, Rotator Cuff Syndrome, Adhesive Capsulitis,
  • Any other Injury, Trauma and
  • Any other Surgery.

Sites / Locations

  • Allied HosptalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

stretching exercises

soft tissue mobilization

Arm Description

Stretching exercise along with manual lymph drainage

soft tissue mobilization along with manual lymph drainage

Outcomes

Primary Outcome Measures

DASH
The DASH (Disabilities of the Arm, Shoulder and Hand) Outcome Measure is a 30-item, self-report questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb.
Numeric Pain Rating Scale
What is the numerical rating scale for pain? The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Goniometer.
A goniometer is a device used in physical therapy to measure a joint's range of motion (ROM).
Breast cancer specific QOL
European Organization for Research and Treatment of Cancer QOL Breast Cancer Specific Version (EORTC QLQ-BR23) . It is a 23-item self-administered breast cancer specific questionnaire, usually administered with the EORTC QLQ-C30, designed to measure QOL in the breast cancer population at various stages and with patients with differing treatment modalities. The assessment is comprised of five domains (body image, sexuality, arm symptoms, breast symptoms, and systemic therapy side effects)
Patient Specific Functional Scale
The Patient Specific Functional Scale (PSFS) is a self-reported valid, reliable, and responsive outcome measure for patients with back, neck, knee and upper extremity problems. It has also been shown to have a high test-retest reliability in both generic lower back pain and knee dysfunction issues.
Dynamometer
dynamometer, or "dyno" for short, is a device for measuring force, moment of force (torque), or power.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2022
Last Updated
July 14, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05463185
Brief Title
Effects Of Lymphatic Drainage on Axillary Web Syndrome
Official Title
Effects Of Lymphatic Drainage With And Without Soft Tissue Mobilization On Pain Threshold, Shoulder Mobility And Quality Of Life In Patients With Axillary Web Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
December 15, 2022 (Anticipated)
Study Completion Date
January 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Axillary web syndrome (AWS) is a common condition related to cording in axilla as a result of axillary lymph nodes dissection surgery in breast cancer patients. This condition comprises of 86% population who underwent breast cancer surgery, but this condition is usually under diagnosed. Usually characterized by pain full cording of soft tissue and contractures at axillary region. This study aims to see the effects of manual lymphatic drainage with or without soft tissue mobilization on patients with axillary web syndrome. It will be a randomized control trial which will be conducted in cancer centers in government sector hospitals. 30 participants will be enrolled by non probability sampling technique through lottery method into two groups, 15 participants in each group. One group will receive manual lymphatic drainage, while other group will receive manual lymphatic drainage in addition to soft tissue mobilization (3-5 treatment sessions per week for 4 weeks). Base line treatment regimen include stretching, range of motion and strengthening exercises. For outcome measures treatment will be assessed on questionnaires including Disabilities of Arm Shoulder and Hand questionnaire (DASH), Numeric Pain Rating scale (NRS), Breast cancer specific QOL questionnaires (EORTC QLQ-C30, EORTC QLQ BR-23), Patient specific Functional Scale (PSFS), Goniometer and Dynamometer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Axillary Web Syndrome
Keywords
Axillary web syndrome, Manual lymphatic drainage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
stretching exercises
Arm Type
Experimental
Arm Description
Stretching exercise along with manual lymph drainage
Arm Title
soft tissue mobilization
Arm Type
Experimental
Arm Description
soft tissue mobilization along with manual lymph drainage
Intervention Type
Other
Intervention Name(s)
Stretching exercises
Intervention Description
Stretching exercises along with manual lymphatic drainage
Intervention Type
Other
Intervention Name(s)
Soft tissue mobilization
Intervention Description
Soft tissue mobilization along with manual lymphatic drainage
Primary Outcome Measure Information:
Title
DASH
Description
The DASH (Disabilities of the Arm, Shoulder and Hand) Outcome Measure is a 30-item, self-report questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb.
Time Frame
10 months
Title
Numeric Pain Rating Scale
Description
What is the numerical rating scale for pain? The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
Time Frame
10 months
Title
Goniometer.
Description
A goniometer is a device used in physical therapy to measure a joint's range of motion (ROM).
Time Frame
10 months
Title
Breast cancer specific QOL
Description
European Organization for Research and Treatment of Cancer QOL Breast Cancer Specific Version (EORTC QLQ-BR23) . It is a 23-item self-administered breast cancer specific questionnaire, usually administered with the EORTC QLQ-C30, designed to measure QOL in the breast cancer population at various stages and with patients with differing treatment modalities. The assessment is comprised of five domains (body image, sexuality, arm symptoms, breast symptoms, and systemic therapy side effects)
Time Frame
10 months
Title
Patient Specific Functional Scale
Description
The Patient Specific Functional Scale (PSFS) is a self-reported valid, reliable, and responsive outcome measure for patients with back, neck, knee and upper extremity problems. It has also been shown to have a high test-retest reliability in both generic lower back pain and knee dysfunction issues.
Time Frame
10 months
Title
Dynamometer
Description
dynamometer, or "dyno" for short, is a device for measuring force, moment of force (torque), or power.
Time Frame
10 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
females having axillary web syndrome
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Breast cancer patients with pain over >3 points, 4 weeks after surgery using Numeric Pain Rating scale on upper limb. With visible and palpable cords in axilla, arm and breast after surgery. Exclusion Criteria: Acute Thrombosis, Musculoskeletal Disorders,Skin Problems: Infections, Osteoarthritis, Rheumatoid Arthritis, Rotator Cuff Syndrome, Adhesive Capsulitis, Any other Injury, Trauma and Any other Surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Rabiya Noor, PhD
Phone
00923344355660
Email
rabiya.noor@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Rabiya Noor, Phd
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allied Hosptal
City
Faisalābad
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
tehniat aamir, MS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30588087
Citation
Koehler LA, Haddad TC, Hunter DW, Tuttle TM. Axillary web syndrome following breast cancer surgery: symptoms, complications, and management strategies. Breast Cancer (Dove Med Press). 2018 Dec 20;11:13-19. doi: 10.2147/BCTT.S146635. eCollection 2019.
Results Reference
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PubMed Identifier
20218085
Citation
Leduc O, Sichere M, Moreau A, Rigolet J, Tinlot A, Darc S, Wilputte F, Strapart J, Parijs T, Clement A, Snoeck T, Pastouret F, Leduc A. Axillary web syndrome: nature and localization. Lymphology. 2009 Dec;42(4):176-81.
Results Reference
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Effects Of Lymphatic Drainage on Axillary Web Syndrome

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