Effects Of Lymphatic Drainage on Axillary Web Syndrome

NCT ID: NCT05463185

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-15

Study Completion Date

2023-01-05

Brief Summary

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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.

Detailed Description

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Conditions

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Axillary Web Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stretching exercises

Stretching exercise along with manual lymph drainage

Group Type EXPERIMENTAL

Stretching exercises

Intervention Type OTHER

Stretching exercises along with manual lymphatic drainage

soft tissue mobilization

soft tissue mobilization along with manual lymph drainage

Group Type EXPERIMENTAL

Soft tissue mobilization

Intervention Type OTHER

Soft tissue mobilization along with manual lymphatic drainage

Interventions

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Stretching exercises

Stretching exercises along with manual lymphatic drainage

Intervention Type OTHER

Soft tissue mobilization

Soft tissue mobilization along with manual lymphatic drainage

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Riphah International University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Rabiya Noor, Phd

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

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Allied Hosptal

Faisalābad, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Dr. Rabiya Noor, PhD

Role: CONTACT

00923344355660

Facility Contacts

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tehniat aamir, MS

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30588087 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20218085 (View on PubMed)

Meer TA, Noor R, Bashir MS, Ikram M. Comparative effects of lymphatic drainage and soft tissue mobilization on pain threshold, shoulder mobility and quality of life in patients with axillary web syndrome after mastectomy. BMC Womens Health. 2023 Nov 10;23(1):588. doi: 10.1186/s12905-023-02762-w.

Reference Type DERIVED
PMID: 37950230 (View on PubMed)

Other Identifiers

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REC/RCR&AHS/22/0511

Identifier Type: -

Identifier Source: org_study_id

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