Effects Of Lymphatic Drainage on Axillary Web Syndrome

NCT05463185 | Unknown DMC

• 1 other identifier: REC/RCR&AHS/22/0511
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Axillary Web Syndrome

Keywords

Axillary web syndrome; Manual lymphatic drainage

Outcome Measures

Primary Outcomes (6)

• 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.

  10 months

• 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).

  10 months

• Goniometer.

  A goniometer is a device used in physical therapy to measure a joint's range of motion (ROM).

  10 months

• 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)

  10 months

• 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.

  10 months

• Dynamometer

  dynamometer, or "dyno" for short, is a device for measuring force, moment of force (torque), or power.

  10 months

Study Arms (2)

stretching exercises

EXPERIMENTAL

Stretching exercise along with manual lymph drainage

Other: Stretching exercises

soft tissue mobilization

EXPERIMENTAL

soft tissue mobilization along with manual lymph drainage

Other: Soft tissue mobilization

Interventions

Stretching exercises OTHER

Stretching exercises along with manual lymphatic drainage

stretching exercises

Soft tissue mobilization OTHER

Soft tissue mobilization along with manual lymphatic drainage

soft tissue mobilization

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: females having axillary web syndrome
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Allied Hosptal

Faisalābad, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (3)

• 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.

  PMID: 30588087 BACKGROUND

• 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.

  PMID: 20218085 BACKGROUND

• 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.

  PMID: 37950230 DERIVED

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Dr. Rabiya Noor, Phd

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Rabiya Noor, PhD

CONTACT

00923344355660; rabiya.noor@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: July 18, 2022
• Study Start: April 15, 2022
• Primary Completion: December 15, 2022
• Study Completion: January 5, 2023
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)