CClinicalTrials.gg
Status unknownNCT05463185Updated Jul 18, 2022

Effects Of Lymphatic Drainage on Axillary Web Syndrome

An interventional study of Stretching exercises and Soft tissue mobilization in Axillary Web Syndrome, sponsored by Riphah International University. Status unknown at 1 site in Pakistan. Open to female participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-07-18.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Axillary Web Syndrome

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Keywords

  • Axillary web syndrome
  • Manual lymphatic drainage
03

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's planned enrollment of 20 is below the median of 50 across 6,515 interventional studies indexed under Syndrome.

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Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    stretching exercises

    Stretching exercise along with manual lymph drainage

    Other: Stretching exercises

  • Experimental
    soft tissue mobilization

    soft tissue mobilization along with manual lymph drainage

    Other: Soft tissue mobilization

Interventions

  • OtherStretching exercises

    Stretching exercises along with manual lymphatic drainage

  • OtherSoft tissue mobilization

    Soft tissue mobilization along with manual lymphatic drainage

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 months

  2. 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).

    Time frame: 10 months

  3. Goniometer.

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

    Time frame: 10 months

  4. 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)

    Time frame: 10 months

  5. 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.

    Time frame: 10 months

  6. Dynamometer

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

    Time frame: 10 months

07

Study locations

1 of 1 sites recruiting
  • Allied Hosptal
    Faisalābad, Punjab 54000, Pakistan
    • tehniat aamir, MS · Contact
    Recruiting
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References and documents

Publications

  • 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. PubMed 30588087 ↗
  • 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. PubMed 20218085 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05463185
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Jul 18, 2022
Start date
Apr 15, 2022
Primary completion
Dec 15, 2022 (estimated)
Completion
Jan 5, 2023 (estimated)
Last update
Jul 18, 2022

Study contacts

Dr. Rabiya Noor, PhD
Contact
rabiya.noor@riphah.edu.pk
00923344355660
Dr. Rabiya Noor, Phd
principal investigator · Riphah International University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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