CClinicalTrials.gg
Not yet recruitingNCT06438848Updated Jun 3, 2024

Effects of Lymph Drainage on Patients With Axillary Web Syndrome

An interventional study of Physical therapy program and Physical therapy program with lymphedema drainage in Movement Disorders, sponsored by Taif University. Not yet recruiting. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-03.

Sponsored by Taif University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2024, 2 years 2 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
20 Years to 65 Years
Sex
All
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Study summary

Effects of a physical therapy program combined with manual lymphatic drainage on shoulder pain and function, quality of life, lymphedema incidence in breast cancer patients with axillary web syndrome following axillary dissection: A randomized controlled trial.

Read the detailed description

This study's objective is to assess the effectiveness of physical therapy (PT) combined with manual lymphatic drainage (MLD) on shoulder pain and function, lymphedema, visible cords, and quality of life (QOL), compared to physical therapy alone, in subjects with breast cancer and suffering of axillary web syndrome (AWS).

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Conditions studied

  • Movement Disorders

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03

In context

Movement Disorders

320 studies on the registry are indexed under Movement Disorders; 98 are open to participants now.

This study's planned enrollment of 34 is below the median of 46 across 180 interventional studies indexed under Movement Disorders.

Browse Movement Disorders studies →

Lead sponsor

Taif University is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

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

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Who can participate

Ages eligible
20 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • had a breast cancer dissection with lymphadenectomy and/or sentinel lymph node biopsy and a subsequent appearance of AWS (diagnosed by physical examination and also by using the Screening Test AWS (ST-AWS)) [35].

    • suffering of pain that exceeds 6-8 points (measured by the numeric rating scale (NRS)) in the region of the cording on the upper/lower arm, elbow, and dorsum site, and
    • have visible or palpable cords in the arm or breast.

Exclusion criteria

Exclusion Criteria:

  • suffering of both acute thrombosis and lymphedema,

    • suffering of skin issues like infections or musculoskeletal conditions like adhesive capsulitis, rheumatoid arthritis, pectoral muscle tightness, and diseases of the rotator cuff, and/or
    • having cording that doesn't involve an arm and only affects the chest or side of the thorax.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Physical therapy program

    group will be prescribed a usual physical therapy program three times a week for four weeks, which will be conducted in the clinic. The program consists of eight sessions comprising warm-up and cool-down, stretching activities, and strengthening exercises, and manual therapy. The program will start with 10-minute warm-up and 10-minute cool-down periods of physical therapy sessions

    Other: Physical therapy program

  • Experimental
    Physical therapy program with lymphedema drainage

    physical therapy program three times a week for four weeks, which will be conducted in the clinic. The program consists of eight sessions comprising warm-up and cool-down, stretching activities, and strengthening exercises,And manual lymphatic drainage prescribed 20 minutes of MLD daily. The program will be prescribed five times a week, for four weeks

    Other: Physical therapy program with lymphedema drainage

Interventions

  • OtherPhysical therapy program

    group will be prescribed a usual physical therapy program three times a week for four weeks, which will be conducted in the clinic. The program consists of eight sessions comprising warm-up and cool-down, stretching activities, and strengthening exercises, and manual therapy. The program will start with 10-minute warm-up and 10-minute cool-down periods of physical therapy sessions

  • OtherPhysical therapy program with lymphedema drainage

    physical therapy program three times a week for four weeks, which will be conducted in the clinic. The program consists of eight sessions comprising warm-up and cool-down, stretching activities, and strengthening exercises,And manual lymphatic drainage prescribed 20 minutes of MLD daily. The program will be prescribed five times a week, for four weeks

06

What researchers measure

Primary outcomes

  1. Pain intensity

    Pain intensity will be assessed using the NRS (0-10). A score of 0 means there is no pain, while a score of 10 means presence of severe pain.

    Time frame: 5 weeks

  2. Disability

    Assessment of disability will be done using the Arabic Quick-DASH questionnaire which is an 11-item self-report questionnaire, The DASH has five response options for each item from 0=no difficulty to perform or no symptoms to 5=unable to do. A higher score reflects greater disability.

    Time frame: 5 weeks

Secondary outcomes

  1. Limb Girth

    The limb girth will be measured using the tape measurement. Upper limb volumes will be calculated from circumference measurements taken at 4-cm intervals from the dorsum of the wrist to the axilla. The diagnostic criterion for lymphedema was ≥3 % volume increase from baseline in the affected upper limb.

    Time frame: 4 weeks

  2. Cording

    lymphedema therapist (PT/CLT) will examine the arm and axilla for any visible or palpable cords. The findings will be either positive for cording or negative. It is a nominal qualitative variable.

    Time frame: 5 weeks

  3. Muscular strength

    Using a hand-held dynamometer, the maximum voluntary isometric contraction of the muscles will be used to assess their strength.

    Time frame: 5 weeks

  4. Range of motion

    The active ROM (AROM) will be assessed using a goniometer which has been proved to have reliability and concurrent validity for measuring shoulder mobility measurements

    Time frame: 5 weeks

  5. Quality of life for participants

    The EORTC QLQ-C30 is a 30-item questionnaire including measuring Global Health status (2 items), Functional scales (15 items) and Symptoms scales/items (13 items). Items were measured using a 4-point Likert Scale ranging from Not at all (1) to Very much (4)

    Time frame: 5 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06438848
Lead sponsor
Taif University
Responsible party
Ibrahim Mohammad Alkayshan (Physical therapist, Taif University) — Principal investigator
First posted
Jun 3, 2024
Start date
Jun 2024 (estimated)
Primary completion
Aug 2024 (estimated)
Completion
Sep 2024 (estimated)
Last update
Jun 3, 2024

Study contacts

Ibrahim Alkayshan, Bachelorette
Contact
Ibrahim.alkayshan@gmail.com
0096650127261
Alaa Baboor, Bachelorette
Contact
Alaa.s.baboor@hotmail.com
00966596628155
Hassan Alzahrani, PHD
study chair · Taif University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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