Movement DisordersNCT06438848
Effects of Lymph Drainage on Patients With Axillary Web Syndrome
A study testing Physical therapy program and Physical therapy program with lymphedema drainage in people with Movement Disorders, run by Taif University.
Trial 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 more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Movement Disorders
- What is being tested?
- Physical therapy program and Physical therapy program with lymphedema drainage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of a Physical Therapy Program Combined With Manual Lymphatic Drainage on Shoulder Function, , and Pain in Breast Cancer Patients With Axillary Web Syndrome Following Axillary Dissection: A Randomized Controlled Trial
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).
- Conditions
- Movement Disorders
- Being tested
- Physical therapy program, Physical therapy program with lymphedema drainage
- Medical subject headings
- Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy programOther
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
Physical therapy program with lymphedema drainageOther
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
| Study group | Role | What they receive |
|---|---|---|
| Physical therapy program | Experimental | 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 Receives: Other: Physical therapy program |
| Physical therapy program with lymphedema drainage | Experimental | 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 Receives: Other: Physical therapy program with lymphedema drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
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.
Measured: 5 weeks
Secondary outcomes (5)
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.
Measured: 4 weeks
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.
Measured: 5 weeks
Muscular strength
Using a hand-held dynamometer, the maximum voluntary isometric contraction of the muscles will be used to assess their strength.
Measured: 5 weeks
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
Measured: 5 weeks
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)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Controlled parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mohammad Alkayshan, Taif University
- Investigators
- Hassan Alzahrani, PHD, Study chair, Taif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438848
- Sponsor's protocol ID
- 24-1241
- Status last verified
- May 2024
- First submitted
- 22 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physical Therapy Program Combined With Manual Lymphatic Drainage on Shoulder Function, , and Pain in Breast Cancer Patients With Axillary Web Syndrome Following Axillary Dissection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06438848
- Acronym / sponsor ID
- 24-1241
- Conditions
- Movement Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Taif UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Controlled parallel groups
| Arm | Type | Receives |
|---|---|---|
| Physical therapy program | Experimental | Other: Physical therapy programgroup 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 |
| Physical therapy program with lymphedema drainage | Experimental | Other: Physical therapy program with lymphedema drainagephysical 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 |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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].
Key exclusion criteria (3 listed)
- suffering of both acute thrombosis and lymphedema,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy programgroup 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 |
| Physical therapy program with lymphedema drainagephysical 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 |
Primary outcome
Pain intensity
Time frame: 5 weeks
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.
Disability
Time frame: 5 weeks
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.
5 secondary outcomes
Limb Girth
Time frame: 4 weeks
Cording
Time frame: 5 weeks
Muscular strength
Time frame: 5 weeks
Range of motion
Time frame: 5 weeks
Quality of life for participants
Time frame: 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Alzahrani, PHD study chair
Taif University
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy program and Physical therapy program with lymphedema drainage in people with Movement Disorders, run by Taif University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ibrahim Alkayshan, Bachelorette (0096650127261, Ibrahim.alkayshan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 5 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.