Axillary Web SyndromeNCT05920369
Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome
A study testing low-energy extracorporeal shockwave and a tailored exercise program, low-energy extracorporeal shockwave and tailored exercise program in people with Axillary Web Syndrome, run by Cairo University at 2 sites in Egypt.
Trial summary
A total of 93 suitable patients will be randomly allocated into three groups: Group A will receive both low-energy extracorporeal shock wave therapy and a tailored exercise program, Group B will receive only low-energy extracorporeal shock wave therapy, and Group C will receive only the tailored exercise program. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women only
- Conditions the study is for
- Axillary Web Syndrome
- What is being tested?
- low-energy extracorporeal shockwave and a tailored exercise program, low-energy extracorporeal shockwave and tailored exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Apr 2023to 1 Sep 2023
- 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 40 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female
- between the ages of 40 and 65 years
Who cannot join
- metastases of any kind
- lymphedema,
- a traumatic injury to the targeted upper extremity
- a musculoskeletal disorder
- taking any anticoagulants
- had undergone bilateral breast cancer surgery
- experienced locoregional recurrence
- had vascular problems in the affected upper extremity
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Hany Mohamed Elgohary
Cairo, 11432
Hany M Elgohary, PhD, 0590997821, gohary75pt@hotmail.com
- Recruiting
Mohamed
Cairo, P.O.Box 11432
Amr A Abouzeid, PH.D, 00201006134539, amrahmedabouzid@mans.edu.eg
About this study
Official title: The Combined Effect of Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome After Breast Cancer Surgery With Axillary Dissection: A Comparative, Controlled Clinical Trial.
A total of 93 suitable patients will be randomly allocated into three groups: Group A will receive both low-energy extracorporeal shock wave therapy and a tailored exercise program, Group B will receive only low-energy extracorporeal shock wave therapy, and Group C will receive only the tailored exercise program.
Read the detailed description
Patients were randomly assigned to one of three groups: Group A, which received a low-energy extracorporeal shockwave treatment and a tailored exercise program; Group B, which received only a low-energy extracorporeal shockwave treatment; and Group C, which received only the tailored exercise program. The randomization process was done using a computer-generated table of random numbers concealed by sealed opaque envelopes. The patients' shoulder range of motion, pain intensity, upper extremity activities, and echogenicity, thickness, and disorganization were assessed using a digital inclinometer, visual analogue scale, quick DASH scale, and diagnostic ultrasound, respectively. The randomization process was overseen by a professional physical therapist who was not involved in the study procedures.
All outcomes were measured at the baseline and four weeks post-intervention. The outcomes were collected by a well-experienced investigator who was blind to the group assignments and considered as part of the research team.
- Conditions
- Axillary Web Syndrome
- Being tested
- low-energy extracorporeal shockwave and a tailored exercise program, low-energy extracorporeal shockwave, tailored exercise program
- Keywords
- axillary web syndrome, shock wave, exercises, breast cancer surgery
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-energy extracorporeal shockwave and a tailored exercise programOther
Also called ESWTTEP
the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a range of 0.056-0.068 mJ/mm.
Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises
low-energy extracorporeal shockwaveOther
Also called ESWT
the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a range of 0.056-0.068 mJ/mm.
tailored exercise programOther
Also called TEP
Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises
| Study group | Role | What they receive |
|---|---|---|
| low-energy extracorporeal shockwave and a tailored exercise program | Experimental | the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a 0.056-0.068 mJ/mm range.
in addition to the following types of exercises: Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises Receives: Other: low-energy extracorporeal shockwave and a tailored exercise program; Other: low-energy extracorporeal shockwave; Other: tailored exercise program |
| low-energy extracorporeal shockwave | Active comparator | the patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a 0.056-0.068 mJ/mm range. Receives: Other: low-energy extracorporeal shockwave |
| tailored exercise program | Active comparator | Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises. a combination of all these types of exercises will be used. Repeat these exercises 5 times, with 3 repetitions done each day for four consecutive weeks. Receives: Other: tailored exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
digital inclinometer
digital inclinometer will be used for the assessment of the shoulder range of motion. The inclinometer is placed near the shoulder at the proximal area with the patient's feet fixed, and the patients then moves their shoulder in different directions (flexion and abduction). The examiner repeats the measurements three times and takes the mean value as the proven measurement.
Measured: 4 weeks
Secondary outcomes (3)
visual analogue scale
the visual analog scale will be used for the assessment of pain intensity. It is a 100mm horizontal continuous line that begins on the left side with no pain and ends on the right side with more pain. The visual analogue point that corresponds to the patient's level of pain was asked to be marked by the patients. The researcher determines a score between 0 and 100 mm by measuring the distance (mm) on the 10 cm line between the patient's mark and the "no pain" sign at the left side end
Measured: 4 weeks
Quick DASH score
the Quick DASH will be used for the assessment of upper limb disability by using shoulder and hand functions. the Arabic version of the Shortened Disabilities of the Arm, Shoulder, and Hand questionnaire (Quick DASH) is a reliable and valid measure for assessing disabilities in the upper extremities of Arabic-speaking populations. Its Cronbach's alpha of 0.89 indicates good internal consistency, while its ICC of 0.94 suggests that it has good test-retest reliability
Measured: 4 weeks
Ultrasonography
this device will be used for the assessment of axillary cord thickness, echogenecity and disorganization. One technique used in ultrasonography is utilizing a high-resolution ultrasound system with 18 MHz frequency, which provides high-definition superficial imaging. A gel technique is also used to reduce artifacts caused by tissue compression. This technique can be used to measure cord thickness, echogenicity, and disorganization
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start15 Apr 2023
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axillary Web SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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, double-blinded, randomized clinical trial, three arms
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mohamed Ibrahim Elgohary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920369
- Sponsor's protocol ID
- F.P.T2207006
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: results
Publications
Elgohary HM, Al Jaouni SK, Selim SA. Effect of ultrasound-enhanced Nigella sativa seeds oil on wound healing: An animal model. J Taibah Univ Med Sci. 2018 Jun 27;13(5):438-443. doi: 10.1016/j.jtumed.2018.02.008. eCollection 2018 Oct.
PubMed 31435359
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effect of Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome After Breast Cancer Surgery With Axillary Dissection: A Comparative, Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05920369
- Acronym / sponsor ID
- F.P.T2207006
- Conditions
- Axillary Web Syndrome
- Keywords
- axillary web syndrome, shock wave, exercises, breast cancer surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 27 Jun 2023 (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.
A total of 93 suitable patients will be randomly allocated into three groups: Group A will receive both low-energy extracorporeal shock wave therapy and a tailored exercise program, Group B will receive only low-energy extracorporeal shock wave therapy, and Group C will receive only the tailored exercise program.
Detailed description
Patients were randomly assigned to one of three groups: Group A, which received a low-energy extracorporeal shockwave treatment and a tailored exercise program; Group B, which received only a low-energy extracorporeal shockwave treatment; and Group C, which received only the tailored exercise program. The randomization process was done using a computer-generated table of random numbers concealed by sealed opaque envelopes. The patients' shoulder range of motion, pain intensity, upper extremity activities, and echogenicity, thickness, and disorganization were assessed using a digital inclinometer, visual analogue scale, quick DASH scale, and diagnostic ultrasound, respectively. The randomization process was overseen by a professional physical therapist who was not involved in the study procedures.
All outcomes were measured at the baseline and four weeks post-intervention. The outcomes were collected by a well-experienced investigator who was blind to the group assignments and considered as part of the research team.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- controlled, double-blinded, randomized clinical trial, three arms
| Arm | Type | Receives |
|---|---|---|
| low-energy extracorporeal shockwave and a tailored exercise program | Experimental | Other: low-energy extracorporeal shockwave and a tailored exercise program, Other: low-energy extracorporeal shockwave, Other: tailored exercise programthe patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a 0.056-0.068 mJ/mm range. in addition to the following types of exercises: Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises |
| low-energy extracorporeal shockwave | Active comparator | Other: low-energy extracorporeal shockwavethe patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a 0.056-0.068 mJ/mm range. |
| tailored exercise program | Active comparator | Other: tailored exercise programSnow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises. a combination of all these types of exercises will be used. Repeat these exercises 5 times, with 3 repetitions done each day for four consecutive weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- female
- between the ages of 40 and 65 years
Key exclusion criteria (8 listed)
- metastases of any kind
- lymphedema,
- a traumatic injury to the targeted upper extremity
- a musculoskeletal disorder
- taking any anticoagulants
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 |
|---|---|---|
| low-energy extracorporeal shockwave and a tailored exercise programAlso: ESWTTEPthe patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a range of 0.056-0.068 mJ/mm. Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises | Other | low-energy extracorporeal shockwave and a tailored exercise program |
| low-energy extracorporeal shockwaveAlso: ESWTthe patient will be positioned lying supine with the affected shoulder in an abducted position to expose the axillary cords. Each patient received a total of 3000 shocks, which were delivered to different areas, including 1000 shocks to the axillary area, 500 shocks to the upper arm, 1000 shocks along the course of the cords, and 500 shocks to the antecubital space. Extracorporeal shock wave therapy (ESWT) was administered in two sessions during the first two weeks of the intervention, and one session each in the 3rd and 4th weeks. The energy flux density was 4 Hz with a range of 0.056-0.068 mJ/mm. | Other | low-energy extracorporeal shockwave, low-energy extracorporeal shockwave and a tailored exercise program |
| tailored exercise programAlso: TEPSnow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises | Other | low-energy extracorporeal shockwave and a tailored exercise program, tailored exercise program |
Primary outcome
digital inclinometer
Time frame: 4 weeks
digital inclinometer will be used for the assessment of the shoulder range of motion. The inclinometer is placed near the shoulder at the proximal area with the patient's feet fixed, and the patients then moves their shoulder in different directions (flexion and abduction). The examiner repeats the measurements three times and takes the mean value as the proven measurement.
3 secondary outcomes
visual analogue scale
Time frame: 4 weeks
Quick DASH score
Time frame: 4 weeks
Ultrasonography
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Background: PubMed 31435359Elgohary HM, Al Jaouni SK, Selim SA. Effect of ultrasound-enhanced Nigella sativa seeds oil on wound healing: An animal model. J Taibah Univ Med Sci. 2018 Jun 27;13(5):438-443. doi: 10.1016/j.jtumed.2018.02.008. eCollection 2018 Oct.
- Individual participant dataSharing planned: No. results
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-energy extracorporeal shockwave and a tailored exercise program, low-energy extracorporeal shockwave and tailored exercise program in people with Axillary Web Syndrome, run by Cairo University at 2 sites in Egypt.
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 2 inclusion and 8 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 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Hany M Elgohary, PHD (00201093182291, hmielgohary@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
digital inclinometer (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920369, which also lists 1 linked publication.
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 27 Jun 2023.