Clinical trial NCT05920369: Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Axillary Web Syndrome
Keywords: axillary web syndrome
shock wave
exercises
breast cancer surgery
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 93
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled, double-blinded, randomized clinical trial, three arms
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* female
* between the ages of 40 and 65 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: digital inclinometer
timeFrame: 4 weeks
Secondary outcomes:
measure: visual analogue scale
timeFrame: 4 weeks
measure: Quick DASH score
timeFrame: 4 weeks
measure: Ultrasonography
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hany Mohamed Elgohary
city: Cairo
country: Egypt
facility: Mohamed
Study officials:
References:
citation: 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.