Extracorporeal Shock Wave and a Tailored Exercise Program on Axillary Web Syndrome

NCT05920369 | Unknown DMC

• 1 other identifier: F.P.T2207006
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

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.

Conditions

Axillary Web Syndrome

Keywords

axillary web syndrome; shock wave; exercises; breast cancer surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (3)

• visual analogue scale

  4 weeks

• Quick DASH score

  4 weeks

• Ultrasonography

  4 weeks

Study Arms (3)

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

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.

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.

Other: tailored exercise program

Interventions

low-energy extracorporeal shockwave and a tailored exercise program OTHER

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

Also known as: ESWTTEP

low-energy extracorporeal shockwave and a tailored exercise program

low-energy extracorporeal shockwave OTHER

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.

Also known as: ESWT

low-energy extracorporeal shockwave; low-energy extracorporeal shockwave and a tailored exercise program

tailored exercise program OTHER

Snow Angel, Butterfly Wings, Forward Pinky Slide, Corner Stretch, Chest Stretch, Self-tissue Stretching, Overhead Moose Stretch, and Crescent Side Bend exercises

Also known as: TEP

low-energy extracorporeal shockwave and a tailored exercise program; tailored exercise program

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female
• between the ages of 40 and 65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Hany Mohamed Elgohary

Cairo, 11432, Egypt

RECRUITING

Mohamed

Cairo, P.O.Box 11432, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 31435359 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

tetraethylpyrazine

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Hany M Elgohary, PHD

CONTACT

00201093182291; hmielgohary@gmail.com

Rehan G Adelnaser, PHD

CONTACT

00201220269787; Dr.rehan.gamal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: a well-experienced outcome assessor and participants are blind to the assignment of groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: controlled, double-blinded, randomized clinical trial, three arms

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 27, 2023
• Study Start: April 15, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)