NCT05546177

Brief Summary

this study will be conducted to investigate instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

September 25, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

September 19, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

September 15, 2022

Last Update Submit

September 15, 2022

Conditions

Keywords

instrumented assisted soft tissue mobilizationshoulder impingement syndrome

Outcome Measures

Primary Outcomes (2)

  • pain intensity

    pain will be measured by visual analogue scale. It is a vertical or horizontal 100 mm line graduated by different levels of pain, starting from 0 (no pain) till 100 (worst pain)

    up to eight weeks

  • shoulder disability

    The Arabic version of Disabilities of arm, shoulder, and hand (DASH) will be used for assessing shoulder function. DASH questionnaire includes 30 items with score from 0 to 100. A score of 0 represents no disability, while a score of 100 represents the most sever.

    up to eight weeks

Secondary Outcomes (3)

  • shoulder range of motion

    up to eight weeks

  • shoulder proprioception

    up to eight weeks

  • rounded shoulder

    up to eight weeks

Study Arms (2)

instrumented assisted soft tissue mobilization

EXPERIMENTAL

the patients will receive instrumented assisted soft tissue mobilization three times a week for eight weeks

Other: instrumented assisted soft tissue mobilizationOther: traditional therapy

traditional therapy

ACTIVE COMPARATOR

the patients will receive traditional therapy three times a week for eight weeks

Other: traditional therapy

Interventions

The subject will be treated with instrumented assisted soft tissue mobilization, applied to the upper and lower fibers of Pectoral, Trapezius (upper, middle and lower), Rhomboids major , Rhomboids minor, Teres minor, Teres major, and Latissimus dorsi muscles. The IASTM technique was performed for 20 seconds parallel to the muscle fibers followed by 20 seconds perpendicular to the muscle fibers of each one of the selected muscle

instrumented assisted soft tissue mobilization

the patients will receive Transcutaneous electrical nerve stimulation (TENS) to manage the pain,Ultrasound , Exercise including (Range of motion exercises, stretching exercises, and strengthening exercises (Scapular stabilization exercises and rotator cuff strengthening exercises)

instrumented assisted soft tissue mobilizationtraditional therapy

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with impingement syndrome from both genders.
  • Age range from 25-40 years
  • Body mass index 18.5-24.9 kg/m2
  • Subjects are non-smokers.
  • Shoulder impingement symptoms lasting at least 6 weeks

You may not qualify if:

  • Hand truma, present pain or other kinds of complaints in the hand area.
  • History of deformities, fractures, or surgery of the tested upper extremity joints affecting hand grip strength within the last 6 months.
  • Presence of cardiopulmonary, hormonal disorder, central or peripheral neurological deficits or any condition that can influence the results.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
opaque sealed envelop
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: instruments assisted soft tissue mobilization and traditional therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nabil mahmoud ismail

Study Record Dates

First Submitted

September 15, 2022

First Posted

September 19, 2022

Study Start

September 25, 2022

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

September 19, 2022

Record last verified: 2022-09