NCT04319250

Brief Summary

The aim of this study is to determine the effects of ischemic compression and IASTM techniques on pain, EHA, functionality, anxiety and depression in patients with the diagnosis of RM tear and presence of ATN. In addition, ischemic compression and EDYDM methods were aimed to compare and to reveal which application would be more useful.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 24, 2020

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

March 19, 2020

Last Update Submit

February 25, 2021

Conditions

Rotator Cuff TearsShoulder PainMyofascial Trigger Point Pain

Keywords

ischemic compressioninstrument assisted soft tissue mobilizationtrigger point

Outcome Measures

Primary Outcomes (1)

  • Disabilities of the Arm, Shoulder, and Hand Questionnaire (DASH)

    This is a questionnaire that identifies both functionality and symptoms that can be used in arm, elbow and hand problems. High scores of individuals mean that functional dysfunction is high. Ratings are made between 0 and 100.

    Change from Baseline at 6 weeks

Secondary Outcomes (7)

  • Visual Analogue Scale (VAS)

    Change from Baseline at 6 weeks

  • Shoulder Range of Motion (ROM)

    Change from Baseline at 6 weeks

  • Active trigger points

    Change from Baseline at 6 weeks

  • Pain Pressure Threshold (PPT)

    Change from Baseline at 6 weeks

  • The American Shoulder and Elbow Surgeons Standardized Shoulder Assesment Form (ASES)

    Change from Baseline at 6 weeks

  • +2 more secondary outcomes

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Ischemic compression and rehabilitation program applied to the group 1

Other: ischemic compressionOther: Rehabilitation Program

Group 2

ACTIVE COMPARATOR

IASTM and rehabilitation program applied to the group 2

Other: IASTMOther: Rehabilitation Program

Interventions

ischemic compressionOTHER

ATNs detected in a total of 13 muscles around the shoulder were applied constant pressure at the level of pain tolerated with the thumb (discomfort severity level 7 to 8 out of 10) and for 90 seconds. This method was applied twice a week for 6 weeks.

Group 1
IASTMOTHER

In order to apply EDYDM in the treatment of ATN, titanium plated stainless steel was divided into two parts, front and back, with two tools. The sweep was applied to the anterior muscle fibers at an angle of 45 ° for 40 seconds. For each TN, continuous pressure was applied with swivel movement at tolerable pain level (discomfort severity level 7 to 8 out of 10) for 1 minute. The back group muscles were applied in the same way.

Group 2
Rehabilitation ProgramOTHER

A rehabilitation program consisting of exercises and manual therapy used in the conservative treatment of rotator cuff tear for both groups was applied twice a week for 6 weeks.

Group 1Group 2

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being between 40-65 years old
  • Having been diagnosed with partial RM rupture
  • RM rupture in MRI image
  • At least 3 ATNs in the shoulder complex
  • Hawkins-Kennedy and Empty Can tests positive Symptoms for at least 3 months

You may not qualify if:

  • Sensory problems in the back and shoulders,
  • Shoulder instability
  • Osteoarthritis in the shoulder joint area
  • Glenoid or bone fracture
  • Frozen shoulder pathology
  • Massive RM rupture
  • Rheumatological joint problems
  • Shoulder surgery history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydin University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rotator Cuff InjuriesShoulder PainMyofascial Pain Syndromes

Interventions

AcupressureRehabilitation

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon InjuriesArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesAftercareContinuity of Patient CarePatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator (MSc)

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 24, 2020

Study Start

February 1, 2019

Primary Completion

August 30, 2019

Study Completion

August 30, 2019

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations

TU(1)