NCT03073655

Brief Summary

The aim of the study to investigate the effectiveness KT application with different verbal inputs on pain, function and range of motion (ROM) on patient with rotator cuff tear.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 8, 2017

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

11 months

First QC Date

January 12, 2017

Last Update Submit

March 9, 2017

Conditions

Keywords

shoulder painshoulder function

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    Pain intensity was assessed using the VAS; each patient was asked the pain during the rest, activity, and at night (on a 0 -10 numerical pain rating scale with zero corresponding to no pain and 10 corresponding to terrible pain). The rest, night and pain in activity were assessed by VAS before, after 30 min and 24 hours after KT application

    The rest, night and pain in activity were assessed by VAS before and after 30 min, before and after 24 hours of KT application

Secondary Outcomes (3)

  • Shoulder range of motion

    ROM (range of motion) assessed by goniometer before and 24 hours of KT application.

  • Disabilities of the Arm, Shoulder and Hand questionnaire

    Disabilities of the Arm, Shoulder and Hand (DASH) was evaluated before and 24 hours of KT application.

  • American Shoulder and Elbow Surgery score (ASES)

    American Shoulder and Elbow Surgery score was evaluated before and 24 hours of KT application.

Study Arms (3)

Group 1

EXPERIMENTAL

it has been limited evidence of KT is effective

Other: Negative Verbal Input

Group 2

EXPERIMENTAL

it has been not known that KT is effective or not

Other: Neutral Verbal Input

Group 3

EXPERIMENTAL

it has been known that KT has excellent result

Other: Positive Verbal Input

Interventions

The treatment group received a standardized therapeutic KT application. The physical therapist said that it has been limited evidence of KT is effective during application.

Group 1

The treatment group received a standardized therapeutic KT application. The physical therapist said that it has been not known that KT is effective or not during application.

Group 2

The treatment group received a standardized therapeutic KT application. The physical therapist said that it has been known that KT has excellent result during application.

Group 3

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients were included in the study if they had a partial rotator cuff tear diagnosed on clinical grounds
  • No episodes of shoulder instability
  • No radiographic signs of fracture of the glenoid or the greater or lesser tuberosity MRI evidence of cuff tear
  • Duration of symptoms of at least 3 months,
  • Inadequate response to nonoperative management (including nonsteroidal anti-inflammatory drugs, physical therapy, rest, and 1 local corticosteroid injection) Positive empty can test indicating possible supraspinatus involvement
  • Positive Hawkins-Kennedy test indicating possible external impingement, -Subjective complaint of difficulty performing activities of daily living
  • to 50 years of age.

You may not qualify if:

  • Patients were excluded from the study if they had inflammatory joint disease -Rheumatologic disease Osteoarthritis of humerus head
  • Prior surgery on the affected shoulder
  • Inability to complete questionnaires because of language problem or cognitive disorder
  • Shoulder girdle fracture
  • Glenohumeral dislocation/subluxation
  • Acromioclavicular sprain
  • Concomitant cervical spine symptoms
  • A history of shoulder surgery
  • Patients who did not accept to participate
  • Patients who did not come to the second evaluation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rotator Cuff InjuriesShoulder Pain

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof.

Study Record Dates

First Submitted

January 12, 2017

First Posted

March 8, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 13, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share