NCT05331963

Brief Summary

To determine the effects of functional kinesio taping on subacromial space in athletes with rotator cuff tendinopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2022

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

First Submitted

Initial submission to the registry

April 2, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

April 6, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

2 months

First QC Date

April 2, 2022

Last Update Submit

December 7, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Subacrimial space measurement by Ultrasonography

    In order to visualize and measure the subacromial space, the Diagnostic Ultrasound will be used with Aquasonic ultrasound gel as the coupling medium. An ultrasound scanner (Canon aplio i600) with frequency of 1 to 22 MHz curved probe will be used in this study to get images. The probe of US will be placed on the anterior-lateral surface of the acromion process, next to the longitudinal axis of the humeral head, and this is the point likely to view the acromion process and humeral head at the same time. The AHD will then measured from inferior surface of acromion process to the superior surface of the humeral head.The distance is basically from cortical layers of both acromion and humerus bone. The acromio humeral distance will be measured at resting position (0° elevation) of shoulder in millimeters.

    Six weeks

  • Visual Analogue Scale

    This scale consist of 0 to 10 rating in which 0 indicates no pain, and 10 indicates the worst pain.(9) The score of VAS is determined by measuring the distance between the no pain or 0 anchor and to the point where patient draw a mark. A higher score indicates greater pain intensity.

    Six weeks

  • The Disabilities of Arm, Shoulder and Hand Questionnaire

    The DASH will be used to measure functional disorder, physical disability and symptoms of the upper limbs. It consists of 30 questions. 21 questions are related to specific physical tasks in which a person felt difficulty performing last week. 6 questions are to assess specific symptoms including pain, numbness and stiffness. 3 questions are about social and occupational limitations. A 100 point score signifies the most severe disability.

    Six weeks

  • The Western Ontario Rotator Cuff Index

    This instrument consists of 21 items with 5 further categories: i) 6 items of Physical symptoms,ii) 4 items of sports and recreation functions, iii) 4 items of work functions, iv) 4items of lifestyle functions and v) emotional function with 3 items. The instrument has clear instructions to the patients in addition to the explanation of each item of every category.

    Six weeks

Study Arms (2)

Kinesio taping with rehabilitation program group

EXPERIMENTAL

Rehabilitation program will be given to this group in addition to Kinesio taping on skin for 72 hour.

Other: Kinesio Taping

Rehabilitation plan group

NO INTERVENTION

The rehabilitation program will be provided individually to all participants (twice weekly during the first 4 weeks, then once weekly)

Interventions

Kinesio tape is designed in a specific way that it mimics the human skin nature. It more or less has the same width as the epidermis layer and can be stretched upto 40% of its resting length.Clinically, kinesio tape (KT) is used both alone and with other physiotherapeutic interventions, mainly for the pain control, to reduce inflammation, and to improve functional activity in patients with shoulder pain

Kinesio taping with rehabilitation program group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 to 35 years
  • Both gender
  • Athletes participating in volley ball, tennis, badminton and golf.
  • Presence of shoulder pain in abduction and external rotation during training for more than three months
  • Three out of five positive results for the following: painful arc, pain or weakness with resisted external rotation, abduction, Neer test, Hawkins Kennedy test, empty can test/Jobe test

You may not qualify if:

  • H/O shoulder fractures,
  • Instability or dislocation (positive apprehension and relocation tests)
  • Frozen shoulder (All stages)
  • Recent shoulder surgery for a shoulder injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain and Spine Clinic

Islamabad, Federal, 44000, Pakistan

Location

Study Officials

  • Aadil Omer, Ph.D.

    Riphah International University

    PRINCIPAL INVESTIGATOR

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
SPONSOR

Study Record Dates

First Submitted

April 2, 2022

First Posted

April 18, 2022

Study Start

April 6, 2022

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations