NCT04346563

Brief Summary

The objective of this research is to study the effect of kinesio tapes with functional correction technique in combination with exercise management to increase strength and decrease pain, in people with rounded shoulders. The study would be evaluated with the EvaltechTM machine, (functional capacity assessment).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

January 7, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

November 21, 2023

Status Verified

November 1, 2023

Enrollment Period

2.3 years

First QC Date

April 11, 2020

Last Update Submit

November 20, 2023

Conditions

Keywords

Kinesio tape, Functional correction, Rounded shoulder

Outcome Measures

Primary Outcomes (3)

  • The pushing force (average of peak force) of both arms (pounds)

    Maximum strength of pushing, measures by Evaltech machine

    2 minutes

  • The pulling force (average of peak force) of both arms (pounds)

    Maximum strength of pulling, measures by Evaltech machine

    2 minutes

  • Time measurement tolerance (TMT) (seconds)

    Time tolerance of overhead reaching, measures by Evaltech machine

    4 minutes

Secondary Outcomes (2)

  • Visual analog pain scale (VAS)

    1 minute

  • The distance from the posterior aspect of acromion to the bed (inches)

    2 minutes

Study Arms (2)

Kinesio tape, functional correction applying

EXPERIMENTAL

The experimental group, trained by Certified Kinesio tape researcher will attache the kinesio tape. Attaching the kinesio tape by using functional correction techniques, apply tape from the front of the acromion process to the spinous process T10 on both sides, providing 50% of the tape's tension (Kase, 2003, Han JT et al) to create a scapular retraction.

Other: Kinesio tape, functional correction techniqueOther: Elastic band strengthening shoulder exercise

Placebo Kinesio taping apply

PLACEBO COMPARATOR

Apply kinesio tape without tension.

Other: Elastic band strengthening shoulder exercise

Interventions

According to Kinesio Taping, functional correction technique could use for correcting shoulder, scapular alignment and decrease pain.

Kinesio tape, functional correction applying

The exercise in which both groups will receive Introduction of exercise with rubber bands (Elastic band) It is a home exercise (Home base exercise program) for patients to do with appropriate resistance. Which can be done at least 10 times and not more than 20 times continuously,will be asked to do all 3 positions. 1\) Shoulder external rotation in shoulder abduction 90 degrees 2) Shoulder horizontal abduction in shoulder abduction 90 degrees 3) Seated bend row, which will be done 15 times, each hold for 10 seconds, do 3 sets, each set rest 2 minutes, 2 times a day ( Morning-evening) consecutively for 1 week

Kinesio tape, functional correction applyingPlacebo Kinesio taping apply

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 25-50 years, male and female
  • People who have a shoulder condition. (By measuring in the supine position, distance from the posterior aspect of acromion to the bed\> 1 inch on both sides)
  • People with moderate to severe neck and shoulder pain (VAS\> 3)
  • People who have to use their arms for work Overall more than 3 hours per day

You may not qualify if:

  • People with neck pain, fracture in the arm, and numbness
  • People who have pain and have limited shoulder movement of the shoulder joint
  • People who have had a history of spine / shoulder surgery
  • People with a history of allergies to cloth tapes
  • People who have rheumatoid arthritis that affects inflammation of the joints such as rheumatoid etc.
  • People receiving medication that affects their participation in the study
  • People with neurological symptoms
  • People with cognitive disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mahidol University

Salaya, Nakhonpathom, 73170, Thailand

Location

Related Publications (6)

  • Han JT, Lee JH, Yoon CH. The mechanical effect of kinesiology tape on rounded shoulder posture in seated male workers: a single-blinded randomized controlled pilot study. Physiother Theory Pract. 2015 Feb;31(2):120-5. doi: 10.3109/09593985.2014.960054. Epub 2014 Sep 29.

    PMID: 25264014BACKGROUND
  • El-Abd AM, Ibrahim AR, El-Hafez HM. Efficacy of kinesiology tape versus postural correction exercises on neck disability and axioscapular muscles fatigue in mechanical neck dysfunction: A randomized blinded clinical trial. J Bodyw Mov Ther. 2017 Apr;21(2):314-321. doi: 10.1016/j.jbmt.2016.07.008. Epub 2016 Jul 26.

    PMID: 28532874BACKGROUND
  • Ay S, Konak HE, Evcik D, Kibar S. The effectiveness of Kinesio Taping on pain and disability in cervical myofascial pain syndrome. Rev Bras Reumatol Engl Ed. 2017 Mar-Apr;57(2):93-99. doi: 10.1016/j.rbre.2016.03.012. Epub 2016 May 10. English, Portuguese.

    PMID: 28343625BACKGROUND
  • Kim MK, Lee JC, Yoo KT. The effects of shoulder stabilization exercises and pectoralis minor stretching on balance and maximal shoulder muscle strength of healthy young adults with round shoulder posture. J Phys Ther Sci. 2018 Mar;30(3):373-380. doi: 10.1589/jpts.30.373. Epub 2018 Mar 2.

    PMID: 29581654BACKGROUND
  • Kim TW, An DI, Lee HY, Jeong HY, Kim DH, Sung YH. Effects of elastic band exercise on subjects with rounded shoulder posture and forward head posture. J Phys Ther Sci. 2016 Jun;28(6):1733-7. doi: 10.1589/jpts.28.1733. Epub 2016 Jun 28.

    PMID: 27390405BACKGROUND
  • Peppers D, Figoni SF, Carroll BW, Chen MM, Song S, Mathiyakom W. Influence of Functional Capacity Evaluation on Physician's Assessment of Physical Capacity of Veterans With Chronic Pain: A Retrospective Analysis. PM R. 2017 Jul;9(7):652-659. doi: 10.1016/j.pmrj.2016.10.011. Epub 2016 Oct 22.

    PMID: 27780768BACKGROUND

MeSH Terms

Conditions

Shoulder Pain

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Prasert Sakulsriprasert, PhD

    Lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Allocated participants, they do not know which group they would be in. Assessor do not know which group of participant that would perform.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: RCT among two groups,
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2020

First Posted

April 15, 2020

Study Start

January 7, 2021

Primary Completion

May 1, 2023

Study Completion

May 31, 2023

Last Updated

November 21, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations