NCT03744195

Brief Summary

Supraspinatus tendonitis is a common clinical problem that causes functional and labor disabilities. It is the most frequent cause of shoulder pain. Manual therapy is a common intervention used by physical therapist for management of supraspinatus tendonitis. Joint mobilization, stretching and strengthening exercises are commonly used techniques for management of this condition. In this study KT will be added to conventional manual therapy and its efficacy will be investigated. The study design will be Randomized Clinical Trial (RCT) that will be used to compare the effects of KT added to manual therapy for management of supraspinatus tendonitis. 38 patients will be participate in this study who will be assigned randomly (biased coin method) to experimental and control groups (19+19). The data collection will be carried out at Railway Hospital Rawalpindi. Patients with shoulder pain at rest and positive for special tests (Neer's, Empty Can, Drop Arm, Hawkin's Kennedy) will be included in this study. There is no restriction on gender and age group will be between 25 and 60 years. Patients with cervical post op, referred pain, open wounds, allergic to KT and with signs of radiculopathy will be excluded from this study. Pre and post treatment evaluation will be done using Visual Analog Scale (VAS), Shoulder Pain and Disability Index (SPADI) and goniometry. Data will be collected on 1st day, 4th day and 7th day for both groups. After data collection is completed, SPSS will be used to analyze the collected data

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
29 days until next milestone

Study Start

First participant enrolled

December 15, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

5 months

First QC Date

November 14, 2018

Last Update Submit

August 7, 2019

Conditions

Keywords

SupraspinatusTendinitisKinesotaping

Outcome Measures

Primary Outcomes (2)

  • Visual Analogue scale

    Visual analogue scale (VAS) is a psychometric measuring instrument designed to document the characteristics of disease-related symptom severity in individual patients and use this to achieve a rapid (statistically measurable and reproducible) classification of symptom severity and disease control.

    change from baseline.This tool is used to measure pain intensity

  • Shoulder Pain and Disability Index

    The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.

    change from baseline.This tool is used to measure pain and disability level.

Secondary Outcomes (1)

  • Goniometry

    change from baseline.This tool is used to measure range of motion of shoulder joint

Study Arms (2)

Group I Experimental Kinesotaping

EXPERIMENTAL

Application of kinesotaping along with conventional treatment

Other: Group I Experimental Kinesotaping

Group II conventional training group

ACTIVE COMPARATOR

Application of conventional treatment

Other: Group II conventional training group

Interventions

For application of kinesotaping following procedure will be adopted: 1. The skin will be cleaned properly with alcohol 2. The first strip will be applied in Y-shape (15-20% stretch) surrounding the deltoid muscle to provide inhibition and muscle relaxation 3. A second strip (I-shape) will be applied for functional correction (50-75% stretch), passing over the supraspinatus, trapezius, glenohumeral joint and middle deltoid Daily Strengthening Exercises (3 sets / 10\~30 reps) Joint mobilization (3 sets / 60 seconds hold / 30 seconds interval) Stretching Exercises (3 sets / 30 seconds hold / 30 seconds interval

Group I Experimental Kinesotaping

Joint mobilization (3 sets / 60 seconds hold / 30 seconds interval) Stretching Exercises (3 sets / 30 seconds hold / 30 seconds interval) Strengthening Exercises (3 sets / 10\~30 reps)

Group II conventional training group

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both Gender / Age b/w 25-60 Shoulder Pain at rest Positive Neer's Test Positive Drop Arm Test Positive Empty Can Test Positive Hawkin's Kennedy Test

You may not qualify if:

  • Cervical Post op, referred pain, radiculopathy, open wound, allergy to KT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imran Amjad

Islamabad, Punjab Province, 46000, Pakistan

Location

Related Publications (10)

  • de Oliveira FCL, Pairot de Fontenay B, Bouyer LJ, Desmeules F, Roy JS. Effects of kinesiotaping added to a rehabilitation programme for patients with rotator cuff tendinopathy: protocol for a single-blind, randomised controlled trial addressing symptoms, functional limitations and underlying deficits. BMJ Open. 2017 Sep 24;7(9):e017951. doi: 10.1136/bmjopen-2017-017951.

    PMID: 28947462BACKGROUND
  • Redondo-Alonso L, Chamorro-Moriana G, Jimenez-Rejano JJ, Lopez-Tarrida P, Ridao-Fernandez C. Relationship between chronic pathologies of the supraspinatus tendon and the long head of the biceps tendon: systematic review. BMC Musculoskelet Disord. 2014 Nov 18;15:377. doi: 10.1186/1471-2474-15-377.

    PMID: 25408141BACKGROUND
  • 3. Cubała A, Śniegocki M, Hoffman J, et al. Use of the kinesio taping method in painful shoulder syndrome. Medical and Biological Sciences2012;26:71-6

    BACKGROUND
  • Aguilar-Ferrandiz ME, Castro-Sanchez AM, Mataran-Penarrocha GA, Guisado-Barrilao R, Garcia-Rios MC, Moreno-Lorenzo C. A randomized controlled trial of a mixed Kinesio taping-compression technique on venous symptoms, pain, peripheral venous flow, clinical severity and overall health status in postmenopausal women with chronic venous insufficiency. Clin Rehabil. 2014 Jan;28(1):69-81. doi: 10.1177/0269215512469120. Epub 2013 Feb 20.

    PMID: 23426563BACKGROUND
  • Drouin JL, McAlpine CT, Primak KA, Kissel J. The effects of kinesiotape on athletic-based performance outcomes in healthy, active individuals: a literature synthesis. J Can Chiropr Assoc. 2013 Dec;57(4):356-65.

    PMID: 24302784BACKGROUND
  • Lin JJ, Hung CJ, Yang PL. The effects of scapular taping on electromyographic muscle activity and proprioception feedback in healthy shoulders. J Orthop Res. 2011 Jan;29(1):53-7. doi: 10.1002/jor.21146.

    PMID: 20607815BACKGROUND
  • 7. Akbaba YA, Mutlu EK, Altun S, Gümüşoğlu G, Çelik D. The effects of Kinesio Tape application with different verbal input given to with patients with rotator cuff tear. Orthopaedic Journal of Sports Medicine. 2017;5(2 suppl2):2325967117S00058.

    BACKGROUND
  • Kaya DO, Baltaci G, Toprak U, Atay AO. The clinical and sonographic effects of kinesiotaping and exercise in comparison with manual therapy and exercise for patients with subacromial impingement syndrome: a preliminary trial. J Manipulative Physiol Ther. 2014 Jul-Aug;37(6):422-32. doi: 10.1016/j.jmpt.2014.03.004. Epub 2014 Aug 6.

    PMID: 25108752BACKGROUND
  • Kim MH, Oh JS. Effects of humeral head compression taping on the isokinetic strength of the shoulder external rotator muscle in patients with rotator cuff tendinitis. J Phys Ther Sci. 2015 Jan;27(1):121-2. doi: 10.1589/jpts.27.121. Epub 2015 Jan 9.

    PMID: 25642053BACKGROUND
  • Senbursa G, Baltaci G, Atay OA. The effectiveness of manual therapy in supraspinatus tendinopathy. Acta Orthop Traumatol Turc. 2011;45(3):162-7. doi: 10.3944/AOTT.2011.2385.

    PMID: 21765229BACKGROUND

MeSH Terms

Conditions

Tendinopathy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesTendon InjuriesWounds and Injuries

Study Officials

  • imran Amjad, phd*

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
This will be a single blinded study.Participants will be randomly allocated to Group (I)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 16, 2018

Study Start

December 15, 2018

Primary Completion

April 30, 2019

Study Completion

May 15, 2019

Last Updated

August 8, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations