NCT04504409

Brief Summary

The aim of the current study was to investigate the effects of KT and DN combined with exercise on pain, range of motion (ROM), and upper extremity function in patients with common shoulder disorders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

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

August 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

August 10, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

5 months

First QC Date

August 5, 2020

Last Update Submit

August 4, 2021

Conditions

Keywords

shoulder painmyofascial trigger pointdry needlingkinesio tapeexercise

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    Pain intensity was assessed using the Visual Analog Scale (VAS), in which the patient is asked to indicate his/her perceived pain during rest, activity and at night (0-10 VAS, with 0 as no pain and 10 as worst imaginable pain.

    3-weeks

  • Range of Motion

    Limited and painful ROM is often observed in patients with shoulder disorders. Shoulder active ROM was measured in a supine position using a universal goniometer. The goniometer is a reliable instrument for measuring shoulder ROM . All measurements will be taken with patients standing. In this study, three repetitions were performed in each direction, and the average of three trials will determine the mean ROM values for each condition.

    3-weeks

Secondary Outcomes (1)

  • Upper extremity functions

    3-weeks

Study Arms (3)

Exercise group (ExG)

ACTIVE COMPARATOR

The exercise program consisted of; Codman , wand, stretching and strengthening exercises \[25\] applied twice a day, 5 times a week and duration of 3 weeks in all groups. All exercises were performed for 10 repetitions and 3 sets. Patients performed exercises with under supervision of physiotherapist in the clinic settings. In ExG, patients received only this exercise protocol for 3-weeks.

Other: Rehabilitation

KT application combined with exercise (KTG)

EXPERIMENTAL

Before KT application, their skin was shaved, cleaned with alcohol, and dried. Prior to application, the patient was seated and asked to flex their neck laterally to the contralateral side and to rotate their head to the same side. KTs (Ares®) tape was used. The first strip was a Y-strip representative of the supraspinatus, which was applied from its insertion to origin with paper off tension. A Y-strip refers to a section of tape that has a portion cut down the middle to produce 2 tails. In KTG, patients wore the KT for a 3-week duration (renewed twice a week periodically in this time).

Other: Rehabilitation

DN combined with exercise (DNG)

ACTIVE COMPARATOR

The MTrP dry needling procedure employed was similar to the MTrP injection described by Hong. The MTrP was located by palpating the taut band and identifying the point of maximal tenderness. This was then firmly compressed by the index finger or middle finger of the nondominant hand to direct the placement of the needle tip while inserting the needle. The needle was inserted into the skin at a point above the taut band, approximately 1 cm from the MTrP region. After penetration of the needle into the subcutaneous layer, it was kept there and obliquely (about 45 degrees) directed to the MTrP region under the fingertip of the non-dominant hand. Then, the needle was inserted rapidly into the MTrP region and withdrawn rapidly. In DNG, patients received DN for a 3-week duration (twice a week periodically in this time).

Other: Rehabilitation

Interventions

Training

DN combined with exercise (DNG)Exercise group (ExG)KT application combined with exercise (KTG)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients were eligible if they had unilateral non-traumatic shoulder pain (described as pain felt in the shoulder or upper arm) for at least six months, were between ages 18-60 years, and diagnosed with at least one active MTrP in shoulder region.

You may not qualify if:

  • Patients who have been diagnosed with shoulder instability, shoulder fractures, neurological diseases, or other severe medical or psychiatric disorders will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rüstem Mustafaoğlu

Istanbul, 34147, Turkey (Türkiye)

Location

Related Publications (4)

  • Roquelaure Y, Ha C, Leclerc A, Touranchet A, Sauteron M, Melchior M, Imbernon E, Goldberg M. Epidemiologic surveillance of upper-extremity musculoskeletal disorders in the working population. Arthritis Rheum. 2006 Oct 15;55(5):765-78. doi: 10.1002/art.22222.

  • Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.

  • Hidalgo-Lozano A, Fernandez-de-las-Penas C, Alonso-Blanco C, Ge HY, Arendt-Nielsen L, Arroyo-Morales M. Muscle trigger points and pressure pain hyperalgesia in the shoulder muscles in patients with unilateral shoulder impingement: a blinded, controlled study. Exp Brain Res. 2010 May;202(4):915-25. doi: 10.1007/s00221-010-2196-4. Epub 2010 Feb 26.

  • Bron C, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA. High prevalence of shoulder girdle muscles with myofascial trigger points in patients with shoulder pain. BMC Musculoskelet Disord. 2011 Jun 28;12:139. doi: 10.1186/1471-2474-12-139.

MeSH Terms

Conditions

Myofascial Pain SyndromesShoulder PainMotor Activity

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesArthralgiaJoint DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

AftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Rüstem Mustafaoğlu

    İstanbul Üniversitesi, Sağlık Bilimleri Fakültesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 7, 2020

Study Start

August 10, 2020

Primary Completion

December 25, 2020

Study Completion

February 10, 2021

Last Updated

August 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations