NCT05313763

Brief Summary

The investigators aimed to evaluate the effect of kinesio tape application on the sense of proprioception in patients with cervical spondylosis.This research aims to determine the relationship between the sense of cervical proprioception and neck pain intensity, neck disability and quality of life, and to determine the relationship between cervical spinal MRI findings and cervical proprioception. Studies conducted to date are limited to the evaluation of patients who underwent kinesio tape for neck pain in terms of joint range of motion, pain, and disability. In a study examining the relationship between cervical kinesio-tape application and cervical proprioception sense; The patient group consists of the young population and the patient evaluation was made immediately after the end of the treatment. The aim of this study is to evaluate the relationship of kinesio tape applied to the elderly patient group with cervical spondylosis, where the cervical proprioception sense is more affected, with cervical proprioception sense in the mid-term and to examine its relationship with cervical spinal MRI phenotypes. The possible relationship between proprioceptive sensory deficit and joint degeneration is based on a combination of neuromuscular control dysfunction and periarticular degeneration. Thus, the investigators aimed to improve the proprioceptive sense, reduce pain and increase functionality in the elderly patient group with kinesio-tape in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

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

Study Start

First participant enrolled

December 2, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

December 6, 2022

Status Verified

December 1, 2022

Enrollment Period

12 months

First QC Date

March 23, 2022

Last Update Submit

December 5, 2022

Conditions

Cervical Spondylosis

Keywords

Cervical Spondylosiskinesio-tapecervical proprioception

Outcome Measures

Primary Outcomes (1)

  • change in cervical proprioception after treatment

    It is measured by the cervical joint position error test. This test assesses whether the patient can return to the previous neutral position after maximum rotation of the head in the coronal and sagittal planes. A headlamp with a laser light source in the middle, an eye patch, a 40 cm diameter target with trigonometric segments, a metal and magnetic apparatus used to adjust the target according to its neutral position are used as equipment.The patient is seated in a chair with his eyes closed in a neutral position; The target is positioned at a distance of 90 cm. The target is a 40 cm diameter circle and contains five separate small circles to which the grading is applied. These small circles are called 1 degree, 2 degrees, 3 degrees, 4.5 degrees, and 6 degrees, which allows to evaluate the deviation. The target is adjusted according to the patient's height.

    change in cervical proprioception will be evaluated 1 month after treatment

Secondary Outcomes (9)

  • cervical joint range of motion

    Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.

  • Hand grip strength

    Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.

  • Upper extremity functionality

    Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.

  • Neck pain

    Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.

  • Neuropathic pain

    Evaluations will be made before treatment, immediately after treatment, and 1 month after treatment.

  • +4 more secondary outcomes

Study Arms (3)

Conventional physical therapy group

EXPERIMENTAL

Conventional physical therapy is the first line of treatment in cervical spondylosis.

Other: conventional physical therapy

Kinesio-tape Group

ACTIVE COMPARATOR

Conventional rehabilitation program will be applied five days a week, 3 weeks, a total of 15 sessions. Kinesio-tape applications will be applied in 6 sessions during conventional physical therapy, twice a week at four-day intervals.

Other: conventional physical therapyOther: Active Kinesiotaping

Sham kinesio-tape Group

SHAM COMPARATOR

Conventional rehabilitation program will be applied five days a week, 3 weeks, a total of 15 sessions. Sham kinesio-tape applications will be applied twice a week at four-day intervals, 6 sessions during conventional physical therapy.

Other: conventional physical therapyOther: Sham Kinesiotaping

Interventions

conventional physical therapyOTHER

A hotpack will be applied to the neck area for 15 minutes in the prone position of the patients. Conventional type Tens with a frequency of 50 Hz and a pulse duration of \<150 microseconds will be applied for 20 minutes, taking the painful area to the center. Ultrasound will be applied to the patients for 5 minutes with a dosage of 1-1.5 watts/cm2. Cervical joint range of motion exercises, stretching exercises for trapezius, scalenia, rhomboid, levator scapulae, pectoral and suboccipital muscles will be applied, then cervical isometric strengthening exercises and stabilization exercises will be carried out in a controlled manner. Conventional physical therapy will be applied by the same physiotherapist 5 days a week for 3 weeks.

Conventional physical therapy groupKinesio-tape GroupSham kinesio-tape Group
Active KinesiotapingOTHER

For kinesio-tape application, a 20 cm long Y strip and a 15 cm long I strip tape will be prepared. The patient will flex his neck, and the application will be started from the midline of the upper thoracic vertebrae. Initially, 4-5 cm stretching will be applied, and the arms of the Y strip will be adhered to the cervical paravertebral muscles without stretching. I strip will be applied to the painful area with the area correction technique, with maximum stretching in the middle and without stretching the ends. The applications will be made by the same physiatrist with 7 years of clinical experience.

Kinesio-tape Group
Sham KinesiotapingOTHER

For Sham kinesio-tape application, a 20 cm long Y strip and a 15 cm long I strip tape will be prepared. The patient will flex his neck, the application will be started from the midline of the upper thoracic vertebrae, and the Y and I bands will be applied without stretching. The applications will be made by the same physiatrist with 7 years of clinical experience.

Sham kinesio-tape Group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 50 and under 70
  • Moderate to severe neck pain and limitation in neck movements according to the Visual Analogue Scale, which has been present for at least 3 months
  • Presence of cervical degeneration radiologically
  • being literate
  • Giving consent by agreeing to participate in the study
  • Having an MRI registered in the system in the last 1 (one) year

You may not qualify if:

  • Being under 50 and over 70
  • Neck pain that has been present for less than 3 months
  • Patients with positive Spurling test and radiculopathy
  • Patients with nerve root compression and stenosis in the evaluation with cervical MRI within the last 1 year
  • History of neurological disease, history of neck trauma, cervical myelopathy, any inflammatory arthritis, tumor, infection involving the cervical spine, and vertebrobasilar artery insufficiency
  • Cervical spinal surgery history
  • Vestibular disorder
  • vision problems
  • cognitive impairment
  • polyneuropathy
  • B12 and vitamin D deficiency (Patients with abnormal values for B12 and vitamin D in the last three months through the hospital examination result system will not be included in the study)
  • No known diagnosis of psychotic disorder
  • Active skin infection, cellulitis, open wounds, presence of cancerous tissue, extreme obesity and allergy to adhesives containing polyacrylate
  • not being literate
  • Patients who received physical therapy, injection, manual therapy, kinesio-tape treatment from the neck region in the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan 2. Abdulhamid Han Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Emre Ata, Ass.Prof.

    Sultan II. Abdulhamidhan Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 6, 2022

Study Start

December 2, 2021

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

December 6, 2022

Record last verified: 2022-12

Locations

TU(1)