Instrument-assisted Soft Tissue Mobilization and Kinesiotape Application in Individuals With Chronic Neck Pain.

August 1, 2021 updated by: KTO Karatay University

Acute Effects of Instrument-assisted Soft Tissue Mobilization and Kinesiotape Application on Pain and Joint Position Sense in Individuals With Chronic Neck Pain.

Chronic neck pain causes errors in joint position sense. There are studies in the literature suggesting that instrument-assisted soft tissue mobilization and Kinesiotape applications improve the joint position sense. There is no study examining these applications acutely on joint position sense and pain in the cervical region. As a result of our study, we will compare the effects of single-session instrument-assisted soft tissue mobilization and Kinesiotape application on pain and joint position sense.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Volunteer individuals between the ages of 18-45 with chronic neck pain will be included in the study after obtaining their informed consent.

Participants will be randomly divided into two groups: Instrument assisted soft tissue mobilization and Kinesiotape Applications.

In the instrument-assisted soft tissue mobilization group, the trapezius and sternocleidomastoideus muscles will be applied in a single session for 90 seconds. Kinesiotape application will be applied to the trapezius and sternocleidomastoideus muscles in one session.

Pain will be evaluated with Visual Analog Scale and joint position sense will be evaluated with Cervical Range of Motion device before and after application.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42020
        • KTO Karatay University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being diagnosed with chronic neck pain
  • Being in the age range of 18-45

Exclusion Criteria:

  • Those with acute injury or infection,
  • Those with open wounds,
  • Osteoporosis,
  • Hematoma,
  • Those with acute cardiac, liver and kidney problems,
  • Those with connective tissue disease, Rheumatoid arthritis, osteoarthritis, Cancer,
  • Those with circulation problems,
  • Those with peripheral vascular disease,
  • Epilepsy
  • Identified as a history of surgery in the cervical region

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Instrument Assisted Soft Tissue Mobilization
The instruments will be applied to the soft tissue at 30º-60º angles, with multi-directional "stroking" movements. Instrument Assisted Soft Tissue Mobilization will be applied to the trapezius and sternocleidomastoideus muscles of the participants for 90 seconds.
Other: Instrument Assisted Soft Tissue Mobilization
Bilateral Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
Experimental: Kinesiotape Application
The application will be made from the insertion of the upper trapezoidal muscle to its origo . During taping, the patient will be allowed to sit in an upright position in a chair with a back, with the scapula fixed, without supporting the arms. Before taping, the patient will be positioned with the shoulder in adduction and the head in lateral flexion towards the contralateral side. The patient will be asked to perform shoulder abduction against resistance, and the insertion area of the upper trapezius fibers will be palpated. The initial 2-3 cm part of the band will be glued to the lateral of the acromion without stretching, after full (100%) stretching is applied to the 2-3 cm part of the band from the insertion area of the upper trapezoid fibers, the patient's head is rotated to the affected side and the arm part of the band is stretched along the muscle fibers. it will be glued up to the hairline without doing it.
Other: Kinesiotape Application
Bilateral Kinesiotape application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Cervical Pain at 2 minutes
Time Frame: Baseline and 2 minutes after intervention
Pain will be evaluated with Visual Analog Scale.
Baseline and 2 minutes after intervention
Change from Baseline Joint Position Sense at 2 minutes
Time Frame: Baseline and 2 minutes after intervention
Joint Position Sense will be evaluated Cervical Range of Motion Device
Baseline and 2 minutes after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
KTO Karatay University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KaratayUH2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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