The Effect of TheraBand® Kinesiology Tape on Post-manipulation Pain and Range of Motion (TBKTManip)

January 27, 2017 updated by: Sport and Spine Rehab Clinical Research Foundation
The purpose of this study is to determine if post-manipulation elastic therapeutic tape (ETT) with TheraBand® Kinesiology Tape to neck pain patients can impact neck range of motion (ROM) and post-manipulation pain. A convenience sample of 50 patients, between the ages of 18-64, who present with acute non-complicated postural neck pain will be recruited from an outpatient chiropractic clinic. Upon providing consent to participate, patients will be randomly assigned into 2 groups; Control Group (manipulation only) and Tape Group (manipulation plus tape). Pain and neck ROM will be recorded at 3 different intervals: (1) pre-cervical manipulation, (2) within 5 minutes of cervical manipulation, (3) with 24-48 hours after manipulation.

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 purpose of this study is to determine if post-manipulation elastic therapeutic tape (ETT) with TheraBand® Kinesiology Tape to neck pain patients can impact neck range of motion (ROM) and post-manipulation pain. A convenience sample of 50 patients, between the ages of 18-64, who present with acute non-complicated postural neck pain will be recruited from an outpatient chiropractic clinic. Complications would include discogenic pain or radicular symptoms. Inclusionary criteria would also consist of onset less than 18 days and the indications for cervical manipulation, including pain, decreased range of motion, and hypertonicity. Exclusionary criteria will include pregnancy, contraindications to manipulation, and previous neck surgery. Patients will be recruited on the first visits to ensure they haven't receive manipulation before for this current plan of care. Upon providing consent to participate, patients will be randomly assigned into 2 groups; Control Group (n=25) and Tape Group (n=25). Pain and neck ROM will be recorded at 3 different intervals: (1) pre-cervical manipulation, (2) within 5 minutes of cervical manipulation, (3) with 24-48 hours after manipulation. The control group will receive manipulation only, while the Tape Group will have ETT TheraBand® Kinesiology Tape applied immediately following cervical manipulation. The taping protocol will be applied by the investigator and consist of a "Y" strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal "I" strip applied at 50% tension at the site of pain. Six cervical ranges of motion values will be recorded utilizing the Acumar DataCapture hand-held dual inclinometer. Range of motion will be measured at maximum (max) degrees and average degrees of 6 trials and will include: flexion (F), extension €, left side-bending (LSB), right side-bending (RSB), left rotation (LR), and right rotation (RR). Measure of pain will be asked of each patient using the Numeric Pain Rating Scale (NPRS) from 0-10. They will be asked to rate their pain at rest and when in motion.

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.
50

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

  • United States
    • Maryland
      • Rockville, Maryland, United States, 20878
        • Sport and Spine Rehab

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria will include ages of 18-64 who present with non-complicated postural neck pain, indications for cervical manipulation, including pain, decreased range of motion, and hypertonicity. Exclusion criteria will include discogenic pain or radicular symptoms, pregnancy, contraindications to manipulation, and previous neck surgery

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: None (Open Label)

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: Manipulation plus Tape
The Tape Group will have TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol will be applied by the investigator and consist of a "Y" strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal "I" strip applied at 50% tension at the site of pain.
Other: TheraBand Kinesiology Tape
One approach to treating musculoskeletal conditions is a elastic therapeutic taping technique designed to target muscles and lymphatic system. Limited research on the efficacy of elastic therapeutic taping (ETT) is available for specific patient populations, including neck pain. ETT it is theorized to impact muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment. In a study by Gonzalez-Iglesias et al. the investigators reported that neck pain and range of motion significantly improved immediately and 24 hours after the application of ETT in acute whiplash patients as compared to a sham taping.
No Intervention: Manipulation Only
The control group will receive manipulation from a licensed chiropractor only

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 in Cervical Range of Motion
Time Frame: 3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours
Six cervical ranges of motion values will be recorded utilizing the Acumar DataCapture hand-held dual inclinometer. Range of motion will be measured at maximum (max) degrees and average degrees of 6 trials and will include: flexion (F), extension (E), left side-bending (LSB), right side-bending (RSB), left rotation (LR), and right rotation (RR).
3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Numeric Pain Rating Scale (NPRS)
Time Frame: 3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours
Subjects rate their pain on the Numeric Pain Rating Scale (NPRS), a scale from 0-10, 0 being none and 10 being the worst imaginable.
3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours

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.
Sport and Spine Rehab Clinical Research Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jena Slaski, MEd, ATC, Sport and Spine Rehab Clinical Research Foundation

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

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.
February 1, 2016

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.
October 1, 2016

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.
December 1, 2016

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 15, 2016

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, 2016

First Posted (Estimate)

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 25, 2016

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.
March 17, 2017

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.
January 27, 2017

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.
January 1, 2017

More Information

Terms related to this study

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.
  • SSR07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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