NCT02691143

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

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

Study Start

First participant enrolled

February 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
4 months until next milestone

Results Posted

Study results publicly available

March 17, 2017

Completed
Last Updated

March 17, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

February 15, 2016

Results QC Date

January 27, 2017

Last Update Submit

January 27, 2017

Conditions

Acute Non-complicated Postural Neck Pain

Outcome Measures

Primary Outcomes (1)

  • Change in Cervical Range of Motion

    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 Outcomes (1)

  • Change in Numeric Pain Rating Scale (NPRS)

    3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours

Study Arms (2)

Manipulation plus Tape

EXPERIMENTAL

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

Manipulation Only

NO INTERVENTION

The control group will receive manipulation from a licensed chiropractor only

Interventions

TheraBand Kinesiology TapeOTHER

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.

Manipulation plus Tape

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport and Spine Rehab

Rockville, Maryland, 20878, United States

Location

Results Point of Contact

Title
Jena Slaski
Organization
Sport and Spine Rehab Clinical Research Foundation
jslaski@ssrehab.com
240-766-0300

Study Officials

  • Jena Slaski, MEd, ATC

    Sport and Spine Rehab Clinical Research Foundation

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2016

First Posted

February 25, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

March 17, 2017

Results First Posted

March 17, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)