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

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: Completed
• Conditions: Acute Non-complicated Postural Neck Pain
• Intervention / Treatment: Other: TheraBand Kinesiology Tape

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: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Numeric Pain Rating Scale (NPRS)	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

• Sponsor: Sport and Spine Rehab Clinical Research Foundation
• Investigators: Study Director: Jena Slaski, MEd, ATC, Sport and Spine Rehab Clinical Research Foundation

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 15, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Actual): March 17, 2017
• Last Update Submitted That Met QC Criteria: January 27, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: SSR07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO