Clinical trial NCT02691143: The Effect of TheraBand® Kinesiology Tape on Post-manipulation Pain and Range of Motion
Official title: The Effect of TheraBand® Kinesiology Tape on Post-manipulation Pain and Range of Motion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Non-complicated Postural Neck Pain
Lead sponsor: Sport and Spine Rehab Clinical Research Foundation
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Cervical Range of Motion
timeFrame: 3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours
Secondary outcomes:
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: 3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Sport and Spine Rehab
state: Maryland
Study officials:
affiliation: Sport and Spine Rehab Clinical Research Foundation
name: Jena Slaski, MEd, ATC
role: STUDY_DIRECTOR
References: