Acute Non-complicated Postural Neck PainTBKTManipNCT02691143
The Effect of TheraBand® Kinesiology Tape on Post-manipulation Pain and Range of Motion
A study testing TheraBand Kinesiology Tape in people with Acute Non-complicated Postural Neck Pain, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Non-complicated Postural Neck Pain
- What is being tested?
- TheraBand Kinesiology Tape
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Acute Non-complicated Postural Neck Pain
- Being tested
- TheraBand Kinesiology Tape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: TheraBand Kinesiology Tape |
| Manipulation Only | No intervention | The control group will receive manipulation from a licensed chiropractor only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours
Secondary outcomes (1)
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.
Measured: 3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionOct 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Non-complicated Postural Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport and Spine Rehab Clinical Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jena Slaski, MEd, ATC, Study director, Sport and Spine Rehab Clinical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691143
- Sponsor's protocol ID
- SSR07
- Acronym
- TBKTManip
- Status last verified
- Jan 2017
- First submitted
- 15 Feb 2016
- Last updated
- 17 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of TheraBand® Kinesiology Tape on Post-manipulation Pain and Range of Motion
- ClinicalTrials.gov ID
- NCT02691143
- Acronym / sponsor ID
- TBKTManip / SSR07
- Conditions
- Acute Non-complicated Postural Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sport and Spine Rehab Clinical Research FoundationUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Posted 17 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manipulation plus Tape | Experimental | Other: TheraBand Kinesiology TapeThe 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. |
| Manipulation Only | No intervention | –The control group will receive manipulation from a licensed chiropractor only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraBand Kinesiology TapeOne 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. | Other | Manipulation plus Tape |
Primary outcome
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).
1 secondary outcome
Change in Numeric Pain Rating Scale (NPRS)
Time frame: 3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jena Slaski, MEd, ATC study director
Sport and Spine Rehab Clinical Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraBand Kinesiology Tape in people with Acute Non-complicated Postural Neck Pain, run by Sport and Spine Rehab Clinical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cervical Range of Motion (time frame: 3 Testing sessions: (T1) Baseline, (T2) Immediate Post, and (T3) 24-48hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.