Complementary Management of Chronic Neck and/or Low Back Pain With a Pain Relief Kit



Status:Completed
Conditions:Back Pain, Back Pain, Orthopedic, Pain
Therapuetic Areas:Musculoskeletal, Orthopedics / Podiatry
Healthy:No
Age Range:18 - 65
Updated:8/1/2018
Start Date:March 1, 2017
End Date:May 30, 2018

Use our guide to learn which trials are right for you!

Complementary Management of Chronic Neck and/or Low Back Pain With a Multimodal Non-pharmacological Pain Relief Kit

The purpose of this project is to determine the effect of a multimodal non-pharmacological
Pain Relief Kit on the pain, functioning, patient satisfaction, and opioid consumption of
individuals suffering from an acute pain episode of chronic neck and/or low back pain over a
3-week duration.

The purpose of this project is to determine the effect of a multimodal non-pharmacological
Pain Relief Kit on the pain, functioning, patient satisfaction, and opioid consumption of
individuals suffering from an acute pain episode of chronic neck and/or low back pain over a
3-week duration. A secondary purpose of this study is to determine the effect of the kit on
product sales and self-reported disability compared to patients who were not offered the kit.

Study Design: A convenience sample of 30 subjects who report being treated by a health care
professional for musculoskeletal pain of an acute episode of chronic neck and/or low back
pain which has lasted longer than 4 weeks will be recruited. Following screening for
inclusion and exclusion criteria eligible individuals will provide informed consent prior to
any data collection taking place. Following providing informed consent, subjects will engage
in the baseline data collection protocol. Then after completing baseline data collection all
participants will receive the intervention that includes the Pain Relief Kit for 3 weeks. All
participants enrolled in the project will complete data collection at 3 data collection
points. Baseline data collection will take place following informed consent. The second data
collection point will take place one week following baseline data collection (T1) and the
third data collection point will take place 3 weeks following baseline data collection (T2).
In addition, all participants will provide a daily rating of their pain and documentation of
pain management interventions they engaged in from the Pain Relief Kit, over the counter
(OTC) treatments &/or treatments prescribed by a health care provider. This will result in a
one group repeated measures design in which eligible participants will be provided with a
Pain Relief Kit for 3 weeks.

Analysis: Repeated measures ANOVA will determine if the participants changed on any of the
outcome variables over the duration of the project (p<.05). This analysis will be repeated to
determine the impact of treatment compliance rates on the outcome variables. Main or
interaction effects detected by the R-ANOVA will be explored further through calculated
Tukey's post hoc comparisons.

Inclusion Criteria:

- Over age 18 and report experiencing average daily musculoskeletal pain of moderate
intensity (>3/10) in the neck or low back for greater than 4 weeks.

Exclusion Criteria:

- Report any indication for medical clearance prior to engaging in moderate intensity
exercise or if they have any other health limitations to engaging in moderate
exercise.

- Additional exclusion criteria are the individual is unable to complete any of the data
collection protocols, has previously been diagnosed with schizophrenia, dementia or is
mentally incapable of providing informed consent or report a previous allergic
reaction to kinesiotape or menthol.
We found this trial at
2
sites
Fairfax, Virginia 22030
Phone: 301-251-2777
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
McLean, Virginia 22101
Phone: 301-251-2777
?
mi
from
McLean, VA
Click here to add this to my saved trials