Clinical trial NCT03157544: Complementary Management of Chronic Neck and/or Low Back Pain With a Pain Relief Kit
Official title: Complementary Management of Chronic Neck and/or Low Back Pain With a Multimodal Non-pharmacological Pain Relief Kit
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain, Chronic
Musculoskeletal Pain
Low Back Pain
Neck Pain
Keywords: Chronic Neck Pain
Chronic Back Pain
non-pharmacological
pain relief
Lead sponsor: Sport and Spine Rehab Clinical Research Foundation
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Medical Outcomes Study (MOS)-36 Physical functioning scale at 3 weeks
timeFrame: 3 (Baseline, 1 week, 3 weeks)
measure: Change in visual analog scale (VAS) of pain at 3 weeks
timeFrame: 3 (Baseline, 1 week, 3 weeks)
measure: Change in Timed performance of functional tasks at 3 weeks
timeFrame: 3 (Baseline, 1 week, 3 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Sport and Spine Rehab
state: Virginia
city: McLean
country: United States
facility: Sport and Spine Rehab
state: Virginia
Study officials:
References: