Low Back Pain, Musculoskeletal Pain, Neck Pain, Pain, Chronic
Conditions
Keywords
Chronic Neck Pain, Chronic Back Pain, non-pharmacological, pain relief
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.
Interventions
BEHAVIORALmultimodal non-pharmacological Pain Relief Kit
Participants will be told: No two people have the same kind of pain and that pain management must be individualized to your pain. Thus, we want you to try the four modes of the non-pharmacological interventions included in the kit individually and in combination in order to determine what works best to relieve your pain The Pain Relief kit will also include written instructions and materials for three behavioral techniques directed at maintaining compliance with the non-pharmacological interventions. During the review of the Pain Relief Kit with a member of the research staff participants will be informed about the recommended use of the three behavioral techniques including setting goals, working with a buddy and keeping a graph of your progress. This information will also be included in written form in the Pain Relief Kit.
Sponsors
Sport and Spine Rehab Clinical Research Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Medical Outcomes Study (MOS)-36 Physical functioning scale at 3 weeks | 3 (Baseline, 1 week, 3 weeks) |
| Change in visual analog scale (VAS) of pain at 3 weeks | 3 (Baseline, 1 week, 3 weeks) |
| Change in Timed performance of functional tasks at 3 weeks | 3 (Baseline, 1 week, 3 weeks) |
Countries
United States
Outcome results
None listed