Complementary Management of Chronic Neck and/or Low Back Pain With a Pain Relief Kit
Condition: Pain, Chronic; Musculoskeletal Pain; Low Back Pain; Neck Pain
MeSH terms: Musculoskeletal Pain; Back Pain; Low Back Pain; Neck Pain; Chronic Pain
Study type: Interventional

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.
    

Intervention name(s): multimodal non-pharmacological Pain Relief Kit
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Neck Pain; Chronic Back Pain; non-pharmacological; pain relief