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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03157544
• Other study ID #: SSR_Toolkit
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: July 2018
• Source: Sport and Spine Rehab Clinical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: May 30, 2018
• Est. primary completion date: May 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Low Back Pain
• Musculoskeletal Pain
• Neck Pain
• Pain, Chronic

Intervention

Behavioral:
• multimodal 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.

Locations

Country	Name	City	State
United States	Sport and Spine Rehab	Fairfax	Virginia
United States	Sport and Spine Rehab	McLean	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Sport and Spine Rehab Clinical Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Medical Outcomes Study (MOS)-36 Physical functioning scale at 3 weeks		3 (Baseline, 1 week, 3 weeks)
Primary	Change in visual analog scale (VAS) of pain at 3 weeks		3 (Baseline, 1 week, 3 weeks)
Primary	Change in Timed performance of functional tasks at 3 weeks		3 (Baseline, 1 week, 3 weeks)