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

Primary Purpose

Pain, Chronic, Musculoskeletal Pain, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
multimodal non-pharmacological Pain Relief Kit
Sponsored by
Sport and Spine Rehab Clinical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic focused on measuring Chronic Neck Pain, Chronic Back Pain, non-pharmacological, pain relief

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sport and Spine Rehab
  • Sport and Spine Rehab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pain Relief Kit

Arm Description

Immediately following baseline data collection participants will be given the Pain Relief Kit and instructed about the contents. From this kit, a sample of Biofreeze® and TheraBand® Kinesiology Tape will be applied to the participant. The contents of the Pain Relief Kit will include four modes of non-pharmacological interventions that have been previously demonstrated to relieve musculoskeletal pain. Following Baseline data collection, participants will review the content of the Pain Relief Kit with a member of the research staff. During this review the subject will be informed about the recommended use of all the four modes of the non-pharmacological interventions included in the kit. This information will also be included in written form in the Pain Relief Kit.

Outcomes

Primary Outcome Measures

Change in Medical Outcomes Study (MOS)-36 Physical functioning scale at 3 weeks
Change in visual analog scale (VAS) of pain at 3 weeks
Change in Timed performance of functional tasks at 3 weeks

Secondary Outcome Measures

Full Information

First Posted
May 12, 2017
Last Updated
July 26, 2018
Sponsor
Sport and Spine Rehab Clinical Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03157544
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
May 27, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sport and Spine Rehab Clinical Research Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Musculoskeletal Pain, Low Back Pain, Neck Pain
Keywords
Chronic Neck Pain, Chronic Back Pain, non-pharmacological, pain relief

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Relief Kit
Arm Type
Experimental
Arm Description
Immediately following baseline data collection participants will be given the Pain Relief Kit and instructed about the contents. From this kit, a sample of Biofreeze® and TheraBand® Kinesiology Tape will be applied to the participant. The contents of the Pain Relief Kit will include four modes of non-pharmacological interventions that have been previously demonstrated to relieve musculoskeletal pain. Following Baseline data collection, participants will review the content of the Pain Relief Kit with a member of the research staff. During this review the subject will be informed about the recommended use of all the four modes of the non-pharmacological interventions included in the kit. This information will also be included in written form in the Pain Relief Kit.
Intervention Type
Behavioral
Intervention Name(s)
multimodal non-pharmacological Pain Relief Kit
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Medical Outcomes Study (MOS)-36 Physical functioning scale at 3 weeks
Time Frame
3 (Baseline, 1 week, 3 weeks)
Title
Change in visual analog scale (VAS) of pain at 3 weeks
Time Frame
3 (Baseline, 1 week, 3 weeks)
Title
Change in Timed performance of functional tasks at 3 weeks
Time Frame
3 (Baseline, 1 week, 3 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Sport and Spine Rehab
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22030
Country
United States
Facility Name
Sport and Spine Rehab
City
McLean
State/Province
Virginia
ZIP/Postal Code
22101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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