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

This study is currently recruiting participants.
See Contacts and Locations
Verified May 2017 by Sport and Spine Rehab Clinical Research Foundation
Sponsor:
Collaborator:
University of San Diego
Information provided by (Responsible Party):
Sport and Spine Rehab Clinical Research Foundation
ClinicalTrials.gov Identifier:
NCT03157544
First received: May 12, 2017
Last updated: May 16, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention
Pain, Chronic Musculoskeletal Pain Low Back Pain Neck Pain Behavioral: multimodal non-pharmacological Pain Relief Kit

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Complementary Management of Chronic Neck and/or Low Back Pain With a Multimodal Non-pharmacological Pain Relief Kit

Resource links provided by NLM:


Further study details as provided by Sport and Spine Rehab Clinical Research Foundation:

Primary Outcome Measures:
  • Change in Medical Outcomes Study (MOS)-36 Physical functioning scale at 3 weeks [ Time Frame: 3 (Baseline, 1 week, 3 weeks) ]
  • Change in visual analog scale (VAS) of pain at 3 weeks [ Time Frame: 3 (Baseline, 1 week, 3 weeks) ]
  • Change in Timed performance of functional tasks at 3 weeks [ Time Frame: 3 (Baseline, 1 week, 3 weeks) ]

Estimated Enrollment: 30
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: September 30, 2017
Estimated Primary Completion Date: June 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pain Relief Kit
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.
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.


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

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03157544

Contacts
Contact: Jena Etnoyer-Slaski, ATC,M.S.Ed 301-251-2777 ext 838 jslaski@ssrehb.com

Locations
United States, Virginia
Sport and Spine Rehab Recruiting
Fairfax, Virginia, United States, 22030
Contact: Jena Etnoyer-Slaski, ATC,M.S.Ed    301-251-2777 ext 838    jslaski@ssrehab.com   
Sport and Spine Rehab Recruiting
McLean, Virginia, United States, 22101
Contact: Jena Etnoyer-Slaski, ATC,M.S.Ed    301-251-2777 ext 838    jslaski@ssrehab.com   
Sponsors and Collaborators
Sport and Spine Rehab Clinical Research Foundation
University of San Diego
  More Information

Responsible Party: Sport and Spine Rehab Clinical Research Foundation
ClinicalTrials.gov Identifier: NCT03157544     History of Changes
Other Study ID Numbers: SSR_Toolkit
Study First Received: May 12, 2017
Last Updated: May 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sport and Spine Rehab Clinical Research Foundation:
Chronic Neck Pain
Chronic Back Pain
non-pharmacological
pain relief

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neck Pain
Musculoskeletal Pain
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 18, 2017