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

NCT03157544 | Terminated

• 1 other identifier: SSR_Toolkit
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Pain, Chronic; Musculoskeletal Pain; Low Back Pain; Neck Pain

Keywords

Chronic Neck Pain; Chronic Back Pain; non-pharmacological; pain relief

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Pain Relief Kit

EXPERIMENTAL

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

Interventions

multimodal non-pharmacological Pain Relief Kit BEHAVIORAL

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.

Pain Relief Kit

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sport and Spine Rehab Clinical Research Foundation: lead

Study Sites (2)

Sport and Spine Rehab

Fairfax, Virginia, 22030, United States

Location

Sport and Spine Rehab

McLean, Virginia, 22101, United States

Location

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain; Low Back Pain; Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Back Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 17, 2017
• Study Start: March 1, 2017
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 2, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)