RECRUITING

A Novel Device for Neck Pain in Active-duty Military Personnel With Forward Head Posture.

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Neck pain is a common complaint among active duty military personnel, and can have tremendous impacts on quality of life and participation in duty-related activities. Treatments for spinal pain in military personnel are typically multimodal, relying upon physical therapy, pharmacological agents, spinal manipulation, and psychotherapy. However, there does not exist a wide body of evidence to support many of these treatments in active-duty military. The Cervigard neck collar was designed to treat posture-related neck pain with minimal effort and time required for treatment by the patient. However, this has yet to be tested experimentally. The objective of this study is to evaluate the treatment effect and safety of a novel device for the treatment of neck pain using self-reported pain and function measures, as well as objective radiological measures of cervical lordosis and head posture. Participants will be randomized to be fitted with and receive the Cervigard neck collar either immediately, or 6-weeks after being screened. Participants will complete neck pain and function questionnaires, and have cervical X-Rays collected at screening, treatment, 6 weeks, and 12 weeks (for the immediate group). Participants will be instructed to wear the collar every day for the duration of the trial. Self-reported neck pain and function measures will be collected, as well as cervical X-Rays, protocol adherence measures, and adverse events. The intervention is expected to reduce neck pain/discomfort, improve function, and improve cervical lordosis.

Official Title

Safety and Treatment Effect of a Novel Device for Neck Pain in Active-duty Military Personnel With Forward Head Posture.

Quick Facts

Study Start:2022-06-20
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05433025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * DEERS Eligible
  2. * Age 18 and 45 year old (inclusive)
  3. * Neck pain duration ≥ 3 months without neurological signs and have been seen by a provider.
  4. * Conventional treatments have not decreased neck pain
  5. * Neck pain ≥ 4 on a 0-10 point numerical rating scale (0 = "no pain", 10 = "maximum pain")
  6. * Forward head posture, indicated by forward placement of the head relative to the shoulders.
  1. * History of a tumor in the cervical spine and/or head/neck region within the past 6 months.
  2. * Infection involving the cervical spine and/or head/neck region within the past 6 months.
  3. * Generalized medical disorders that would weaken the vertebrae or other tissue structures within the cervical spine region.
  4. * Fracture that is acute and/or still healing
  5. * Spinal deformities (e.g. Fixed kyphosis, Ankylosing spondylosis)
  6. * Medical and/or psychological condition that would preclude safe participation

Contacts and Locations

Study Contact

Nathan Hogaboom, PhD
CONTACT
9733243584
nhogaboom@kesslerfoundation.org

Study Locations (Sites)

Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
United States

Collaborators and Investigators

Sponsor: Kessler Foundation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-20
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-06-20
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Neck Pain