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Completed

NCT Number: NCT01168986

The Effectiveness of a Mechanical Manual Therapy Device in the Treatment of Neck Pain

This study is comparing the effectiveness of a mechanical manual therapy device to a specific exercise to no treatment in individuals experiencing neck pain. We are interested in the effects of the interventions on neck pain, disability related to neck pain, and pain sensitivity.

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Key information

Conditions

Neck Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • currently experiencing neck pain which does not extend below the elbow
  • pain at least 4/10 over the past 24 hours
  • appropriate for conservative management of neck pain
  • english speaking

Exclusion criteria

  • surgery to the neck within the past 6 months
  • systemic problem know to affect sensation
  • other chronic pain condition other than neck pain
  • neck pain as the result of trauma such as whiplash
  • neck pain as the result of a fracture

Treatment and study plan

Pulstar Multiple Impulse Therapy

Other

Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.

Exercise

Other

Participants perform an exercise to strengthen the deep neck flexors

Primary outcomes

  1. 2 Week Change in Pain Score on a Numeric Rating Scale

    Time frame: 2 weeks

    a 101 point numeric rating scale of neck pain with 0 indicating no pain at all and 100 indicating the worst pain imaginable

  2. 2 Week Change in Disability on the Neck Disability Index

    Time frame: 2 weeks

    A functional questionnaire (the neck disability index) to assess self report of disability related to neck pain. The neck disability index is a 10 item questionnaire assessing neck pain related disability. Items are scored from 0 to 5 with the total score doubled resulting in a final score from 0 to 100 with higher scores indicating higher levels of perceived disability.

  3. Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale

    Time frame: Immediate within session change pre to post intervention

    Participants rated the pain associated with a standardized (51 degrees Celsius) thermal stimulus applied to the plantar surface of their dominant foot using a 0 to 100 numeric pain rating scale with 0 indicating no pain at all and 100 indicating the most intense pain sensation imaginable.

Secondary outcomes

  1. Change From Baseline in Neck Extension Range of Motion at 2 Weeks

    Time frame: 2 weeks

    change in neck extension range of motion over a 2 week period

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jul 23, 2010
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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