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

NCT01168986 | Completed Phase 1 Results

• 1 other identifier: 340-2009
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neck Pain

Keywords

neck pain; manual therapy; exercise

Outcome Measures

Primary Outcomes (3)

• 2 Week Change in Pain Score on a Numeric Rating Scale

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

  2 weeks

• 2 Week Change in Disability on the Neck Disability Index

  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.

  2 weeks

• Immediate Change in Pain Sensitivity Using a Numeric Pain Rating Scale

  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.

  Immediate within session change pre to post intervention

Secondary Outcomes (1)

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

  2 weeks

Study Arms (3)

Pulstar Multiple Impulse Therapy

ACTIVE COMPARATOR

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

Other: Pulstar Multiple Impulse Therapy

Exercise

ACTIVE COMPARATOR

Participants perform an exercise to strengthen the deep neck flexors

Other: Exercise

No intervention

NO INTERVENTION

Participants receive/perform no intervention

Interventions

Pulstar Multiple Impulse Therapy OTHER

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

Pulstar Multiple Impulse Therapy

Exercise OTHER

Participants perform an exercise to strengthen the deep neck flexors

Exercise

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Neck Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Participants were individuals with neck pain responding to a study and not necessarily seeking care. As a result, the findings may not directly translate to individuals with neck pain seeking care from a healthcare provider.

Results Point of Contact

• Title: Joel Bialosky, PT, PhD
• Organization: University of Florida

jbialosky@phhp.ufl.edu

352-273-8636

Study Officials

• Joel E Bialosky, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 23, 2010
• Study Start: September 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 20, 2016
• Results First Posted: June 20, 2016

Record last verified: 2016-05

Locations

US (1)