Study Evaluating the Benefit of Dry Needling for Patients With Neck Pain

February 22, 2011 updated by: Integrated Therapy Practice PC

The Effectiveness of Dry Needling for Patients With Neck Pain: A Randomized Clinical Trial

The purpose of this study is to determine whether individuals with neck pain will respond favorably to a program of manual therapy, directed at the cervical and thoracic spine (including thrust manipulation), and exercise, in combination with dry needling, as compared to manual therapy, directed to the cervical and thoracic spine (including thrust manipulation), and an exercise program alone.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Hobart, Indiana, United States, 46342
        • Recruiting
        • Integrated therapy Practice PC
        • Contact:
        • Principal Investigator:
          • Rob Sillevis, PT,DPT,PhD
        • Sub-Investigator:
          • Joshua Cleland, PT,DPT,PhD

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18-60 years old
  2. Primary complaint of neck pain
  3. Restricted cervical extension/and or cervical rotation ROM
  4. Neck Disability Index > 20 points

Exclusion Criteria:

  1. Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, symptoms of vertebrobasilary insufficiency, pregnancy, cervical spinal stenosis, bilateral upper extremity symptoms etc.
  2. Use of blood thinners
  3. History of whiplash injury within the past six weeks
  4. Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.

  5. Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:

    • Muscle weakness involving a major muscle group of the upper extremity
    • Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps)
    • Diminished or absent sensation to pinprick in any upper extremity dermatome
  6. Prior surgery to the neck or thoracic spine
  7. Chiropractic, Physical Therapy, or Acupuncture treatment for their neck pain in the last 12-months
  8. Workers compensation or pending legal action regarding their headaches
  9. Insufficient English language skills to complete all questionnaires
  10. Inability to comply with treatment and follow-up schedule

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
neck disability index (NDI)
Time Frame: 4,12, 24 weeks
4,12, 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Global Rating of Change (GROC)
Time Frame: 4, 12, 24 weeks
4, 12, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Integrated Therapy Practice PC

Investigators

  • Principal Investigator: Rob Sillevis, PT,DPT,PhD, adjunct faculty University of St. Augustine for Health Sciences

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 Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

November 1, 2011

Study Completion (Anticipated)

March 1, 2012

Study Registration Dates

First Submitted

February 22, 2011

First Submitted That Met QC Criteria

February 22, 2011

First Posted (Estimate)

February 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 23, 2011

Last Update Submitted That Met QC Criteria

February 22, 2011

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UR-0922-129

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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