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

Primary Purpose

Neck Pain

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
dry needling
Sponsored by
Integrated Therapy Practice PC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck pain, Dry Needling, Manual Therapy, Manipulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Integrated Therapy Practice PCRecruiting

Outcomes

Primary Outcome Measures

neck disability index (NDI)

Secondary Outcome Measures

Patient Global Rating of Change (GROC)

Full Information

First Posted
February 22, 2011
Last Updated
February 22, 2011
Sponsor
Integrated Therapy Practice PC
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1. Study Identification

Unique Protocol Identification Number
NCT01301170
Brief Title
Study Evaluating the Benefit of Dry Needling for Patients With Neck Pain
Official Title
The Effectiveness of Dry Needling for Patients With Neck Pain: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Integrated Therapy Practice PC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck pain, Dry Needling, Manual Therapy, Manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
dry needling
Intervention Description
The needling will take place bilaterally at both the suboccipital region and the paravertebral muscles between C4 and T4. The needling will take place with the patient in the prone position. Following all needle placement, they will rotated clockwise till the point that tension on the needle is felt by the therapist. This will create more tension between the needle and tissue fibers, after which the needles were removed.
Primary Outcome Measure Information:
Title
neck disability index (NDI)
Time Frame
4,12, 24 weeks
Secondary Outcome Measure Information:
Title
Patient Global Rating of Change (GROC)
Time Frame
4, 12, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 18-60 years old Primary complaint of neck pain Restricted cervical extension/and or cervical rotation ROM Neck Disability Index > 20 points Exclusion Criteria: 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. Use of blood thinners History of whiplash injury within the past six weeks 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. 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 Prior surgery to the neck or thoracic spine Chiropractic, Physical Therapy, or Acupuncture treatment for their neck pain in the last 12-months Workers compensation or pending legal action regarding their headaches Insufficient English language skills to complete all questionnaires Inability to comply with treatment and follow-up schedule
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob Sillevis, PT,DPT,PhD
Organizational Affiliation
adjunct faculty University of St. Augustine for Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrated Therapy Practice PC
City
Hobart
State/Province
Indiana
ZIP/Postal Code
46342
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rob Sillevis, PT, DPT, PhD
Phone
219-945-1538
Email
r.sillevis@comcast.net
First Name & Middle Initial & Last Name & Degree
Rob Sillevis, PT,DPT,PhD
First Name & Middle Initial & Last Name & Degree
Joshua Cleland, PT,DPT,PhD

12. IPD Sharing Statement

Learn more about this trial

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

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