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

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01301170
• Other study ID #: UR-0922-129
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2011
• Last updated: February 22, 2011
• Start date: February 2011
• Est. completion date: March 2012

Study information

• Verified date: February 2011
• Source: Integrated Therapy Practice PC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: March 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

Procedure:
• dry needling
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.

Locations

Country	Name	City	State
United States	Integrated Therapy Practice PC	Hobart	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Integrated Therapy Practice PC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neck disability index (NDI)		4,12, 24 weeks	No
Secondary	Patient Global Rating of Change (GROC)		4, 12, 24 weeks	No