Clinical trial NCT01301170: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Keywords: Neck pain
Dry Needling
Manual Therapy
Manipulation
Lead sponsor: Integrated Therapy Practice PC
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: neck disability index (NDI)
timeFrame: 4,12, 24 weeks
Secondary outcomes:
measure: Patient Global Rating of Change (GROC)
timeFrame: 4, 12, 24 weeks
Other outcomes:
Locations:
city: Hobart
country: United States
facility: Integrated Therapy Practice PC
state: Indiana
Study officials:
affiliation: adjunct faculty University of St. Augustine for Health Sciences
name: Rob Sillevis, PT,DPT,PhD
role: PRINCIPAL_INVESTIGATOR
References: