NCT01301170

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

February 23, 2011

Status Verified

February 1, 2011

Enrollment Period

9 months

First QC Date

February 22, 2011

Last Update Submit

February 22, 2011

Conditions

Neck Pain

Keywords

Neck painDry NeedlingManual TherapyManipulation

Outcome Measures

Primary Outcomes (1)

  • neck disability index (NDI)

    4,12, 24 weeks

Secondary Outcomes (1)

  • Patient Global Rating of Change (GROC)

    4, 12, 24 weeks

Interventions

dry needlingPROCEDURE

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-60 years old
  • Primary complaint of neck pain
  • Restricted cervical extension/and or cervical rotation ROM
  • Neck Disability Index \> 20 points

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Integrated Therapy Practice PC

Hobart, Indiana, 46342, United States

RECRUITING

MeSH Terms

Conditions

Neck Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Rob Sillevis, PT,DPT,PhD

    adjunct faculty University of St. Augustine for Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 23, 2011

Study Start

February 1, 2011

Primary Completion

November 1, 2011

Study Completion

March 1, 2012

Last Updated

February 23, 2011

Record last verified: 2011-02

Locations

US(1)