Study Evaluating the Benefit of Dry Needling for Patients... | NCT01301170

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

NCT01301170

Sponsor

Integrated Therapy Practice PC

Status

Unknown status

Last Update Posted

Feb 23, 2011Estimated

Enrollment

66Estimated

Phase

Not Applicable

Conditions

Neck Pain

Interventions

dry needling

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Nov 2011Estimated

Completion Date

Mar 2012Estimated

First Submitted Date

Feb 22, 2011

First Submission Date that Met QC Criteria

Feb 22, 2011

First Posted Date

Feb 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2011

Last Update Posted Date

Feb 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

66Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dry needling	Procedure	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.

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

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities