Neck PainNCT01301170
Study Evaluating the Benefit of Dry Needling for Patients With Neck Pain
A study testing dry needling in people with Neck Pain, run by Integrated Therapy Practice PC at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain
- What is being tested?
- dry needling
- Type of treatment
- Surgery or procedure
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-60 years old
- Primary complaint of neck pain
- Restricted cervical extension/and or cervical rotation ROM
- Neck Disability Index > 20 points
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Integrated Therapy Practice PC
Hobart, Indiana, 46342
Rob Sillevis, PT, DPT, PhD, 219-945-1538, r.sillevis@comcast.net
Rob Sillevis, PT,DPT,PhD
About this study
Official title: The Effectiveness of Dry Needling for Patients With Neck Pain: A Randomized Clinical Trial
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.
- Conditions
- Neck Pain
- Being tested
- dry needling
- Keywords
- Neck pain, Dry Needling, Manual Therapy, Manipulation
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dry needlingProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
neck disability index (NDI)
Measured: 4,12, 24 weeks
Secondary outcomes (1)
Patient Global Rating of Change (GROC)
Measured: 4, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2011 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrated Therapy Practice PC
- Sponsor type
- University, hospital or other
- Investigators
- Rob Sillevis, PT,DPT,PhD, Principal investigator, adjunct faculty University of St. Augustine for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301170
- Sponsor's protocol ID
- UR-0922-129
- Status last verified
- Feb 2011
- First submitted
- 22 Feb 2011
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dry Needling for Patients With Neck Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01301170
- Acronym / sponsor ID
- UR-0922-129
- Conditions
- Neck Pain
- Keywords
- Neck pain, Dry Needling, Manual Therapy, Manipulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Integrated Therapy Practice PCUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 23 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18-60 years old
- Primary complaint of neck pain
- Restricted cervical extension/and or cervical rotation ROM
- Neck Disability Index > 20 points
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dry needlingThe 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. | Procedure or surgery | – |
Primary outcome
neck disability index (NDI)
Time frame: 4,12, 24 weeks
1 secondary outcome
Patient Global Rating of Change (GROC)
Time frame: 4, 12, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Sillevis, PT,DPT,PhD principal investigator
adjunct faculty University of St. Augustine for Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dry needling in people with Neck Pain, run by Integrated Therapy Practice PC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neck disability index (NDI) (time frame: 4,12, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2011.