Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
77 participants
INTERVENTIONAL
2016-09-30
2019-09-30
Brief Summary
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Detailed Description
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Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues, and muscle with the intent to mechanically disrupt tissue without the use of an anesthetic. Dry needling is emerging as a treatment modality that is widely used clinically to address a variety of musculoskeletal conditions. Recent studies of dry needling in mechanical neck pain have shown decreased pain, increased pain pressure threshold, improved range of motion, and decreased disability in the short term. The majority of these studies examined dry needling using methods atypical to clinical practice (dry needling as a sole treatment, or fewer visits than is common practice). None included long-term follow up. A clinical trial with realistic treatment time frames and methods consistent with clinical practice is needed to examine the effectiveness of dry needling on reducing pain and enhancing function in patients presenting with mechanical neck pain.
Purpose: The aim of this trial will be to examine the short and long term effectiveness of dry needling on pain, disability, and patient perceived improvements in patients with neck pain.
Design: The investigators will conduct a randomized single blind placebo controlled trial in accordance with the CONSORT guidelines. All patients with mechanical neck pain referred to physical therapy will be screened for eligibility criteria. Participants will be randomized to receive 1) dry needling, manual therapy, and exercise or 2) sham dry needling, manual therapy and exercise. Participants will receive 7 treatments over a maximum of 4 weeks.
Methods: The primary outcome will be disability as measured by the Neck Disability Index. Pain and patient perceived improvement will also be recorded. Outcome measures will be assessed at 4 weeks, 6 months, and 12-months by an assessor who is blind to the group allocation of the participants to determine the short and long-term treatment effects.
Data Analysis: The investigators will examine the primary aim with a 2-way repeated-measures analysis of variance (ANOVA) with treatment group as the between subject variable and time as the within-subjects variable. The hypothesis of interest will be the 2-way group by time interaction.
Significance: The successful completion of this trial will provide evidence to demonstrate whether dry needling is effective for the management of mechanical neck pain when used in a combined treatment approach as is commonly practiced clinically.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dry Needling Group
Dry Needling, Manual Therapy, and Exercise.
Dry Needling
Dry Needling targeting the posterior musculature of the cervical and thoracic spine.
Manual Therapy
Manual Therapy(mobilization/ manipulation) to address joint mobility of the cervical and thoracic spine.
Exercise
Exercise designed to improve performance of both the deep neck flexor musculature as well as the scapular musculature. The exercise portion will also include a stretching program targeting the cervicothoracic muscles which have been placed in a shortened position as a result of poor postures.
Sham Dry Needling Group
Sham Dry Needling, Manual Therapy, and Exercise.
Sham Dry Needling
Sham Dry Needling performed with Park sham acupuncture needles (Acuprime, UK) will be used to perform sham dry-needling. The device consists of 2 plastic tubes that slide into one another and cause a pricking sensation when pushed against the skin.
Manual Therapy
Manual Therapy(mobilization/ manipulation) to address joint mobility of the cervical and thoracic spine.
Exercise
Exercise designed to improve performance of both the deep neck flexor musculature as well as the scapular musculature. The exercise portion will also include a stretching program targeting the cervicothoracic muscles which have been placed in a shortened position as a result of poor postures.
Interventions
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Dry Needling
Dry Needling targeting the posterior musculature of the cervical and thoracic spine.
Sham Dry Needling
Sham Dry Needling performed with Park sham acupuncture needles (Acuprime, UK) will be used to perform sham dry-needling. The device consists of 2 plastic tubes that slide into one another and cause a pricking sensation when pushed against the skin.
Manual Therapy
Manual Therapy(mobilization/ manipulation) to address joint mobility of the cervical and thoracic spine.
Exercise
Exercise designed to improve performance of both the deep neck flexor musculature as well as the scapular musculature. The exercise portion will also include a stretching program targeting the cervicothoracic muscles which have been placed in a shortened position as a result of poor postures.
Eligibility Criteria
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Inclusion Criteria
2. Primary complaint of neck pain
3. Neck Disability Index \> 10 points=20%
Exclusion Criteria
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 neck pain
9. Insufficient English language skills to complete all questionnaires
10. Inability to comply with treatment and follow-up schedule
18 Years
ALL
No
Sponsors
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Newcastle University
OTHER
Concord Hospital
OTHER
Franklin Pierce University
OTHER
Responsible Party
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Joshua Cleland, DPT, OCS
Professor of Physical Therapy
Locations
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Franciscan, ST.Francis Health
Indianapolis, Indiana, United States
Concord Hospital Rehabilitation Services
Concord, New Hampshire, United States
Countries
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References
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Gattie ER, Cleland JA, Snodgrass SJ. Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial. JMIR Res Protoc. 2017 Nov 22;6(11):e227. doi: 10.2196/resprot.7980.
Other Identifiers
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HIC 15-6
Identifier Type: -
Identifier Source: org_study_id