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      Dry Needling for Patients With Neck Pain: Protocol of a Randomized Clinical Trial

      , PT 1 , , , PT, PhD 2 , , PT, PhD 3
      (Reviewer), (Reviewer), (Reviewer)
      JMIR Research Protocols
      JMIR Publications
      neck pain, dry needling, physical therapy

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          Neck pain is a costly and common problem. Current treatments are not adequately effective for a large proportion of patients who continue to experience recurrent pain. Therefore, new treatment strategies should be investigated in an attempt to reduce the disability and high costs associated with neck pain. 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 suggest potential benefits, but do not utilize methods typical to clinical practice and lack long-term follow-up. Therefore, 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 to physical therapy with mechanical neck pain.


          The aim of this trial will be to examine the short- and long-term effectiveness of dry needling delivered by a physical therapist on pain, disability, and patient-perceived improvements in patients with mechanical neck pain.


          We will conduct a randomized, double-blind, placebo-controlled trial in accordance with the CONSORT guidelines. A total of 76 patients over the age of 18 with acute or chronic mechanical neck pain resulting from postural dysfunction, trauma, or insidious onset who are referred to physical therapy will be enrolled after meeting the eligibility criteria. Subjects will be excluded if they have previous history of surgery, whiplash in the last 6 weeks, nerve root compression, red flags, or contraindications to dry needling or manual therapy. 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 seven physical therapy treatments lasting 45 minutes each over a maximum of 4 weeks. The primary outcome will be disability as measured by the Neck Disability Index. Secondary outcomes include the following: pain, patient-perceived improvement, patient expectations, and successful blinding to the needling intervention. 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. We will examine the primary aim with a two-way, repeated-measures analysis of variance with treatment group as the between-subjects variable and time as the within-subjects variable. The hypothesis of interest will be the two-way group by time interaction. An a priori alpha level of .05 will be used for all analyses.


          Recruitment is currently underway and is expected to be completed by the end of 2017. Data collection for long-term outcomes will occur throughout 2017 and 2018. Data analysis, preparation, and publication submission is expected to occur throughout the final three quarters of 2018.


          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 the common clinical practice.

          Trial Registration

          ClinicalTrials.gov NCT02731014; https://clinicaltrials.gov/ct2/show/NCT02731014 (Archived by WebCite at http://www.webcitation.org/6ujZgbhsq)

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          Most cited references61

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          Measurement of health status. Ascertaining the minimal clinically important difference.

          In recent years quality of life instruments have been featured as primary outcomes in many randomized trials. One of the challenges facing the investigator using such measures is determining the significance of any differences observed, and communicating that significance to clinicians who will be applying the trial results. We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change. Using this approach we have established a plausible range within which the minimal clinically important difference (MCID) falls. In three studies in which instruments measuring dyspnea, fatigue, and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item, when responses were presented on a seven point Likert scale. Furthermore, we have established ranges for changes in questionnaire scores that correspond to moderate and large changes in the domains of interest. This information will be useful in interpreting questionnaire scores, both in individuals and in groups of patients participating in controlled trials, and in the planning of new trials.
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            Expenditures and health status among adults with back and neck problems.

            Back and neck problems are among the symptoms most commonly encountered in clinical practice. However, few studies have examined national trends in expenditures for back and neck problems or related these trends to health status measures. To estimate inpatient, outpatient, emergency department, and pharmacy expenditures related to back and neck problems in the United States from 1997 through 2005 and to examine associated trends in health status. Age- and sex-adjusted analysis of the nationally representative Medical Expenditure Panel Survey (MEPS) from 1997 to 2005 using complex survey regression methods. The MEPS is a household survey of medical expenditures weighted to represent national estimates. Respondents were US adults (> 17 years) who self-reported back and neck problems (referred to as "spine problems" based on MEPS descriptions and International Classification of Diseases, Ninth Revision, Clinical Modification definitions). Spine-related expenditures for health services (inflation-adjusted); annual surveys of self-reported health status. National estimates were based on annual samples of survey respondents with and without self-reported spine problems from 1997 through 2005. A total of 23 045 respondents were sampled in 1997, including 3139 who reported spine problems. In 2005, the sample included 22 258 respondents, including 3187 who reported spine problems. In 1997, the mean age- and sex-adjusted medical costs for respondents with spine problems was $4695 (95% confidence interval [CI], $4181-$5209), compared with $2731 (95% CI, $2557-$2904) among those without spine problems (inflation-adjusted to 2005 dollars). In 2005, the mean age- and sex- adjusted medical expenditure among respondents with spine problems was $6096 (95% CI, $5670-$6522), compared with $3516 (95% CI, $3266-$3765) among those without spine problems. Total estimated expenditures among respondents with spine problems increased 65% (adjusted for inflation) from 1997 to 2005, more rapidly than overall health expenditures. The estimated proportion of persons with back or neck problems who self-reported physical functioning limitations increased from 20.7% (95% CI, 19.9%-21.4%) to 24.7% (95% CI, 23.7%-25.6%) from 1997 to 2005. Age- and sex-adjusted self-reported measures of mental health, physical functioning, work or school limitations, and social limitations among adults with spine problems were worse in 2005 than in 1997. In this survey population, self-reported back and neck problems accounted for a large proportion of health care expenditures. These spine-related expenditures have increased substantially from 1997 to 2005, without evidence of corresponding improvement in self-assessed health status.
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              The burden and determinants of neck pain in the general population: results of the Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders.

              Best evidence synthesis. To undertake a best evidence synthesis of the published evidence on the burden and determinants of neck pain and its associated disorders in the general population. The evidence on burden and determinants of neck has not previously been summarized. The Bone and Joint Decade 2000-2010 Task Force on Neck Pain and Its Associated Disorders performed a systematic search and critical review of literature published between 1980 and 2006 to assemble the best evidence on neck pain. Studies meeting criteria for scientific validity were included in a best evidence synthesis. We identified 469 studies on burden and determinants of neck pain, and judged 249 to be scientifically admissible; 101 articles related to the burden and determinants of neck pain in the general population. Incidence ranged from 0.055 per 1000 person years (disc herniation with radiculopathy) to 213 per 1000 persons (self-reported neck pain). Incidence of neck injuries during competitive sports ranged from 0.02 to 21 per 1000 exposures. The 12-month prevalence of pain typically ranged between 30% and 50%; the 12-month prevalence of activity-limiting pain was 1.7% to 11.5%. Neck pain was more prevalent among women and prevalence peaked in middle age. Risk factors for neck pain included genetics, poor psychological health, and exposure to tobacco. Disc degeneration was not identified as a risk factor. The use of sporting gear (helmets, face shields) to prevent other types of injury was not associated with increased neck injuries in bicycling, hockey, or skiing. Neck pain is common. Nonmodifiable risk factors for neck pain included age, gender, and genetics. Modifiable factors included smoking, exposure to tobacco, and psychological health. Disc degeneration was not identified as a risk factor. Future research should concentrate on longitudinal designs exploring preventive strategies and modifiable risk factors for neck pain.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications (Toronto, Canada )
                November 2017
                22 November 2017
                : 6
                : 11
                : e227
                [1] 1 Rehabilitation Services Concord Hospital Concord, NH United States
                [2] 2 Physical Therapy Program Franklin Pierce University Manchester, NH United States
                [3] 3 University of Newcastle Callaghan Australia
                Author notes
                Corresponding Author: Eric Robert Gattie ericgattie@ 123456gmail.com
                Author information
                ©Eric Robert Gattie, Joshua A Cleland, Suzanne J Snodgrass. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.11.2017.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 29 May 2017
                : 12 July 2017
                : 21 August 2017
                : 21 August 2017

                neck pain,dry needling,physical therapy
                neck pain, dry needling, physical therapy


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