An interventional study of Dry Needling and Sham Dry Needling in Neck Pain, sponsored by Franklin Pierce University. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-18.
Sponsored by Franklin Pierce University · Not applicable, Interventional, and Treatment
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 attending physical therapy. The investigators hypothesize that patients who receive dry needling, manual therapy, and exercise will achieve greater reductions in pain and disability in the short (4 weeks) and long term (6 and 12 months) compared to those who receive sham dry needling, manual therapy, and exercise.
Background: 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 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.
1,232 studies on the registry are indexed under Neck Pain; 254 are open to participants now.
This study's enrollment of 77 is above the median of 52 across 1,004 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →Franklin Pierce University is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
Dry Needling, Manual Therapy, and Exercise.
Other: Dry Needling · Other: Manual Therapy · Other: Exercise
Sham Dry Needling, Manual Therapy, and Exercise.
Other: Sham Dry Needling · Other: Manual Therapy · Other: Exercise
Dry Needling targeting the posterior musculature of the cervical and thoracic spine.
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(mobilization/ manipulation) to address joint mobility of the cervical and thoracic spine.
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.
Change from baseline on the Neck Disability Index (NDI)
The Neck Disability Index (NDI) was created to measure pain related disability associated with activities of daily living in people with neck pain. The NDI contains ten focused sections. The NDI is easy to complete and score. Each item is scored on a 6 point scale and can reach a maximum score of 5; therefore, the maximum score is 50. This score will calculated as a percentage, with higher scores indicating higher levels of disability.
Time frame: 4 weeks, 6 months, 12 months
Change from baseline on The Global Rating Of Change Scale (GROC)
The GROC is a 15-point scale used to quantify a patient's improvement with treatment or to record the clinical course of a condition over time. Patients are asked to describe their overall condition since the start of treatment until the present time with options ranging from -7 ("a very great deal worse") to +7 ("a very great deal better") and 0 being described as "about the same."
Time frame: 4 weeks, 6 months, 12 months
Questionnaire used to assess blinding of patients to which needling intervention they received
Used to assess blinding of patients as to which dry needling intervention the received (real or sham).
Time frame: 4 weeks
Change from baseline on the Visual Analog Scale (VAS) Pain
The VAS is a single item measure of pain using a 100 mm horizontal line anchored on the left side of which represents "no pain" and the right side represents "the worst pain imaginable". The VAS will be used to calculate change in pain score from baseline to 4 weeks, 6 months, and 12 months.
Time frame: 4 weeks, 6 months, 12 months
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Franklin Pierce University