An interventional study of Ultrasound-guided electrical dry needling and Conventional Physical Therapy in Cervical Radiculopathy, sponsored by Liberty University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Liberty University · Not applicable, Interventional, and Treatment
This randomized controlled trial aims to investigate whether ultrasound-guided electrical dry needling with conventional physical therapy is more effective than conventional physical therapy alone in the following outcome measures: disability (Neck Disability Index and Upper Extremity Functional Index-20), average pain over the last 24 hours (Numeric Pain Rating Scale), paraspinal mechanosensitivity (pain-pressure threshold), cervical ipsilateral rotation range-of-motion, and medication intake.
Chronic cervical radiculopathy (CRAD) is a debilitating condition with often multi-year morbidity that may often appear recalcitrant to conservative management options, resulting in a high surgical rate and warranting further investigation of adjunct interventions in physical therapy (PT). Ultrasound-guided electrical dry needling (USEDN) is postulated to reduce pain and disability by reducing inflammatory cytokines and neuropeptide expression, improving the mechanochemical environment of the paraspinals, facilitating changes ion channel expression (e.g., P2X3), and improving central inhibition. Therefore, this study proposes a single-site and single-blinded randomized controlled trial (RCT) with an intention-to-treat (ITT) analysis to assess the clinical efficacy of ultrasound-guided electrical dry needling (USEDN) to the cervical multifidus and lamina as an adjunct to conventional physical therapy (CPT) versus CPT alone.
The Neck Disability Index (NDI), Upper Extremity Functional Index-20 (UEFI-20), Numeric Pain Rating Scale (NPRS), pain-pressure threshold (PPT) of the cervical paraspinals, and ipsilateral cervical rotation will be measured at baseline, two weeks, and four weeks and analyzed via a 2-by-3 analysis of covariance (ANCOVA) with symptom duration as the covariate. Medication intake will be measured at baseline and four weeks and analyzed via chi-square (χ²) tests.
The results of this study will contribute to a growing body of literature on perineural and periosteal dry needling for predominantly peripheral neurogenic pain syndromes.
504 studies on the registry are indexed under Radiculopathy; 147 are open to participants now.
This study's planned enrollment of 58 is close to the median of 60 across 390 interventional studies indexed under Radiculopathy.
Browse Radiculopathy studies →Liberty University is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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The participants in this group will receive 30 minutes of ultrasound-guided electrical dry needling to the cervical multifidi and lamina. The participant will then proceed to participate in conventional physical therapy (e.g., stretching, strengthening, joint mobilization, neural mobilization)
Procedure: Ultrasound-guided electrical dry needling · Procedure: Conventional Physical Therapy
Participants in this group will only perform conventional physical therapy exercises. Prescription will be governed by the participants' reported severity and irritability within the SINSS protocol, offering a means of standardizing care across differing participant presentations.
Procedure: Conventional Physical Therapy
With ultrasound guidance using sterile gel, between 40mm and 60mm by 0.30mm diameter J-SEIRIN needles will be inserted lateral to medial at a 45 to 60 degree angle to the laminas from C5 to T1. Needles will be angled inferiorly by 10 degrees secondary to the perched nature of the cervical vertebra. Needles (n=4) will be left in situ for 30 minutes with electrical stimulation at low frequency (2 Hz) and moderate pulse duration (250 microseconds) via an ITO ES-160 at the maximum tolerable intensity. Electrical stimulation will be coupled with manual manipulation via four clockwise 360-degree turns every five minutes as tolerated.
Classification of patients into high, moderate, and low severity and irritability groups will be done within the severity and irritability components of the SINSS protocol. Severity and irritability levels will be assessed at the start of each visit to guide CPT prescription. If these levels differ, then the allotted interventions will be the more conservative option. CPT will incorporate stretching, graded cervical and periscapular exercises, joint mobilization, and neural mobilization at different intensities per their respective severity and irritability.
Neck Disability, as Measured by the Neck Disability Index, from Baseline to Two and Four Weeks
The Neck Disability Index measures cervical pain and disability through 10 questions regarding pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreational activity with a minimum score of 0 points (i.e., 0% disability) and a maximum score of 50 points (i.e., 100% disability). These components provide insight into perceived severity, functional independence, lifting tolerance, sustained positional tolerance, cognitive functioning, occupational functioning, sleep, and participation in personally meaningful activities.
Time frame: Baseline, two weeks, and four weeks
Upper Extremity Disability, as Measured by the Upper Extremity Functional Index-20, from Baseline to Two and Four Weeks
The Upper Extremity Functional Index-20 was developed through analysis of patient responses on existing questionnaires, namely the Patient Specific Functional Scale. It measures upper extremity functional capacity through a 20-item questionnaire with a maximum score of 80 (i.e., 0% disability) and a minimum score of 0 (i.e., 100% disability). Components include perceived disability related to lifting, reaching, carrying, dressing, household-level activities, and occupational participation related specifically to upper extremity problems
Time frame: Baseline, two weeks, and four weeks
Pain Over the Last 24 Hours, as Measured by the Numeric Pain Rating Scale, from Baseline to Two and Four Weeks
The NPRS offers a subjective report on pain and is scaled from 0 (no pain) to 10 (the worst pain imaginable). This measure captures the patients' subjective report of pain intensity over the last 24 hours.
Time frame: Baseline, two weeks, and four weeks
Cervical Paraspinal Pain Pressure Threshold, as Measured by a Pain-Pressure Algometer, from Baseline to Two and Four Weeks
A pain-pressure algometer will be used to measure pain-pressure threshold: the minimum amount of pressure used to produce pain. This study will use a Wagner FPX 50 that was calibrated on February 11, 2025, with an accuracy of plus or minus 0.3% of full scale.
Time frame: Baseline, two weeks, and four weeks
Cervical Ipsilateral Rotation Active Range of Motion, as Measured by Universal Goniometry, from Baseline to Two and Four Weeks
Ipsilateral cervical spine rotation will be measured via universal goniometry with the patient seated, the axis of rotation at the center of the cranial aspect of the head, the stationary arm aligned with an imaginary line between the two acromions, and the movement arm aligned with the tip of the nose.
Time frame: Baseline, two weeks, and four weeks
Cervical Radiculopathy Medication Intake, via Paper Format that Categorizes Intake Frequency, from Baseline to Four Weeks
This research categorizes medication intake into five options: (1) = not at all, (2) once a week, (3) once every couple of days, (4) once or twice a day, and (5) three or more times a day. Participants will report only the medications that they are taking specific for their cervical radiculopathy symptoms.
Time frame: Baseline and four weeks.
Plan to share: Yes — De-identified individual participant data underlying the published results, along with the study protocol and statistical analysis plan, will be available immediately after publication and for 3 years via Microsoft Excel.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Immediately after publication (start date) Three years (end date)
Access criteria: Data will be shared with researchers who submit a methodologically sound proposal via a data use agreement. Requests should be directed to the principal investigator.
Started Nov 2026 (actual). Primary completion is estimated for Dec 2027, 13 months after the start.
Of 218 non-industry interventional studies with no phase under Radiculopathy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 41. This study's planned 13 months is close to that.
Counting every sponsor, half of 228 studies reached it within 12 months; a quarter within 5 and three quarters within 48.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 4, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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