Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Brooke Army Medical Center
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Change in Neck Disability Index (NDI)
Study Overview
Brief Summary
This study will assess the short term response of thoracic spinal manipulation with or without trigger point dry needling in 58 subjects with a primary complaint of mechanical neck pain.
Detailed Description
Neck pain is common, and return to duty rates after medical evacuation from theater for spinal pain is low. Muscles comprise the majority of the stability for the cervical spine, yet neck muscle function can be altered in the presence of pain. Research has consistently shown the benefit of including thoracic spine manipulation (SMT) in the treatment of patients with mechanical neck pain. Emerging evidence is now also showing promising benefit of including trigger point dry needling (TDN) for the treatment of mechanical neck pain. Treatment regimens commonly address anterior cervical stabilizing musculature, but little is known regarding the response to treatment of the deep posterior stabilizing musculature.
This study will assess the short term response of thoracic SMT with or without TDN in 58 subjects with a primary complaint of mechanical neck pain. Subjects will be randomized to receive 2 treatment visits approximately 2-3 days apart of either SMT+sham TDN or SMT+TDN. TDN will be directed to the upper trapezius and deep cervical extensor muscles of the neck. Outcomes of interest will be changes in function and pain. Assessments will be made at baseline, immediately after the first treatment, at the 2nd treatment, and approximately 5-7 days after the 2nd treatment visit. A subgroup of 20 subjects (10 per group) will also have the upper trapezius and deep cervical extensor muscle activation assessed via shear wave elastography, and deep cervical flexor activation assessed via the craniocervical flexion test.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18-64 years and eligible for military health care
- •Primary complaint of mechanical neck pain provoked by posture, movement or palpation of neck musculature, with or without unilateral upper extremity symptoms.
- •Presence of active trigger points in either the upper trapezius or deep cervical extensor muscles.
- •Able to make one initial appointment at the Army Medical Department Center and School at Fort Sam Houston, one treatment visit approximately 2-3 days after the initial visit, and then a final outcome visit approximately 5-7 days after 2nd visit.
- •No less than 10 points (0-50 range) on the Neck Disability Index.
Exclusion Criteria
- •Prior history of whiplash injury resulting in neck pain which required medical treatment.
- •Any prior physical therapy, chiropractic, acupuncture treatment or injections for neck pain within the past 3 months.
- •History of cervical spine surgery.
- •History of any systemic disorder in which thoracic spine manipulation and TDN would be contraindicated (i.e. osteoporosis, bleeding disorders or anticoagulant medication use)
- •Signs and symptoms consistent with nerve root compression (i.e. diminished upper extremity strength, sensation or reflexes), cervical artery insufficiency (i.e. nystagmus, gait disturbances, Horner Syndrome) or upper cervical ligament instability (i.e. Sharp-Purser, alar ligament, transverse ligament tests).
- •Current primary complaint of headaches
- •Pending legal action regarding their neck pain
- •Inability to read and understand English
- •Females known or thought to be pregnant
Arms & Interventions
SMT and TDN
Thoracic spinal manipulation and trigger point dry needling using Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.
Intervention: Thoracic spinal manipulation (Procedure)
SMT and TDN
Thoracic spinal manipulation and trigger point dry needling using Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.
Intervention: Trigger point dry needling (Procedure)
SMT and TDN
Thoracic spinal manipulation and trigger point dry needling using Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.
Intervention: Cervical range of motion exercises (Behavioral)
SMT and TDN
Thoracic spinal manipulation and trigger point dry needling using Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.
Intervention: Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm (Device)
SMT and TDN
Thoracic spinal manipulation and trigger point dry needling using Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.
Intervention: Posterior neck muscle activation exercise (Behavioral)
SMT and Sham TDN
Thoracic spinal manipulation and trigger point dry needling sham. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.
Intervention: Thoracic spinal manipulation (Procedure)
SMT and Sham TDN
Thoracic spinal manipulation and trigger point dry needling sham. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.
Intervention: Cervical range of motion exercises (Behavioral)
SMT and Sham TDN
Thoracic spinal manipulation and trigger point dry needling sham. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.
Intervention: Posterior neck muscle activation exercise (Behavioral)
SMT and Sham TDN
Thoracic spinal manipulation and trigger point dry needling sham. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise.
Intervention: Trigger point dry needling sham (Procedure)
Outcomes
Primary Outcomes
Change in Neck Disability Index (NDI)
Time Frame: Change in NDI at 7-10 days
The NDI is a revised form of the Oswestry Low Back Pain Index. It is designed to measure the activities of daily living in persons with neck pain.
Change in Neck Disability Index (NDI)
Time Frame: Change in NDI from baseline to 2-3 days
The NDI is a revised form of the Oswestry Low Back Pain Index. It is designed to measure the activities of daily living in persons with neck pain.
Secondary Outcomes
- Change in Numeric Pain Rating Scale (NPRS)(7-10 days)
- Change in Deep Neck Flexor (DNF) Activation(7-10 days)
- Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.(7-10 days)
- Global Rate of Change (GRC)(7-10 days)
- Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)(7-10 days)
- Change in Numeric Pain Rating Scale (NPRS)(Change in pain from baseline to 2-3 days)
- Global Rate of Change (GRC)(2-3 days)
- Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)(Day 1 pre and post intervention)
- Change in Deep Neck Flexor (DNF) Activation(Day 1 pre and post intervention)
- Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.(Day 1 pre and post intervention)
Investigators
Brian Young
Assistant Professor, Army-Baylor Doctoral Program in PT
Brooke Army Medical Center