Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain: A Randomized Clinical Trial

Conditions
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Neck Pain

Intervention / Treatment
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* Procedure: Thoracic spinal manipulation
* Procedure: Trigger point dry needling
* Behavioral: Cervical range of motion exercises
* Behavioral: Posterior neck muscle activation exercise
* Procedure: Trigger point dry needling sham
* Device: Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SMT and TDN<br>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. | Procedure: Thoracic spinal manipulation<br>* All patients will receive 3 different thrust joint manipulations to the middle and upper thoracic spine region. Each technique will be applied up to 2 times, per the discretion of the treating therapist discretion<br>Procedure: Trigger point dry needling<br>* The TDN treatment will consist of a trained investigator inserting a needle through the participant's skin, into the deep cervical extensor muscles and/or the upper trapezius muscles using FDA approved (FDA regulation # 880.5580) disposable 0.2-0.3 x 40-50 mm stainless steel Seirin J-type needles (Seirin, Japan). Those subjects randomized to TDN will undergo this treatment.<br>Behavioral: Cervical range of motion exercises<br>* The patient will be instructed to place 5 fingers along the manubrium, and to flex the neck down until the chin touches the fingers. The patient will then be instructed to rotate the head as far as comfortably possible to one side, and then to the other side for 10 repetitions to each side, 3-4 times per day. The patient will progress from 5 fingers, to 4, 3, 2 and eventually 1 finger as neck mobility improves.<br>Behavioral: Posterior neck muscle activation exercise<br>* The patient will be instructed to sit upright in a chair, and place 1-2 fingers over the C2 spinous process. Education to localize this landmark will be provided. The patient will then perform an isometric chin tuck exercise against the resistance they will apply at C2. This position will be held x 5 seconds and repeated 10 times, 3-4 times per day.<br>Device: Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm<br>* A trained investigator will insert the needle through the participants skin into the deep cervical extensors and/or the upper trapezius muscles. Needles are FDA approved (#880.5580)<br>|
| Sham Comparator: SMT and Sham TDN<br>Thoracic spinal manipulation and trigger point dry needling sham. Exercise program consists of cervical range of motion exercises and posterior neck muscle activation exercise. | Procedure: Thoracic spinal manipulation<br>* All patients will receive 3 different thrust joint manipulations to the middle and upper thoracic spine region. Each technique will be applied up to 2 times, per the discretion of the treating therapist discretion<br>Behavioral: Cervical range of motion exercises<br>* The patient will be instructed to place 5 fingers along the manubrium, and to flex the neck down until the chin touches the fingers. The patient will then be instructed to rotate the head as far as comfortably possible to one side, and then to the other side for 10 repetitions to each side, 3-4 times per day. The patient will progress from 5 fingers, to 4, 3, 2 and eventually 1 finger as neck mobility improves.<br>Behavioral: Posterior neck muscle activation exercise<br>* The patient will be instructed to sit upright in a chair, and place 1-2 fingers over the C2 spinous process. Education to localize this landmark will be provided. The patient will then perform an isometric chin tuck exercise against the resistance they will apply at C2. This position will be held x 5 seconds and repeated 10 times, 3-4 times per day.<br>Procedure: Trigger point dry needling sham<br>* The sham group will receive a simulated TDN. Using a toothpick in a needle guide-tube, the investigator will tap, rest, and twist the toothpick for approximately 30 seconds in the same 2 muscles, 2 sites in each muscle. The sham treatment will not penetrate the skin.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neck Disability Index (NDI) | 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 NDI from baseline to 2-3 days | 
| Change in Neck Disability Index (NDI) | 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 NDI at 7-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Numeric Pain Rating Scale (NPRS) | An 11-point NPRS will be used to measure pain intensity. The scale is anchored on the left with the phrase No Pain and on the right with the phrase Worst Imaginable Pain. | Change in pain from baseline to 2-3 days | 
| Change in Numeric Pain Rating Scale (NPRS) | An 11-point NPRS will be used to measure pain intensity. The scale is anchored on the left with the phrase No Pain and on the right with the phrase Worst Imaginable Pain. | 7-10 days | 
| Global Rate of Change (GRC) | The GRC assesses subjective perception of overall change over time and the importance of that change. A 15-point Likert type scale ranging from -7 (very great deal worse) to +7 (a very great deal better) will be used. | 2-3 days | 
| Global Rate of Change (GRC) | The GRC assesses subjective perception of overall change over time and the importance of that change. A 15-point Likert type scale ranging from -7 (very great deal worse) to +7 (a very great deal better) will be used. | 7-10 days | 
| Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE) | Shear-Wave Elastography (SWE) is an evolving technology that uses advanced ultrasound imaging to quantify tissue stiffness (i.e., elasticity). This technology will be utilized to assess change in passive muscle activation response to treatment. | Day 1 pre and post intervention | 
| Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE) | Shear-Wave Elastography (SWE) is an evolving technology that uses advanced ultrasound imaging to quantify tissue stiffness (i.e., elasticity). This technology will be utilized to assess change in passive muscle activation response to treatment. | 7-10 days | 
| Change in Deep Neck Flexor (DNF) Activation | Change in DNF muscle activation will be assessed via the chin tuck head lift test (CTHL). | Day 1 pre and post intervention | 
| Change in Deep Neck Flexor (DNF) Activation | Change in DNF muscle activation will be assessed via the chin tuck head lift test (CTHL). | 7-10 days | 
| Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer. | PPT is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgesia. | Day 1 pre and post intervention | 
| Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer. | PPT is the minimal amount of pressure that produces pain and is used to assess abnormalities in nociceptive processing or hyperalgesia. | 7-10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trigger point dry needling, thoracic spine manipulation, deep cervical extensor muscle, deep cervical flexor muscle, shear wave elastography