Clinical trial NCT02415660: Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain
Official title: Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: trigger point dry needling
thoracic spine manipulation
deep cervical extensor muscle
deep cervical flexor muscle
shear wave elastography
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2015-04-14
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-64 years and eligible for military health care
2. Primary complaint of mechanical neck pain provoked by posture, movement or palpation of neck musculature, with or without unilateral upper extremity symptoms.
3. Presence of active trigger points in either the upper trapezius or deep cervical extensor muscles.
4. 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.
5. No less than 10 points (0-50 range) on the Neck Disability Index.

Exclusion Criteria:

1. Prior history of whiplash injury resulting in neck pain which required medical treatment.
2. Any prior physical therapy, chiropractic, acupuncture treatment or injections for neck pain within the past 3 months.
3. History of cervical spine surgery.
4. History of any systemic disorder in which thoracic spine manipulation and TDN would be contraindicated (i.e. osteoporosis, bleeding disorders or anticoagulant medication use)
5. 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).
6. Current primary complaint of headaches
7. Pending legal action regarding their neck pain
8. Inability to read and understand English
9. Females known or thought to be pregnant

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Primary outcomes:
measure: Change in Neck Disability Index (NDI)
timeFrame: Change in NDI from baseline to 2-3 days
measure: Change in Neck Disability Index (NDI)
timeFrame: Change in NDI at 7-10 days
Secondary outcomes:
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: Change in pain from baseline to 2-3 days
measure: Change in Numeric Pain Rating Scale (NPRS)
timeFrame: 7-10 days
measure: Global Rate of Change (GRC)
timeFrame: 2-3 days
measure: Global Rate of Change (GRC)
timeFrame: 7-10 days
measure: Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)
timeFrame: Day 1 pre and post intervention
measure: Change in Deep cervical multifidus activation using ultrasound Shear Wave Elastography (SWE)
timeFrame: 7-10 days
measure: Change in Deep Neck Flexor (DNF) Activation
timeFrame: Day 1 pre and post intervention
measure: Change in Deep Neck Flexor (DNF) Activation
timeFrame: 7-10 days
measure: Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.
timeFrame: Day 1 pre and post intervention
measure: Change in Pain Pressure Threshold (PPT) as assessed using an electronic algometer.
timeFrame: 7-10 days
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: AMEDD Center & School
state: Texas
Study officials:
affiliation: Assistant Professor, Army-Baylor Doctoral Program in PT
name: David M Boland, PT, DPT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Walker MJ, Boyles RE, Young BA, Strunce JB, Garber MB, Whitman JM, Deyle G, Wainner RS. The effectiveness of manual physical therapy and exercise for mechanical neck pain: a randomized clinical trial. Spine (Phila Pa 1976). 2008 Oct 15;33(22):2371-8. doi: 10.1097/BRS.0b013e318183391e.
citation: O'Leary S, Cagnie B, Reeve A, Jull G, Elliott JM. Is there altered activity of the extensor muscles in chronic mechanical neck pain? A functional magnetic resonance imaging study. Arch Phys Med Rehabil. 2011 Jun;92(6):929-34. doi: 10.1016/j.apmr.2010.12.021. Epub 2011 May 6.
citation: Schomacher J, Falla D. Function and structure of the deep cervical extensor muscles in patients with neck pain. Man Ther. 2013 Oct;18(5):360-6. doi: 10.1016/j.math.2013.05.009. Epub 2013 Jul 12.
citation: Cleland JA, Mintken PE, Carpenter K, Fritz JM, Glynn P, Whitman J, Childs JD. Examination of a clinical prediction rule to identify patients with neck pain likely to benefit from thoracic spine thrust manipulation and a general cervical range of motion exercise: multi-center randomized clinical trial. Phys Ther. 2010 Sep;90(9):1239-50. doi: 10.2522/ptj.20100123. Epub 2010 Jul 15.
citation: Maher RM, Hayes DM, Shinohara M. Quantification of dry needling and posture effects on myofascial trigger points using ultrasound shear-wave elastography. Arch Phys Med Rehabil. 2013 Nov;94(11):2146-50. doi: 10.1016/j.apmr.2013.04.021. Epub 2013 May 14.