Neck Pain Clinical Trial
Official title:
Short-Term Response of Thoracic Spine Manipulation With or Without Trigger Point Dry Needling for Mechanical Neck Pain: A Randomized Clinical Trial
NCT number | NCT02415660 |
Other study ID # | 404153-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2016 |
Est. completion date | August 1, 2020 |
Verified date | January 2021 |
Source | Brooke Army Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 42 |
Est. completion date | August 1, 2020 |
Est. primary completion date | March 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | 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 - |
Country | Name | City | State |
---|---|---|---|
United States | AMEDD Center & School | Fort Sam Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Brooke Army Medical Center |
United States,
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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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