Cervical Radiculopathy Clinical Trial
Official title:
The Effects of Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain With Evidence of Neural Mechanical Sensitivity: A Randomized Clinical Trial
NCT number | NCT02081456 |
Other study ID # | 20-242 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2009 |
Est. completion date | June 2012 |
Verified date | October 2018 |
Source | University of Nevada, Las Vegas |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to investigate effects of soft tissue mobilization versus therapeutic ultrasound in subjects with neck and arm pain who demonstrate neural mechanical sensitivity.
Status | Completed |
Enrollment | 23 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Active movement dysfunction that could be related to mechanical sensitivity of the neural structures of the upper limb. (i.e. painful shoulder abduction with elbow extension that is limited more when the wrist is extended than when the wrist is in neutral.) 2. Positive response to upper limb neural provocation testing (ULNT 1) (see description below for details) 3. Tenderness to palpation over the cervical nerve trunks, brachial plexus, or along the median nerve. 4. Tender points or taut bands in the muscles of the upper quadrant including the scalenes, cervical paraspinals, trapezius, deltoid, pectoralis major or minor, rotator cuff, biceps, triceps, coracobrachialis, brachialis, radiobrachialis, pronator teres, supinator, forearm extensor, forearm flexor, pronator quadratus, and hand intrinsic muscles. Exclusion Criteria: 1. Red flags noted in the medical screening questionnaire such as tumor, fracture, history of metabolic disease, prolonged history of corticosteroid use. 2. Signs of central nervous system involvement such as hyper-reflexia (exaggerated response to deep tendon reflex testing), unsteadiness during gait, ataxia, disturbed vision, nystagmus, altered taste, positive Babinski's or Hoffman's reflexes. 3. Cervical spine surgery within the last 3 months. 4. Litigation associated with their neck and/or upper limb pain. 5. Insufficient English language skills to complete the questionnaires and follow-up instructions. 6. Inability to complete the treatment and follow-up schedule. 7. Current pregnancy. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Emilio J Puentedura, PT, DPT, PhD |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion | up to 2-4 day follow up | ||
Primary | Numeric Pain Rating Scale | Measures perceived level of pain on a scale from 0 to 10, where 0 indicates 'no pain' and 10 indicates 'worst imaginable pain'. Therefore, lower scores are better. Outcome results are given and mean changes from pre to post interventions, therefore, a negative value indicates improvement. | up to 2-4 day follow up | |
Secondary | Neck Disability Index | Measure of perceived disability on a scale of 0 to 50, where 0 indicates no disability and 50 indicates maximum disability. Therefore, lower scores are better. Outcome results are given and mean changes from pre to post interventions, therefore, a negative value indicates improvement. | 2-4 day follow up | |
Secondary | Patient Specific Functional Scale | Perceived ability to perform specific activities on a scale of 0 to 30, where 0 indicates complete inability to perform and 30 indicates able to perform activity at the same level as before injury or problem. Therefore higher scores are better. Outcome results are given and mean changes from pre to post interventions, therefore, a positive value indicates improvement. | at 2-4 day follow up |
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