Clinical trial NCT02081456: Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Radiculopathy
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: To investigate the immediate effects of soft tissue mobilization (STM) versus therapeutic ultrasound (US) in patients with neck and arm pain who demonstrate neural mechanical sensitivity. Twenty-three patients with neck and arm pain and a positive upper limb neurodynamic test (ULNT) were randomly assigned to receive STM or therapeutic US during a single session. Outcome measures were collected immediately before and after treatment, and at 2-4 day follow-up. Primary outcomes were the Global Rating of Change (GROC), range of motion (ROM) during the ULNT, and pain rating during the ULNT. Secondary measures included the Neck Disability Index (NDI), Patient-Specific Functional Scale (PSFS), Numeric Pain Rating Scale (NPRS), and active range of shoulder abduction motion combined with the wrist neutral or wrist extension.

Eligibility criteria: 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.

Primary outcomes:
measure: Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion
timeFrame: up to 2-4 day follow up
measure: Numeric Pain Rating Scale
timeFrame: up to 2-4 day follow up
Secondary outcomes:
measure: Neck Disability Index
timeFrame: 2-4 day follow up
measure: Patient Specific Functional Scale
timeFrame: at 2-4 day follow up
Other outcomes:
Locations:
Study officials:
affiliation: Rocky Mountain University Health Sciences
name: Michael Costello, PT, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: UNLV
name: Emilio j Puentedura, PT, DPT, PhD
role: STUDY_DIRECTOR
References: