Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain

Not Applicable

Completed

• Conditions: Cervical Radiculopathy
• Interventions: Device: Therapeutic Ultrasound; Other: Soft Tissue Mobilization

• Registration Number: NCT02081456
• Lead Sponsor: Emilio J Puentedura, PT, DPT, PhD

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.

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-07
• Results First Submitted: 2014-12-01
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-22
• Last Update Submitted: 2018-10-22
• Results First Posted: 2018-10-23
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic Ultrasound	Therapeutic Ultrasound	Therapeutic ultrasound applied for a period of 5 minutes to the most painful region of the neck, then a second 5 minute dose at the most painful region of the upper extremity
Soft Tissue Mobilization	Soft Tissue Mobilization	Passive soft tissue mobilization to the neck and upper extremity

Primary Outcome Measures

Name	Time	Method
Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion	up to 2-4 day follow up
Numeric Pain Rating Scale	up to 2-4 day follow up	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.

Secondary Outcome Measures

Name	Time	Method
Neck Disability Index	2-4 day follow up	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.
Patient Specific Functional Scale	at 2-4 day follow up	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.