Back to resultsSoft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain
Primary Purpose
Cervical Radiculopathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Soft Tissue Mobilization
Therapeutic Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Radiculopathy
Eligibility Criteria
Inclusion Criteria:
- 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.)
- Positive response to upper limb neural provocation testing (ULNT 1) (see description below for details)
- Tenderness to palpation over the cervical nerve trunks, brachial plexus, or along the median nerve.
- 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:
- Red flags noted in the medical screening questionnaire such as tumor, fracture, history of metabolic disease, prolonged history of corticosteroid use.
- 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.
- Cervical spine surgery within the last 3 months.
- Litigation associated with their neck and/or upper limb pain.
- Insufficient English language skills to complete the questionnaires and follow-up instructions.
- Inability to complete the treatment and follow-up schedule.
- Current pregnancy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Therapeutic Ultrasound
Soft Tissue Mobilization
Arm Description
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
Passive soft tissue mobilization to the neck and upper extremity
Outcomes
Primary Outcome Measures
Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT02081456
First Posted
March 4, 2014
Last Updated
October 22, 2018
Sponsor
Emilio J Puentedura, PT, DPT, PhD
1. Study Identification
Unique Protocol Identification Number
NCT02081456
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Emilio J Puentedura, PT, DPT, PhD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Radiculopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Therapeutic Ultrasound
Arm Type
Active Comparator
Arm Description
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
Arm Title
Soft Tissue Mobilization
Arm Type
Experimental
Arm Description
Passive soft tissue mobilization to the neck and upper extremity
Intervention Type
Other
Intervention Name(s)
Soft Tissue Mobilization
Intervention Description
Patients in the STM group received treatment in supine, with their head resting on one pillow and the involved UE positioned in abduction and external rotation to preload the neural structures of the upper limb. Manual pressure was applied to the soft tissues of the upper quadrant in a deep, stroking manner with the intention to improve the mobility of the soft tissues surrounding the pathway of the neural structures of the upper limb as well as any tender or tight tissues. The therapist spent approximately 7 minutes on the neck and scapular region, 4 minutes on the upper arm, and 4 minutes on the forearm and hand. The therapist was allowed to vary the time spent on each region according to his/her assessment of the patient's condition. The procedure lasted a total of 15 minutes.
Intervention Type
Device
Intervention Name(s)
Therapeutic Ultrasound
Intervention Description
Patients received therapeutic US 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. The US dose was 0.5 w/cm2, with sonation time 50% and frequency 1 MHz.40,52 The patient lay supine with the hand of the involved upper extremity placed on the abdomen and the elbow supported on a pillow. The two US doses and interaction time with the patient lasted a total of 15 minutes in an attempt to have equal patient/therapist contact between the two groups.
Primary Outcome Measure Information:
Title
Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion
Time Frame
up to 2-4 day follow up
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
up to 2-4 day follow up
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
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.
Time Frame
2-4 day follow up
Title
Patient Specific Functional Scale
Description
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.
Time Frame
at 2-4 day follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.)
Positive response to upper limb neural provocation testing (ULNT 1) (see description below for details)
Tenderness to palpation over the cervical nerve trunks, brachial plexus, or along the median nerve.
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:
Red flags noted in the medical screening questionnaire such as tumor, fracture, history of metabolic disease, prolonged history of corticosteroid use.
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.
Cervical spine surgery within the last 3 months.
Litigation associated with their neck and/or upper limb pain.
Insufficient English language skills to complete the questionnaires and follow-up instructions.
Inability to complete the treatment and follow-up schedule.
Current pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Costello, PT, DSc
Organizational Affiliation
Rocky Mountain University Health Sciences
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emilio j Puentedura, PT, DPT, PhD
Organizational Affiliation
UNLV
Official's Role
Study Director
12. IPD Sharing Statement
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Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain
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