- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02081456
Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain
October 22, 2018 updated by: Emilio J Puentedura, PT, DPT, PhD
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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
|
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.
|
EXPERIMENTAL: Soft Tissue Mobilization
Passive soft tissue mobilization to the neck and upper extremity
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion
Time Frame: up to 2-4 day follow up
|
up to 2-4 day follow up
|
|
Numeric Pain Rating Scale
Time Frame: 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.
|
up to 2-4 day follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index
Time Frame: 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.
|
2-4 day follow up
|
Patient Specific Functional Scale
Time Frame: 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.
|
at 2-4 day follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Michael Costello, PT, DSc, Rocky Mountain University Health Sciences
- Study Director: Emilio j Puentedura, PT, DPT, PhD, UNLV
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (ACTUAL)
June 1, 2012
Study Completion (ACTUAL)
June 1, 2012
Study Registration Dates
First Submitted
March 4, 2014
First Submitted That Met QC Criteria
March 6, 2014
First Posted (ESTIMATE)
March 7, 2014
Study Record Updates
Last Update Posted (ACTUAL)
October 23, 2018
Last Update Submitted That Met QC Criteria
October 22, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-242
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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