Cervical RadiculopathyNCT02081456
Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain
A study testing Soft Tissue Mobilization and Therapeutic Ultrasound in people with Cervical Radiculopathy, run by Emilio J Puentedura, PT, DPT, PhD.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Radiculopathy
- What is being tested?
- Soft Tissue Mobilization and Therapeutic Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read the 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.
- Conditions
- Cervical Radiculopathy
- Being tested
- Soft Tissue Mobilization, Therapeutic Ultrasound
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft Tissue MobilizationOther
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.
Therapeutic UltrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Ultrasound | Active comparator | 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 Receives: Device: Therapeutic Ultrasound |
| Soft Tissue Mobilization | Experimental | Passive soft tissue mobilization to the neck and upper extremity Receives: Other: Soft Tissue Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion
Measured: up to 2-4 day follow up
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.
Measured: up to 2-4 day follow up
Secondary outcomes (2)
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.
Measured: 2-4 day follow up
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.
Measured: at 2-4 day follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startNov 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emilio J Puentedura, PT, DPT, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emilio J Puentedura, PT, DPT, PhD, University of Nevada, Las Vegas
- Investigators
- Michael Costello, PT, DSc, Principal investigator, Rocky Mountain University Health SciencesEmilio j Puentedura, PT, DPT, PhD, Study director, UNLV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081456
- Sponsor's protocol ID
- 20-242
- Status last verified
- Oct 2018
- First submitted
- 4 Mar 2014
- Last updated
- 23 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02081456
- Acronym / sponsor ID
- 20-242
- Conditions
- Cervical Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Emilio J Puentedura, PT, DPT, PhDUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Mar 2014 (estimated)
- Results
- Posted 23 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Ultrasound | Active comparator | Device: Therapeutic UltrasoundTherapeutic 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 | Experimental | Other: Soft Tissue MobilizationPassive soft tissue mobilization to the neck and upper extremity |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft Tissue MobilizationPatients 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. | Other | Soft Tissue Mobilization |
| Therapeutic UltrasoundPatients 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. | Device | Therapeutic Ultrasound |
Primary outcome
Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion
Time frame: 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.
2 secondary outcomes
Neck Disability Index
Time frame: 2-4 day follow up
Patient Specific Functional Scale
Time frame: at 2-4 day follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Costello, PT, DSc principal investigator
Rocky Mountain University Health Sciences
Emilio j Puentedura, PT, DPT, PhD study director
UNLV
Questions about this trial
What is this clinical trial studying?
A study testing Soft Tissue Mobilization and Therapeutic Ultrasound in people with Cervical Radiculopathy, run by Emilio J Puentedura, PT, DPT, PhD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion (time frame: up to 2-4 day follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.