Cervical Radiculopathy
Conditions
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.
Interventions
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.
DEVICETherapeutic Ultrasound
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.
Sponsors
Emilio J Puentedura, PT, DPT, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Recruitment details
Between November 2009 and June 2012 consecutive patients with neck and arm pain presenting to Cayuga Medical Center's Physical Therapy Department were screened for eligibility criteria
Pre-assignment details
Patients were excluded if they exhibited Red flags in the medical screening questionnaire such as tumor, fracture; had signs of CNS involvement such as hyper-reflexia, ataxia, nystagmus, etc. Cervical spine surgery within 3 months. Litigation, insufficient English language skills, inability to complete study schedule, or were pregnant.
Participants by arm
| Arm | Count |
|---|---|
| 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
Therapeutic Ultrasound | 11 |
| Soft Tissue Mobilization Passive soft tissue mobilization to the neck and upper extremity
Soft Tissue Mobilization | 12 |
| Total | 23 |
Baseline characteristics
| Characteristic | Therapeutic Ultrasound | Soft Tissue Mobilization | Total |
|---|---|---|---|
| Age, Continuous | 42.00 years STANDARD_DEVIATION 10.42 | 46.25 years STANDARD_DEVIATION 10.42 | 44.22 years STANDARD_DEVIATION 10.24 |
| Sex: Female, Male Female | 10 Participants | 11 Participants | 21 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 11 | 0 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
Primary
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.
Time frame: up to 2-4 day follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Therapeutic Ultrasound | Numeric Pain Rating Scale | -0.80 units on a scale |
| Soft Tissue Mobilization | Numeric Pain Rating Scale | -1.31 units on a scale |
Primary
Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion
Time frame: up to 2-4 day follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Therapeutic Ultrasound | Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion | 4.60 degrees |
| Soft Tissue Mobilization | Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion | 16.00 degrees |
Secondary
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.
Time frame: 2-4 day follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Therapeutic Ultrasound | Neck Disability Index | -1.20 units on a scale |
| Soft Tissue Mobilization | Neck Disability Index | -6.00 units on a scale |
Secondary
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.
Time frame: at 2-4 day follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Therapeutic Ultrasound | Patient Specific Functional Scale | 0.30 units on a scale |
| Soft Tissue Mobilization | Patient Specific Functional Scale | 1.67 units on a scale |