An interventional study of Soft Tissue Mobilization and Therapeutic Ultrasound in Cervical Radiculopathy, sponsored by Emilio J Puentedura, PT, DPT, PhD. Completed. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-23.
Sponsored by Emilio J Puentedura, PT, DPT, PhD · Not applicable, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
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
Device: Therapeutic Ultrasound
Passive soft tissue mobilization to the neck and upper extremity
Other: Soft Tissue Mobilization
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.
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.
Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion
Time frame: 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.
Time frame: up to 2-4 day follow up
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
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
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
| Milestone | Therapeutic Ultrasound | Soft Tissue Mobilization |
|---|---|---|
| Started | 11 | 12 |
| Completed | 11 | 12 |
| Not completed | 0 | 0 |
| degrees | Therapeutic Ultrasound | Soft Tissue Mobilization |
|---|---|---|
| Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion | 4.60 (-0.60 to 9.80) | 16.00 (9.88 to 22.12) |
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.
| units on a scale | Therapeutic Ultrasound | Soft Tissue Mobilization |
|---|---|---|
| Numeric Pain Rating Scale | -0.80 (-2.18 to 0.58) | -1.31 (-2.10 to -0.51) |
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.
| units on a scale | Therapeutic Ultrasound | Soft Tissue Mobilization |
|---|---|---|
| Neck Disability Index | -1.20 (-5.63 to 3.23) | -6.00 (-12.55 to 0.55) |
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.
| units on a scale | Therapeutic Ultrasound | Soft Tissue Mobilization |
|---|---|---|
| Patient Specific Functional Scale | 0.30 (-0.16 to 0.76) | 1.67 (0.80 to 2.53) |
Collected over Baseline to 2 - 4 days follow up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Therapeutic Ultrasound | — | 0/11 (0%) | 0/11 (0%) |
| Soft Tissue Mobilization | — | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | Therapeutic Ultrasound | Soft Tissue Mobilization | Total |
|---|---|---|---|
| Mean | 42.00 ± 10.42 | 46.25 ± 10.42 | 44.22 ± 10.24 |
| Sex: Female, Male(Participants) | Therapeutic Ultrasound | Soft Tissue Mobilization | Total |
|---|---|---|---|
| Female | 10 | 11 | 21 |
| Male | 1 | 1 | 2 |
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