Trial Outcomes & Findings for Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain (NCT NCT02081456)
NCT ID: NCT02081456
Last Updated: 2018-10-23
Results Overview
COMPLETED
NA
23 participants
up to 2-4 day follow up
2018-10-23
Participant Flow
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
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.
Participant milestones
| Measure |
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
|
Soft Tissue Mobilization
Passive soft tissue mobilization to the neck and upper extremity
Soft Tissue Mobilization
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
|
Overall Study
COMPLETED
|
11
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Soft Tissue Mobilization Versus Therapeutic Ultrasound for Subjects With Neck and Arm Pain
Baseline characteristics by cohort
| Measure |
Therapeutic Ultrasound
n=11 Participants
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
|
Soft Tissue Mobilization
n=12 Participants
Passive soft tissue mobilization to the neck and upper extremity
Soft Tissue Mobilization
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.00 years
STANDARD_DEVIATION 10.42 • n=5 Participants
|
46.25 years
STANDARD_DEVIATION 10.42 • n=7 Participants
|
44.22 years
STANDARD_DEVIATION 10.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 2-4 day follow upOutcome measures
| Measure |
Therapeutic Ultrasound
n=11 Participants
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
|
Soft Tissue Mobilization
n=12 Participants
Passive soft tissue mobilization to the neck and upper extremity
Soft Tissue Mobilization
|
|---|---|---|
|
Upper Limb Neurodynamic Tesnion (UNLT) Range of Motion
|
4.60 degrees
Interval -0.6 to 9.8
|
16.00 degrees
Interval 9.88 to 22.12
|
PRIMARY outcome
Timeframe: up to 2-4 day follow upMeasures 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.
Outcome measures
| Measure |
Therapeutic Ultrasound
n=11 Participants
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
|
Soft Tissue Mobilization
n=12 Participants
Passive soft tissue mobilization to the neck and upper extremity
Soft Tissue Mobilization
|
|---|---|---|
|
Numeric Pain Rating Scale
|
-0.80 units on a scale
Interval -2.18 to 0.58
|
-1.31 units on a scale
Interval -2.1 to -0.51
|
SECONDARY outcome
Timeframe: 2-4 day follow upMeasure 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.
Outcome measures
| Measure |
Therapeutic Ultrasound
n=11 Participants
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
|
Soft Tissue Mobilization
n=12 Participants
Passive soft tissue mobilization to the neck and upper extremity
Soft Tissue Mobilization
|
|---|---|---|
|
Neck Disability Index
|
-1.20 units on a scale
Interval -5.63 to 3.23
|
-6.00 units on a scale
Interval -12.55 to 0.55
|
SECONDARY outcome
Timeframe: at 2-4 day follow upPerceived 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.
Outcome measures
| Measure |
Therapeutic Ultrasound
n=11 Participants
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
|
Soft Tissue Mobilization
n=12 Participants
Passive soft tissue mobilization to the neck and upper extremity
Soft Tissue Mobilization
|
|---|---|---|
|
Patient Specific Functional Scale
|
0.30 units on a scale
Interval -0.16 to 0.76
|
1.67 units on a scale
Interval 0.8 to 2.53
|
Adverse Events
Therapeutic Ultrasound
Soft Tissue Mobilization
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michael Costello, PT, DSc, OCS, MTC
Cayuga Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place