Trial Outcomes & Findings for Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome (NCT NCT01190891)
NCT ID: NCT01190891
Last Updated: 2016-04-29
Results Overview
The SPADI is a 100-point, 13 item self-administered questionnaire divided into two subscales (pain and disability), with higher scores indicating greater pain and disability. It is responsive to change and accurately discriminates between patients who are improving or worsening. It has high test-retest reliability and internal consistency. The minimal detectable change (MDC) is 18 and the minimally clinically important difference (MCID) is between 8-13 points. The validity and responsiveness to change of SPADI have been described in physical therapy, as well as primary and secondary care settings.
COMPLETED
NA
104 participants
1 year
2016-04-29
Participant Flow
Participant milestones
| Measure |
Manual Physical Therapy
The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.
Manual Physical Therapy: Same as arm description
|
Corticosteroid Injection (Subacromial)
Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL
Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
|
Overall Study
COMPLETED
|
46
|
52
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
Manual Physical Therapy
The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.
Manual Physical Therapy: Same as arm description
|
Corticosteroid Injection (Subacromial)
Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL
Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
5
|
0
|
Baseline Characteristics
Physical Therapy Versus Steroid Injection for Shoulder Impingement Syndrome
Baseline characteristics by cohort
| Measure |
Manual Physical Therapy
n=46 Participants
Manual Physical Therapy: Same as arm description
|
Corticosteroid Injection (Subacromial)
n=52 Participants
Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL
Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 12 • n=5 Participants
|
42 years
STANDARD_DEVIATION 12 • n=7 Participants
|
41 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
52 participants
n=7 Participants
|
98 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe SPADI is a 100-point, 13 item self-administered questionnaire divided into two subscales (pain and disability), with higher scores indicating greater pain and disability. It is responsive to change and accurately discriminates between patients who are improving or worsening. It has high test-retest reliability and internal consistency. The minimal detectable change (MDC) is 18 and the minimally clinically important difference (MCID) is between 8-13 points. The validity and responsiveness to change of SPADI have been described in physical therapy, as well as primary and secondary care settings.
Outcome measures
| Measure |
Manual Physical Therapy
n=46 Participants
The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.
Manual Physical Therapy: Same as arm description
|
Corticosteroid Injection (Subacromial)
n=52 Participants
Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL
Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).
|
|---|---|---|
|
Shoulder Pain and Disability Index
|
21.6 units on a scale
Interval 16.0 to 27.2
|
23.1 units on a scale
Interval 17.7 to 28.6
|
SECONDARY outcome
Timeframe: 1 yearThe GROC questionnaire is an instrument that measures overall changes in the quality of life of the subject. The use of a GROC is a common, feasible, and useful method for assessing outcome, and has been shown to be a valid measurement of change in patient status in other pain populations. A change in score of three rating points has been established as a clinically significant in the patients perception of quality of life. The GROC has 15 possible choices, with 0 being equal to no change and -1 to -7 indicating a negative change and +1 to +7 indicating a positive change.
Outcome measures
| Measure |
Manual Physical Therapy
n=46 Participants
The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.
Manual Physical Therapy: Same as arm description
|
Corticosteroid Injection (Subacromial)
n=52 Participants
Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL
Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).
|
|---|---|---|
|
Global Rating of Change
|
3 units on a scale
Interval 2.0 to 4.0
|
3 units on a scale
Interval 2.0 to 4.0
|
Adverse Events
Manual Physical Therapy
Corticosteroid Injection (Subacromial)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Troy Patience, Research Operations Service
Madigan Army Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place