Trial Outcomes & Findings for PiPT in ADSM With MSD (NCT NCT05132400)
NCT ID: NCT05132400
Last Updated: 2025-05-11
Results Overview
PDI consists of 7 categories of life activity. The participant is asked to circle the number on the scale that describes the level of disability on typically experiences. A score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which one would normally be involved have been totally disrupted or prevented by pain. The total range of score is 0-70; the higher the score, the greater the person's disability due to pain.
COMPLETED
427 participants
Baseline, Follow-up 4 weeks
2025-05-11
Participant Flow
Participant milestones
| Measure |
Pre-Training Arm (Control)
To receive physical therapy treatment as usual, before PiPT occurs
|
Post-Training Arm (Intervention)
Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation.
|
|---|---|---|
|
Overall Study
STARTED
|
219
|
208
|
|
Overall Study
COMPLETED
|
73
|
79
|
|
Overall Study
NOT COMPLETED
|
146
|
129
|
Reasons for withdrawal
| Measure |
Pre-Training Arm (Control)
To receive physical therapy treatment as usual, before PiPT occurs
|
Post-Training Arm (Intervention)
Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
8
|
|
Overall Study
Lost to Follow-up
|
132
|
121
|
Baseline Characteristics
PiPT in ADSM With MSD
Baseline characteristics by cohort
| Measure |
Pre-Training Arm (Control)
n=219 Participants
To receive physical therapy treatment as usual, before PiPT occurs
|
Post-Training Arm (Intervention)
n=208 Participants
Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation.
|
Total
n=427 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 9 • n=5 Participants
|
32 years
STANDARD_DEVIATION 8 • n=7 Participants
|
32 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
254 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
41 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
177 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
344 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
67 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
242 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
219 participants
n=5 Participants
|
208 participants
n=7 Participants
|
427 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Follow-up 4 weeksPopulation: Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis.
PDI consists of 7 categories of life activity. The participant is asked to circle the number on the scale that describes the level of disability on typically experiences. A score of 0 means no disability at all, and a score of 10 signifies that all of the activities in which one would normally be involved have been totally disrupted or prevented by pain. The total range of score is 0-70; the higher the score, the greater the person's disability due to pain.
Outcome measures
| Measure |
Pre-Training Arm (Control)
n=71 Participants
To receive physical therapy treatment as usual, before PiPT occurs
|
Post-Training Arm (Intervention)
n=70 Participants
Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation.
|
|---|---|---|
|
Change in Pain Disability Index (PDI) Score
|
0 Change in PDI score
Standard Deviation 11
|
33 Change in PDI score
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Baseline, Follow-up 4 weeksPopulation: Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis.
PCS is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain. Each item is rated on a 5-point Likert scale, from 0 (not at all) to 4 (all the time). The total range of score is 0-52; a higher score indicates a higher level of catastrophizing. A total score \>30 indicates clinically relevant level of catastrophizing.
Outcome measures
| Measure |
Pre-Training Arm (Control)
n=69 Participants
To receive physical therapy treatment as usual, before PiPT occurs
|
Post-Training Arm (Intervention)
n=69 Participants
Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation.
|
|---|---|---|
|
Change in Pain Catastrophizing Scale (PCS) Score
|
0 Change in PCS score
Standard Deviation 8
|
1 Change in PCS score
Standard Deviation 7
|
SECONDARY outcome
Timeframe: Baseline, Follow-up 4 weeksPopulation: Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis.
HADS consists of two separate sub-sections: Anxiety and Depression. Each sub-section contains 7 items, where participants reply with responses that are closest to how he/she has been feeling in the past week with a score of 0-3. The total score range for both sub-sections is 0-21; a score of 0-7 indicates a "normal" range of anxiety, 8-10 = borderline abnormal, 11-21 = abnormal. The higher the score, the more abnormal the participant feels.
Outcome measures
| Measure |
Pre-Training Arm (Control)
n=69 Participants
To receive physical therapy treatment as usual, before PiPT occurs
|
Post-Training Arm (Intervention)
n=69 Participants
Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation.
|
|---|---|---|
|
Change in Hospital Anxiety and Depression Scale (HADS) Score
|
-1 Change in HADS score
Standard Deviation 5
|
0 Change in HADS score
Standard Deviation 5
|
SECONDARY outcome
Timeframe: Baseline, Follow-up 4 weeksPopulation: Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis.
FABQ is a self-reported questionnaire consisting of 16 questions scaled from 0-6. FABQ assesses the fear-avoidance beliefs of patients with chronic low back pain The total range of score is 0-96; a higher score indicates fear avoidance behaviors. For the purposes of this study, "I have a claim for compensation for my pain" will be excluded due to no relevance to the study.
Outcome measures
| Measure |
Pre-Training Arm (Control)
n=69 Participants
To receive physical therapy treatment as usual, before PiPT occurs
|
Post-Training Arm (Intervention)
n=69 Participants
Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation.
|
|---|---|---|
|
Change in Fear Avoidance Beliefs Questionnaire (FABQ) Score
|
-3 Change in FABQ score
Standard Deviation 11
|
1 Change in FABQ score
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Baseline, Follow-up 4 weeksPopulation: Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis.
PSEQ is a 10-item questionnaire developed to assess the confidence people with ongoing pain have in performing activities while in pain. The total range of score is 0-60; a higher score indicates greater levels of confidence in dealing with pain. High scores are strongly associated with clinically-significant functional levels.
Outcome measures
| Measure |
Pre-Training Arm (Control)
n=70 Participants
To receive physical therapy treatment as usual, before PiPT occurs
|
Post-Training Arm (Intervention)
n=69 Participants
Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation.
|
|---|---|---|
|
Change in Pain Self-Efficacy Questionnaire (PSEQ) Score
|
0 Change in PSEQ score
Standard Deviation 9
|
0 Change in PSEQ score
Standard Deviation 13
|
SECONDARY outcome
Timeframe: Follow-up 4 weeksPopulation: Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis.
Satisfaction with process of care is measured by the "process of care" subscale of the MRPS. There are 8 items in this subscale scored on a Likert scale of 1-5. The total score range is 8-40; the higher the score, the greater the satisfaction.
Outcome measures
| Measure |
Pre-Training Arm (Control)
n=69 Participants
To receive physical therapy treatment as usual, before PiPT occurs
|
Post-Training Arm (Intervention)
n=69 Participants
Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation.
|
|---|---|---|
|
MedRisk Instrument for Measuring Patient Satisfaction (MRPS) - Satisfaction With Process of Care Score
|
32 score on a scale
Standard Deviation 6
|
32 score on a scale
Standard Deviation 6
|
SECONDARY outcome
Timeframe: Follow-up 4 weeksPopulation: Not all participants completed the follow-up questionnaire in full. Participants who did not complete the measure or only completed one measure but not others were not included in the analysis.
Satisfaction with the outcome is measured by a single item derived from COMI: "If you had to spend the rest of life with the symptoms you have right now, how would you feel about it?". The total range of score is 0-10; the higher the score, the worse one feels about the outcome.
Outcome measures
| Measure |
Pre-Training Arm (Control)
n=68 Participants
To receive physical therapy treatment as usual, before PiPT occurs
|
Post-Training Arm (Intervention)
n=68 Participants
Psychological-informed Physical Therapy (PiPT) Training: An approach designed to incorporate the concepts of cognitive behavioral therapy (CBT) for pain management into routine clinical PT practice in order to modify maladaptive responses associated with chronicity. The goal of PiPT is to promote a fast and optimal recovery by removing psychological obstacles, obviating the need for referral to a psychologist and facilitating triage to other health professionals in a timely manner when needed. PiPT training includes education about the neuropsychology of pain, patient communication skills, and identification of psychosocial risk factors for chronicity and treatment approaches that include reassurance, relaxation, and psycho-behavioral reactivation.
|
|---|---|---|
|
Core Outcome Measures Index (COMI) - Satisfaction With the Outcome Score
|
1 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
Adverse Events
Pre-Training Arm (Control)
Post-Training Arm (Intervention)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place