PiPT in ADSM With MSD

The Implementation of Psychologically Informed Physical Therapy to Prevent Chronification in Service Members With Musculoskeletal Disorders

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05132400

Enrollment

427

Registered

2021-11-24

Start date

2021-12-28

Completion date

2024-06-01

Last updated

2025-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Musculoskeletal Diseases or Conditions

Keywords

Psychologically informed Physical Therapy (PiPT)

Brief summary

The study objective is to establish feasibility of implementing a psychologically informed rehabilitation strategy while concurrently assessing its' effectiveness in Active duty service members (ADSM) with musculoskeletal disorders (MSD) seeking care in a US Navy shore-based healthcare setting. This intervention is intended to improve the management of chronic pain in order to optimize ADSM function. The study team is proposing an observational prospective comparative cohort study. This study tests an implementation/strategy while observing/gathering information on the clinical intervention and related outcomes.

Interventions

BEHAVIORALPsychological-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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

* ADSM (at baseline; separation from the military post-treatment will not be grounds for exclusion) * Patients presenting to an NMCP or a branch clinic physical therapy department * Patients who have only receive their evaluation appointment for their primary complaint * Patients prescribing for a primary complaint of a MSD (the following ICD-10 codes will be included: M13, M14.8, M15-19, M21-25, M40-43, M46-48, M50-54, M60-71, M73, M75-77)

Exclusion criteria

* Patients not eligible to receive outpatient physical therapy * Patients receiving fewer than four treatment sessions of physical therapy * Patients who are pregnant * Patients receiving physical therapy for acute post-surgical recovery * Patients scheduled for or subject to a Physical Evaluation Board (PEB) at baseline * Coast Guard

Design outcomes

Primary

Measure	Time frame	Description
Change in Pain Disability Index (PDI) Score	Baseline, Follow-up 4 weeks	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.

Secondary

Measure	Time frame	Description
Change in Hospital Anxiety and Depression Scale (HADS) Score	Baseline, Follow-up 4 weeks	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.
Change in Fear Avoidance Beliefs Questionnaire (FABQ) Score	Baseline, Follow-up 4 weeks	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.
Change in Pain Catastrophizing Scale (PCS) Score	Baseline, Follow-up 4 weeks	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.
MedRisk Instrument for Measuring Patient Satisfaction (MRPS) - Satisfaction With Process of Care Score	Follow-up 4 weeks	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.
Core Outcome Measures Index (COMI) - Satisfaction With the Outcome Score	Follow-up 4 weeks	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.
Change in Pain Self-Efficacy Questionnaire (PSEQ) Score	Baseline, Follow-up 4 weeks	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Pre-Training Arm (Control) To receive physical therapy treatment as usual, before PiPT occurs	219
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.	208
Total	427

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	132	121
Overall Study	Withdrawal by Subject	14	8

Baseline characteristics

Characteristic	Pre-Training Arm (Control)	Total	Post-Training Arm (Intervention)
Age, Continuous	32 years STANDARD_DEVIATION 9	32 years STANDARD_DEVIATION 8	32 years STANDARD_DEVIATION 8
Ethnicity (NIH/OMB) Hispanic or Latino	41 Participants	76 Participants	35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	177 Participants	344 Participants	167 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	7 Participants	6 Participants
Race (NIH/OMB) American Indian or Alaska Native	5 Participants	9 Participants	4 Participants
Race (NIH/OMB) Asian	11 Participants	22 Participants	11 Participants
Race (NIH/OMB) Black or African American	67 Participants	137 Participants	70 Participants
Race (NIH/OMB) More than one race	0 Participants	1 Participants	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants	4 Participants	2 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants	12 Participants	0 Participants
Race (NIH/OMB) White	122 Participants	242 Participants	120 Participants
Region of Enrollment United States	219 participants	427 participants	208 participants
Sex: Female, Male Female	88 Participants	173 Participants	85 Participants
Sex: Female, Male Male	131 Participants	254 Participants	123 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 219	0 / 208
other Total, other adverse events	0 / 219	0 / 208
serious Total, serious adverse events	0 / 219	0 / 208

Outcome results

Primary

Change in Pain Disability Index (PDI) Score

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.