Chronic PainNCT05132400
PiPT in ADSM With MSD
An observational study of Chronic Pain and Musculoskeletal Diseases or Conditions, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Chronic Pain, Musculoskeletal Diseases or Conditions
- What is being tested?
- Psychological-informed Physical Therapy (PiPT) Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 427 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Dec 2021to 1 Jun 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: US active duty service members (ADSM) receiving physical therapy for musculoskeletal disorders at Naval Medical Center Portsmouth (NMCP) and its branch health clinics.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
About this study
Official title: The Implementation of Psychologically Informed Physical Therapy to Prevent Chronification in Service Members With Musculoskeletal Disorders
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.
- Being tested
- Psychological-informed Physical Therapy (PiPT) Training
- Keywords
- Psychologically informed Physical Therapy (PiPT)
- Medical subject headings
- Chronic Pain, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological-informed Physical Therapy (PiPT) TrainingBehavioural
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 group | Role | What they receive |
|---|---|---|
| Pre-Training Arm (Control) | To receive physical therapy treatment as usual, before PiPT occurs | |
| Post-Training Arm (Intervention) | Not described Receives: Behavioral: Psychological-informed Physical Therapy (PiPT) Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Follow-up 4 weeks
Secondary outcomes (6)
Change in Pain Catastrophizing Scale (PCS) Score
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.
Measured: Baseline, Follow-up 4 weeks
Change in Hospital Anxiety and Depression Scale (HADS) Score
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.
Measured: Baseline, Follow-up 4 weeks
Change in Fear Avoidance Beliefs Questionnaire (FABQ) Score
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.
Measured: Baseline, Follow-up 4 weeks
Change in Pain Self-Efficacy Questionnaire (PSEQ) Score
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.
Measured: Baseline, Follow-up 4 weeks
MedRisk Instrument for Measuring Patient Satisfaction (MRPS) - Satisfaction With Process of Care Score
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.
Measured: Follow-up 4 weeks
Core Outcome Measures Index (COMI) - Satisfaction With the Outcome Score
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.
Measured: Follow-up 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start28 Dec 2021
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, United States Naval Medical Center, Portsmouth, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Responsible party
- Sponsor
- Investigators
- Marco Campello, PT, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05132400
- Sponsor's protocol ID
- 21-01351
- Status last verified
- Apr 2025
- First submitted
- 12 Nov 2021
- Last updated
- 11 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Implementation of Psychologically Informed Physical Therapy to Prevent Chronification in Service Members With Musculoskeletal Disorders
- ClinicalTrials.gov ID
- NCT05132400
- Acronym / sponsor ID
- 21-01351
- Keywords
- Psychologically informed Physical Therapy (PiPT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- United States Department of Defense, United States Naval Medical Center, Portsmouth, Henry M. Jackson Foundation for the Advancement of Military Medicine
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Posted 11 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Training Arm (Control) | – | –To receive physical therapy treatment as usual, before PiPT occurs |
| Post-Training Arm (Intervention) | – | Behavioral: Psychological-informed Physical Therapy (PiPT) Training |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- US active duty service members (ADSM) receiving physical therapy for musculoskeletal disorders at Naval Medical Center Portsmouth (NMCP) and its branch health clinics.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological-informed Physical Therapy (PiPT) TrainingAn 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. | Behavioural | Post-Training Arm (Intervention) |
Primary outcome
Change in Pain Disability Index (PDI) Score
Time frame: 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.
6 secondary outcomes
Change in Pain Catastrophizing Scale (PCS) Score
Time frame: Baseline, Follow-up 4 weeks
Change in Hospital Anxiety and Depression Scale (HADS) Score
Time frame: Baseline, Follow-up 4 weeks
Change in Fear Avoidance Beliefs Questionnaire (FABQ) Score
Time frame: Baseline, Follow-up 4 weeks
Change in Pain Self-Efficacy Questionnaire (PSEQ) Score
Time frame: Baseline, Follow-up 4 weeks
MedRisk Instrument for Measuring Patient Satisfaction (MRPS) - Satisfaction With Process of Care Score
Time frame: Follow-up 4 weeks
Core Outcome Measures Index (COMI) - Satisfaction With the Outcome Score
Time frame: Follow-up 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Related trials for Chronic Pain
Not yet recruiting
Effects of Adding Vagal Neuromodulation to Manual Therapy in Women With Fibromyalgia
Fibromyalgia (FM) OR Fibromyalgia Syndrome, Manuel Therapy
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Campello, PT, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Musculoskeletal Diseases or Conditions, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Disability Index (PDI) Score (time frame: Baseline, Follow-up 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.