Chronic Low Back Pain, Physical Therapy, Trust
Conditions
Brief summary
To investigate whether changes in trust between physical therapist and patient correlate to outcomes after receiving physical therapy care. We will be utilizing established questionnaires from the medical literature and one new generated questionnaire.
Detailed description
1. The clinic site staff and physical therapist will fill out facility consent form to participate as a treatment site. The treating physical therapist participant will complete an informed consent form at their clinic site, if willing to participate via phone call with PI. If they consent, they will fill in a demographics form and be given an ID# that will be used for data collection by PI after informed consent received. This will take about 5 minutes. 2. Front office staff at each physical therapy clinic will provide recruitment letter for each new patient that potentially meets inclusion/exclusion criteria (coming into the clinic with low back that has persisted for greater than 3 month). If patient agrees to participate, they will fill out informed consent and HIPPA form on-line via PsychData link provided to them by clinic staff. 3. After completing the informed consent process, the patient participant will complete the necessary forms provided in PsychData link prior to the initial visit (Baseline demographics, General Trust in Physician Scale, Wake Forest Scale, Trust in Physician Scale, Patient Care Assessment Survey, Modified Oswestry Disability Index, Numeric Pain Rating Scale) Completing the forms will take place in the waiting room as they fill out their other normal initial paperwork needed for clinic site. This should take about 10-15 minutes. The forms will be handled electronically as the information is placed in the PI's individual PsychData account. The therapist participants will be blinded to research questionnaires information through the whole research project. 4. The patient then will receive a normal physical therapy initial evaluation and treatment as directed by the physical therapist based on the patient presentation. 5. At the conclusion of the initial visit, the patient participant will complete the necessary forms on-line through a second PsychData link (Wake Forest Scale, Trust in Physician Scale, Patient Care Assessment Survey, Working Alliance Inventory - Short Revised). This should take about 5-10 minutes. 6. Participant will continue to receive normal physical therapy care as directed by the physical therapist based on patient presentation. The majority of the visits (80%) have to be with the initial physical therapist involved in the care of the patient for that patient participant to be eligible for the study. The patient participant will still be eligible for all the gift cards even if they are eventually excluded due to not seeing the same therapist for 80% of the visits. 7. At the conclusion of care for the current episode (or at the end of 6 months of continual care by the provider), the patient participant will fill out forms on line to a third PsychData link (Wake Forest Scale, Trust in Physician Scale, Patient Care Assessment Survey, Working Alliance Inventory - Short Revised, Modified Oswestry Disability Index, Numeric Pain Rating Scale, Global Rate of Change). This should take about 10-15 minutes. If the patient is a no show and does not return for follow up visits, the principle investigator will send follow up letters to try to get final surveys completed. 8. After the second visit, the treating physical therapist will complete a PT Survey of Patient Connection and Engagement form on the patient via an on-line PyschData link. This will take less than 5 minutes. Treating therapist participant will be notified by PI that patient has consented into the study. This on-line PsychData information will be kept confidential from the patient participant. 9. At the conclusion of care (or 6 month time period), the physical therapist and clinic site will complete appropriate forms (PT Survey of Patient Connection and Engagement, number of visits, compliance (no show/cancellations), discharge disposition, and Current Procedural Terminology (CPT) billing codes for patients care) and send back to the principle investigator.
Interventions
standard plan of care delivered to patient with chronic low back within scope of licensure
Sponsors
Study design
Eligibility
Inclusion criteria
* age range 18 years of age or older, able to speak and read English, seeking physical therapy treatment for persistent low back pain of 3 months or greater. Being treated by a PT participant in the study
Exclusion criteria
* younger than 18 years of age, unable to speak or read English, patient needing to be referred out at any time for different level of medical care, concurrent pregnancy or cancer diagnosis, initial treating physical therapist does not see patient for 80% of treatments during episode of care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Rate of Change | through study completion, an average of 1 year | Global measurement of change of status during care. 11-point scale used (-5=very much worse, 0 = unchanged, 5 = completely recovered). Higher score represents better recovery. |
| Change in Trust in Physician Scale | through study completion, an average of 1 year | Measurement of trust of patient toward provider during clinical encounter. 11 item scale using 5-point Likert scale. Score range from 11-55, with higher score indicating higher levels of trust. |
| Change in Oswestry Disability Index 2.0 | through study completion, an average of 1 year | Measurement of function for individuals with low back pain. 10 categories with 6 statements scoring (0-5) for function. Raw scores range from 0-50, they are divided by highest possible score to produce a percentage. Lower percentage demonstrates less disability. |
| Change in Numeric Pain Rating Scale | through study completion, an average of 1 year | Pain measurement scale. Measurement on 11-point scale from 0= no pain to 10= worst pain imaginable. Measure current, best in last 24 hours, and worst in last 24 hours and take average of all 3 measurements. Lower score represents lower pain rating. |
| Change in Patient Care Assessment Survey | through study completion, an average of 1 year | Measurement of trust of patient toward provider during clinical encounter. Minimum score of 8, maximal score of 40. Questions 1-7 are scored with a 5-point Likert scale, Question 8 is scored with a 11-point Likert scale. Higher score indicate better levels of trust. |
| Change in Wake Forest Scale | through study completion, an average of 1 year | Measurement of trust of patient toward provider during clinical encounter. 10 item scale using a 5-point Likert scale. Score range from 10-50, with higher score indicating higher levels of trust. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Working Alliance Inventory - Short Revised | after initial visit and discontinuation of services, an average of 4-8 weeks. | therapeutic alliance measurement. 12 item short form utilizing 5 point Likert scale. minimum score 12, maximum score 60. Higher score means higher therapeutic (working) alliance. |
| Change in PT Survey of Patient Connection and Engagement | after 2nd visit and discontinuation of services, an average of 4-8 weeks. | Questionnaire completed by PT regarding their perceptions of the patients connection and engagement during the course of care. 10 question survey, using 5 point Likert scale. minimum score 10, maximum score 50. Higher score demonstrates higher patient connection and engagement. |
| General Trust in Physician Scale | through study completion, an average of 1 year | global trust measurement of patient, 11 item scale using 5 point Likert scale. Minimum score 11, maximum score 55. Higher values, higher levels of trust. No subscales. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patient Participants patients with chronic low back pain receiving standard physical therapy care
Standard physical therapy care: standard plan of care delivered to patient with chronic low back within scope of licensure | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Influential outlier | 1 |
| Overall Study | Lost to Follow-up | 13 |
Baseline characteristics
| Characteristic | Patient Participants |
|---|---|
| Age, Continuous | 49.3 years STANDARD_DEVIATION 15 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 23 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 29 |
| other Total, other adverse events | 0 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Change in Numeric Pain Rating Scale
Pain measurement scale. Measurement on 11-point scale from 0= no pain to 10= worst pain imaginable. Measure current, best in last 24 hours, and worst in last 24 hours and take average of all 3 measurements. Lower score represents lower pain rating.
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Participants | Change in Numeric Pain Rating Scale | 1.1 score on a scale | Standard Deviation 2.6 |
Change in Oswestry Disability Index 2.0
Measurement of function for individuals with low back pain. 10 categories with 6 statements scoring (0-5) for function. Raw scores range from 0-50, they are divided by highest possible score to produce a percentage. Lower percentage demonstrates less disability.
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Participants | Change in Oswestry Disability Index 2.0 | 11.1 score on a scale | Standard Deviation 17.7 |
Change in Patient Care Assessment Survey
Measurement of trust of patient toward provider during clinical encounter. Minimum score of 8, maximal score of 40. Questions 1-7 are scored with a 5-point Likert scale, Question 8 is scored with a 11-point Likert scale. Higher score indicate better levels of trust.
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Participants | Change in Patient Care Assessment Survey | 3.3 score on a scale | Standard Deviation 1.1 |
Change in Trust in Physician Scale
Measurement of trust of patient toward provider during clinical encounter. 11 item scale using 5-point Likert scale. Score range from 11-55, with higher score indicating higher levels of trust.
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Participants | Change in Trust in Physician Scale | 5.2 score on a scale | Standard Deviation 0.5 |
Change in Wake Forest Scale
Measurement of trust of patient toward provider during clinical encounter. 10 item scale using a 5-point Likert scale. Score range from 10-50, with higher score indicating higher levels of trust.
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Participants | Change in Wake Forest Scale | 4.2 score on a scale | Standard Deviation 1.5 |
Global Rate of Change
Global measurement of change of status during care. 11-point scale used (-5=very much worse, 0 = unchanged, 5 = completely recovered). Higher score represents better recovery.
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Participants | Global Rate of Change | 2.3 score on a scale | Standard Deviation 0.5 |
Change in PT Survey of Patient Connection and Engagement
Questionnaire completed by PT regarding their perceptions of the patients connection and engagement during the course of care. 10 question survey, using 5 point Likert scale. minimum score 10, maximum score 50. Higher score demonstrates higher patient connection and engagement.
Time frame: after 2nd visit and discontinuation of services, an average of 4-8 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Participants | Change in PT Survey of Patient Connection and Engagement | 0 score on a scale | Standard Deviation 0.5 |
Change in Working Alliance Inventory - Short Revised
therapeutic alliance measurement. 12 item short form utilizing 5 point Likert scale. minimum score 12, maximum score 60. Higher score means higher therapeutic (working) alliance.
Time frame: after initial visit and discontinuation of services, an average of 4-8 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Participants | Change in Working Alliance Inventory - Short Revised | 5.6 score on a scale | Standard Deviation 2.3 |
General Trust in Physician Scale
global trust measurement of patient, 11 item scale using 5 point Likert scale. Minimum score 11, maximum score 55. Higher values, higher levels of trust. No subscales.
Time frame: through study completion, an average of 1 year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patient Participants | General Trust in Physician Scale | 43.89 score on a scale | Standard Deviation 6.27 |