Chronic Low Back Pain Clinical Trial
Official title:
Correlation of Trust and Outcomes Following Physical Therapy for Chronic Low Back Pain
NCT number | NCT03443401 |
Other study ID # | 2017.154 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 8, 2018 |
Est. completion date | September 24, 2020 |
Verified date | September 2020 |
Source | University of South Dakota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 59 |
Est. completion date | September 24, 2020 |
Est. primary completion date | September 24, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Phileo Health | Altoona | Wisconsin |
United States | One Accord Physical Therapy Casa Grande | Casa Grande | Arizona |
United States | Butte Premier Physical Therapy | Chico | California |
United States | Outpatient Physical Therapy | Kent | Washington |
United States | Hackensack Meridian Health-Mountainside Medical Center | Montclair | New Jersey |
United States | Foothills Sports Medicine Physical Therapy | Phoenix | Arizona |
United States | Miriam Hospital Outpatient Rehab | Providence | Rhode Island |
United States | Signature Physical Therapy | San Clemente | California |
United States | Kitsap Physical Therapy and Sports Clinic | Silverdale | Washington |
United States | Rock Valley Physical Therapy | Silvis | Illinois |
United States | PRO Physical Therapy | Winchester | Virginia |
Lead Sponsor | Collaborator |
---|---|
University of South Dakota | Iowa Physical Therapy Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | through study completion, an average of 1 year | |
Primary | 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. | through study completion, an average of 1 year | |
Primary | 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. | through study completion, an average of 1 year | |
Primary | 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. | through study completion, an average of 1 year | |
Primary | 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. | through study completion, an average of 1 year | |
Primary | 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. | through study completion, an average of 1 year | |
Secondary | General trust in physician scale | global trust measurement of patient | through study completion, an average of 1 year | |
Secondary | Change in Working alliance inventory - short revised | therapeutic alliance measurement | after initial visit and discontinuation of services, an average of 4-8 weeks. | |
Secondary | 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 | after 2nd visit and discontinuation of services, an average of 4-8 weeks. | |
Secondary | Number of PT visits | actual number of visits seen during duration of care | discontinuation of services, an average of 4-8 weeks. | |
Secondary | Patient visit compliance | no show and cancellations of scheduled appointments. A no show will be defined for purposes of this study, as any time a patient does not show for a scheduled visit. A cancellation will be defined as, anytime a patient contacts the clinic site prior to their visit to cancel the visit and does not schedule a subsequent visit to make up for that cancelled visit | discontinuation of services, an average of 4-8 weeks. | |
Secondary | Discontinuation disposition | level of patient at discontinuation of services. 1 = Patient met all goals and current episode discontinued by PT and patient, 2 = Patient met at least one, but not all, goals and current episode discontinued by PT and patient, 3 = Patient did not meet goals and current episode discontinued by PT and patient, 4 = Patient discontinued due to financial constraints with continued care, 5 = Patient self-discharged prior to meeting goals (no show for continued visits), 6 = Patient still receiving care after 6 months from initial visit, 7 = Patient had to be referred out for additional health care from different provider, 8 = Other | discontinuation of services, an average of 4-8 weeks. | |
Secondary | CPT codes | billing information (current procedural terminology - CPT) through course of care. Specific billed codes based on amount and type will be analyzed in relation to outcome variables. | discontinuation of services, an average of 4-8 weeks. |
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