Clinical trial NCT03118453: Implementation of a Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain
Official title: A Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain - Evaluation of the Implementation Process and Outcome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain
Keywords: Musculoskeletal pain/*therapy
Behavioral medicine
Physical therapy
Cost-benefit analyses
Treatment outcome
Adults
Lead sponsor: Mälardalen University
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Implementation of a behavioral medicine (BM) approach in physical therapy (PT) for patients with persistent musculoskeletal pain is in accordance with the state of science. Translation of research into clinical PT practice is challenging and may demand active implementation strategies.

The aim is to evaluate the implementation of a behavioural medicine approach for patients with persistent musculoskeletal pain concerning sustainable health benefits and sick-leave, as well as the cost-effectiveness of the implemented treatment.

Treatment outcomes for patients from two groups of physical therapists in primary care will be compared. In one group active implementation strategies have been employed, and in the other (control) passive implementation strategies during a 6-months intervention period. Patients are recruited during one-year after the implementation period.

The short and long-term effects of the implementation of the BM approach in PT treatment on patients' sick-leave, activity and participation, and health related quality of life will be compared to the patients from control condition clinics. The cost-effect and cost-benefit of an implementation of a behavioral medicine approach in physical therapy is evaluated from the perspective of the health care organization and society.

Detailed description: The aim is to investigate the short and long-term effects for the implementation of a behavioral medicine approach in physical therapy on patients' sick-leave, activity and participation, and health related quality of life, compared to the control condition. Further the aim is to evaluate the cost-effect and cost-benefit of an active implementation of a behavioural medicine approach in physical therapy, compared to the passive implementation in the control condition.

In total 109 primary care patients with musculoskeletal pain ≥ 4 weeks are included consecutively in the active implementation and passive implementation (control) clinics. The sample size was based on a priori power analysis on differences in primary outcome between conditions and expected attrition. Patients from both conditions are included during the first year after the implementation period.

Data collection has been at onset and end of patients' treatment period, and will be at 6, 12, and 18 months post treatment (in both implementation and control clinics).

Recommended core outcomes regarding body structure, activity and participation are used. Primary outcomes: Participation in work life defined as days of sick-leave and participation in everyday life. Secondary outcomes will be patients' ratings of global treatment effects and pain intensity. Process measures: prognostic psychosocial factors possible to address in physical therapy such as functional self-efficacy, fear of movement and patient expectations on treatment effects. Depression, seen as a confounder, will be controlled for. Calculation of costs will include avoidable cost of the implementation, sunk costs will be ignored. Direct health care costs, i.e. use of health care services will be identified, measured and priced to assess costs from a societal perspective. Indirect costs, i.e. production loss due to sick leave and health care visits will be estimated. Cost-benefit will be calculated from the perspective of the society. Economic benefits will be measured as the net value of production gained for society, with an appropriate discount rate. Costs for society will be calculated on direct health care costs.

Data analyses: Regression models are used to compare patient outcomes between implementation and control clinics and performed per protocol and on an intention-to-treat-basis. Total costs, i.e. direct health care costs, direct and indirect non-health care costs and incremental costs, will be compared between conditions. A ratio between difference in outcome scores and costs between baseline and 6, 12, and 18 months post treatment will be. Incremental costs will be calculated per cost-benefit ratio associated with treatments in the two conditions. Bootstrapping is used for confidence intervals for cost-effectiveness and cost-benefit ratios.

Eligibility criteria: Inclusion criteria:

* Patients who presents for physical therapy in primary care.
* 18 - 65 years of age
* musculoskeletal pain for 4 weeks or more
* ability to speak and understand spoken and written Swedish

Exclusion criteria:

* systemic disease
* malignity
* serious spinal pathology
* osteoarthritis waiting for surgery
* diagnosed depression
* neurological disease or injury that severely affect activity capacity

Primary outcomes:
measure: Change in days of sick-leave
timeFrame: through study completion, an average of 1 year
measure: Change in pain-related disability using Pain Disability Index
timeFrame: through study completion, an average of 1 year
measure: Change in health related quality of life using EQ-5D
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Change in the patients' perceptions of global treatment effect Change in perceived global treatment effect using the Patient Global Impression of Change Scale
timeFrame: through study completion, an average of 1 year
measure: Change in self-efficacy for daily activities using the Self-efficacy Scale
timeFrame: through study completion, an average of 1 year
measure: Change in catastrophizing thoughts about pain using the Catastrophizing subscale of the Coping Strategies Questionnaire
timeFrame: through study completion, an average of 1 year
measure: Change in fear of movement/(re)injury using the Tampa Scale of Kinesiophobia
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Gavle
country: Sweden
facility: Region Gävleborg
city: Nykoping
country: Sweden
facility: Landstinget Sörmland
city: Vasteras
country: Sweden
facility: Region Västmanland
Study officials:
affiliation: Mälardalen University, Box 883, SE-721 23 Västerås, Sweden
name: Anne Söderlund, professor
role: PRINCIPAL_INVESTIGATOR
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