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Implementation of a Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain

Primary Purpose

Chronic Pain, Musculoskeletal Pain

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Active implementation clinics
Passive implementation clinics
Sponsored by
Mälardalen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Musculoskeletal pain/*therapy, Behavioral medicine, Physical therapy, Cost-benefit analyses, Treatment outcome, Adults

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Region Gävleborg
  • Landstinget Sörmland
  • Region Västmanland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active implementation clinics

Passive implementation clinics

Arm Description

Patients recruited by physical therapists who underwent an implementation period with active implementations strategies, such as supervision, web lectures, peer learning in groups consisting of colleagues. A behavioral medicine approach in physical therapy for patients with musculoskeletal pain was encouraged with these active implementation strategies.

Patients recruited by physical therapists who underwent an implementation period with passive implementations strategies, such as written material and a short web lecture. A behavioral medicine approach in physical therapy for patients with musculoskeletal pain was encouraged with these passive implementation strategies

Outcomes

Primary Outcome Measures

Change in days of sick-leave
Self-reports and sick-leave data from the Swedish Social Insurance Administration
Change in pain-related disability using Pain Disability Index
Pain Disability Index: Measure of disruptions in seven dimensions of everyday life. Self-reports on a11-graded numerical rating scale
Change in health related quality of life using EQ-5D
EuroQol, Quality of life scale in 5 dimensions (EQ-5D) which provides a simple descriptive profile and a single index value for health status.

Secondary Outcome Measures

Change in the patients' perceptions of global treatment effect Change in perceived global treatment effect using the Patient Global Impression of Change Scale
Patients Global Impression of Change (PGIC) scale which provides the patient's belief about the treatment effect rated on a 7-graded scale
Change in self-efficacy for daily activities using the Self-efficacy Scale
The Self-efficacy Scale: ratings of self-efficacy for 20 common activities in daily life
Change in catastrophizing thoughts about pain using the Catastrophizing subscale of the Coping Strategies Questionnaire
The Catastrophizing subscale of the Coping Strategies Questionnaire: ratings of pain-related catastrophizing thoughts
Change in fear of movement/(re)injury using the Tampa Scale of Kinesiophobia
The Tampa Scale of Kinesiophobia: ratings of fear and avoidance of movement

Full Information

First Posted
March 20, 2017
Last Updated
November 15, 2019
Sponsor
Mälardalen University
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1. Study Identification

Unique Protocol Identification Number
NCT03118453
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
November 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mälardalen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Musculoskeletal Pain
Keywords
Musculoskeletal pain/*therapy, Behavioral medicine, Physical therapy, Cost-benefit analyses, Treatment outcome, Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active implementation clinics
Arm Type
Experimental
Arm Description
Patients recruited by physical therapists who underwent an implementation period with active implementations strategies, such as supervision, web lectures, peer learning in groups consisting of colleagues. A behavioral medicine approach in physical therapy for patients with musculoskeletal pain was encouraged with these active implementation strategies.
Arm Title
Passive implementation clinics
Arm Type
Active Comparator
Arm Description
Patients recruited by physical therapists who underwent an implementation period with passive implementations strategies, such as written material and a short web lecture. A behavioral medicine approach in physical therapy for patients with musculoskeletal pain was encouraged with these passive implementation strategies
Intervention Type
Behavioral
Intervention Name(s)
Active implementation clinics
Intervention Description
Physical therapy treatment as the physical therapist chooses
Intervention Type
Behavioral
Intervention Name(s)
Passive implementation clinics
Intervention Description
Physical therapy treatment as the physical therapist chooses
Primary Outcome Measure Information:
Title
Change in days of sick-leave
Description
Self-reports and sick-leave data from the Swedish Social Insurance Administration
Time Frame
through study completion, an average of 1 year
Title
Change in pain-related disability using Pain Disability Index
Description
Pain Disability Index: Measure of disruptions in seven dimensions of everyday life. Self-reports on a11-graded numerical rating scale
Time Frame
through study completion, an average of 1 year
Title
Change in health related quality of life using EQ-5D
Description
EuroQol, Quality of life scale in 5 dimensions (EQ-5D) which provides a simple descriptive profile and a single index value for health status.
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Change in the patients' perceptions of global treatment effect Change in perceived global treatment effect using the Patient Global Impression of Change Scale
Description
Patients Global Impression of Change (PGIC) scale which provides the patient's belief about the treatment effect rated on a 7-graded scale
Time Frame
through study completion, an average of 1 year
Title
Change in self-efficacy for daily activities using the Self-efficacy Scale
Description
The Self-efficacy Scale: ratings of self-efficacy for 20 common activities in daily life
Time Frame
through study completion, an average of 1 year
Title
Change in catastrophizing thoughts about pain using the Catastrophizing subscale of the Coping Strategies Questionnaire
Description
The Catastrophizing subscale of the Coping Strategies Questionnaire: ratings of pain-related catastrophizing thoughts
Time Frame
through study completion, an average of 1 year
Title
Change in fear of movement/(re)injury using the Tampa Scale of Kinesiophobia
Description
The Tampa Scale of Kinesiophobia: ratings of fear and avoidance of movement
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Söderlund, professor
Organizational Affiliation
Mälardalen University, Box 883, SE-721 23 Västerås, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Region Gävleborg
City
Gavle
Country
Sweden
Facility Name
Landstinget Sörmland
City
Nykoping
ZIP/Postal Code
SE-61188
Country
Sweden
Facility Name
Region Västmanland
City
Vasteras
ZIP/Postal Code
SE-72189
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual participant data (IPD) because the participants have been assured of confidentiality and that only the researchers in the Project will have access to IPD
Citations:
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21963002
Citation
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Results Reference
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Citation
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Citation
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Results Reference
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Implementation of a Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain

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