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

• ClinicalTrials.gov Identifier: NCT03118453
• Recruitment Status: Active, not recruiting
• First Posted: April 18, 2017
• Last Update Posted: November 18, 2019
• Sponsor: Mälardalen University
• Information provided by (Responsible Party): Mälardalen University

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain; Musculoskeletal Pain	Behavioral: Active implementation clinics; Behavioral: Passive implementation clinics	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 109 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain - Evaluation of the Implementation Process and Outcome
• Study Start Date: November 2016
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: November 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Active implementation clinics; 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.	Behavioral: Active implementation clinics; Physical therapy treatment as the physical therapist chooses
Active Comparator: Passive implementation clinics; 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	Behavioral: Passive implementation clinics; Physical therapy treatment as the physical therapist chooses

Outcome Measures

Primary Outcome Measures :

1. Change in days of sick-leave [ Time Frame: through study completion, an average of 1 year ]
   Self-reports and sick-leave data from the Swedish Social Insurance Administration
2. Change in pain-related disability using Pain Disability Index [ Time Frame: through study completion, an average of 1 year ]
   Pain Disability Index: Measure of disruptions in seven dimensions of everyday life. Self-reports on a11-graded numerical rating scale
3. Change in health related quality of life using EQ-5D [ Time Frame: through study completion, an average of 1 year ]
   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 :

1. Change in the patients' perceptions of global treatment effect Change in perceived global treatment effect using the Patient Global Impression of Change Scale [ Time Frame: through study completion, an average of 1 year ]
   Patients Global Impression of Change (PGIC) scale which provides the patient's belief about the treatment effect rated on a 7-graded scale
2. Change in self-efficacy for daily activities using the Self-efficacy Scale [ Time Frame: through study completion, an average of 1 year ]
   The Self-efficacy Scale: ratings of self-efficacy for 20 common activities in daily life
3. Change in catastrophizing thoughts about pain using the Catastrophizing subscale of the Coping Strategies Questionnaire [ Time Frame: through study completion, an average of 1 year ]
   The Catastrophizing subscale of the Coping Strategies Questionnaire: ratings of pain-related catastrophizing thoughts
4. Change in fear of movement/(re)injury using the Tampa Scale of Kinesiophobia [ Time Frame: through study completion, an average of 1 year ]
   The Tampa Scale of Kinesiophobia: ratings of fear and avoidance of movement

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Sweden

Region Gävleborg

Gavle, Sweden

Landstinget Sörmland

Nykoping, Sweden, SE-61188

Region Västmanland

Vasteras, Sweden, SE-72189

Sponsors and Collaborators

Mälardalen University

Investigators

• Principal Investigator: Anne Söderlund, professor; Mälardalen University, Box 883, SE-721 23 Västerås, Sweden

More Information

Publications:

Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011 Oct 29;378(9802):1560-71. doi: 10.1016/S0140-6736(11)60937-9. Epub 2011 Sep 28.

Söderlund A, Lindberg P. Cognitive behavioural components in physiotherapy management of chronic whiplash associated disorders (WAD)--a randomised group study. G Ital Med Lav Ergon. 2007 Jan-Mar;29(1 Suppl A):A5-11.

Denison E, Asenlöf P, Sandborgh M, Lindberg P. Musculoskeletal pain in primary health care: subgroups based on pain intensity, disability, self-efficacy, and fear-avoidance variables. J Pain. 2007 Jan;8(1):67-74. Epub 2006 Sep 1.

Asenlöf P, Denison E, Lindberg P. Individually tailored treatment targeting activity, motor behavior, and cognition reduces pain-related disability: a randomized controlled trial in patients with musculoskeletal pain. J Pain. 2005 Sep;6(9):588-603.

Sandborgh M, Åsenlöf P, Lindberg P, Denison, E. Implementing behavioural medicine in physiotherapy treatment. Part II: Adherence to treatment protocol. Advances in Physiotherapy 12: 13-23, 2010 doi: 10.3109/14038190903480672

Phillips CJ. Economic burden of chronic pain. Expert Rev Pharmacoecon Outcomes Res. 2006 Oct;6(5):591-601. doi: 10.1586/14737167.6.5.591.

Mäntyselkä PT, Kumpusalo EA, Ahonen RS, Takala JK. Direct and indirect costs of managing patients with musculoskeletal pain-challenge for health care. Eur J Pain. 2002;6(2):141-8.

Lamb SE, Lall R, Hansen Z, Castelnuovo E, Withers EJ, Nichols V, Griffiths F, Potter R, Szczepura A, Underwood M; BeST trial group. A multicentred randomised controlled trial of a primary care-based cognitive behavioural programme for low back pain. The Back Skills Training (BeST) trial. Health Technol Assess. 2010 Aug;14(41):1-253, iii-iv. doi: 10.3310/hta14410.

Wiltsey Stirman S, Kimberly J, Cook N, Calloway A, Castro F, Charns M. The sustainability of new programs and innovations: a review of the empirical literature and recommendations for future research. Implement Sci. 2012 Mar 14;7:17. doi: 10.1186/1748-5908-7-17. Review.

Hahne AJ, Ford JJ, Richards MC, Surkitt LD, Chan AYP, Slater SL, Taylor NF. Who Benefits Most From Individualized Physiotherapy or Advice for Low Back Disorders? A Preplanned Effect Modifier Analysis of a Randomized Controlled Trial. Spine (Phila Pa 1976). 2017 Nov 1;42(21):E1215-E1224. doi: 10.1097/BRS.0000000000002148.

• Responsible Party: Mälardalen University
• ClinicalTrials.gov Identifier: NCT03118453
• Other Study ID Numbers: 140369
• First Posted: April 18, 2017
• Last Update Posted: November 18, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mälardalen University:

Musculoskeletal pain/*therapy; Behavioral medicine; Physical therapy; Cost-benefit analyses; Treatment outcome; Adults

Additional relevant MeSH terms:

Musculoskeletal Pain; Chronic Pain; Pain; Neurologic Manifestations; Muscular Diseases; Musculoskeletal Diseases