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

Chronic Pain Clinical Trial

Official title:

A Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain - Evaluation of the Implementation Process and Outcome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03118453
• Other study ID #: 140369
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 2022

Study information

• Verified date: November 2019
• Source: Mälardalen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 109
• Est. completion date: November 2022
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Musculoskeletal Pain

Intervention

Behavioral:
• Active implementation clinics
Physical therapy treatment as the physical therapist chooses
• Passive implementation clinics
Physical therapy treatment as the physical therapist chooses

Locations

Country	Name	City	State
Sweden	Region Gävleborg	Gavle
Sweden	Landstinget Sörmland	Nykoping
Sweden	Region Västmanland	Vasteras

Sponsors (1)

Lead Sponsor	Collaborator
Mälardalen University

Country where clinical trial is conducted

Sweden, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in days of sick-leave	Self-reports and sick-leave data from the Swedish Social Insurance Administration	through study completion, an average of 1 year
Primary	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	through study completion, an average of 1 year
Primary	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.	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year
Secondary	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	through study completion, an average of 1 year