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

NCT03118453 | Unknown

• 1 other identifier: 140369
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Pain; Musculoskeletal Pain

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (4)

• Change in the patients' perceptions of global treatment effect Change in perceived global treatment effect using the Patient Global Impression of Change Scale

  through study completion, an average of 1 year

• Change in self-efficacy for daily activities using the Self-efficacy Scale

  through study completion, an average of 1 year

• Change in catastrophizing thoughts about pain using the Catastrophizing subscale of the Coping Strategies Questionnaire

  through study completion, an average of 1 year

• Change in fear of movement/(re)injury using the Tampa Scale of Kinesiophobia

  through study completion, an average of 1 year

Study Arms (2)

Active implementation clinics

EXPERIMENTAL

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

Passive implementation clinics

ACTIVE COMPARATOR

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

Interventions

Active implementation clinics BEHAVIORAL

Physical therapy treatment as the physical therapist chooses

Active implementation clinics

Passive implementation clinics BEHAVIORAL

Physical therapy treatment as the physical therapist chooses

Passive implementation clinics

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mälardalen University: lead

Study Sites (3)

Region Gävleborg

Gävle, Sweden

Location

Landstinget Sörmland

Nyköping, SE-61188, Sweden

Location

Region Västmanland

Västerås, SE-72189, Sweden

Location

Related Publications (11)

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  PMID: 21963002 BACKGROUND

• Soderlund 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.

  PMID: 17650736 BACKGROUND

• Denison E, Asenlof 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. doi: 10.1016/j.jpain.2006.06.007. Epub 2006 Sep 1.

  PMID: 16950657 BACKGROUND

• Asenlof 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. doi: 10.1016/j.jpain.2005.03.008.

  PMID: 16139778 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 20528505 BACKGROUND

• Mantyselka 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. doi: 10.1053/eujp.2001.0311.

  PMID: 11900474 BACKGROUND

• 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.

  PMID: 20807469 BACKGROUND

• 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.

  PMID: 22417162 BACKGROUND

• 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.

  PMID: 28263227 BACKGROUND

• Fritz J, Almqvist L, Soderlund A, Wallin L, Sandborgh M. Patients' health outcomes after an implementation intervention targeting the physiotherapists' clinical behaviour. Arch Physiother. 2021 Oct 9;11(1):22. doi: 10.1186/s40945-021-00116-z.

  PMID: 34625120 DERIVED

MeSH Terms

Conditions

Chronic Pain; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Anne Söderlund, professor

  Mälardalen University, Box 883, SE-721 23 Västerås, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 18, 2017
• Study Start: November 1, 2016
• Primary Completion: September 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)