Study Results
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Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2022-09-01
2024-04-01
Brief Summary
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One promising approach to treating chronic pain is PACT - Physiotherapy informed by Acceptance and Commitment Therapy (ACT), a form of cognitive-behavioral therapy. PACT aims to increase psychological flexibility and focus on improving function rather than reducing pain.
According to several studies, the effects of ACT can be maintained up to 3 years post-treatment, which is essential in a condition such as chronic pain and its typical relapses.
According to self-determination theory (SDT), facilitating an environment of acceptance and autonomy support enhances treatment motivation, thus offering a good interface for applying SDT´s research concepts to ACT interventions.
The primary objective of this study is to investigate the impact of physiotherapists´ autonomy-supportive behavior within PACT on the motivation process in chronic low back pain patients. Other objectives are to evaluate the efficacy of PACT on the functioning and disability due to CLBP, adherence to recommended physical activity, and the acceptance of pain.
This prospective, randomized controlled trial will include 2 treatment groups (PACT treatment group and Usual physiotherapy Care group\[UC\]) in 1:1 ratio. Participants in the PACT treatment group will undergo a physiotherapy intervention guided by ACT principles.
Participants randomized to UC will receive treatment considered suitable by their treating physiotherapist, including exercises based on the DNS concept and manual therapy.
Regardless of group assignment, all participants will undergo 6 physiotherapy face-to-face interventions lasting 45 minutes, each once a week.
Study outcomes will include measures of treatment motivation, perceived degree of autonomy support within the care settings, functioning, and disability, adherence to recommended physical activity, and acceptance of pain.
While we acknowledge the value of usual physiotherapy care, CLBP is best suited to a biopsychosocial model for care. Further research is needed to understand which underlying processes and components are causing the improvement.
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Detailed Description
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PACT treatment will include an initial physical assesment with feedback, identification of value-based goals, individualized physical exercise based on the DNS concept, manual therapy, addressing barriers and facilitators to self-management, and skills training to promote psychological flexibility.
UC will include an initial physical assesment with feedback, treatment considered suitable by their treating physiotherapist that will be based on exercises according to the DNS concept and manual therapy.
The self-report questionnaires will be completed by participants at baseline and 6 weeks, all to be completed at home.
Treatment will be provided by an experienced physiotherapist and will be conducted in a private room.
To avoid contamination, the same clinician will deliver both PACT and UC as CBT-based methods are sometimes employed within usual physiotherapy care.
A clinical psychologist and expert in the ACT will provide training. There will be group face-to-face training that will last 2 days followed by self-experience group training that will last 6 weeks (2 hours/week).
All PACT sessions will be audio-recorded to assesing treatment fidelity. Recordings will be used for supervision. Supervisor will be a clinical psychologist experienced in ACT and will review one tape per month.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PACT treatment group
PACT treatment will include an initial physical assesment with feedback, identification of value-based goals, individualized physical exercise based on the DNS concept, manual therapy, addressing barriers and facilitators to self-management, and skills training to promote psychological flexibility.
Treatment
ACT-informed interventions combined with standard physiotherapy methods.
Usual physiotherapy care group
UC will include an initial physical assesment with feedback, treatment considered suitable by their treating physiotherapist that will be based on exercises according to the DNS concept and manual therapy.
Active control group
Standard physiotherapy methods.
Interventions
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Treatment
ACT-informed interventions combined with standard physiotherapy methods.
Active control group
Standard physiotherapy methods.
Eligibility Criteria
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Inclusion Criteria
* Chronic low-back pain longer than 12 weeks
* Scoring more than 3 points in Roland-Morris Disability Questionnaire (RMDQ)
* Adequate understanding of spoken and written czech language
Exclusion Criteria
* Injection therapy within 3 months
* Specific medically diagnosed lubar spine pathology (eg, fracture, cancer)
* Deteorating neurological sings
* Patients with current psychiatric illness
* Current alcohol or drug misuse
18 Years
ALL
No
Sponsors
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Brno University Hospital
OTHER
Responsible Party
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Ladislav Batalik
Ladislav Batalik, PT, PhD
Principal Investigators
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Marketa Nevelikova, PT
Role: STUDY_DIRECTOR
Department of Rehabilitation, University Hospital Brno, Czech Republic
Locations
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University Hospital Brno
Brno, , Czechia
Countries
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References
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Nevelikova M, Zlamal F, Dosbaba F, Su JJ, Batalik L. Motivation to exercise in patients with chronic low back pain. BMC Musculoskelet Disord. 2025 Mar 6;26(1):226. doi: 10.1186/s12891-025-08461-x.
Other Identifiers
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RHO/G5
Identifier Type: -
Identifier Source: org_study_id
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