NCT05512338

Motivation and Adherence to Exercise Recommendations

Completed NA Last updated 29 April 2024

What this trial tests

NA trial testing Treatment in Chronic Low-back Pain in 54 participants. Completed in 1 April 2024.

Timeline

1 September 2022

Primary endpoint
1 December 2023

1 April 2024

Quick facts

Lead sponsor	Brno University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	54
Start date	1 September 2022
Primary completion	1 December 2023
Estimated completion	1 April 2024
Sites	1 location across Czechia

Drugs / interventions tested

• Treatment — full drug profile →
• Active control group

Conditions studied

• Chronic Low-back Pain — all drugs for Chronic Low-back Pain →

Sponsor

Brno University Hospital

Who can join

18 and older, any sex, with Chronic Low-back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Low back pain is a common condition that occurs in up to 70% of the population in industrialized countries and is the second most common cause of work inability. Physiotherapy is the usual treatment for low back pain. Recent studies showed that combining theory-based psychological methods with physiotherapy can enhance the effectiveness of physiotherapy treatment for people with chronic low back pain.

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Motivation to exercise in patients with chronic low back pain.
   Nevelikova M, Zlamal F, Dosbaba F, Su JJ, et al · · 2025 · cited 3× · PMID 40050856 · DOI 10.1186/s12891-025-08461-x
2. Physiotherapy informed by acceptance and commitment therapy for chronic low back pain: A randomized trial.
   Nevelikova M, Zlamal F, Dosbaba F, Su JJ, et al · · 2026 · PMID 42016046 · DOI 10.1142/s1013702526500022