Motivation and Adherence to Exercise Recommendations

NCT05512338 | Completed

• 1 other identifier: RHO/G5
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

• Treatment motivation

  We will assess individual differences in the types of motivation to exercise by using Exercise Self-Regulation Questionnaire. Values ranges from 1-7, higher scores mean a better outcome.

  Change from baseline to 6 weeks

Secondary Outcomes (4)

• Autonomy support from from physiotherapist

  Change from baseline to 6 weeks

• Adherence to recommended physical activity

  Change from baseline to 6 weeks

• Functioning and disability

  Change from baseline to 6 weeks

• Acceptance of Pain

  Change from baseline to 6 weeks

Study Arms (2)

PACT treatment group

EXPERIMENTAL

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.

Other: Treatment

Usual physiotherapy care group

ACTIVE COMPARATOR

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.

Other: Active control group

Interventions

Treatment OTHER

ACT-informed interventions combined with standard physiotherapy methods.

PACT treatment group

Active control group OTHER

Standard physiotherapy methods.

Usual physiotherapy care group

Eligibility Criteria

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

You may qualify if:

• Individuals over the age of 18
• 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

You may not qualify if:

• Prior treatment from cognitive-behavioural therapy pain management at any time and other physiotherapy treatment in the previous 6 months
• 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

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

University Hospital Brno

Brno, 62500, Czechia

Location

Related Publications (1)

• 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.

  PMID: 40050856 DERIVED

MeSH Terms

Interventions

Therapeutics

Study Officials

• Marketa Nevelikova, PT

  Department of Rehabilitation, University Hospital Brno, Czech Republic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ladislav Batalik, PT, PhD

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 23, 2022
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: April 1, 2024
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

CZ (1)