Chronic Low-back PainNCT05512338
Motivation and Adherence to Exercise Recommendations
A study testing Treatment in people with Chronic Low-back Pain, run by Brno University Hospital at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Sep 2022to 1 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Motivation and Adherence to Rehabilitation Exercise Recommendations in Patients With Chronic Low Back Pain- PACT vs. Usual Physiotherapy
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.
Read more
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.
Read the detailed description
Eligible participants will be randomly assigned to one of the treatment groups. All subjects will undergo 6 weeks of weekly face-to-face sessions.
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
- Chronic Low-back Pain
- Being tested
- Treatment, Active control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentOther
ACT-informed interventions combined with standard physiotherapy methods.
Active control groupOther
Standard physiotherapy methods.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Active control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 6 weeks
Secondary outcomes (4)
Autonomy support from from physiotherapist
We will assess patients´ perception of their physiotherapist autonomy support using Health Care Climate Questionnaire. Values ranges from 1-7, higher scores mean a better outcome.
Measured: Change from baseline to 6 weeks
Adherence to recommended physical activity
Adherence to prescribed home exercise will be obtained by Exercise Adherence Rating Scale questionnaire.Values ranges from 1-5, lower scores mean a better outcome.
Measured: Change from baseline to 6 weeks
Functioning and disability
Patient functioning and diability will be measured by the Roland-Morris Disability Questionnaire. Values ranges from 0-24, lower scores mean a better outcome.
Measured: Change from baseline to 6 weeks
Acceptance of Pain
Acceptance of Pain will be measured by the Chronic Pain Acceptance Questionnaire-8. Values ranges from 0-6, higher scores mean a better outcome.
Measured: Change from baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Sep 2022
- Primary completion1 Dec 2023
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ladislav Batalik, Brno University Hospital
- Investigators
- Marketa Nevelikova, PT, Study director, Department of Rehabilitation, University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512338
- Sponsor's protocol ID
- RHO/G5
- Status last verified
- Apr 2024
- First submitted
- 22 Aug 2022
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40050856
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Motivation and Adherence to Rehabilitation Exercise Recommendations in Patients With Chronic Low Back Pain- PACT vs. Usual Physiotherapy
- ClinicalTrials.gov ID
- NCT05512338
- Acronym / sponsor ID
- RHO/G5
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eligible participants will be randomly assigned to one of the treatment groups. All subjects will undergo 6 weeks of weekly face-to-face sessions.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACT treatment group | Experimental | Other: TreatmentPACT 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. |
| Usual physiotherapy care group | Active comparator | Other: Active control groupUC 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TreatmentACT-informed interventions combined with standard physiotherapy methods. | Other | PACT treatment group |
| Active control groupStandard physiotherapy methods. | Other | Usual physiotherapy care group |
Primary outcome
Treatment motivation
Time frame: Change from baseline to 6 weeks
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.
4 secondary outcomes
Autonomy support from from physiotherapist
Time frame: Change from baseline to 6 weeks
Adherence to recommended physical activity
Time frame: Change from baseline to 6 weeks
Functioning and disability
Time frame: Change from baseline to 6 weeks
Acceptance of Pain
Time frame: Change from baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Derived from this study: PubMed 40050856Nevelikova 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marketa Nevelikova, PT study director
Department of Rehabilitation, University Hospital Brno, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment in people with Chronic Low-back Pain, run by Brno University Hospital at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment motivation (time frame: Change from baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05512338, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2024.