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Motivation and Adherence to Exercise Recommendations

Primary Purpose

Chronic Low-back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Treatment
Active control group
Sponsored by
Brno University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • University Hospital BrnoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PACT treatment group

Usual physiotherapy care group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 22, 2022
Last Updated
November 1, 2022
Sponsor
Brno University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05512338
Brief Title
Motivation and Adherence to Exercise Recommendations
Official Title
Patient Motivation and Adherence to Rehabilitation Exercise Recommendations in Patients With Chronic Low Back Pain- PACT vs. Usual Physiotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brno University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PACT treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual physiotherapy care group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment
Intervention Description
ACT-informed interventions combined with standard physiotherapy methods.
Intervention Type
Other
Intervention Name(s)
Active control group
Intervention Description
Standard physiotherapy methods.
Primary Outcome Measure Information:
Title
Treatment motivation
Description
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.
Time Frame
Change from baseline to 6 weeks
Secondary Outcome Measure Information:
Title
Autonomy support from from physiotherapist
Description
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.
Time Frame
Change from baseline to 6 weeks
Title
Adherence to recommended physical activity
Description
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.
Time Frame
Change from baseline to 6 weeks
Title
Functioning and disability
Description
Patient functioning and diability will be measured by the Roland-Morris Disability Questionnaire. Values ranges from 0-24, lower scores mean a better outcome.
Time Frame
Change from baseline to 6 weeks
Title
Acceptance of Pain
Description
Acceptance of Pain will be measured by the Chronic Pain Acceptance Questionnaire-8. Values ranges from 0-6, higher scores mean a better outcome.
Time Frame
Change from baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marketa Nevelikova, PT
Phone
00420605762243
Email
nevelikova.marketa@fnbrno.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Ladislav Batalik, PT,PhD
Email
batalik.ladislav@fnbrno.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marketa Nevelikova, PT
Organizational Affiliation
Department of Rehabilitation, University Hospital Brno, Czech Republic
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ladislav Batalik

12. IPD Sharing Statement

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Motivation and Adherence to Exercise Recommendations

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