Non-specific Chronic Low Back PainNCT04962282
Research on Influencing Factors of Compliance of Spinal Exercise Therapy
An observational study of Non-specific Chronic Low Back Pain, run by Peking University Third Hospital at 1 site in China.
Trial summary
Explore the many factors that affect the compliance of home exercise therapy in patients with non-specific chronic low back pain, establish a theoretical model of the factors affecting compliance behavior, in order to guide rehabilitation clinical practice, and improve the compliance of patients with non-specific… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-specific Chronic Low Back Pain
- What is being tested?
- Follow-up by telephone
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Sep 2022
- Phase
- Observational
- 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 to 80 years
- All sexes
- Adult, Older adult
Study population: From February 2019 to August 2019, due to recurrent low back pain, he was treated in the Department of Rehabilitation Medicine of Peking University Third Hospital and prescribed home exercise therapy.
Who may be able to join
- 1.Age from 18 to 80 years old; 2.The clinical diagnosis is non-specific low back pain, the course of disease is ≥12 weeks;
Who cannot join
- 1.Combined with specific lumbar spine diseases, physical diseases affecting sports 2.Due to mental or psychological abnormalities; refused to accept telephone interviews; 3.Failed to answer the interview call for 3 consecutive times;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Research on Influencing Factors of Compliance of Spinal Exercise Therapy
Beijing, Beijing Municipality, 100191
Mouwang Zhou, +86 15611908378, zhoumouwang@163.com
About this study
Explore the many factors that affect the compliance of home exercise therapy in patients with non-specific chronic low back pain, establish a theoretical model of the factors affecting compliance behavior, in order to guide rehabilitation clinical practice, and improve the compliance of patients with non-specific chronic low back pain to home exercise prescriptions.
Read the detailed description
ABSTRACT Objective: To achieve more information and establish better guidance for the clinical practice of rehabilitation, to improve the adherence of non-specific chronic low back pain patients with home-based exercise prescription by exploring the factors that affect the adherence of patients, and by building a theoretical model of adherence influencing factors.
Method: From February 2019 to August 2019, 39 patients were diagnosed as non-specific chronic low back pain and prescribed home-based exercise prescription in the Department of rehabilitation medicine of Peking University Third Hospital. They were recruited by criterion-based sampling and had face-to-face exercise therapy guidance from the same physiotherapist. We have a semi-structured 20-40 minutes telephone interview 2-3 months later. The conversation was recorded with the consent of the patients, then the recorded content was documented as text data. By the patient's exercise type, intensity, duration and frequency, the patient adherence was classified as complete adherent, partial adherent and complete not adherent. The qualitative research method was used to analyze the data under the guidance of grounded theory with the help of qualitative analysis software NVivo. NVivo was used to encode the text data of patient's conversation in three levels, and the themes were extracted to explain the causes of adherence.
Result: Of the 39 patients interviewed, 32 responded to the interview, with a response rate of 82.0%. The average age of these 32 responded patients was 48.8±18.6 years old. There were 9 males (28.1%) and 23 females (71.9%). There were 4 complete adherent patients, 5 not adherent, and 23 partial adherent (including 14 giving up halfway and 9 intermittent exercise). The open coding got 19 initial sub-categories; then axial coding classified 19 initial sub-categories into five main categories, namely health belief, self-efficacy, exercise prescription, self-management and family support. Selective coding classified health belief and self-efficacy as "internal environment", while exercise prescription and family support as "external environment". Based on this discovery, two theories are established: (1) patients' "self-management" ability is the internal motivation of adherence behavior; (2) the "internal environment" and "external environment" play a regulatory role in adherence behavior.
Conclusion: Patients' adherence behavior is directly affected by the ability of self-management and tends to be standardized under the regulation of good internal and external environment. Regular follow-up, health education and adjusting the structure of exercise prescription are necessary measures to improve patients' adherence.
- Conditions
- Non-specific Chronic Low Back Pain
- Being tested
- Follow-up by telephone
- Keywords
- Non-specific Chronic Low Back Pain, Home-based Exercise Therapy, Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up by telephoneOther
Studies have shown that the compliance of patients at 8-12 weeks reaches a peak, so this time node is the most suitable time node to investigate compliance. Telephone follow-up is irreplaceable convenience, so the telephone follow-up survey of patient compliance with exercise prescriptions is The most feasible method The purpose of the telephone follow-up is to 1. Investigate the compliance of the patients; 2. Make the patients fill out a self-made research compliance scale influencing factors through the telephone.The purpose of the telephone follow-up is to 1. Investigate the compliance of the patients; 2. Make the patients fill out a self-made research compliance scale influencing factors through the telephone.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Follow-up by telephone for researching compliance of patients receiving exercise prescriptions Receives: Other: Follow-up by telephone |
What is being measured
The primary outcome is the main question the study is designed to answer.
main result 1
The number of patients with good compliance;
Measured: 8 weeks after receiving treatment
main result 2
the number of patients with poor compliance
Measured: 8 weeks after receiving treatment
main result 3
Self-made scale scores in 8 dimensions
Measured: 8 weeks after receiving treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Jan 2019
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Family based
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962282
- Sponsor's protocol ID
- M2019385
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Influencing Factors of Compliance of Spinal Exercise Therapy
- ClinicalTrials.gov ID
- NCT04962282
- Acronym / sponsor ID
- M2019385
- Conditions
- Non-specific Chronic Low Back Pain
- Keywords
- Non-specific Chronic Low Back Pain, Home-based Exercise Therapy, Adherence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 14 Jul 2021 (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.
Explore the many factors that affect the compliance of home exercise therapy in patients with non-specific chronic low back pain, establish a theoretical model of the factors affecting compliance behavior, in order to guide rehabilitation clinical practice, and improve the compliance of patients with non-specific chronic low back pain to home exercise prescriptions.
Detailed description
ABSTRACT Objective: To achieve more information and establish better guidance for the clinical practice of rehabilitation, to improve the adherence of non-specific chronic low back pain patients with home-based exercise prescription by exploring the factors that affect the adherence of patients, and by building a theoretical model of adherence influencing factors.
Method: From February 2019 to August 2019, 39 patients were diagnosed as non-specific chronic low back pain and prescribed home-based exercise prescription in the Department of rehabilitation medicine of Peking University Third Hospital. They were recruited by criterion-based sampling and had face-to-face exercise therapy guidance from the same physiotherapist. We have a semi-structured 20-40 minutes telephone interview 2-3 months later. The conversation was recorded with the consent of the patients, then the recorded content was documented as text data. By the patient's exercise type, intensity, duration and frequency, the patient adherence was classified as complete adherent, partial adherent and complete not adherent. The qualitative research method was used to analyze the data under the guidance of grounded theory with the help of qualitative analysis software NVivo. NVivo was used to encode the text data of patient's conversation in three levels, and the themes were extracted to explain the causes of adherence.
Result: Of the 39 patients interviewed, 32 responded to the interview, with a response rate of 82.0%. The average age of these 32 responded patients was 48.8±18.6 years old. There were 9 males (28.1%) and 23 females (71.9%). There were 4 complete adherent patients, 5 not adherent, and 23 partial adherent (including 14 giving up halfway and 9 intermittent exercise). The open coding got 19 initial sub-categories; then axial coding classified 19 initial sub-categories into five main categories, namely health belief, self-efficacy, exercise prescription, self-management and family support. Selective coding classified health belief and self-efficacy as "internal environment", while exercise prescription and family support as "external environment". Based on this discovery, two theories are established: (1) patients' "self-management" ability is the internal motivation of adherence behavior; (2) the "internal environment" and "external environment" play a regulatory role in adherence behavior.
Conclusion: Patients' adherence behavior is directly affected by the ability of self-management and tends to be standardized under the regulation of good internal and external environment. Regular follow-up, health education and adjusting the structure of exercise prescription are necessary measures to improve patients' adherence.
Study design
- Observational model
- Family based
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | Other: Follow-up by telephoneFollow-up by telephone for researching compliance of patients receiving exercise prescriptions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- From February 2019 to August 2019, due to recurrent low back pain, he was treated in the Department of Rehabilitation Medicine of Peking University Third Hospital and prescribed home exercise therapy.
Key inclusion criteria (1 listed)
- 1.Age from 18 to 80 years old; 2.The clinical diagnosis is non-specific low back pain, the course of disease is ≥12 weeks;
Key exclusion criteria (1 listed)
- 1.Combined with specific lumbar spine diseases, physical diseases affecting sports 2.Due to mental or psychological abnormalities; refused to accept telephone interviews; 3.Failed to answer the interview call for 3 consecutive times;
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 |
|---|---|---|
| Follow-up by telephoneStudies have shown that the compliance of patients at 8-12 weeks reaches a peak, so this time node is the most suitable time node to investigate compliance. Telephone follow-up is irreplaceable convenience, so the telephone follow-up survey of patient compliance with exercise prescriptions is The most feasible method The purpose of the telephone follow-up is to 1. Investigate the compliance of the patients; 2. Make the patients fill out a self-made research compliance scale influencing factors through the telephone.The purpose of the telephone follow-up is to 1. Investigate the compliance of the patients; 2. Make the patients fill out a self-made research compliance scale influencing factors through the telephone. | Other | group 1 |
Primary outcome
main result 1
Time frame: 8 weeks after receiving treatment
The number of patients with good compliance;
main result 2
Time frame: 8 weeks after receiving treatment
the number of patients with poor compliance
main result 3
Time frame: 8 weeks after receiving treatment
Self-made scale scores in 8 dimensions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-specific Chronic Low Back Pain, run by Peking University Third Hospital at 1 site in China.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 14 Jul 2021. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mouwang Zhou (+86 15611908378, zhoumouwang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
main result 1 (time frame: 8 weeks after receiving treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jul 2021.