Research on Influencing Factors of Compliance of Spinal Exercise Therapy

Non-specific Chronic Low Back Pain Clinical Trial

Official title:

Research on Influencing Factors of Compliance of Spinal Exercise Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962282
• Other study ID #: M2019385
• Status: Recruiting
• Start date: January 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: Mouwang Zhou
• Phone: +86 15611908378
• Email: zhoumouwang[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 chronic low back pain to home exercise prescriptions.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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;

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non-specific Chronic Low Back Pain

Intervention

Other:
• Follow-up by telephone
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.

Locations

Country	Name	City	State
China	Research on Influencing Factors of Compliance of Spinal Exercise Therapy	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	main result 1	The number of patients with good compliance;	8 weeks after receiving treatment
Primary	main result 2	the number of patients with poor compliance	8 weeks after receiving treatment
Primary	main result 3	Self-made scale scores in 8 dimensions	8 weeks after receiving treatment