Low Back PainNCT05148364
Pain Resilience and Spiritual Health in Low Back Pain
An observational study of Low Back Pain, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
In the management of chronic pain, it is very important to reaffirm the patient's self-worth and ability through psychological support and spiritual care. The role of spiritual consultant is to provide spiritual consultation and spiritual care, so that the medical team can truly implement a whole-person care of the… Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jul 2022to 31 May 2024
- 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 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants should have persistent low back pain that has lasted for at least three months. Pain is a very subjective experience, so it is not necessary that the participant has to be diagnosed by a physician.
Who may be able to join
- Individual with non-malignant persistent low back pain that has lasted for at least three months.
- Individual that is willing to undergo interview about their pain experience.
- Individual ages between 20 and 100.
Who cannot join
- Individual with cognitive or psychological impairments that may compromise the ability to understand the interviewing questionnaire.
- Individual younger that 20 years old.
- The pain is clearly related to spinal cancer.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Changhua Christian Hospital
Chang-hua, 500
Ling-Jun Liu, M.S., +886-4-7238595 ext. 3236, 180348@cch.org.tw
About this study
Official title: How Pain Resilience and Spiritual Health Affect the Pain Experience in Patients With Low Back Pain
In the management of chronic pain, it is very important to reaffirm the patient's self-worth and ability through psychological support and spiritual care. The role of spiritual consultant is to provide spiritual consultation and spiritual care, so that the medical team can truly implement a whole-person care of the patient including the body, mind, and family. Pain resilience of chronic pain patients' has been found to be a different construct from the general resilience in the field of chronic diseases. Pain resilience emphasizes the cognitive/emotional positivity and behavior persistence of pain patients' when facing pain. So far, there has been no research on the theme of "pain resilience and spiritual health". Researchers have seen the necessity of care and assistance for patients with chronic low back pain. Hence, this study would like to explore "how pain resilience and spiritual health affect the pain experience of patients with chronic low back pain ".
Research objectives: 1. To understand how spiritual health and pain resilience interact to influence the the pain experience in patients with chronic low back pain and 2. To understand how spiritual health and pain resilience interact and influence they way how patients with chronic low back pain cope with pain.
Read more
Method: This research plan will be implemented upon obtaining the approval from IRB. An estimated 15 cases will be enrolled. Through in-depth interviews and collection of observational data during interviews, the interviewer will record, transcribe and analyze the narratives and experience descriptions.
The results of this study can become an important basis for clinical care of patients with chronic low back pain.
Read the detailed description
In the management of chronic pain, it is very important to reaffirm the patient's self-worth and ability through psychological support and spiritual care. The role of spiritual consultant is to provide spiritual consultation and spiritual care, so that the medical team can truly implement a whole-person care of the patient including the body, mind, and family. Pain resilience of chronic pain patients' has been found to be a different construct from the general resilience in the field of chronic diseases. Pain resilience emphasizes the cognitive/emotional positivity and behavior persistence of pain patients' when facing pain. So far, there has been no research on the theme of "pain resilience and spiritual health". Researchers have seen the necessity of care and assistance for patients with chronic low back pain. Hence, this study would like to explore "how pain resilience and spiritual health affect the pain experience of patients with chronic low back pain ".
Research objectives: 1. To understand how spiritual health and pain resilience interact to influence the the pain experience in patients with chronic low back pain and 2. To understand how spiritual health and pain resilience interact and influence they way how patients with chronic low back pain cope with pain.
Method: This research plan will be implemented upon obtaining the approval from IRB. An estimated 15 cases will be enrolled. Through in-depth interviews and collection of observational data during interviews, the interviewer will record, transcribe and analyze the narratives and experience descriptions.
A spiritual consultant and a psychologist will interview the participants about their experiences of chronic low back pain, how they interpret their pain experience and how they cope with the persistent pain. Each participant will be interviewed individually.
Questions related to the following three aspects will be asked:
- Attributes: describe the changes in your personality, mood, and general happiness you have observed after you starting having chronic low back pain.
- Pain resilience: How would you describe this persisting pain experience? How do you arrange your daily activity? What do you do to deal with this persistent pain?
- Spirituality: As a person with chronic low back pain, how do you interpret this pain experience? Do you seek connections with higher powers (such as powers from religion) when you are desperate because of pain? Since the pain is chronic and persistent, it might not go away, how would you define your life?
Plan of analysis: The current study will adopt interpretative phenomenological analysis to to examine the pain experience of the participants. After data was collected through interview, transcripts will be coded in detail. In the process of analyzing the text, the investigators will categorize the text into themes.
The results of this study can become an important basis for clinical care of patients with chronic low back pain.
- Conditions
- Low Back Pain
- Being tested
- interview
- Keywords
- spirituality, low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewBehavioural
A spiritual consultant and a psychologist will interview the participants about their experiences of chronic low back pain, how they interpret their pain experience and how they cope with the persistent pain. Each participant will be interviewed individually.
Questions related to the following three aspects will be asked:
- Attributes: describe the changes in your personality, mood, and general happiness you have observed after you starting having chronic low back pain.
- Pain resilience: How would you describe this persisting pain experience? How do you arrange your daily activity? What do you do to deal with this persistent pain?
- Spirituality: As a person with chronic low back pain, how do you interpret this pain experience? Do you seek connections with higher powers (such as powers from religion) when you are desperate because of pain? Since the pain is chronic and persistent, it might not go away, how would you define your life?
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain resilience scale (PRS)
A 14-item scale used to measure the level of pain resilience. Participant could choose from 0 to 4 on each item to indicate how much one agrees to the statement used to describe one's reaction under persisting pain. "0" indicates "strongly disagree" while "4" indicates "fully agree". Higher total score on the PRS indicates higher resilience to pain.
Measured: 8 weeks
Spirituality
Participant gives a simple yes/no answer as to whether the participant has a religion or participate in religious activities.
Measured: 8 weeks
Patient Health Questionnaire-9
Patient Health Questionnaire-9 is a 9-item scale used to measure the level of depression in a respondent. Participant chooses from 0 to 3 on each item to indicate the frequency of experiencing each listed symptoms that might be part of depression. Higher total score indicates higher level of depression.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start20 Jul 2022
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ling-Jun Liu, MSc, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05148364
- Sponsor's protocol ID
- 211102
- Status last verified
- May 2024
- First submitted
- 25 Nov 2021
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Personal identifiers will be removed before data sharing (if we decide to share the data). Currently, we prefer to share only the descriptive statistics of the demographic data.
Publications
Slepian PM, Ankawi B, Himawan LK, France CR. Development and Initial Validation of the Pain Resilience Scale. J Pain. 2016 Apr;17(4):462-72. doi: 10.1016/j.jpain.2015.12.010. Epub 2015 Dec 31.
PubMed 26748044Ankawi B, Slepian PM, Himawan LK, France CR. Validation of the Pain Resilience Scale in a Chronic Pain Sample. J Pain. 2017 Aug;18(8):984-993. doi: 10.1016/j.jpain.2017.03.013. Epub 2017 Apr 18.
PubMed 28428092Gonzalez CE, Okunbor JI, Parker R, Owens MA, White DM, Merlin JS, Goodin BR. Pain-Specific Resilience in People Living With HIV and Chronic Pain: Beneficial Associations With Coping Strategies and Catastrophizing. Front Psychol. 2019 Sep 6;10:2046. doi: 10.3389/fpsyg.2019.02046. eCollection 2019.
PubMed 31555190Liu LJ, Peng HL, Lin EM, Liang WP. Do We Ask What the Deities Can Do for Us? The Roles of Dao Religion and Resilience in Suicidality in Chronic Pain. Pain Res Manag. 2025 Apr 17;2025:3056383. doi: 10.1155/prm/3056383. eCollection 2025.
PubMed 40276019
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Pain Resilience and Spiritual Health Affect the Pain Experience in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT05148364
- Acronym / sponsor ID
- 211102
- Conditions
- Low Back Pain
- Keywords
- spirituality, low back pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 20 Jul 2022 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 8 Dec 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.
In the management of chronic pain, it is very important to reaffirm the patient's self-worth and ability through psychological support and spiritual care. The role of spiritual consultant is to provide spiritual consultation and spiritual care, so that the medical team can truly implement a whole-person care of the patient including the body, mind, and family. Pain resilience of chronic pain patients' has been found to be a different construct from the general resilience in the field of chronic diseases. Pain resilience emphasizes the cognitive/emotional positivity and behavior persistence of pain patients' when facing pain. So far, there has been no research on the theme of "pain resilience and spiritual health". Researchers have seen the necessity of care and assistance for patients with chronic low back pain. Hence, this study would like to explore "how pain resilience and spiritual health affect the pain experience of patients with chronic low back pain ".
Research objectives: 1. To understand how spiritual health and pain resilience interact to influence the the pain experience in patients with chronic low back pain and 2. To understand how spiritual health and pain resilience interact and influence they way how patients with chronic low back pain cope with pain.
Method: This research plan will be implemented upon obtaining the approval from IRB. An estimated 15 cases will be enrolled. Through in-depth interviews and collection of observational data during interviews, the interviewer will record, transcribe and analyze the narratives and experience descriptions.
The results of this study can become an important basis for clinical care of patients with chronic low back pain.
Detailed description
In the management of chronic pain, it is very important to reaffirm the patient's self-worth and ability through psychological support and spiritual care. The role of spiritual consultant is to provide spiritual consultation and spiritual care, so that the medical team can truly implement a whole-person care of the patient including the body, mind, and family. Pain resilience of chronic pain patients' has been found to be a different construct from the general resilience in the field of chronic diseases. Pain resilience emphasizes the cognitive/emotional positivity and behavior persistence of pain patients' when facing pain. So far, there has been no research on the theme of "pain resilience and spiritual health". Researchers have seen the necessity of care and assistance for patients with chronic low back pain. Hence, this study would like to explore "how pain resilience and spiritual health affect the pain experience of patients with chronic low back pain ".
Research objectives: 1. To understand how spiritual health and pain resilience interact to influence the the pain experience in patients with chronic low back pain and 2. To understand how spiritual health and pain resilience interact and influence they way how patients with chronic low back pain cope with pain.
Method: This research plan will be implemented upon obtaining the approval from IRB. An estimated 15 cases will be enrolled. Through in-depth interviews and collection of observational data during interviews, the interviewer will record, transcribe and analyze the narratives and experience descriptions.
A spiritual consultant and a psychologist will interview the participants about their experiences of chronic low back pain, how they interpret their pain experience and how they cope with the persistent pain. Each participant will be interviewed individually.
Questions related to the following three aspects will be asked:
- Attributes: describe the changes in your personality, mood, and general happiness you have observed after you starting having chronic low back pain.
- Pain resilience: How would you describe this persisting pain experience? How do you arrange your daily activity? What do you do to deal with this persistent pain?
- Spirituality: As a person with chronic low back pain, how do you interpret this pain experience? Do you seek connections with higher powers (such as powers from religion) when you are desperate because of pain? Since the pain is chronic and persistent, it might not go away, how would you define your life?
Plan of analysis: The current study will adopt interpretative phenomenological analysis to to examine the pain experience of the participants. After data was collected through interview, transcripts will be coded in detail. In the process of analyzing the text, the investigators will categorize the text into themes.
The results of this study can become an important basis for clinical care of patients with chronic low back pain.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants should have persistent low back pain that has lasted for at least three months. Pain is a very subjective experience, so it is not necessary that the participant has to be diagnosed by a physician.
Key inclusion criteria (3 listed)
- Individual with non-malignant persistent low back pain that has lasted for at least three months.
- Individual that is willing to undergo interview about their pain experience.
- Individual ages between 20 and 100.
Key exclusion criteria (3 listed)
- Individual with cognitive or psychological impairments that may compromise the ability to understand the interviewing questionnaire.
- Individual younger that 20 years old.
- The pain is clearly related to spinal cancer.
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 |
|---|---|---|
| interviewA spiritual consultant and a psychologist will interview the participants about their experiences of chronic low back pain, how they interpret their pain experience and how they cope with the persistent pain. Each participant will be interviewed individually. Questions related to the following three aspects will be asked: 1. Attributes: describe the changes in your personality, mood, and general happiness you have observed after you starting having chronic low back pain. 2. Pain resilience: How would you describe this persisting pain experience? How do you arrange your daily activity? What do you do to deal with this persistent pain? 3. Spirituality: As a person with chronic low back pain, how do you interpret this pain experience? Do you seek connections with higher powers (such as powers from religion) when you are desperate because of pain? Since the pain is chronic and persistent, it might not go away, how would you define your life? | Behavioural | – |
Primary outcome
Pain resilience scale (PRS)
Time frame: 8 weeks
A 14-item scale used to measure the level of pain resilience. Participant could choose from 0 to 4 on each item to indicate how much one agrees to the statement used to describe one's reaction under persisting pain. "0" indicates "strongly disagree" while "4" indicates "fully agree". Higher total score on the PRS indicates higher resilience to pain.
Spirituality
Time frame: 8 weeks
Participant gives a simple yes/no answer as to whether the participant has a religion or participate in religious activities.
Patient Health Questionnaire-9
Time frame: 8 weeks
Patient Health Questionnaire-9 is a 9-item scale used to measure the level of depression in a respondent. Participant chooses from 0 to 3 on each item to indicate the frequency of experiencing each listed symptoms that might be part of depression. Higher total score indicates higher level of depression.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Results publication: PubMed 26748044Slepian PM, Ankawi B, Himawan LK, France CR. Development and Initial Validation of the Pain Resilience Scale. J Pain. 2016 Apr;17(4):462-72. doi: 10.1016/j.jpain.2015.12.010. Epub 2015 Dec 31.
- Results publication: PubMed 28428092Ankawi B, Slepian PM, Himawan LK, France CR. Validation of the Pain Resilience Scale in a Chronic Pain Sample. J Pain. 2017 Aug;18(8):984-993. doi: 10.1016/j.jpain.2017.03.013. Epub 2017 Apr 18.
- Results publication: PubMed 31555190Gonzalez CE, Okunbor JI, Parker R, Owens MA, White DM, Merlin JS, Goodin BR. Pain-Specific Resilience in People Living With HIV and Chronic Pain: Beneficial Associations With Coping Strategies and Catastrophizing. Front Psychol. 2019 Sep 6;10:2046. doi: 10.3389/fpsyg.2019.02046. eCollection 2019.
- Derived from this study: PubMed 40276019Liu LJ, Peng HL, Lin EM, Liang WP. Do We Ask What the Deities Can Do for Us? The Roles of Dao Religion and Resilience in Suicidality in Chronic Pain. Pain Res Manag. 2025 Apr 17;2025:3056383. doi: 10.1155/prm/3056383. eCollection 2025.
- Individual participant dataSharing planned: Undecided. Personal identifiers will be removed before data sharing (if we decide to share the data). Currently, we prefer to share only the descriptive statistics of the demographic data.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Ling-Jun Liu, MSc principal investigator
Changhua Christian Hospital
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 Low Back Pain, run by Changhua Christian Hospital at 1 site in Taiwan.
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 3 inclusion and 3 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 21 May 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 Taiwan. 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 Ling-Jun Liu, MSc (+886-47238595 ext. 3236, lingjun.liu1203@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain resilience scale (PRS) (time frame: 8 weeks). 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?
On the ClinicalTrials.gov record for NCT05148364, which also lists 4 linked publications.
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 21 May 2024.