Chronic PainNCT04106271
Dyadic Pain Management Program for Older Adults and Informal Caregivers With Chronic Pain
A study testing dyadic pain management program in people with Chronic Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Chronic pain is a common health problem among older adults and their informal caregivers. Chronic pain has negative effects on physical and psychological health status and it is a strong predictor of poor quality of life. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- dyadic pain management program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Jun 2019to 28 Jun 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For Older adults:
- Aged 65 or above;
- Have an informal caregiver willing to participate this program;
- Can understand Chinese;
- Have a history of non-cancer pain in past 6 months;
- Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric scale;
Show all 16Show fewer
- Have behavioral abilities to do a light exercise and stretch program;
- Able to attend the whole sessions in community activity center.
- For Informal caregivers:
- Aged 18 or above;
- As an informal caregiver for one older adult;
- Can understand Chinese;
- Have a history of non-cancer pain in past 6 months;
- Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric scale;
- Own a smartphone and can assess the internet;
- Able to attend the whole sessions in community activity center.
Who cannot join
- For Older adults:
- Have serious organic disease or malignant tumor;
- Have a history of consciousness or mental disorder diagnosed by neurologists or psychiatrists;
- Have a further medical/surgical treatment in two months or have joined in other pain management program.
- Experience a drug addiction problem.
- For Informal caregivers:
Show all 10Show fewer
- Have serious organic disease or malignant tumor;
- Have a history of consciousness or mental disorder diagnosed by neurologists or psychiatrists;
- Have a further medical/surgical treatment in two months or have joined in other pain management program.
- Experience a drug addiction problem.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Nursing
Hung Hom, Kowloon
Mimi Tse, PhD, 852-27666541, mimi.tse@polyu.edu.hk
About this study
Official title: The Effectiveness of a Dyadic Pain Management Program for Older People and Informal Caregivers With Chronic Pain: A Pilot Randomized Controlled Trial
Chronic pain is a common health problem among older adults and their informal caregivers. Chronic pain has negative effects on physical and psychological health status and it is a strong predictor of poor quality of life. In this study, a dyadic face-to-face pain management program will be provided to older adults and informal caregivers to help the dyads equip with pain-related knowledge and pain coping skills. The effectiveness of the dyadic program will be assessed. Participants will be recruited follow snowball sampling and will be randomly allocated to experimental group and control group using 1: 1 radio. The dyadic pain management program will last four weeks, including group discussion, pain-related knowledge and physical exercises. Pain intensity, anxiety, depression, stress, pain self-efficacy and quality of life will be measured in baseline, post-treatment and at one-month follow. Acceptability and satisfaction to the program will be collected.
This study will be held in Caritas District Elderly Centre-Yeun Long (Tin Chak Centre) and Caritas Cheng Shing Fung District Elderly Center (Shamshuipo) in Hong Kong. For sample size, no suitable standard deviation and effect size was found in previous similar study through the literature review, so this study will be a pilot RCT study with a total 60 dyads of sample size. 30 older adults and 30 informal caregivers will be in each group (experimental group and control group). The dyadic pain management program will be held in the community activity center at weekends and will involve three parts: demographic data, outcome measures (baseline, post-treatment and one-month follow-up measures) and pain education.
Read more
Potential participants' eligibility will be confirmed by a questionnaire designed according to inclusion criteria and exclusion criteria. An information sheet will be provided to the eligible dyads and informed consent will be signed on the scene. Experimental group will start pain management program when finish the baseline assessment and control group will be given one page of pain management information download from Department of Health. (http://www.elderly.gov.hk/english/common_health_problems/bones_and_joints/index.html). For optimal communication, two WhatsApp groups will be created consisting of all the caregivers in experimental group and control group respectively.
Outcomes will be measured at three times during the whole intervention, T0 baseline prior to intervention, T1 in week four when the experimental group finish all the program and T2 in week eight with one-month follow-up after the program. Dyads' demographic and caregiving-related questions will be completed prior to beginning the program in T0. Pain related situations, anxiety, depression, stress, quality of life, pain self-efficacy will be measured from older adults and informal caregivers at T0, T1, T2, using a same battery of questionnaires. Dyads' acceptability and satisfaction will be administered immediately after the last session. Data will be collected by a research assistant blinded to the dyads' group assignments.
Read the detailed description
Participants
This study is a dyadic intervention. Target populations are older adults and informal caregivers with chronic pain. A pair of informal caregiver and older adult will be regarded as a dyad. Dyads will be recruited in the community following the snowball sampling, the eligibility will be accessed based on the following details:
Older adults
Inclusion criteria for older adults:
- Aged 65 or above;
- Have an informal caregiver willing to participate this program;
- Can understand Chinese;
- Have a history of non-cancer pain in past 6 months;
- Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric scale ;
- Have behavioral abilities to do a light exercise and stretch program;
- Able to attend the whole sessions in community activity center.
Exclusion criteria for older adults:
- Have serious organic disease or malignant tumor;
- Have a history of consciousness or mental disorder diagnosed by neurologists or psychiatrists;
- Have a further medical/surgical treatment in two months or have joined in other pain management program.
- Experience a drug addiction problem
Informal caregivers Inclusion criteria for informal caregivers
- Aged 18 or above;
- As an informal caregiver for one older adult;
- Can understand Chinese;
- Have a history of non-cancer pain in past 6 months;
- Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric scale ;
- Own a smartphone and can assess the internet;
- Able to attend the whole sessions in community activity center.
Exclusion criteria for informal caregivers
- Have serious organic disease or malignant tumor;
- Have a history of consciousness or mental disorder diagnosed by neurologists or psychiatrists;
- Have a further medical/surgical treatment in two months or have joined in other pain management program.
- Experience a drug addiction problem
Outcome measures It is a dyadic intervention so outcomes will be measured from older adults and informal caregivers.
Primary outcome The Brief Pain Inventory-Chinese Version It is a tool to evaluate the intensity, site, quality, relief, interference and causes of pain in patients. Four items for the degree of pain severity, one item for the degree of pain relief and seven items for degree of pain interferes will assess, numbering the different pain sites from 0 to 10. For BPI-C, the Cronbach's α for the pain severity and pain interference items are 0.83-0.89 and 0.90-0.91 and has good acceptable test-retest reliability .
Secondary outcomes:
World Health Organization Quality of Life-Brief It is a self-report questionnaire which assesses 4 domains of quality of life, including physical health, psychological health, social relationships, and environment. Participants will express how much they have experienced in the preceding two weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). Previous studies showed that WHOQOL-BRIF has good internal consistency and validity.
Depression Anxiety Stress Scale It is a self-administered psychological instrument to evaluate the degree of depression, anxiety and stress involving 21 items. Every part has seven items on a 4-point Likert scale ranging from 0 to 3. The instrument was used in previous studies and had good internal consistency and validity.
Pain Self-efficacy Questionnaire It is a tool to measure the self-efficacy in coping with daily activities with pain . A Chinese version of the PSEQ will be used in this study. Participants will express participants' confidence in performing ten activities experiencing pain on a 7-point Likert scale ranging from 0 (not at all confident) to 6 (completely cinfident). Previous studies illustrated the test-rest reliability coefficient of PSEQ was 0.75 and internal consistency, Cronbach's alpha was 0.95, which was reliable .
Satisfaction and acceptability Participants' satisfaction and acceptability of the dyadic intervention will be assessed at the end of the grogram. Some open-ended questions will be asked, including "What topics, content, or concepts could have been covered in more/less detail?" "As a result of participating in dyadic pain management intervention, did you make some positive changes in your life?" "Would you feel the group discussions interesting and informative? Did the activities and exercises relieve your pain symptom?" These questions were used in previous studies to evaluate the satisfaction and acceptability of intervention program.
- Conditions
- Chronic Pain
- Being tested
- dyadic pain management program
- Keywords
- Chronic Pain, dyadic pain management program, older adults, informal caregiver
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dyadic pain management programOther
a dyadic pain management program for older adults and their informal caregivers is developed as intervention. The program will be conducted at community activity center face-to-face combined with digital-based activities and the program will include 4 sessions, weekly 1 hours. Each session will be classified into three stages, including 10 minutes for watching videos and group discussion, 20 minutes for theoretical knowledge and coping skills and 20 minutes for exercising together. Last 10 minutes of each session is to wrap up and Q \& A. There will be a brief introduction of program and self-introduction of participants at the beginning of the first session. One exercise book is given to each pair and researchers have a 4-week follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | dyadic pain management program will be accessible by the intervention group Receives: Other: dyadic pain management program |
| Control group | No intervention | No intervention for the control group, only one-page simple material related to pain will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity and pain interference
Changes from baseline to Week 4 and one-month after the intervention in pain intensity and pain interference using Brief Pain Inventory
Measured: Baseline, Week 4, one-month after intervention
Secondary outcomes (4)
Depression, Anxiety and Stress
Changes from baseline to Week 4 and one-month after the intervention in depression, anxiety and stress using Depression Anxiety Stress Scale - 21 Scale (DASS-21#. The DASS-21 is a set of three self-reported scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items and divided into subscales. The score of each item ranges feom 0 to 3 (o = do not apply to me at all, 3 = applied to me very much or most of the time). Total score is multiplied by 2 of the sum of each subscales. Higher score indicates the greater degree of the symptom.
Measured: Baseline, Week 4, one-month after intervention
Pain self-efficacy
Changes from baseline to Week 4 and one-month after the intervention in pain self-efficacy using Pain Self-Efficacy Questionnaire (PSEQ). PSEQ is a 10-item questionnaire assessing the confidence people with ongoing pain have in performing activities while in pain. Score of each item ranges from 0 to 6 (0 = not at all confident, 6 = completely confident). A total score is calculated by adding the scores for each item which ranging from 0 to 60. Higher scores reflect stronger self-efficacy beliefs.
Measured: Baseline, Week 4, one-month after intervention
World Health Organization Quality of Life-Brief
Changes from baseline to Week 4 and one-month after the intervention in quality of life using World Health Organization Quality of Life-Brief. It is a self-report questionnaire which assesses 4 domains of quality of life, including physical health, psychological health, social relationships, and environment. Participants will express how much they have experienced in the preceding two weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely).
Measured: Baseline, Week 4, one-month after intervention
Participant's Satisfaction and acceptability to the program
Participants satisfaction and acceptability to the online pain education program will be assessed at post-treatment by several questions, including "do you think this online pain education program useful?" "does it worth your time following the program?" "would you feel confident to recommend this program to others?" Participants are required to answer the questions by "Yes" or "No". Open-ended question "what are the advantages and disadvantages of the program?" will also be asked. These questions have in the previous studies to assess the acceptability and satisfaction to the internet-delivered program.
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start28 Jun 2019
- Primary completion28 Jun 2022 (estimated)
- Study completion28 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSE Mun Yee Mimi, The Hong Kong Polytechnic University
- Investigators
- Tse Tse, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106271
- Sponsor's protocol ID
- DPMCP
- Status last verified
- Jul 2020
- First submitted
- 25 Sep 2019
- Last updated
- 29 Jul 2020
- Results posted
- 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 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of a Dyadic Pain Management Program for Older People and Informal Caregivers With Chronic Pain: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04106271
- Acronym / sponsor ID
- DPMCP
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, dyadic pain management program, older adults, informal caregiver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 28 Jun 2019 (actual)
- Primary completion
- 28 Jun 2022 (estimated)
- Study completion
- 28 Jun 2022 (estimated)
- First posted
- 27 Sep 2019 (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.
Chronic pain is a common health problem among older adults and their informal caregivers. Chronic pain has negative effects on physical and psychological health status and it is a strong predictor of poor quality of life. In this study, a dyadic face-to-face pain management program will be provided to older adults and informal caregivers to help the dyads equip with pain-related knowledge and pain coping skills. The effectiveness of the dyadic program will be assessed. Participants will be recruited follow snowball sampling and will be randomly allocated to experimental group and control group using 1: 1 radio. The dyadic pain management program will last four weeks, including group discussion, pain-related knowledge and physical exercises. Pain intensity, anxiety, depression, stress, pain self-efficacy and quality of life will be measured in baseline, post-treatment and at one-month follow. Acceptability and satisfaction to the program will be collected.
This study will be held in Caritas District Elderly Centre-Yeun Long (Tin Chak Centre) and Caritas Cheng Shing Fung District Elderly Center (Shamshuipo) in Hong Kong. For sample size, no suitable standard deviation and effect size was found in previous similar study through the literature review, so this study will be a pilot RCT study with a total 60 dyads of sample size. 30 older adults and 30 informal caregivers will be in each group (experimental group and control group). The dyadic pain management program will be held in the community activity center at weekends and will involve three parts: demographic data, outcome measures (baseline, post-treatment and one-month follow-up measures) and pain education.
Potential participants' eligibility will be confirmed by a questionnaire designed according to inclusion criteria and exclusion criteria. An information sheet will be provided to the eligible dyads and informed consent will be signed on the scene. Experimental group will start pain management program when finish the baseline assessment and control group will be given one page of pain management information download from Department of Health. (http://www.elderly.gov.hk/english/common_health_problems/bones_and_joints/index.html). For optimal communication, two WhatsApp groups will be created consisting of all the caregivers in experimental group and control group respectively.
Outcomes will be measured at three times during the whole intervention, T0 baseline prior to intervention, T1 in week four when the experimental group finish all the program and T2 in week eight with one-month follow-up after the program. Dyads' demographic and caregiving-related questions will be completed prior to beginning the program in T0. Pain related situations, anxiety, depression, stress, quality of life, pain self-efficacy will be measured from older adults and informal caregivers at T0, T1, T2, using a same battery of questionnaires. Dyads' acceptability and satisfaction will be administered immediately after the last session. Data will be collected by a research assistant blinded to the dyads' group assignments.
Detailed description
Participants
This study is a dyadic intervention. Target populations are older adults and informal caregivers with chronic pain. A pair of informal caregiver and older adult will be regarded as a dyad. Dyads will be recruited in the community following the snowball sampling, the eligibility will be accessed based on the following details:
Older adults
Inclusion criteria for older adults:
- Aged 65 or above;
- Have an informal caregiver willing to participate this program;
- Can understand Chinese;
- Have a history of non-cancer pain in past 6 months;
- Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric scale ;
- Have behavioral abilities to do a light exercise and stretch program;
- Able to attend the whole sessions in community activity center.
Exclusion criteria for older adults:
- Have serious organic disease or malignant tumor;
- Have a history of consciousness or mental disorder diagnosed by neurologists or psychiatrists;
- Have a further medical/surgical treatment in two months or have joined in other pain management program.
- Experience a drug addiction problem
Informal caregivers Inclusion criteria for informal caregivers
- Aged 18 or above;
- As an informal caregiver for one older adult;
- Can understand Chinese;
- Have a history of non-cancer pain in past 6 months;
- Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric scale ;
- Own a smartphone and can assess the internet;
- Able to attend the whole sessions in community activity center.
Exclusion criteria for informal caregivers
- Have serious organic disease or malignant tumor;
- Have a history of consciousness or mental disorder diagnosed by neurologists or psychiatrists;
- Have a further medical/surgical treatment in two months or have joined in other pain management program.
- Experience a drug addiction problem
Outcome measures It is a dyadic intervention so outcomes will be measured from older adults and informal caregivers.
Primary outcome The Brief Pain Inventory-Chinese Version It is a tool to evaluate the intensity, site, quality, relief, interference and causes of pain in patients. Four items for the degree of pain severity, one item for the degree of pain relief and seven items for degree of pain interferes will assess, numbering the different pain sites from 0 to 10. For BPI-C, the Cronbach's α for the pain severity and pain interference items are 0.83-0.89 and 0.90-0.91 and has good acceptable test-retest reliability .
Secondary outcomes:
World Health Organization Quality of Life-Brief It is a self-report questionnaire which assesses 4 domains of quality of life, including physical health, psychological health, social relationships, and environment. Participants will express how much they have experienced in the preceding two weeks on a 5-point Likert scale ranging from 1 (not at all) to 5 (completely). Previous studies showed that WHOQOL-BRIF has good internal consistency and validity.
Depression Anxiety Stress Scale It is a self-administered psychological instrument to evaluate the degree of depression, anxiety and stress involving 21 items. Every part has seven items on a 4-point Likert scale ranging from 0 to 3. The instrument was used in previous studies and had good internal consistency and validity.
Pain Self-efficacy Questionnaire It is a tool to measure the self-efficacy in coping with daily activities with pain . A Chinese version of the PSEQ will be used in this study. Participants will express participants' confidence in performing ten activities experiencing pain on a 7-point Likert scale ranging from 0 (not at all confident) to 6 (completely cinfident). Previous studies illustrated the test-rest reliability coefficient of PSEQ was 0.75 and internal consistency, Cronbach's alpha was 0.95, which was reliable .
Satisfaction and acceptability Participants' satisfaction and acceptability of the dyadic intervention will be assessed at the end of the grogram. Some open-ended questions will be asked, including "What topics, content, or concepts could have been covered in more/less detail?" "As a result of participating in dyadic pain management intervention, did you make some positive changes in your life?" "Would you feel the group discussions interesting and informative? Did the activities and exercises relieve your pain symptom?" These questions were used in previous studies to evaluate the satisfaction and acceptability of intervention program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: dyadic pain management programdyadic pain management program will be accessible by the intervention group |
| Control group | No intervention | –No intervention for the control group, only one-page simple material related to pain will be provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Aged 65 or above;
- Have an informal caregiver willing to participate this program;
- Can understand Chinese;
- Have a history of non-cancer pain in past 6 months;
- Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric scale;
Key exclusion criteria (10 listed)
- Have serious organic disease or malignant tumor;
- Have a history of consciousness or mental disorder diagnosed by neurologists or psychiatrists;
- Have a further medical/surgical treatment in two months or have joined in other pain management program.
- Experience a drug addiction problem.
- Have serious organic disease or malignant tumor;
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 |
|---|---|---|
| dyadic pain management programa dyadic pain management program for older adults and their informal caregivers is developed as intervention. The program will be conducted at community activity center face-to-face combined with digital-based activities and the program will include 4 sessions, weekly 1 hours. Each session will be classified into three stages, including 10 minutes for watching videos and group discussion, 20 minutes for theoretical knowledge and coping skills and 20 minutes for exercising together. Last 10 minutes of each session is to wrap up and Q \& A. There will be a brief introduction of program and self-introduction of participants at the beginning of the first session. One exercise book is given to each pair and researchers have a 4-week follow-up. | Other | Experimental group |
Primary outcome
Pain intensity and pain interference
Time frame: Baseline, Week 4, one-month after intervention
Changes from baseline to Week 4 and one-month after the intervention in pain intensity and pain interference using Brief Pain Inventory
4 secondary outcomes
Depression, Anxiety and Stress
Time frame: Baseline, Week 4, one-month after intervention
Pain self-efficacy
Time frame: Baseline, Week 4, one-month after intervention
World Health Organization Quality of Life-Brief
Time frame: Baseline, Week 4, one-month after intervention
Participant's Satisfaction and acceptability to the program
Time frame: week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- 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.
Tse Tse, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dyadic pain management program in people with Chronic Pain, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 16 inclusion and 10 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 29 Jul 2020. 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 Hong Kong. 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 Mimi Tse, PhD (852-27666541, mimi.tse@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity and pain interference (time frame: Baseline, Week 4, one-month after intervention). 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 29 Jul 2020.