Chronic PainNCT04899622
Mindfulness Online and Virtual Exercise (MOVE) Compared With Self-Management for Chronic Pain
A study testing MBSR, Exercise and Online Self-Management Guide in people with Chronic Pain, run by Orla Deegan at 1 site in Ireland.
Trial summary
The aim of this study is to assess the feasibility and acceptability of a combined Mindfulness Based Stress Reduction (MBSR) and exercise online programme compared to an online self-management guide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- MBSR, Exercise and Online Self-Management Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteIreland
- Study dates
- 1 Apr 2021to 1 Jul 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •. Aged >18 years
- Diagnosis of chronic pain by a Consultant in Pain Medicine or General Practitioner
- Presence of pain NRS ≥ 3 of greater than three months' duration
- Ability to provide informed consent
- Ability to communicate in English and understand English
Who cannot join
- Need for further diagnostic evaluation (determined by doctor)
- Presence of any contraindications to participation in an exercise programme E.g. severe shortness of breath at rest, angina, uncontrolled diabetes or epilepsy, recent (previous 3 weeks) myocardial infarction, pulmonary embolism, deep vein thrombosis or asthma attack.
- Presence of active cancer
- Concurrent participation (or in the previous 3 months) with any form of psychological, physiotherapy or supervised exercise in addition to the study intervention.
- Presence of substance misuse (diagnosed by the Pain Consultant/GP).
- Inability to take part in an online exercise programme
- Standard MBSR exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindfulness Combined With Virtual Exercise Online (MOVE) Compared With a Self-Management Guide for Adults With Chronic Pain: Study Protocol for a Feasibility Randomised Controlled Trial
The aim of this study is to assess the feasibility and acceptability of a combined Mindfulness Based Stress Reduction (MBSR) and exercise online programme compared to an online self-management guide. Pain management programmes are the recommended treatment for chronic pain, however a number of barriers to their widespread implementation have been identified including geographical distance from speciality programmes, functional disability limiting the mobility of people with CP and economic limitations(1). eHealth interventions have the potential to address a number of these barriers and recent reviews have reported reductions in pain(2), improved knowledge and understanding about chronic pain and chronic pain management, improved function(3) and improvements in quality of life(4) following eHealth interventions.
The intervention in this study will be delivered online. Participants will be randomly allocated to a combined MBSR and exercise programme (Group A) or an online self-management guide (Group B). Group A will take part in an 8 week live online weekly mindfulness sessions based on the Mindfulness Based Stress Reduction (MBSR) programme facilitated by a qualified mindfulness teacher, in addition to a supervised exercise classes led by a Physiotherapist. Group B will receive access to an 8 week online self-management guide containing 8 self-directed guides, which will be made available to participants biweekly.
Outcomes of feasibility and acceptability will be investigated in addition to a preliminary examination of between group clinical effects at baseline immediately post intervention and at a three month follow up, using validated patient reported outcome measures. In addition all participants will wear a Fitbit activity monitor for the duration of the eight-week interventions to capture activity measures. A qualitative study will also be conducted to gather participants' perceptions of the programme and its usefulness
Read the detailed description
This study is a parallel-groups, randomised-controlled, feasibility trial. Seventy-five participants aged 18 years and over, who have been diagnosed with a chronic pain condition by a Consultant in Pain Medicine or a General Practitioner will be recruited to the feasibility study. Participants will be individually randomised to one of two interventions. Group A will take part in live online weekly mindfulness sessions based on the Mindfulness Based Stress Reduction (MBSR) programme facilitated by a qualified mindfulness teacher, in addition to supervised exercise classes led by a Physiotherapist. The combined 3 hour intervention (2 hours MBSR, 1 hour exercise) will take place one day per week for 8 weeks. Group B will receive access to an 8 week online self-management guide containing 8 self-directed guides, with the material released biweekly.
The key outcomes measures will include; (1) recruitment rates, eligibility rates, willingness to be randomised; (2) feasibility and acceptability of data collection instruments and procedures; (3) intervention adherence, engagement and attrition rates; (4) feasibility and acceptability of the interventions and; (5) participants' subjective perceptions of the programmes.
The study will also include a preliminary examination of between group clinical effects at baseline, immediately post intervention and at a three month follow up, using the following validated patient reported outcome measures; Pain Self-Efficacy Questionnaire, Brief Pain Inventory, Pain Catastrophizing Scale, Generalised Anxiety Depression Assessment, Patient Health Questionnaire-9, Pain Disability Index, Fear Avoidance Belief Questionnaire, Short-Form-36 Health Survey, Patient Global Impression of Change Scale and measure of treatment satisfaction adapted from the Client Satisfaction Questionnaire (CSQ-8).
Physical activity levels (average daily step count, distance travelled and active minutes) will be measured for all participants using Fitbit Charge 4 activity monitors for the duration of the eight-week intervention period.
Analyses of the feasibility study will primarily be descriptive and will address the outcomes relating to the feasibility and acceptability of the interventions and the procedures of the study. Between-group comparisons of clinical treatment effects will be descriptive and exploratory to consider the viability of the combined MBSR and exercise intervention that may warrant further exploration in a fully powered RCT.
A sample of participants will be invited to attend focus groups where semi-structured interviews will be conducted with the aim of gathering information on the participants' subjective perceptions of the programme and its usefulness.
- Conditions
- Chronic Pain
- Being tested
- MBSR, Exercise, Online Self-Management Guide
- Keywords
- Chronic Pain, Pain Management Programme, e-Health, Mindfulness Based Stress Reduction, Exercise
- Medical subject headings
- Chronic Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBSRBehavioural
Participants will attend weekly online classes (two hours duration) of MBSR for eight weeks. The classes will be delivered live online to groups of up to fifteen participants and will be led by Mindfulness instructors with MSc degrees in Mindfulness Based Interventions. The programme content will be based on the standard MBSR programme and is tailored towards key concerns and difficulties experienced by individuals with chronic pain.
ExerciseBehavioural
Participants will attend weekly classes of supervised classes (1 hour) for eight weeks, following the MBSR class. The exercise class will be delivered live online to the group by an experienced Physiotherapist and will consist of a range of flexibility and strengthening exercises which will be advanced every two weeks for the duration of the eight week programme. The exercises will also be available in video format on the mobile application "Physitrack" which each participant will be invited to download. This will allow the participants to review the exercises between sessions, record online if they have completed each exercise and in addition rate their pain experience while completing the exercises.
Online Self-Management GuideBehavioural
Participants will receive standard evidence based self-guided information which they will access independently via the members area of the study website. This 'Online Self-Management Guide' will consist of eight categories of self-management; (1) What is chronic pain? (2) Chronic pain and nutrition (3) Sleep issues with chronic pain (4) Activity and exercise (5) Pacing (6) Using a pain diary (7) Relaxation and mindfulness and (8) Course summary. The information will be presented in the form of general text, links to online resources and videos. The information in this area will be updated biweekly during the eight week programme with the participants receiving bi-weekly email reminders.
| Study group | Role | What they receive |
|---|---|---|
| Combined MBSR and exercise | Experimental | Group A will take part in live online weekly mindfulness sessions based on the Mindfulness Based Stress Reduction (MBSR) programme, in addition to supervised exercise classes. Receives: Behavioral: MBSR; Behavioral: Exercise |
| Online Self-Management Guide | Active comparator | Group B will be invited to interact with an online self-management guide accessible in the members area of the study website. Receives: Behavioral: Online Self-Management Guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of eligible participants identified per programme
Prior to each programme the number of eligible participants will be recorded by the primary researcher
Measured: Baseline
Number of eligible participants recruited per programme
Prior to each programme the number of eligible participants who are recruited will be recorded by the primary researcher
Measured: Baseline
Reasons for non-participation
This measure will be recorded by the primary researcher when screening participants
Measured: Baseline
Number of participants who complete the study
The number of participants that complete >50% of the online classes programme
Measured: immediately post intervention (8 weeks from baseline)
Adherence to completion of baseline patient reported outcome measures
Numbers of participants completing > 90% of baseline patient reported outcome measures
Measured: Baseline
Adherence to completion of immediate follow-up patient reported outcome measures
Numbers of participants completing > 90% of follow-up patient reported outcome measures
Measured: Immediately post intervention (8 weeks from baseline)
Adherence to completion of long term follow-up patient reported outcome measures
Numbers of participants completing > 90% of follow-up patient reported outcome measures
Measured: 3 months post intervention (20 weeks from baseline)
Interaction with online self-management guide
The study website analytics will measure the number of views that each element of the online guide receives (Group B)
Measured: Immediately post intervention (8 weeks from baseline)
Treatment Acceptability (Satisfaction assessed by Client Satisfaction Questionnaire-8)
Patient satisfaction with treatment will be measured with an adapted version of the Client Satisfaction Questionnaire-8. Responses are scored from 1-4, and the possible total scores range from 8 to 32. Higher scores indicate greater satisfaction.
Measured: Immediately post intervention (8 weeks from baseline)
Interface usability
Measures of website usability will be investigated with an adapted System Usability Scale (SUS) Scores range from 10-50. Higher scores indicated greater ease of usability.
Measured: immediately post intervention (8 weeks from baseline)
Secondary outcomes (12)
Change in pain self-efficacy measured with the Pain Self-Efficacy Questionnaire
The Pain Self-Efficacy Questionnaire is a ten item questionnaire which assesses an individual's confidence in their ability to perform a variety of activities or tasks despite pain. Scores can range from 0 - 60. Higher scores represent lower confidence to function with pain.
Measured: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Change in symptoms of anxiety measured with the Generalized Anxiety Disorder Assessment
The Generalized Anxiety Disorder 7 assesses symptoms of anxiety experienced during the last two weeks. The total score for the seven items ranges from 0 to 21. Higher scores represent higher levels of anxiety.
Measured: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Changes in symptoms of depression measured with the Patient Health Questionnaire 9
Symptoms of depression will be assessed using the Patient Health Questionnaire 9, which is a nine-item questionnaire generating scores ranging from 0-27. Higher scores indicate increased severity of depression.
Measured: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Changes in pain severity and pain interference measured with the Brief Pain Inventory-Composite pain score
Pain severity will be measured using the pain severity subscale of the Brief Pain Inventory. Pain interference will be measured using the interference subscale of the Brief Pain Inventory, which measures the extent to which pain interferes with functions such as general activity, walking ability, normal work, mood, relationships with people, enjoyment of life and sleep. For each scale, the total score is the average of all items (range, 0-10), where a higher score indicates greater severity and more interference.
Measured: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Changes in the impact of pain on individuals life participation measured with the Pain Disability Index
The Pain Disability Index measure asks patients to rate how much pain interferes in seven areas of life activity: family/home, recreation, social, occupation, sexual, self-care and life-support. Total score ranges from 0-70. The higher the score the greater the person's disability due to pain.
Measured: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Changes in fear avoidance of physical activity measured with the Fear Avoidance Belief Questionnaire.
The Fear Avoidance Belief Questionnaire measures patients' fear of pain and consequent avoidance of physical activity because of their fear. The questionnaire consists of 16 items in which a patient rates their agreement with each statement on a 7-point Likert scale. The scores range from 0-96; higher scores indicates increased fear avoidance behaviours.
Measured: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Change in pain catastrophising measured with the Pain Catastrophising Scale.
The Pain Catastrophising Scale is a 13-item instrument designed to assess catastrophic thinking in relation to pain. It yields a total score and three subscale scores assessing rumination, magnification and helplessness. Scores range from 0-52. Higher scores are associated with higher amounts of pain catastrophising.
Measured: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Change in quality of life measured with the Short Form-36 Health Survey
The Short Form-36 Health Survey comprises of 36 questions which cover eight domains of general health. Scores range from 0-100. The lower the score the more disability.
Measured: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Patient Global Impression of Change Scale
The Patient Global Impression of Change Scale scale measures a patient's rating of overall improvement or lack thereof due to the intervention. It is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Measured: immediately post intervention (8 weeks from baseline)
Changes in step count (Fitbit)
Average weekly step count will be measured using a Fitbit Charge 4 activity monitor worn by participants for the eight weeks of the intervention.
Measured: immediately post intervention (8 weeks from baseline)
Changes in distance travelled (Fitbit)
Average weekly distance travelled will be measured using a Fitbit Charge 4 activity monitor worn by participants for the eight weeks of the intervention.
Measured: immediately post intervention (8 weeks from baseline)
Changes in active minutes (Fitbit)
Average active minutes will be measured using a Fitbit Charge 4 activity monitor worn by participants for the eight weeks of the intervention.
Measured: immediately post intervention (8 weeks from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start1 Apr 2021
- Primary completion15 Mar 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orla Deegan
- Sponsor type
- University, hospital or other
- Collaborators
- Mater Misericordiae University Hospital, University College Dublin
- Responsible party
- Sponsor-investigator, Orla Deegan, University College Dublin
- Investigators
- Catherine Doody, Study director, University College Dublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899622
- Sponsor's protocol ID
- MOVE-Online
- Status last verified
- Oct 2022
- First submitted
- 20 Apr 2021
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keogh E, Rosser BA, Eccleston C. e-Health and chronic pain management: current status and developments. Pain. 2010 Oct;151(1):18-21. doi: 10.1016/j.pain.2010.07.014. Epub 2010 Jul 31. No abstract available.
PubMed 20674174Macea DD, Gajos K, Daglia Calil YA, Fregni F. The efficacy of Web-based cognitive behavioral interventions for chronic pain: a systematic review and meta-analysis. J Pain. 2010 Oct;11(10):917-29. doi: 10.1016/j.jpain.2010.06.005. Epub 2010 Jul 22.
PubMed 20650691Bender JL, Radhakrishnan A, Diorio C, Englesakis M, Jadad AR. Can pain be managed through the Internet? A systematic review of randomized controlled trials. Pain. 2011 Aug;152(8):1740-1750. doi: 10.1016/j.pain.2011.02.012. Epub 2011 May 11.
PubMed 21565446Mariano TY, Wan L, Edwards RR, Jamison RN. Online teletherapy for chronic pain: A systematic review. J Telemed Telecare. 2021 May;27(4):195-208. doi: 10.1177/1357633X19871746. Epub 2019 Sep 5.
PubMed 31488004Deegan O, Fullen BM, Casey MB, Segurado R, Hearty C, Doody CM. Combined online interactive mindfulness and exercise programme (MOVE-Online) compared with a self-management guide for adults with chronic pain: protocol for a randomised controlled feasibility trial. BMJ Open. 2022 Feb 9;12(2):e058265. doi: 10.1136/bmjopen-2021-058265.
PubMed 35140163
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Combined With Virtual Exercise Online (MOVE) Compared With a Self-Management Guide for Adults With Chronic Pain: Study Protocol for a Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04899622
- Acronym / sponsor ID
- MOVE-Online
- Conditions
- Chronic Pain
- Keywords
- Chronic Pain, Pain Management Programme, e-Health, Mindfulness Based Stress Reduction, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Orla DeeganUniversity, hospital or other
- Collaborators
- Mater Misericordiae University Hospital, University College Dublin
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 24 May 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.
The aim of this study is to assess the feasibility and acceptability of a combined Mindfulness Based Stress Reduction (MBSR) and exercise online programme compared to an online self-management guide. Pain management programmes are the recommended treatment for chronic pain, however a number of barriers to their widespread implementation have been identified including geographical distance from speciality programmes, functional disability limiting the mobility of people with CP and economic limitations(1). eHealth interventions have the potential to address a number of these barriers and recent reviews have reported reductions in pain(2), improved knowledge and understanding about chronic pain and chronic pain management, improved function(3) and improvements in quality of life(4) following eHealth interventions.
The intervention in this study will be delivered online. Participants will be randomly allocated to a combined MBSR and exercise programme (Group A) or an online self-management guide (Group B). Group A will take part in an 8 week live online weekly mindfulness sessions based on the Mindfulness Based Stress Reduction (MBSR) programme facilitated by a qualified mindfulness teacher, in addition to a supervised exercise classes led by a Physiotherapist. Group B will receive access to an 8 week online self-management guide containing 8 self-directed guides, which will be made available to participants biweekly.
Outcomes of feasibility and acceptability will be investigated in addition to a preliminary examination of between group clinical effects at baseline immediately post intervention and at a three month follow up, using validated patient reported outcome measures. In addition all participants will wear a Fitbit activity monitor for the duration of the eight-week interventions to capture activity measures. A qualitative study will also be conducted to gather participants' perceptions of the programme and its usefulness
Detailed description
This study is a parallel-groups, randomised-controlled, feasibility trial. Seventy-five participants aged 18 years and over, who have been diagnosed with a chronic pain condition by a Consultant in Pain Medicine or a General Practitioner will be recruited to the feasibility study. Participants will be individually randomised to one of two interventions. Group A will take part in live online weekly mindfulness sessions based on the Mindfulness Based Stress Reduction (MBSR) programme facilitated by a qualified mindfulness teacher, in addition to supervised exercise classes led by a Physiotherapist. The combined 3 hour intervention (2 hours MBSR, 1 hour exercise) will take place one day per week for 8 weeks. Group B will receive access to an 8 week online self-management guide containing 8 self-directed guides, with the material released biweekly.
The key outcomes measures will include; (1) recruitment rates, eligibility rates, willingness to be randomised; (2) feasibility and acceptability of data collection instruments and procedures; (3) intervention adherence, engagement and attrition rates; (4) feasibility and acceptability of the interventions and; (5) participants' subjective perceptions of the programmes.
The study will also include a preliminary examination of between group clinical effects at baseline, immediately post intervention and at a three month follow up, using the following validated patient reported outcome measures; Pain Self-Efficacy Questionnaire, Brief Pain Inventory, Pain Catastrophizing Scale, Generalised Anxiety Depression Assessment, Patient Health Questionnaire-9, Pain Disability Index, Fear Avoidance Belief Questionnaire, Short-Form-36 Health Survey, Patient Global Impression of Change Scale and measure of treatment satisfaction adapted from the Client Satisfaction Questionnaire (CSQ-8).
Physical activity levels (average daily step count, distance travelled and active minutes) will be measured for all participants using Fitbit Charge 4 activity monitors for the duration of the eight-week intervention period.
Analyses of the feasibility study will primarily be descriptive and will address the outcomes relating to the feasibility and acceptability of the interventions and the procedures of the study. Between-group comparisons of clinical treatment effects will be descriptive and exploratory to consider the viability of the combined MBSR and exercise intervention that may warrant further exploration in a fully powered RCT.
A sample of participants will be invited to attend focus groups where semi-structured interviews will be conducted with the aim of gathering information on the participants' subjective perceptions of the programme and its usefulness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined MBSR and exercise | Experimental | Behavioral: MBSR, Behavioral: ExerciseGroup A will take part in live online weekly mindfulness sessions based on the Mindfulness Based Stress Reduction (MBSR) programme, in addition to supervised exercise classes. |
| Online Self-Management Guide | Active comparator | Behavioral: Online Self-Management GuideGroup B will be invited to interact with an online self-management guide accessible in the members area of the study website. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- •. Aged >18 years
- Diagnosis of chronic pain by a Consultant in Pain Medicine or General Practitioner
- Presence of pain NRS ≥ 3 of greater than three months' duration
- Ability to provide informed consent
- Ability to communicate in English and understand English
Key exclusion criteria (7 listed)
- Need for further diagnostic evaluation (determined by doctor)
- Presence of any contraindications to participation in an exercise programme E.g. severe shortness of breath at rest, angina, uncontrolled diabetes or epilepsy, recent (previous 3 weeks) myocardial infarction, pulmonary embolism, deep vein thrombosis or asthma attack.
- Presence of active cancer
- Concurrent participation (or in the previous 3 months) with any form of psychological, physiotherapy or supervised exercise in addition to the study intervention.
- Presence of substance misuse (diagnosed by the Pain Consultant/GP).
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 |
|---|---|---|
| MBSRParticipants will attend weekly online classes (two hours duration) of MBSR for eight weeks. The classes will be delivered live online to groups of up to fifteen participants and will be led by Mindfulness instructors with MSc degrees in Mindfulness Based Interventions. The programme content will be based on the standard MBSR programme and is tailored towards key concerns and difficulties experienced by individuals with chronic pain. | Behavioural | Combined MBSR and exercise |
| ExerciseParticipants will attend weekly classes of supervised classes (1 hour) for eight weeks, following the MBSR class. The exercise class will be delivered live online to the group by an experienced Physiotherapist and will consist of a range of flexibility and strengthening exercises which will be advanced every two weeks for the duration of the eight week programme. The exercises will also be available in video format on the mobile application "Physitrack" which each participant will be invited to download. This will allow the participants to review the exercises between sessions, record online if they have completed each exercise and in addition rate their pain experience while completing the exercises. | Behavioural | Combined MBSR and exercise |
| Online Self-Management GuideParticipants will receive standard evidence based self-guided information which they will access independently via the members area of the study website. This 'Online Self-Management Guide' will consist of eight categories of self-management; (1) What is chronic pain? (2) Chronic pain and nutrition (3) Sleep issues with chronic pain (4) Activity and exercise (5) Pacing (6) Using a pain diary (7) Relaxation and mindfulness and (8) Course summary. The information will be presented in the form of general text, links to online resources and videos. The information in this area will be updated biweekly during the eight week programme with the participants receiving bi-weekly email reminders. | Behavioural | Online Self-Management Guide |
Primary outcome
Number of eligible participants identified per programme
Time frame: Baseline
Prior to each programme the number of eligible participants will be recorded by the primary researcher
Number of eligible participants recruited per programme
Time frame: Baseline
Prior to each programme the number of eligible participants who are recruited will be recorded by the primary researcher
Reasons for non-participation
Time frame: Baseline
This measure will be recorded by the primary researcher when screening participants
Number of participants who complete the study
Time frame: immediately post intervention (8 weeks from baseline)
The number of participants that complete >50% of the online classes programme
Adherence to completion of baseline patient reported outcome measures
Time frame: Baseline
Numbers of participants completing > 90% of baseline patient reported outcome measures
Adherence to completion of immediate follow-up patient reported outcome measures
Time frame: Immediately post intervention (8 weeks from baseline)
Numbers of participants completing > 90% of follow-up patient reported outcome measures
Adherence to completion of long term follow-up patient reported outcome measures
Time frame: 3 months post intervention (20 weeks from baseline)
Numbers of participants completing > 90% of follow-up patient reported outcome measures
Interaction with online self-management guide
Time frame: Immediately post intervention (8 weeks from baseline)
The study website analytics will measure the number of views that each element of the online guide receives (Group B)
Treatment Acceptability (Satisfaction assessed by Client Satisfaction Questionnaire-8)
Time frame: Immediately post intervention (8 weeks from baseline)
Patient satisfaction with treatment will be measured with an adapted version of the Client Satisfaction Questionnaire-8. Responses are scored from 1-4, and the possible total scores range from 8 to 32. Higher scores indicate greater satisfaction.
Interface usability
Time frame: immediately post intervention (8 weeks from baseline)
Measures of website usability will be investigated with an adapted System Usability Scale (SUS) Scores range from 10-50. Higher scores indicated greater ease of usability.
12 secondary outcomes
Change in pain self-efficacy measured with the Pain Self-Efficacy Questionnaire
Time frame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Change in symptoms of anxiety measured with the Generalized Anxiety Disorder Assessment
Time frame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Changes in symptoms of depression measured with the Patient Health Questionnaire 9
Time frame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Changes in pain severity and pain interference measured with the Brief Pain Inventory-Composite pain score
Time frame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Changes in the impact of pain on individuals life participation measured with the Pain Disability Index
Time frame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Changes in fear avoidance of physical activity measured with the Fear Avoidance Belief Questionnaire.
Time frame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Change in pain catastrophising measured with the Pain Catastrophising Scale.
Time frame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Change in quality of life measured with the Short Form-36 Health Survey
Time frame: immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)
Patient Global Impression of Change Scale
Time frame: immediately post intervention (8 weeks from baseline)
Changes in step count (Fitbit)
Time frame: immediately post intervention (8 weeks from baseline)
Changes in distance travelled (Fitbit)
Time frame: immediately post intervention (8 weeks from baseline)
Changes in active minutes (Fitbit)
Time frame: immediately post intervention (8 weeks from baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Background: PubMed 20674174Keogh E, Rosser BA, Eccleston C. e-Health and chronic pain management: current status and developments. Pain. 2010 Oct;151(1):18-21. doi: 10.1016/j.pain.2010.07.014. Epub 2010 Jul 31. No abstract available.
- Background: PubMed 20650691Macea DD, Gajos K, Daglia Calil YA, Fregni F. The efficacy of Web-based cognitive behavioral interventions for chronic pain: a systematic review and meta-analysis. J Pain. 2010 Oct;11(10):917-29. doi: 10.1016/j.jpain.2010.06.005. Epub 2010 Jul 22.
- Background: PubMed 21565446Bender JL, Radhakrishnan A, Diorio C, Englesakis M, Jadad AR. Can pain be managed through the Internet? A systematic review of randomized controlled trials. Pain. 2011 Aug;152(8):1740-1750. doi: 10.1016/j.pain.2011.02.012. Epub 2011 May 11.
- Background: PubMed 31488004Mariano TY, Wan L, Edwards RR, Jamison RN. Online teletherapy for chronic pain: A systematic review. J Telemed Telecare. 2021 May;27(4):195-208. doi: 10.1177/1357633X19871746. Epub 2019 Sep 5.
- Derived from this study: PubMed 35140163Deegan O, Fullen BM, Casey MB, Segurado R, Hearty C, Doody CM. Combined online interactive mindfulness and exercise programme (MOVE-Online) compared with a self-management guide for adults with chronic pain: protocol for a randomised controlled feasibility trial. BMJ Open. 2022 Feb 9;12(2):e058265. doi: 10.1136/bmjopen-2021-058265.
- Individual participant dataSharing planned: No
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Chronic Pain, Body Mass Index >=85th Percentile
Not yet recruiting
Comparison of the Effectiveness of Motor Imagery Exercises and Suboccipital Myofascial Release Techniques in Nonspecific Chronic Neck Pain
Non-specific Chronic Neck Pain
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.
Catherine Doody study director
University College Dublin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBSR, Exercise and Online Self-Management Guide in people with Chronic Pain, run by Orla Deegan at 1 site in Ireland.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 5 Oct 2022. 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 Ireland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of eligible participants identified per programme (time frame: Baseline). The study lists 10 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 NCT04899622, which also lists 5 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 5 Oct 2022.