Mindfulness Online and Virtual Exercise (MOVE) Compared With Self-Management for Chronic Pain

NCT04899622 | Completed

• 1 other identifier: MOVE-Online
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Chronic Pain

Keywords

Chronic Pain; Pain Management Programme; e-Health; Mindfulness Based Stress Reduction; Exercise

Outcome Measures

Primary Outcomes (10)

• Number of eligible participants identified per programme

  Prior to each programme the number of eligible participants will be recorded by the primary researcher

  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

  Baseline

• Reasons for non-participation

  This measure will be recorded by the primary researcher when screening participants

  Baseline

• Number of participants who complete the study

  The number of participants that complete \>50% of the online classes programme

  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

  Baseline

• Adherence to completion of immediate follow-up patient reported outcome measures

  Numbers of participants completing \> 90% of follow-up patient reported outcome measures

  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

  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)

  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.

  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.

  immediately post intervention (8 weeks from baseline)

Secondary Outcomes (12)

• Change in pain self-efficacy measured with the Pain Self-Efficacy Questionnaire

  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

  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

  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

  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

  immediately post intervention (8 weeks from baseline) and 12 week follow up (20 weeks from baseline)

Study Arms (2)

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.

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.

Behavioral: Online Self-Management Guide

Interventions

MBSR BEHAVIORAL

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.

Combined MBSR and exercise

Exercise BEHAVIORAL

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.

Combined MBSR and exercise

Online Self-Management Guide BEHAVIORAL

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.

Online Self-Management Guide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• . 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orla Deegan: lead
• Mater Misericordiae University Hospital: collaborator
• University College Dublin: collaborator

Study Sites (1)

University College Dublin

Dublin, Ireland

Location

Related Publications (5)

• 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.

  PMID: 20674174 BACKGROUND

• Macea 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.

  PMID: 20650691 BACKGROUND

• Bender 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.

  PMID: 21565446 BACKGROUND

• Mariano 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.

  PMID: 31488004 BACKGROUND

• Deegan 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.

  PMID: 35140163 DERIVED

Related Links

• The MOVE-Online pain management programme is hosted at the mentioned URL. Both the online classes of mindfulness and exercise and the online self-management guide are accessed by participants via the members area of the website.

MeSH Terms

Conditions

Chronic Pain; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Catherine Doody

  University College Dublin

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: May 24, 2021
• Study Start: April 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: July 1, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)