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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of a Mind-Body Based Approach for Chronic Pain Treatment

NCT07143396

Chronic Pain Migraine Chronic Pain Syndrome

NOT_YET_RECRUITING NA

Mindful Walking for Adults With Chronic Pain

NCT06088329

Chronic Pain

RECRUITING NA

Mindfulness And Placebo for Pain (MAPP) Study

NCT06720909

Chronic Pain

RECRUITING NA

Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain.

NCT05090683

Chronic Pain Migraine Chronic Pain Syndrome

COMPLETED NA

Association Between Types of Pain and Motor Activities Physical Activity

NCT05236933

Spinal Cord Injury Chronic Pain

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Combined MBSR and exercise

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.

Group Type EXPERIMENTAL

MBSR

Intervention Type 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.

Exercise

Intervention Type 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.

Online Self-Management Guide

Group B will be invited to interact with an online self-management guide accessible in the members area of the study website.

Group Type ACTIVE_COMPARATOR

Online Self-Management Guide

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MBSR

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.

Intervention Type BEHAVIORAL

Exercise

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.

Intervention Type BEHAVIORAL

Online Self-Management Guide

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

•. 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No