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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05090683
• Other study ID #: 100820
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: November 2022
• Source: University of the Fraser Valley
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We are investigating the effects of a mind-body based mobile application on the experience of chronic pain.

Participants meeting our criteria for chronic pain (confirmed via self-report) will complete an online baseline questionnaire. Eligible participants will be enrolled in the study and randomized into control (usual care, waitlisted) or intervention group (6-week mind-body based mobile application intervention). Randomization will be stratified by pain intensity and gender using computer-generated block randomization to create varying block sizes of 4 and 8. We will run the trial in multiple cohorts in series to obtain desired sample size.

All participants will complete online questionnaires at baseline and post-intervention at 6 weeks that measure pain intensity, interference with daily living, pain perceptions, mental health outcomes, and medication use. Participants will also complete weekly questionnaires on weeks 2 to 6 to gauge frequency of application usage (intervention) or other pain treatments (control). Participants in the intervention group will be asked to repeat the follow-up questionnaire at 12-weeks.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 197
• Est. completion date: December 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

Inclusion Criteria:

• Participants aged 19 to 75 years with chronic pain.

• chronic pain is defined as having non-malignant chronic or persistent pain for at least 6 months.

• Participants must experience pain at least half the days in the last 6 months.

• Pain can include bodily pain or head (migraine) pain.

Exclusion Criteria:

• Individuals reporting a cognitive impairment that can interfere with completing questionnaires and using a mobile application.

• Individuals reporting any of the following psychiatric illness: schizophrenia, dissociative or personality disorders, bipolar disorder.

• Individuals reporting any of the following medical conditions: metastatic cancer, rheumatoid arthritis, lupus, scleroderma, polymyositis.

• Individuals reporting substance use disorder (within the last 6 months).

• Individuals that have previously used mind-body apps for the treatment of chronic pain.

Related Conditions & MeSH terms

• Chronic Pain
• Chronic Pain Syndrome
• Migraine

Intervention

Behavioral:
• Mind-body mobile application
Self-directed; Study team will recommend daily use of mobile app for 6 weeks with a minimum of 4 times/week usage of mobile app for 6 weeks. Frequency will be monitored via weekly surveys.

Locations

Country	Name	City	State
Canada	University of the Fraser Valley	Chilliwack	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of the Fraser Valley

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Ashar YK, Gordon A, Schubiner H, Uipi C, Knight K, Anderson Z, Carlisle J, Polisky L, Geuter S, Flood TF, Kragel PA, Dimidjian S, Lumley MA, Wager TD. Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jan 1;79(1):13-23. doi: 10.1001/jamapsychiatry.2021.2669. — View Citation

Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007 Dec;60(12):1234-8. Epub 2007 Jun 6. — View Citation

Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. Review. — View Citation

Gatchel RJ, Peng YB, Peters ML, Fuchs PN, Turk DC. The biopsychosocial approach to chronic pain: scientific advances and future directions. Psychol Bull. 2007 Jul;133(4):581-624. Review. — View Citation

GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1211-1259. doi: 10.1016/S0140-6736(17)32154-2. Erratum in: Lancet. 2017 Oct 28;390(10106):e38. — View Citation

Kean J, Monahan PO, Kroenke K, Wu J, Yu Z, Stump TE, Krebs EE. Comparative Responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale. Med Care. 2016 Apr;54(4):414-21. doi: 10.1097/MLR.0000000000000497. — View Citation

Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. — View Citation

Morone NE, Greco CM. Mind-body interventions for chronic pain in older adults: a structured review. Pain Med. 2007 May-Jun;8(4):359-75. Review. — View Citation

Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O'Neill E. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med. 1997 Dec;20(6):589-605. — View Citation

Pfeifer AC, Uddin R, Schröder-Pfeifer P, Holl F, Swoboda W, Schiltenwolf M. Mobile Application-Based Interventions for Chronic Pain Patients: A Systematic Review and Meta-Analysis of Effectiveness. J Clin Med. 2020 Nov 5;9(11). pii: E3557. doi: 10.3390/jcm9113557. Review. — View Citation

Schopflocher D, Taenzer P, Jovey R. The prevalence of chronic pain in Canada. Pain Res Manag. 2011 Nov-Dec;16(6):445-50. — View Citation

Treede RD, Rief W, Barke A, Aziz Q, Bennett MI, Benoliel R, Cohen M, Evers S, Finnerup NB, First MB, Giamberardino MA, Kaasa S, Kosek E, Lavand'homme P, Nicholas M, Perrot S, Scholz J, Schug S, Smith BH, Svensson P, Vlaeyen JWS, Wang SJ. A classification of chronic pain for ICD-11. Pain. 2015 Jun;156(6):1003-1007. doi: 10.1097/j.pain.0000000000000160. — View Citation

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Brief Pain Inventory-short form (BPI-SF)	Measures self reported pain intensity (on average); Pain interference	6 weeks
Secondary	Change in PROMIS Pain Intensity short form	Measures self reported pain intensity over 7 days	6 weeks
Secondary	Change in PROMIS Pain Interference short form 8a	Measures self reported pain interference in daily activities (over 7 days)	6 and 12 weeks
Secondary	Change in Pain Catastrophizing Questionnaire (PCS)	Measures thoughts and perceptions of pain	6 and 12 weeks
Secondary	Change in DASS-21 (Depression, Anxiety, and Stress Scale)	Measures self reported emotional states	6 and 12 weeks
Secondary	Change in Quality of Life Short Form 12 (SF-12)	Measures self-reported impact of health on daily life	6 and 12 weeks
Secondary	Change in Brief Pain Inventory-short form (BPI-SF)	Measures self reported pain intensity; Pain interference (over past 24 hours)	12 weeks
Secondary	Change in PROMIS Pain Intensity short form	Measures self reported pain intensity over 7 days	12 weeks
Secondary	Medication use (daily)	Self-reported quantify of medication used (dosage, number of pills in 24 hours)	6 weeks
Secondary	Medication use (occasional)	Self-reported quantify of medication used (dosage, number of pills in 7 days)	6 weeks