Brief Mindfulness and Nutrition-Based Interventions for Chronic Pain: Strategies to Ease Pain

NCT03563911 | Withdrawn

• 4 other identifiers: 2018-0864A532007SMPH/FAMILY MED/RES GRANTSProtocol Version 6/25/2018
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot randomized clinical trial (RCT) will randomize adults with chronic pain to one, 20-minute session of either: Brief Mindfulness-Based Intervention (BMBI) mindfulness training or nutrition education (Control). Following the session, participants will be encouraged to practice a technique associated with their intervention (i.e., practicing mindfulness technique in BMBI, preparing healthy meals in Control) 20 minutes/day for one week at home. Quantitative sensory testing (with cold pressor and algometer) will be conducted before and after the session, and self-reported outcome assessments will be conducted before and after the session and at 1-week follow-up.

Conditions

Opioid Use; Chronic Pain

Outcome Measures

Primary Outcomes (8)

• Cold pressor testing

  Cold pressor testing will be used to characterize pain processing (e.g., pain threshold, pain tolerance, pain severity). In the cold pressor test, a participant is asked to place his or her hand and forearm in an ice bath until the pain is too great to remain in the water. Consistent with past research, a 15 liter refrigerated circulator (Polyscience MX15R-30-A11B) with water temperature set as low as 1°C will be used in the present study.

  1 hour

• Pressure algometer testing

  Pressure algometer testing will be used to characterize pain processing (e.g., pain threshold, pain tolerance, pain severity). In the pressure algometer test, the algometer is used to apply pressure to the skin until the pain can no longer be tolerated. In the current study, we will utilize a device widely used in alogmeter pain research (Wagnder Force One Alogmeter FIPX).

  1 hour

• Brief Pain Inventory

  Measures: 1) pain severity= mean of items 3-6 (ranges from 0-10 with higher scores indicating greater pain severity), and 2) pain interference= mean of items 9A-9G (ranges from 0-10 with higher scores indicating greater pain interference).

  4 weeks

• Hospital Anxiety and Depression Scale

  Measures: 1) Anxiety (sum of 7 items; ranges from 0-21, with higher scores indicating greater anxiety), and 2) Depression (sum of 7 items; ranges from 0-21, with higher scores indicating greater depressive symptoms).

  4 weeks

• Mindful Attention Awareness Scale

  Measures mindfulness; mean of 15 items (ranges from 1 to 6, with higher scores indicating greater levels of mindfulness)

  4 weeks

• Schwartz Outcome Scale

  Measures general well-being; sum of 10 items (ranges from 0 to 60, with higher scores indicating greater well-being)

  4 weeks

• Toronto Mindfulness Scale-Decentering Subscale

  Measures decentering; sum of 7 items (higher scores indicate greater levels of decentering)

  1 hour

• Opioid Compliance Checklist

  Measure misuse of opioid medications (scores range from 0 to 12, with higher scoring indicating greater misuse)

  4 weeks

Study Arms (2)

Brief Mindfulness-Based Intervention

EXPERIMENTAL

Those assigned to the Brief Mindfulness-Based Intervention (BMBI) Arm will receive BMBI.

Behavioral: Brief Mindfulness-Based Intervention (BMBI)

Control/Nutrition Education

ACTIVE COMPARATOR

Those assigned to the Control/Nutrition Education Arm will receive the nutrition education intervention.

Behavioral: Control/Nutrition Education

Interventions

Brief Mindfulness-Based Intervention (BMBI) BEHAVIORAL

The BMBI is be based on a BMBI which demonstrated analgesic effects in a previous study. Relative to full-length interventions, we will employ a brief intervention; the 20-minute BMBI session will include education on the foundational concepts of mindfulness and its relevance to chronic pain (5 minutes) and a guided mindfulness practice involving focused attention on the breath and monitoring of thoughts, feelings, and body sensations (15 minutes). BMBI participants will be encouraged to practice the taught mindfulness technique at home at least 20 minutes/day for 1 week (a handout and link to an online guided mindfulness practice will be provided).

Brief Mindfulness-Based Intervention

Control/Nutrition Education BEHAVIORAL

The Control intervention will involve nutrition education, adapted from an existing manual of cognitive-behavioral therapy for opioid-treated chronic pain. Control intervention protocol will match the BMBI in terms of time / structure to control for the non-specific, non-mindfulness effects of BMBI. The 20-minute Control session will include education on the relationship between diet and pain (10 minutes) and recommendations for a healthy diet (10 minutes). Control participants will be encouraged to prepare healthy meals at home at least 20 minutes/day for 1 week (a handout and link to online resources will be provided).

Control/Nutrition Education

Eligibility Criteria

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

You may qualify if:

• English-speaking
• ≥ 18 years old
• Chronic non-cancer pain (daily pain for at least 3 months)
• Average daily pain score ≥3 on a 0-10 numerical rating scale (question from the Brief Pain Inventory)
• Treatment with ≥30 mg/day of morphine-equivalent dose for ≥3 months
• Capable of giving informed consent
• Willing to complete all study activities

You may not qualify if:

• Cancer pain
• Current pregnancy
• Diagnosed with psychotic or bipolar (mania) disorders ("active" in the prior 12 months)
• Inability to safely or reliably participate in the study
• Regular mindfulness meditation practice

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: June 20, 2018
• Study Start: December 12, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-12

Locations

US (1)