Meditation and Exercise to Treat Chronic Back Pain

NCT03324659 | Completed

• 1 other identifier: Protocol50
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the analgesic effect of a combination treatment of exercise and mindfulness based meditation in patients with chronic back pain. Half of the participants will partake in a 4-week exercise and meditation intervention, while the other half will receive a placebo treatment. The investigators hypothesize that a combination treatment reduces disability and pain more than the control intervention.

Conditions

Chronic Low Back Pain

Keywords

Mindfulness; Exercise; Meditation; Back pain

Outcome Measures

Primary Outcomes (1)

• Change in Roland Morris Disability Questionnaire

  The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The patient is asked to tick a statement when it applies to him that specific day, this makes it possible to follow changes in time. The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 24 (max. disability).

  baseline and 4 weeks

Secondary Outcomes (7)

• Change in Cutaneous Sensation

  baseline and 4 weeks

• Fear Avoidance Beliefs Questionnaire

  baseline and 4 weeks

• Freiburg Mindfulness Inventory

  baseline and 4 weeks

• VAS back pain (intensity & unpleasantness)

  baseline, daily (pre and post intervention), and 4 weeks

• State-Trait Anxiety Inventory (STAI)

  baseline and 4 weeks

Study Arms (2)

Exercise and Meditation

EXPERIMENTAL

The Exercise and Meditation group will practice mindfulness meditation immediately before walking treadmill exercise, five days per week for four weeks.

Behavioral: Exercise and Meditation

Control

SHAM COMPARATOR

The Control group will listen to an audio book followed by quiet rest, five days per week for four weeks.

Behavioral: Control

Interventions

Exercise and Meditation BEHAVIORAL

The Exercise and Meditation group will listen to recorded meditations (15 minutes) that are based on mindfulness. They will then walk on a treadmill for 30 minutes at a moderate intensity. The intervention is completed five days per week for four weeks.

Exercise and Meditation

Control BEHAVIORAL

The Control group will listen to a recorded audio book for 15 minutes, They will then sit quietly for 30 minutes. The intervention is completed five days per week for four weeks.

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Presence of clinically diagnosed nonspecific low back pain for at least 6 months
• Body mass index within the normal to overweight range (18.5-29.9)
• Resting heart rate 60 to 100 beats per minute
• Resting blood pressure less than or equal to 140/90
• Able to independently ambulate community distances without external support (e.g., walker, cane)

You may not qualify if:

• Age less than 18 or greater than 60 years
• BMI ≥ 30 or ≤ 18.4
• Cardiovascular or respiratory disease
• Neurological disease, unrelated to low back pain
• Radicular low back pain
• Back pain associated with neuropathy
• Diabetes mellitus, Types 1 and 2
• Diagnosed with a chronic pain condition, unrelated to low back pain
• Acute pain
• Regular participation in high intensity athletic/sporting activities
• Sedentary lifestyle
• Currently pregnant
• Current cigarette smoker
• On-going litigation associated with back pain
• Inability to walk independently without external support (e.g. walker).

Sponsors & Collaborators

• Duquesne University: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Location

MeSH Terms

Conditions

Motor Activity; Back Pain

Interventions

Exercise; Meditation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Matthew C. Kostek, PhD

  Duquesne University

  PRINCIPAL INVESTIGATOR

• Benedict J Kolber, PhD

  Duquesne University

  PRINCIPAL INVESTIGATOR

• Eric Helm, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 30, 2017
• Study Start: January 26, 2018
• Primary Completion: March 31, 2019
• Study Completion: June 30, 2019
• Last Updated: April 5, 2021

Record last verified: 2021-04

Locations

US (1)