Examining Effects of Aerobic Exercise on Pain Sensation

NCT03546153 | Completed

• 1 other identifier: STUDY00141062
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

By doing this study, researchers hope to learn effects of aerobic exercise on over activated nervous system in people with chronic low back pain.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (4)

• Pain sensitivity (Pressure pain threshold)

  Sensitivity will be measured using a pressure algometer.

  Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

• 2011 FM survey

  Sensitivity will be measured using the 2011 Fibromyalgia (FM) Survey Criteria. The survey includes widespread pain index and symptom severity scale. The total score is 31 and scores more than 13 is considered fibromyalgia positive, suggesting presence of central sensitization.

  Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

• Opioid consumption

  Use of opioids (dose, frequency, and duration) will be obtained by interviewing the subjects

  Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

• Oswestry Disability Index

  This questionnaire consists of questions related to daily functions and degrees to which back pain interferes with these functions. Each items is measured on a 6-point scale with a total possible score of 50. Higher numbers indicate greater disability.

  Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

Secondary Outcomes (7)

• Pain Sensitivity (CPM test)

  Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

• Fear Avoidance Belief Questionnaire

  Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

• Pain Catastrophizing Scale

  Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

• Beck Depression Inventory

  Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

• Beck Anxiety Inventory

  Change from Baseline (pre-treatment) to after completion of 3 months of aerobic exercise training (post-treatment)

Study Arms (1)

Aerobic exercise program

EXPERIMENTAL

Participants will complete 12 week exercise program.

Behavioral: Aerobic exercise program

Interventions

Aerobic exercise program BEHAVIORAL

Exercise program consists of training for 60 minutes, three times per week for 12 weeks. Participants will use a treadmill, Nu stepper/bike or elliptical to exercise.

Aerobic exercise program

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Lower back pain (LBP) for more than 3 months
• A minimal pain level of 3 on the 0-10 pain numerical rating scale (NRS) in the last 7 days
• Can read and understand English.

You may not qualify if:

• Nerve root compression that resulted in numbness or decrease in sensation in the areas for the pain sensitivity tests as reported by the subject
• cervical or thoracic pain as a main complaint
• spinal pathologies such as fracture, tumor, infection, and severe inflammation
• severe spinal deformity
• severe cardiovascular and neurological diseases
• cancer
• history of spinal surgery
• currently seeking active treatments for LBP other than medications
• resting blood pressure more than 160/90 mmHg 49
• currently taking blood thinning medications
• uncontrolled diabetes
• cannot have blood pressure taken
• participated in a similar trial in the past

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Study Officials

• Neena Sharma, PT, PhD, CMPT

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 6, 2018
• Study Start: June 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 27, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)