Dose of Spinal Manipulation for Chronic Low Back Pain

Phase 2

Completed

• Conditions: Low Back Pain
• Interventions: Procedure: Spinal Manipulation; Procedure: Light Massage; Procedure: Pulsed Ultrasound

• Registration Number: NCT00376350
• Lead Sponsor: University of Western States

Brief Summary

This study will determine the number of visits to a chiropractor for spinal manipulation, light massage, and ultrasound necessary for optimal relief of chronic low back pain. The study will also determine the effectiveness of spinal manipulation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-12
• Study First Submitted QC: 2006-09-12
• Study First Posted: 2006-09-14
• Study Start: 2007-03
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Current episode of low back pain
• mechanical origin
• Threshold low back pain level

Exclusion Criteria

• Contraindications to spinal manipulation or massage
• Complicating conditions that could confound clinical outcome
• Prophylactic use of prescription medication
• Health-related litigation, claims, or disability compensation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose manipulation	Spinal Manipulation	High dose spinal manipulation + ultrasound
Moderate dose manipulation	Pulsed Ultrasound	Moderate dose manipulation + low dose massage + ultrasound
Low dose manipulation	Light Massage	low dose spinal manipulation + moderate dose massage + ultrasound
Moderate dose manipulation	Spinal Manipulation	Moderate dose manipulation + low dose massage + ultrasound
High dose manipulation	Pulsed Ultrasound	High dose spinal manipulation + ultrasound
Low dose manipulation	Spinal Manipulation	low dose spinal manipulation + moderate dose massage + ultrasound
Low dose manipulation	Pulsed Ultrasound	low dose spinal manipulation + moderate dose massage + ultrasound
High dose masssage	Light Massage	high dose massage + ultrasound
High dose masssage	Pulsed Ultrasound	high dose massage + ultrasound
Moderate dose manipulation	Light Massage	Moderate dose manipulation + low dose massage + ultrasound

Primary Outcome Measures

Name	Time	Method
Modified Von Korff Pain Scale for low back pain	baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Modified Von Korff Disability Scale	baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

Secondary Outcome Measures

Name	Time	Method
Disability days	baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
Low back pain unpleasantness	baseline 2, 6, 12, 18, 24, 39, 52 weeks
Fear avoidance beliefs	baseline 2, 6, 12, 18, 24, 39, 52 weeks
General health status/QoL	baseline 2; 12, 24, 39, 52 weeks
Patient satisfaction	12 wk
Healthcare utilization	baseline 2; 6, 12, 18, 24, 39, 52 weeks
Objective measures	Baseline 2, 6 wk
Bias monitoring	baseline 1&2; 6, 12, 18, 24, 39, 52 weeks
Pain days	baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

Trial Locations

Locations (1)

Western States Chiropractic College; 🇺🇸 Portland, Oregon, United States