Dose of Spinal Manipulation for Chronic Low Back Pain

Dose-Response/Efficacy of Manipulation for Chronic LBP

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00376350

Enrollment

400

Registered

2006-09-14

Start date

2007-03-31

Completion date

2011-07-31

Last updated

2015-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Low Back Pain, Chronic, Manipulation, Chiropractic, Massage

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.

Interventions

PROCEDURESpinal Manipulation

5 minutes high velocity, low amplitude lumbar thrust

PROCEDURELight Massage

light pressure massage of the low back.

PROCEDUREPulsed Ultrasound

5 minutes pulsed ultrasound

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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
Pain days	baseline 1&2, 6, 12, 18, 24, 39, 52 weeks
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
Patient satisfaction	12 wk
Disability days	baseline 1&2, 6, 12, 18, 24, 39, 52 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026