Dose of Spinal Manipulation for Chronic Low Back Pain

University of Western States

Status and phase: Completed; Phase 3; Phase 2

Conditions: Low Back Pain

Treatments: Procedure: Spinal Manipulation; Procedure: Pulsed Ultrasound; Procedure: Light Massage

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00376350

U01AT001908 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

400 participants in 4 patient groups

High dose manipulation

Experimental group

Description:

High dose spinal manipulation + ultrasound

Treatment:

Procedure: Pulsed Ultrasound

Procedure: Spinal Manipulation

Moderate dose manipulation

Experimental group

Description:

Moderate dose manipulation + low dose massage + ultrasound

Treatment:

Procedure: Pulsed Ultrasound

Procedure: Light Massage

Procedure: Spinal Manipulation

Low dose manipulation

Experimental group

Description:

low dose spinal manipulation + moderate dose massage + ultrasound

Treatment:

Procedure: Pulsed Ultrasound

Procedure: Light Massage

Procedure: Spinal Manipulation

High dose masssage

Other group

Description:

high dose massage + ultrasound

Treatment:

Procedure: Pulsed Ultrasound

Procedure: Light Massage