The Mechanisms of Manual Therapy in the Treatment of Low Back Pain

University of Florida

Status and phase: Completed; Phase 2; Phase 1

Conditions: Low Back Pain

Treatments: Other: sham spinal manipulation; Other: Enhanced sham spinal manipulation; Other: spinal manipulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01168999

345-2009

Details and patient eligibility

About

The purpose of this study is to determine whether a novel placebo for comparison to spinal manipulation is believable and creates similar expectation for treatment effectiveness as the studied spinal manipulation technique. Additionally, we wish to compare outcomes related to low back pain, function, and pain sensitivity between people receiving the placebo, spinal manipulation, and no therapy.

Enrollment: 110 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• currently experiencing low back pain which does not extend below the knees
• rate the low back pain as a minimum of 4/10 at worst over the past 24 hours
• appropriate for conservative management of low back pain
• english speaking

Exclusion criteria

• surgery to the low back over the past 6 months
• systemic disease known to effect sensation
• other chronic pain condition unrelated to low back pain
• fracture as a cause of low back pain

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 4 patient groups, including a placebo group

spinal manipulation

Active Comparator group

Description:

a spinal manipulation known to be effective in the treatment of low back pain for some individuals

Treatment:

Other: spinal manipulation

sham spinal manipulation

Placebo Comparator group

Description:

a sham spinal manipulation intended to mimic the studied spinal manipulation

Treatment:

Other: sham spinal manipulation

natural history

No Intervention group

Description:

No intervention is provided to participants in this arm of the study

Enhanced sham spinal manipulation

Placebo Comparator group

Description:

a sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, "The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"

Treatment:

Other: Enhanced sham spinal manipulation