The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Low Back Pain (SMTDNLBP)

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Non-specific Low Back Pain

Treatments: Procedure: Spinal manipulation; Procedure: Dry needling; Procedure: Spinal manipulation and dry needling

Study type: Interventional

Funder types: Other

Identifiers

NCT05802901

144339

Details and patient eligibility

About

The goal of this study is to enroll and randomize 99 participants with non-specific low back pain into a multimodal strategy of treatment consisting of a combination of dry needling (DN) and spinal manipulation therapy (SMT), DN only, and SMT only, followed by an at home exercise program. All groups will receive their respective treatment twice a week for 2 weeks followed by a 2-week home exercise program. Primary outcomes include clinical subjective (Oswestry Disability Index, numeric pain intensity rating) and mechanistic (lumbar multifidus, erector spinae, and gluteus medius muscle activation) measures assessed at baseline, 1, 2, and 4 weeks. Timepoints at 2-weeks and 4-weeks will be compared to baseline measures to determine effectiveness of the combination group against the other single treatment groups. Exercise compliance will be measured by participants self-reporting adherence to the program by selecting average number of days per week the exercises are completed.

Enrollment: 96 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of nonspecific low back pain defined as pain between the twelfth rib and buttocks with or without symptoms into one or both legs
• Current patient-reported pain rating score greater than 3 based on the numeric pain rating score 0-10 scale
• Oswestry Disability Index > 20%

Exclusion criteria

• Prior surgery to the lumbosacral spine
• Pregnancy
• Currently receiving mind-body or exercise treatment for low back pain with a healthcare provider (e.g., chiropractic, physical therapy, massage therapy, etc.)
• Signs of neurogenic low back pain arising from clinical examination (e.g., positive straight leg raise test, diminished muscle stretch reflex, etc.)
• Evidence of significant spinal pathology (e.g., spinal fracture, infection, etc.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 3 patient groups

Spinal manipulation

Active Comparator group

Description:

Spinal manipulation of the lumbar spine only group.

Treatment:

Procedure: Spinal manipulation

Dry needling

Active Comparator group

Description:

Dry needling of the symptomatic side of the lumbar spine only group.

Treatment:

Procedure: Dry needling

Spinal manipulation and dry needling

Active Comparator group

Description:

Combination of spinal manipulation and dry needling of the lumbar spine group

Treatment:

Procedure: Spinal manipulation and dry needling