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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-28

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-specific Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups of participants receive one of three different interventions. One group receives spinal manipulation only, another group receives dry needling only, and the last group receives the combination of spinal manipulation and dry needling. Participants in each group receive their respective treatment in parallel with the other groups.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Spinal manipulation

Spinal manipulation of the lumbar spine only group.

Group Type ACTIVE_COMPARATOR

Spinal manipulation

Intervention Type PROCEDURE

Spinal manipulation of the lumbar spine only to be performed in the spinal manipulation arm/group.

Dry needling

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

Group Type ACTIVE_COMPARATOR

Dry needling

Intervention Type PROCEDURE

Dry needling of the lumbar erector spinae, multifidus, and gluteus medius on the symptomatic side performed in the dry needling arm/group.

Spinal manipulation and dry needling

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

Group Type ACTIVE_COMPARATOR

Spinal manipulation and dry needling

Intervention Type PROCEDURE

The spinal manipulation and dry needling arm/group receive both spinal manipulation and dry needling as outlined in the other groups.

Interventions

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Spinal manipulation

Spinal manipulation of the lumbar spine only to be performed in the spinal manipulation arm/group.

Intervention Type PROCEDURE

Dry needling

Dry needling of the lumbar erector spinae, multifidus, and gluteus medius on the symptomatic side performed in the dry needling arm/group.

Intervention Type PROCEDURE

Spinal manipulation and dry needling

The spinal manipulation and dry needling arm/group receive both spinal manipulation and dry needling as outlined in the other groups.

Intervention Type PROCEDURE

Eligibility Criteria

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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.).

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No