Clinical trial NCT05802901: The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Low Back Pain
Official title: The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Non-specific Low Back
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Low Back Pain
Keywords: Low back pain
Spinal manipulation
Dry needling
Diagnostic ultrasound
Oswestry disability index
Numeric pain rating scale
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2023-04-07
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.).

Primary outcomes:
measure: Numeric pain rating scale at Baseline
timeFrame: Baseline
measure: Low back pain Oswestry Disability Index Questionnaire at Baseline
timeFrame: Baseline
measure: Numeric pain rating scale at 1-week
timeFrame: 1-week
measure: Low back pain Oswestry Disability Index Questionnaire at 1-week
timeFrame: 1-week
measure: Numeric pain rating scale at 2-weeks
timeFrame: 2-weeks
measure: Low back pain Oswestry Disability Index Questionnaire at 2-weeks
timeFrame: 2-weeks
measure: Numeric pain rating scale at 4-weeks
timeFrame: 4-weeks
measure: Low back pain Oswestry Disability Index Questionnaire at 4-weeks
timeFrame: 4-weeks
Secondary outcomes:
measure: Lumbar multifidus muscle change in thickness at Baseline
timeFrame: Baseline
measure: Erector spinae muscle change in thickness at Baseline
timeFrame: Baseline
measure: Gluteus medius muscle change in thickness at Baseline
timeFrame: Baseline
measure: Lumbar multifidus muscle change in thickness at 2-weeks
timeFrame: 2-weeks
measure: Erector spinae muscle change in thickness at 2-weeks
timeFrame: 2-weeks
measure: Gluteus medius muscle change in thickness at 2-weeks
timeFrame: 2-weeks
measure: Lumbar multifidus muscle change in thickness at 4-weeks
timeFrame: 4-weeks
measure: Erector spinae muscle change in thickness at 4-weeks
timeFrame: 4-weeks
measure: Gluteus medius muscle change in thickness at 4-weeks
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Jedidiah Farley, PhD
role: PRINCIPAL_INVESTIGATOR
References: