The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Non-specific Low Back
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Low back pain Oswestry Disability Index Questionnaire at Baseline
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.).
Arms & Interventions
Spinal manipulation
Spinal manipulation of the lumbar spine only group.
Intervention: Spinal manipulation (Procedure)
Dry needling
Dry needling of the symptomatic side of the lumbar spine only group.
Intervention: Dry needling (Procedure)
Spinal manipulation and dry needling
Combination of spinal manipulation and dry needling of the lumbar spine group
Intervention: Spinal manipulation and dry needling (Procedure)
Outcomes
Primary Outcomes
Low back pain Oswestry Disability Index Questionnaire at Baseline
Time Frame: Baseline
The ODI score is derived from the Oswestry Disability Questionnaire, resulting in a score ranging from 0-100 with higher numbers indicating a greater level of disability.
Numeric pain rating scale at 2-weeks
Time Frame: 2-weeks
Participants were asked to make separate ratings of current pain intensity and the best and worst intensity over the past 24 hours on a 0-10 scale ("0" no pain and "10" worst imaginable pain). The mean of the three ratings was used to represent pain intensity.
Numeric pain rating scale at Baseline
Time Frame: Baseline
Participants were asked to make separate ratings of current pain intensity and the best and worst intensity over the past 24 hours on a 0-10 scale ("0" no pain and "10" worst imaginable pain). The mean of the three ratings was used to represent pain intensity.
Low back pain Oswestry Disability Index Questionnaire at 1-week
Time Frame: 1-week
The ODI score is derived from the Oswestry Disability Questionnaire, resulting in a score ranging from 0-100 with higher numbers indicating a greater level of disability.
Low back pain Oswestry Disability Index Questionnaire at 2-weeks
Time Frame: 2-weeks
The ODI score is derived from the Oswestry Disability Questionnaire, resulting in a score ranging from 0-100 with higher numbers indicating a greater level of disability.
Numeric pain rating scale at 4-weeks
Time Frame: 4-weeks
Participants were asked to make separate ratings of current pain intensity and the best and worst intensity over the past 24 hours on a 0-10 scale ("0" no pain and "10" worst imaginable pain). The mean of the three ratings was used to represent pain intensity.
Numeric pain rating scale at 1-week
Time Frame: 1-week
Participants were asked to make separate ratings of current pain intensity and the best and worst intensity over the past 24 hours on a 0-10 scale ("0" no pain and "10" worst imaginable pain). The mean of the three ratings was used to represent pain intensity.
Low back pain Oswestry Disability Index Questionnaire at 4-weeks
Time Frame: 4-weeks
The ODI score is derived from the Oswestry Disability Questionnaire, resulting in a score ranging from 0-100 with higher numbers indicating a greater level of disability.
Secondary Outcomes
- Lumbar multifidus muscle change in thickness at Baseline(Baseline)
- Gluteus medius muscle change in thickness at 2-weeks(2-weeks)
- Erector spinae muscle change in thickness at 4-weeks(4-weeks)
- Lumbar multifidus muscle change in thickness at 2-weeks(2-weeks)
- Lumbar multifidus muscle change in thickness at 4-weeks(4-weeks)
- Gluteus medius muscle change in thickness at 4-weeks(4-weeks)
- Erector spinae muscle change in thickness at Baseline(Baseline)
- Gluteus medius muscle change in thickness at Baseline(Baseline)
- Erector spinae muscle change in thickness at 2-weeks(2-weeks)
Investigators
Jedidiah Farley
Research Fellow
University of Utah