The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Low Back Pain
- Conditions
- Non-specific Low Back Pain
- Interventions
- Procedure: Spinal manipulation and dry needlingProcedure: Spinal manipulationProcedure: Dry needling
- Registration Number
- NCT05802901
- Lead Sponsor
- University of Utah
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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%
- 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.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Spinal manipulation and dry needling Spinal manipulation and dry needling Combination of spinal manipulation and dry needling of the lumbar spine group Spinal manipulation Spinal manipulation Spinal manipulation of the lumbar spine only group. Dry needling Dry needling Dry needling of the symptomatic side of the lumbar spine only group.
- Primary Outcome Measures
Name Time Method Low back pain Oswestry Disability Index Questionnaire at Baseline 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 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 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 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 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 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 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 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 Outcome Measures
Name Time Method Lumbar multifidus muscle change in thickness at Baseline Baseline Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Gluteus medius muscle change in thickness at 2-weeks 2-weeks Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Erector spinae muscle change in thickness at 4-weeks 4-weeks Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Lumbar multifidus muscle change in thickness at 2-weeks 2-weeks Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Lumbar multifidus muscle change in thickness at 4-weeks 4-weeks Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Gluteus medius muscle change in thickness at 4-weeks 4-weeks Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Erector spinae muscle change in thickness at Baseline Baseline Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Gluteus medius muscle change in thickness at Baseline Baseline Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Erector spinae muscle change in thickness at 2-weeks 2-weeks Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Trial Locations
- Locations (1)
University of Utah
🇺🇸Salt Lake City, Utah, United States