SMTDNLBP: The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Low Back Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Spinal manipulation Spinal manipulation of the lumbar spine only group. |
Procedure: Spinal manipulation
Spinal manipulation of the lumbar spine only to be performed in the spinal manipulation arm/group.
|
| Active Comparator: Dry needling Dry needling of the symptomatic side of the lumbar spine only group. |
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.
|
| Active Comparator: Spinal manipulation and dry needling Combination of spinal manipulation and dry needling of the lumbar spine group |
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.
|
Outcome Measures
Primary Outcome Measures
- 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 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 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 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
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
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Current patient-reported pain rating score greater than 3 based on the numeric pain rating score 0-10 scale
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Oswestry Disability Index > 20%
Exclusion Criteria:
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Prior surgery to the lumbosacral spine
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Pregnancy
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Currently receiving mind-body or exercise treatment for low back pain with a healthcare provider (e.g., chiropractic, physical therapy, massage therapy, etc.)
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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.).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Utah | Salt Lake City | Utah | United States | 84112 |
Sponsors and Collaborators
- University of Utah
Investigators
- Principal Investigator: Jedidiah Farley, PhD, University of Utah
Study Documents (Full-Text)
More Information
Publications
None provided.- 144339