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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal manipulation | Active Comparator | Spinal manipulation of the lumbar spine only group. |
|
| Dry needling | Active Comparator | Dry needling of the symptomatic side of the lumbar spine only group. |
|
| Spinal manipulation and dry needling | Active Comparator | Combination of spinal manipulation and dry needling of the lumbar spine group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal manipulation | Procedure | Spinal manipulation of the lumbar spine only to be performed in the spinal manipulation arm/group. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric pain rating scale at 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. | Baseline |
| Low back pain Oswestry Disability Index Questionnaire at 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. | Baseline |
| Numeric pain rating scale at 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. | 1-week |
| Low back pain Oswestry Disability Index Questionnaire at 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. | 1-week |
| Numeric pain rating scale at 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. | 2-weeks |
| Low back pain Oswestry Disability Index Questionnaire at 2-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar multifidus muscle change in thickness at Baseline | Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound. | Baseline |
| Erector spinae muscle change in thickness at Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jedidiah Farley, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38484853 | Derived | Farley J, Taylor-Swanson L, Koppenhaver S, Thackeray A, Magel J, Fritz JM. The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Nonspecific Low Back Pain. J Pain. 2024 Aug;25(8):104506. doi: 10.1016/j.jpain.2024.03.002. Epub 2024 Mar 12. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 10, 2022 | Feb 17, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 16, 2021 | Feb 17, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| D000079245 | Dry Needling |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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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.
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| Dry needling | 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 | Procedure | The spinal manipulation and dry needling arm/group receive both spinal manipulation and dry needling as outlined in the other groups. |
|
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.
| 2-weeks |
| Numeric pain rating scale at 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. | 4-weeks |
| Low back pain Oswestry Disability Index Questionnaire at 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. | 4-weeks |
Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound. |
| Baseline |
| Gluteus medius muscle change in thickness at Baseline | Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound. | Baseline |
| Lumbar multifidus muscle change in thickness at 2-weeks | Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound. | 2-weeks |
| Erector spinae muscle change in thickness at 2-weeks | Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound. | 2-weeks |
| Gluteus medius muscle change in thickness at 2-weeks | Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound. | 2-weeks |
| Lumbar multifidus muscle change in thickness at 4-weeks | Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound. | 4-weeks |
| Erector spinae muscle change in thickness at 4-weeks | Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound. | 4-weeks |
| Gluteus medius muscle change in thickness at 4-weeks | Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound. | 4-weeks |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000529 |
| Complementary Therapies |