The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Non-specific Low Back

Conditions
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Non-specific Low Back Pain

Intervention / Treatment
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* Procedure: Spinal manipulation
* Procedure: Dry needling
* Procedure: Spinal manipulation and dry needling


Participation Criteria
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Eligibility Criteria
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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.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal manipulation<br>Spinal manipulation of the lumbar spine only group. | Procedure: Spinal manipulation<br>* Spinal manipulation of the lumbar spine only to be performed in the spinal manipulation arm/group.<br>|
| Active Comparator: Dry needling<br>Dry needling of the symptomatic side of the lumbar spine only group. | Procedure: Dry needling<br>* Dry needling of the lumbar erector spinae, multifidus, and gluteus medius on the symptomatic side performed in the dry needling arm/group.<br>|
| Active Comparator: Spinal manipulation and dry needling<br>Combination of spinal manipulation and dry needling of the lumbar spine group | Procedure: Spinal manipulation and dry needling<br>* The spinal manipulation and dry needling arm/group receive both spinal manipulation and dry needling as outlined in the other groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low back pain, Spinal manipulation, Dry needling, Diagnostic ultrasound, Oswestry disability index, Numeric pain rating scale