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

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

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 Overview

• Status: Completed
• Conditions: Non-specific Low Back Pain
• Intervention / Treatment: Procedure: Spinal manipulation; Procedure: Dry needling; Procedure: Spinal manipulation and dry needling

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Jedidiah Farley, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 25, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Low back pain; Dry needling; Spinal manipulation; Numeric pain rating scale; Oswestry disability index; Diagnostic ultrasound
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 144339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No