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

Non-specific Low Back Pain Clinical Trial

— SMTDNLBP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05802901
• Other study ID #: 144339
• Status: Completed
• Phase: N/A
• Start date: February 28, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Non-specific Low Back Pain

Intervention

Procedure:
• Spinal manipulation
Spinal manipulation of the lumbar spine only to be performed in the spinal manipulation arm/group.
• Dry needling
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
The spinal manipulation and dry needling arm/group receive both spinal manipulation and dry needling as outlined in the other groups.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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