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

Primary Purpose

Non-specific Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal manipulation
Dry needling
Spinal manipulation and dry needling
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Low Back Pain focused on measuring Low back pain, Spinal manipulation, Dry needling, Diagnostic ultrasound, Oswestry disability index, Numeric pain rating scale

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Spinal manipulation

Dry needling

Spinal manipulation and dry needling

Arm Description

Spinal manipulation of the lumbar spine only group.

Dry needling of the symptomatic side of the lumbar spine only group.

Combination of spinal manipulation and dry needling of the lumbar spine group

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 7, 2023
Last Updated
July 31, 2023
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT05802901
Brief Title
The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Low Back Pain
Acronym
SMTDNLBP
Official Title
The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Non-specific Low Back
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 28, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Low Back Pain
Keywords
Low back pain, Spinal manipulation, Dry needling, Diagnostic ultrasound, Oswestry disability index, Numeric pain rating scale

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal manipulation
Arm Type
Active Comparator
Arm Description
Spinal manipulation of the lumbar spine only group.
Arm Title
Dry needling
Arm Type
Active Comparator
Arm Description
Dry needling of the symptomatic side of the lumbar spine only group.
Arm Title
Spinal manipulation and dry needling
Arm Type
Active Comparator
Arm Description
Combination of spinal manipulation and dry needling of the lumbar spine group
Intervention Type
Procedure
Intervention Name(s)
Spinal manipulation
Intervention Description
Spinal manipulation of the lumbar spine only to be performed in the spinal manipulation arm/group.
Intervention Type
Procedure
Intervention Name(s)
Dry needling
Intervention Description
Dry needling of the lumbar erector spinae, multifidus, and gluteus medius on the symptomatic side performed in the dry needling arm/group.
Intervention Type
Procedure
Intervention Name(s)
Spinal manipulation and dry needling
Intervention Description
The spinal manipulation and dry needling arm/group receive both spinal manipulation and dry needling as outlined in the other groups.
Primary Outcome Measure Information:
Title
Numeric pain rating scale at Baseline
Description
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.
Time Frame
Baseline
Title
Low back pain Oswestry Disability Index Questionnaire at Baseline
Description
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.
Time Frame
Baseline
Title
Numeric pain rating scale at 1-week
Description
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.
Time Frame
1-week
Title
Low back pain Oswestry Disability Index Questionnaire at 1-week
Description
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.
Time Frame
1-week
Title
Numeric pain rating scale at 2-weeks
Description
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.
Time Frame
2-weeks
Title
Low back pain Oswestry Disability Index Questionnaire at 2-weeks
Description
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.
Time Frame
2-weeks
Title
Numeric pain rating scale at 4-weeks
Description
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.
Time Frame
4-weeks
Title
Low back pain Oswestry Disability Index Questionnaire at 4-weeks
Description
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.
Time Frame
4-weeks
Secondary Outcome Measure Information:
Title
Lumbar multifidus muscle change in thickness at Baseline
Description
Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Time Frame
Baseline
Title
Erector spinae muscle change in thickness at Baseline
Description
Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Time Frame
Baseline
Title
Gluteus medius muscle change in thickness at Baseline
Description
Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Time Frame
Baseline
Title
Lumbar multifidus muscle change in thickness at 2-weeks
Description
Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Time Frame
2-weeks
Title
Erector spinae muscle change in thickness at 2-weeks
Description
Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Time Frame
2-weeks
Title
Gluteus medius muscle change in thickness at 2-weeks
Description
Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Time Frame
2-weeks
Title
Lumbar multifidus muscle change in thickness at 4-weeks
Description
Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Time Frame
4-weeks
Title
Erector spinae muscle change in thickness at 4-weeks
Description
Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Time Frame
4-weeks
Title
Gluteus medius muscle change in thickness at 4-weeks
Description
Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.
Time Frame
4-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jedidiah Farley, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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