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

NCT05802901 | Completed DMC

• 1 other identifier: 144339
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-specific Low Back Pain

Keywords

Low back pain; Spinal manipulation; Dry needling; Diagnostic ultrasound; Oswestry disability index; Numeric pain rating scale

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (9)

• Lumbar multifidus muscle change in thickness at Baseline

  Baseline

• Erector spinae muscle change in thickness at Baseline

  Baseline

• Gluteus medius muscle change in thickness at Baseline

  Baseline

• Lumbar multifidus muscle change in thickness at 2-weeks

  2-weeks

• Erector spinae muscle change in thickness at 2-weeks

  2-weeks

Study Arms (3)

Spinal manipulation

ACTIVE COMPARATOR

Spinal manipulation of the lumbar spine only group.

Procedure: Spinal manipulation

Dry needling

ACTIVE COMPARATOR

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

Procedure: Dry needling

Spinal manipulation and dry needling

ACTIVE COMPARATOR

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

Procedure: Spinal manipulation and dry needling

Interventions

Spinal manipulation PROCEDURE

Spinal manipulation of the lumbar spine only to be performed in the spinal manipulation arm/group.

Spinal manipulation

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.

Dry needling

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.

Spinal manipulation and dry needling

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%

You may not qualify if:

• 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.).

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• 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.

  PMID: 38484853 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Spinal; Dry Needling

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation; Complementary Therapies

Study Officials

• Jedidiah Farley, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Model Details: 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.

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 7, 2023
• Study Start: February 28, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)