Skip to main content
OpenTrials
Completed

NCT Number: NCT05802901

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-specific Low Back Pain Back Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Spinal manipulation

Procedure

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

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.

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.

Primary outcomes

  1. Numeric pain rating scale at Baseline

    Time frame: 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.

  2. Low back pain Oswestry Disability Index Questionnaire at Baseline

    Time frame: 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.

  3. Numeric pain rating scale at 1-week

    Time frame: 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.

  4. Low back pain Oswestry Disability Index Questionnaire at 1-week

    Time frame: 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.

  5. Numeric pain rating scale at 2-weeks

    Time frame: 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.

  6. Low back pain Oswestry Disability Index Questionnaire at 2-weeks

    Time frame: 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.

  7. Numeric pain rating scale at 4-weeks

    Time frame: 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.

  8. Low back pain Oswestry Disability Index Questionnaire at 4-weeks

    Time frame: 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 outcomes

  1. Lumbar multifidus muscle change in thickness at Baseline

    Time frame: Baseline

    Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.

  2. Erector spinae muscle change in thickness at Baseline

    Time frame: Baseline

    Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.

  3. Gluteus medius muscle change in thickness at Baseline

    Time frame: Baseline

    Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.

  4. Lumbar multifidus muscle change in thickness at 2-weeks

    Time frame: 2-weeks

    Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.

  5. Erector spinae muscle change in thickness at 2-weeks

    Time frame: 2-weeks

    Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.

  6. Gluteus medius muscle change in thickness at 2-weeks

    Time frame: 2-weeks

    Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.

  7. Lumbar multifidus muscle change in thickness at 4-weeks

    Time frame: 4-weeks

    Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.

  8. Erector spinae muscle change in thickness at 4-weeks

    Time frame: 4-weeks

    Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.

  9. Gluteus medius muscle change in thickness at 4-weeks

    Time frame: 4-weeks

    Muscle activation measured by changes in contraction thickness at rest and sub-maximal isometric contraction utilizing diagnostic ultrasound.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Acronym: SMTDNLBP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 7, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.