Non-specific Low Back PainSMTDNLBPNCT05802901
The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Low Back Pain
A study testing Spinal manipulation, Dry needling and Spinal manipulation and dry needling in people with Non-specific Low Back Pain, run by University of Utah at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- Spinal manipulation, Dry needling and Spinal manipulation and dry needling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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%
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Non-specific Low Back Pain
- Being tested
- Spinal manipulation, Dry needling, Spinal manipulation and dry needling
- Keywords
- Low back pain, Spinal manipulation, Dry needling, Diagnostic ultrasound, Oswestry disability index, Numeric pain rating scale
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal manipulationProcedure or surgery
Spinal manipulation of the lumbar spine only to be performed in the spinal manipulation arm/group.
Dry needlingProcedure or surgery
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 needlingProcedure or surgery
The spinal manipulation and dry needling arm/group receive both spinal manipulation and dry needling as outlined in the other groups.
| Study group | Role | What they receive |
|---|---|---|
| Spinal manipulation | Active comparator | Spinal manipulation of the lumbar spine only group. Receives: Procedure: Spinal manipulation |
| Dry needling | Active comparator | Dry needling of the symptomatic side of the lumbar spine only group. Receives: Procedure: Dry needling |
| Spinal manipulation and dry needling | Active comparator | Combination of spinal manipulation and dry needling of the lumbar spine group Receives: Procedure: Spinal manipulation and dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4-weeks
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start28 Feb 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-specific Low Back PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jedidiah Farley, University of Utah
- Investigators
- Jedidiah Farley, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802901
- Sponsor's protocol ID
- 144339
- Acronym
- SMTDNLBP
- Status last verified
- Jul 2023
- First submitted
- 7 Mar 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38484853
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combining Spinal Manipulation and Dry Needling in Individuals With Non-specific Low Back
- ClinicalTrials.gov ID
- NCT05802901
- Acronym / sponsor ID
- SMTDNLBP / 144339
- Conditions
- Non-specific Low Back Pain
- Keywords
- Low back pain, Spinal manipulation, Dry needling, Diagnostic ultrasound, Oswestry disability index, Numeric pain rating scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 28 Feb 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Spinal manipulation | Active comparator | Procedure: Spinal manipulationSpinal manipulation of the lumbar spine only group. |
| Dry needling | Active comparator | Procedure: Dry needlingDry needling of the symptomatic side of the lumbar spine only group. |
| Spinal manipulation and dry needling | Active comparator | Procedure: Spinal manipulation and dry needlingCombination of spinal manipulation and dry needling of the lumbar spine group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (5 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal manipulationSpinal manipulation of the lumbar spine only to be performed in the spinal manipulation arm/group. | Procedure or surgery | Spinal manipulation |
| Dry needlingDry needling of the lumbar erector spinae, multifidus, and gluteus medius on the symptomatic side performed in the dry needling arm/group. | Procedure or surgery | Dry needling |
| Spinal manipulation and dry needlingThe spinal manipulation and dry needling arm/group receive both spinal manipulation and dry needling as outlined in the other groups. | Procedure or surgery | Spinal manipulation and dry needling |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
9 secondary outcomes
Lumbar multifidus muscle change in thickness at Baseline
Time frame: Baseline
Erector spinae muscle change in thickness at Baseline
Time frame: Baseline
Gluteus medius muscle change in thickness at Baseline
Time frame: Baseline
Lumbar multifidus muscle change in thickness at 2-weeks
Time frame: 2-weeks
Erector spinae muscle change in thickness at 2-weeks
Time frame: 2-weeks
Gluteus medius muscle change in thickness at 2-weeks
Time frame: 2-weeks
Lumbar multifidus muscle change in thickness at 4-weeks
Time frame: 4-weeks
Erector spinae muscle change in thickness at 4-weeks
Time frame: 4-weeks
Gluteus medius muscle change in thickness at 4-weeks
Time frame: 4-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Derived from this study: PubMed 38484853Farley 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jedidiah Farley, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal manipulation, Dry needling and Spinal manipulation and dry needling in people with Non-specific Low Back Pain, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric pain rating scale at Baseline (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.