Low Back PainNCT06204055
The Derivation of a Clinical Prediction Rule to Identify Those With Low Back Pain Who Will Respond Favorably to Intramuscular Dry-needling
A study testing Intramuscular Dry-Needling in people with Low Back Pain, run by Whitworth University at 1 site in United States.
Trial summary
The purpose of this study is to investigate specific clinical characteristics, amongst those with low back pain, that identify patient appropriateness for Intermuscular Dry-Needling (IMDN) and to develop a prediction tool that can be used by clinicians. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Intramuscular Dry-Needling
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2024to Nov 2024
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females between the ages of 18 and 60 years with non-traumatic low back pain between the 12th rib and the buttock region.
- Participants must also report an Oswestry Disability Index score of at least 20/100 points.
Who cannot join
- Participants must be able to speak and read English.
- Individuals who are currently pregnant, currently taking pain narcotic medication or have had a prior surgery in the lumbosacral spine
- Those participants whose BMI is greater than 35
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Whitworth University
Spokane, Washington, 99251
Dominic Severino, 509-777-4687, dseverino@whitworth.edu
dseverino@whitworth.edu
About this study
Official title: The Derivation of a Clinical Prediction Rule to Identify Those With Low Back Pain Who Will
The purpose of this study is to investigate specific clinical characteristics, amongst those with low back pain, that identify patient appropriateness for Intermuscular Dry-Needling (IMDN) and to develop a prediction tool that can be used by clinicians.
Read the detailed description
The aim of the CPR is to identify patients with LBP who are likely to benefit from IMDN. Improvement of patient-reported outcomes and clinical measures of pain are the outcomes being predicted by the model. The CPR will be developed in a double-phase design. The first phase will be an RCT, 2 x 3 group (IMDN or Sham) by time (pretest, post-treatment week 1, post-treatment week 2, posttest, follow-up) with repeated measures on timeframe. This design will establish if improvement of patient reported outcomes and clinical measures of pain are achieved because of the IMDN treatment. Furthermore, each group will receive the same type and volume of lumbar and hip stretching exercises in conjunction with their assigned needling regimen. The second phase will utilize logistic regression analysis to identify associations between the groups' demographic, historical, clinical variables and short-term pain and disability outcomes. This type of analysis will be able to identify strong predictors of the treatment outcome. Various processes will be used to determine optimal model fit for analysis.
- Conditions
- Low Back Pain
- Being tested
- Intramuscular Dry-Needling
- Keywords
- Low Back Pain, Dry-Needling, Myofascial Pain, Treatment Based Classification
- 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.
Intramuscular Dry-NeedlingOther
It is a minimally invasive procedure where a solid filament needle is inserted deeply into a myofascial trigger point (MTrP) within a muscle in an attempt to abate it and illicit a desired treatment effect.
| Study group | Role | What they receive |
|---|---|---|
| Intramuscular Dry-Needling | Experimental | (IMDN) is a minimally invasive procedure where a solid filament needle is inserted into a myofascial trigger point. Receives: Other: Intramuscular Dry-Needling |
| Sham Intramuscular Dry-Needling | Sham comparator | ). Park sham acupuncture needles (AcuPrime) will be used to perform sham needling for this group. The sham needle functions by allowing the blunted needle to cause a pricking sensation when pushed against the skin, but does not penetrate. This will allow the patient to perceive that the needle is entering the skin while also maintaining therapist-patient contact and interaction time Receives: Other: Intramuscular Dry-Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
self reported questionnaire that is used to measure a patient's permanent functional disability.
Measured: Baseline, week 1, week 2 and week 3
Secondary outcomes (2)
Fear-Avoidance Beliefs Questionnaire
self reported questionnaire that is used to measure a patient's fear associated with movement and/or work
Measured: Baseline, week 1, week 2 and week 3
11 point Numeric Pain-Rating Scale
self reported scale that is used to rate subjective intensity of back and leg pain
Measured: Baseline, week 1, week 2 and week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Single group
- Model description
- The first phase will be an RCT, 2 x 3 group (IMDN or Sham) by time (pretest, post-treatment week 1, post-treatment week 2, posttest, follow-up) with repeated measures on timeframe. The second phase will utilize logistic regression analysis to identify associations between the groups' demographic, historical, clinical variables and short-term pain and disability outcomes. This type of analysis will be able to identify strong predictors of the treatment outcome. Various processes will be used to determine optimal model fit for analysis.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Whitworth University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dominic Severino, Whitworth University
- Investigators
- Dominic Severino, PT,DPT, Principal investigator, Whitworth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204055
- Sponsor's protocol ID
- 878_Severino
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Derivation of a Clinical Prediction Rule to Identify Those With Low Back Pain Who Will
- ClinicalTrials.gov ID
- NCT06204055
- Acronym / sponsor ID
- 878_Severino
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Dry-Needling, Myofascial Pain, Treatment Based Classification
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Whitworth UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 12 Jan 2024 (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 purpose of this study is to investigate specific clinical characteristics, amongst those with low back pain, that identify patient appropriateness for Intermuscular Dry-Needling (IMDN) and to develop a prediction tool that can be used by clinicians.
Detailed description
The aim of the CPR is to identify patients with LBP who are likely to benefit from IMDN. Improvement of patient-reported outcomes and clinical measures of pain are the outcomes being predicted by the model. The CPR will be developed in a double-phase design. The first phase will be an RCT, 2 x 3 group (IMDN or Sham) by time (pretest, post-treatment week 1, post-treatment week 2, posttest, follow-up) with repeated measures on timeframe. This design will establish if improvement of patient reported outcomes and clinical measures of pain are achieved because of the IMDN treatment. Furthermore, each group will receive the same type and volume of lumbar and hip stretching exercises in conjunction with their assigned needling regimen. The second phase will utilize logistic regression analysis to identify associations between the groups' demographic, historical, clinical variables and short-term pain and disability outcomes. This type of analysis will be able to identify strong predictors of the treatment outcome. Various processes will be used to determine optimal model fit for analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The first phase will be an RCT, 2 x 3 group (IMDN or Sham) by time (pretest, post-treatment week 1, post-treatment week 2, posttest, follow-up) with repeated measures on timeframe. The second phase will utilize logistic regression analysis to identify associations between the groups' demographic, historical, clinical variables and short-term pain and disability outcomes. This type of analysis will be able to identify strong predictors of the treatment outcome. Various processes will be used to determine optimal model fit for analysis.
| Arm | Type | Receives |
|---|---|---|
| Intramuscular Dry-Needling | Experimental | Other: Intramuscular Dry-Needling(IMDN) is a minimally invasive procedure where a solid filament needle is inserted into a myofascial trigger point. |
| Sham Intramuscular Dry-Needling | Sham comparator | Other: Intramuscular Dry-Needling). Park sham acupuncture needles (AcuPrime) will be used to perform sham needling for this group. The sham needle functions by allowing the blunted needle to cause a pricking sensation when pushed against the skin, but does not penetrate. This will allow the patient to perceive that the needle is entering the skin while also maintaining therapist-patient contact and interaction time |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Males and females between the ages of 18 and 60 years with non-traumatic low back pain between the 12th rib and the buttock region.
- Participants must also report an Oswestry Disability Index score of at least 20/100 points.
Key exclusion criteria (3 listed)
- Participants must be able to speak and read English.
- Individuals who are currently pregnant, currently taking pain narcotic medication or have had a prior surgery in the lumbosacral spine
- Those participants whose BMI is greater than 35
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 |
|---|---|---|
| Intramuscular Dry-NeedlingIt is a minimally invasive procedure where a solid filament needle is inserted deeply into a myofascial trigger point (MTrP) within a muscle in an attempt to abate it and illicit a desired treatment effect. | Other | Intramuscular Dry-Needling, Sham Intramuscular Dry-Needling |
Primary outcome
Oswestry Disability Index
Time frame: Baseline, week 1, week 2 and week 3
self reported questionnaire that is used to measure a patient's permanent functional disability.
2 secondary outcomes
Fear-Avoidance Beliefs Questionnaire
Time frame: Baseline, week 1, week 2 and week 3
11 point Numeric Pain-Rating Scale
Time frame: Baseline, week 1, week 2 and week 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
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Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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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.
Dominic Severino, PT,DPT principal investigator
Whitworth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramuscular Dry-Needling in people with Low Back Pain, run by Whitworth University 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dominic J Severino, PT,DPT (5097774687, dseverino@whitworth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oswestry Disability Index (time frame: Baseline, week 1, week 2 and week 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2024.