Low Back PainNCT03749564
Influence of Opioid Use on the Effects of Spinal Manipulative Therapy for Low Back Pain
A study testing SMT, Activation Exercises and Mobilizing Exercises in people with Low Back Pain and Opioid Use, run by University of Utah at 1 site in United States.
Trial summary
This project is a supplement to the parent project (UH3AT009293) entitled "Optimization of Spinal Manipulative Therapy (SMT) Protocols". The goal of the parent project is to examine strategies to optimize SMT treatment protocols for patients with low back pain (LBP). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain, Opioid Use
- What is being tested?
- SMT, Activation Exercises and Mobilizing Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2019to 3 Mar 2020
- 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
- Pain between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the examiner, originate from the lumbar region.
- Age 18 - 60 years
- Oswestry disability score > 20%
- Self-reported
Who cannot join
- Prior surgery to the lumbosacral spine
- Currently pregnant
- Currently receiving mind-body or exercise treatment for LBP from a healthcare provider (e.g., chiropractic, physical therapy, massage therapy, etc.)
- Neurogenic signs including any of the following: positive ipsi- or contra-lateral straight leg raise test; reflex, sensory, or strength deficit in a pattern consistent with lumbar nerve root compression
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah, Department of Physical Therapy
Salt Lake City, Utah, 84112
About this study
Official title: Examining the Influence of Opioid Use on the Effects of Spinal Manipulative Therapy for Low Back Pain: Administrative Supplement to UH3AT009293 - Optimization of Spinal Manipulative Therapy (SMT) Protocols
This project is a supplement to the parent project (UH3AT009293) entitled "Optimization of Spinal Manipulative Therapy (SMT) Protocols". The goal of the parent project is to examine strategies to optimize SMT treatment protocols for patients with low back pain (LBP). The parent project is investigating mechanistic and clinical outcomes of SMT combined with varying co-interventions. This supplemental project will examine the impact of opioid use on these outcomes.
Read the detailed description
This supplement expands the parent research project to include three additional Aims and the recruitment of the 70 additional participants. The additional participants will undergo the same assessment and intervention procedures outlined in the parent project to permit leveraging the full cohort to evaluate the supplemental Aims.
The overall objective is to examine the impact of opioid use on patient-centered and mechanistic outcomes related to SMT and explore the impact on SMT followed by various co-interventions. The goal of this research is to better tailor SMT protocols to optimize outcomes for patients with LBP who are opioid users and facilitate efforts to reduce reliance on opioid pain management among those with LBP. Accomplishing this goal will facilitate future research evaluating the efficacy of non-pharmacologic alternative pain management strategies for individuals with LBP.
Specific Aims to be addressed through this supplement are:
- Compare baseline psychological, mechanistic and LBP-related characteristics between sub-groups of participants with LBP based on opioid use.
- Examine the association of opioid use with changes in mechanistic and patient-centered outcomes between a baseline assessment and subsequent assessment after 1-week and completion of a 2-session SMT intervention protocol.
- Explore the moderating effects of opioid use on mechanistic and patient-centered outcomes obtained 4 weeks following SMT intervention with varied co-intervention components.
Examining these aims as a supplement to the parent project will allow evaluation of whether or not opioid use impacts short-term mechanistic and patient-centered outcomes of SMT (Aim 2), and will explore if the longer-term effects of the three co-interventions differ between opioid users and non-users. (Aim 3). This research will also compare baseline characteristics between participants who are or are not opioid users (Aim 1).
- Conditions
- Low Back Pain, Opioid Use
- Being tested
- SMT, Activation Exercises, Mobilizing Exercises, Extended SMT
- Keywords
- Spinal Manipulative Therapy, Optimization
- 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.
SMTBehavioural
Also called spinal manipulative therapy
The subject is supine. The clinician stands opposite the side to be manipulated and side-bends the subject away from the side to manipulate. The side to be manipulated is the more painful. If the subject cannot identify a more painful side the clinician selects a side. The clinician rotates the subject, and delivers a high-velocity, low-amplitude (HVLA) thrust to the pelvis in a posterior/inferior direction. The clinician notes if a cavitation (ie, a "pop") occurred. If it does, SMT treatment is complete. If no cavitation occurs, the subject is repositioned and SMT is performed again. If no cavitation occurs on the second attempt, the clinician manipulates the opposite side. A maximum of 2 attempts per side is permitted. If no cavitation is noted by that time, SMT treatment is complete. Substitution with a side-posture HVLA technique is allowed if the preferred technique is not possible due to subject preference or comfort.
Activation ExercisesBehavioural
Activation exercises are designed to facilitate use of the lumbar multifidus muscle. Exercises will begin with isometric multifidus contractions in different positions with clinician feedback and exercises to isometrically co-contract the multifidus and deep abdominal muscles. Subjects will also perform lumbar extensor strengthening exercises shown to produce 20%-50% of multifidus maximum voluntary contraction. Subjects will continue to perform isometric exercises throughout treatment. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days.
Mobilizing ExercisesBehavioural
Mobilizing exercises include a program of repeated movements progressing into end-ranges of spinal flexion and/or extension shown in past studies to improve ROM and reduce spinal stiffness. Patients will be instructed in mid-range exercises and will be further assessed for a directional preference. A directional preference is present if movement in a particular direction decreases LBP intensity or causes symptoms to centralize towards the midline. If a subject has a directional preference he or she will be prescribed exercises specifically in that direction along with mid-range exercise. Otherwise the subject will be assigned exercises moving into either flexion or extension based on the clinician's discretion. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days.
Extended SMTBehavioural
Additional 6 SMT sessions provided
| Study group | Role | What they receive |
|---|---|---|
| SMT Only | Experimental | All patients receive 2 SMT sessions in the first week. Receives: Behavioral: SMT |
| SMT extended | Experimental | All patients receive 2 SMT sessions in the first week. This arm also involves 6 additional SMT sessions. Each SMT session is conducted as described previously. Receives: Behavioral: SMT; Behavioral: Extended SMT |
| SMT with Activation Exercises | Experimental | All patients receive 2 SMT sessions in the first week.
This arm receives 6 additional sessions of activation exercises. Receives: Behavioral: SMT; Behavioral: Activation Exercises |
| SMT with Mobilizing Exercises | Experimental | All patients receive 2 SMT sessions in the first week.
This arm involves 6 additional sessions of mobilizing exercise. Receives: Behavioral: SMT; Behavioral: Mobilizing Exercises |
| SMT with Mobilizing and Activation Exercises | Experimental | All patients receive 2 SMT sessions in the first week.
This arm involves 6 additions sessions including both activation and mobilizing exercises. Receives: Behavioral: SMT; Behavioral: Activation Exercises; Behavioral: Mobilizing Exercises |
| SMT extended with Mobilizing Exercises | Experimental | All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including both SMT and mobilizing exercises. Receives: Behavioral: SMT; Behavioral: Mobilizing Exercises; Behavioral: Extended SMT |
| SMT extended with Activation Exercises | Experimental | All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including both SMT and activation exercises. Receives: Behavioral: SMT; Behavioral: Activation Exercises; Behavioral: Extended SMT |
| SMT extended with Mobilizing and Activation Exercises | Experimental | All patients receive 2 SMT sessions in the first week.
This arm includes 6 additional sessions including SMT, activation and mobilizing exercises. Receives: Behavioral: SMT; Behavioral: Activation Exercises; Behavioral: Mobilizing Exercises; Behavioral: Extended SMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry
The Oswestry Index measures back pain-related disability. The scale contains 10 items with a final score ranging from 0-100. Higher numbers indicate more disability.
Measured: 1 week
Pain intensity: 0-10 numeric pain rating
A 0-10 numeric pain rating is used to assess pain intensity. Higher numbers indicate greater pain intensity.
Measured: 1 week
Secondary outcomes (2)
Multifidus Activation
Multifidus activation wis measured with brightness-mode ultrasound images using a 60mm, 2-5 MHz curvilinear array. The subject is prone. The ultrasound transducer is placed just lateral to midline and angled medially until a parasagittal view of the multifidus is obtained. Images are acquired at each level with the multifidus at rest and during submaximal contraction elicited by the subject lifting the contralateral arm about 2 inches while holding a weight proportional to body weight. Three images in each state are acquired and averaged. Offline multifidus thickness measures are obtained from the distance between the posterior-most aspect of the facet joint inferiorly and the plane between the multifidus and thoracolumbar fascia superior. Muscle activation is calculated as the change in thickness at rest and submaximal contraction and expressed in mm.
Measured: Baseline, 1-week, 4-weeks, 3 months
Spinal Stiffness
Spinal stiffness is assessed with a mechanically-assisted indentation device over the spinous processes. Indentation involves advancement of the probe from a 5 N pre-load to 60 N final load maintained for 1 second, then the probe raises automatically. Three indentation trials are performed with mean values used for analysis. Indentation data (force and displacement) are used to calculate stiffness variables. Global stiffness (N) is calculated as the slope of the force displacement curve between 5 - 60 N, representing stiffness of underlying tissues during indentation.
Measured: Baseline, 1-week, 4-weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start17 Jan 2019
- Primary completion3 Mar 2020
- Study completion3 Mar 2020
Why it stopped: COVID-19 restrictions on research activities
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.
- 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
- Factorial
- Model description
- Factorial design examining the outcomes of SMT with varying combinations of co-interventions.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Fritz, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749564
- Sponsor's protocol ID
- 59006084
- Status last verified
- Sep 2022
- First submitted
- 19 Nov 2018
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Influence of Opioid Use on the Effects of Spinal Manipulative Therapy for Low Back Pain: Administrative Supplement to UH3AT009293 - Optimization of Spinal Manipulative Therapy (SMT) Protocols
- ClinicalTrials.gov ID
- NCT03749564
- Acronym / sponsor ID
- 59006084
- Conditions
- Low Back Pain, Opioid Use
- Keywords
- Spinal Manipulative Therapy, Optimization
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 restrictions on research activities
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 3 Mar 2020 (actual)
- Study completion
- 3 Mar 2020 (actual)
- First posted
- 21 Nov 2018 (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.
This project is a supplement to the parent project (UH3AT009293) entitled "Optimization of Spinal Manipulative Therapy (SMT) Protocols". The goal of the parent project is to examine strategies to optimize SMT treatment protocols for patients with low back pain (LBP). The parent project is investigating mechanistic and clinical outcomes of SMT combined with varying co-interventions. This supplemental project will examine the impact of opioid use on these outcomes.
Detailed description
This supplement expands the parent research project to include three additional Aims and the recruitment of the 70 additional participants. The additional participants will undergo the same assessment and intervention procedures outlined in the parent project to permit leveraging the full cohort to evaluate the supplemental Aims.
The overall objective is to examine the impact of opioid use on patient-centered and mechanistic outcomes related to SMT and explore the impact on SMT followed by various co-interventions. The goal of this research is to better tailor SMT protocols to optimize outcomes for patients with LBP who are opioid users and facilitate efforts to reduce reliance on opioid pain management among those with LBP. Accomplishing this goal will facilitate future research evaluating the efficacy of non-pharmacologic alternative pain management strategies for individuals with LBP.
Specific Aims to be addressed through this supplement are:
- Compare baseline psychological, mechanistic and LBP-related characteristics between sub-groups of participants with LBP based on opioid use.
- Examine the association of opioid use with changes in mechanistic and patient-centered outcomes between a baseline assessment and subsequent assessment after 1-week and completion of a 2-session SMT intervention protocol.
- Explore the moderating effects of opioid use on mechanistic and patient-centered outcomes obtained 4 weeks following SMT intervention with varied co-intervention components.
Examining these aims as a supplement to the parent project will allow evaluation of whether or not opioid use impacts short-term mechanistic and patient-centered outcomes of SMT (Aim 2), and will explore if the longer-term effects of the three co-interventions differ between opioid users and non-users. (Aim 3). This research will also compare baseline characteristics between participants who are or are not opioid users (Aim 1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Factorial design examining the outcomes of SMT with varying combinations of co-interventions.
| Arm | Type | Receives |
|---|---|---|
| SMT Only | Experimental | Behavioral: SMTAll patients receive 2 SMT sessions in the first week. |
| SMT extended | Experimental | Behavioral: SMT, Behavioral: Extended SMTAll patients receive 2 SMT sessions in the first week. This arm also involves 6 additional SMT sessions. Each SMT session is conducted as described previously. |
| SMT with Activation Exercises | Experimental | Behavioral: SMT, Behavioral: Activation ExercisesAll patients receive 2 SMT sessions in the first week. This arm receives 6 additional sessions of activation exercises. |
| SMT with Mobilizing Exercises | Experimental | Behavioral: SMT, Behavioral: Mobilizing ExercisesAll patients receive 2 SMT sessions in the first week. This arm involves 6 additional sessions of mobilizing exercise. |
| SMT with Mobilizing and Activation Exercises | Experimental | Behavioral: SMT, Behavioral: Activation Exercises, Behavioral: Mobilizing ExercisesAll patients receive 2 SMT sessions in the first week. This arm involves 6 additions sessions including both activation and mobilizing exercises. |
| SMT extended with Mobilizing Exercises | Experimental | Behavioral: SMT, Behavioral: Mobilizing Exercises, Behavioral: Extended SMTAll patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including both SMT and mobilizing exercises. |
| SMT extended with Activation Exercises | Experimental | Behavioral: SMT, Behavioral: Activation Exercises, Behavioral: Extended SMTAll patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including both SMT and activation exercises. |
| SMT extended with Mobilizing and Activation Exercises | Experimental | Behavioral: SMT, Behavioral: Activation Exercises, Behavioral: Mobilizing Exercises, Behavioral: Extended SMTAll patients receive 2 SMT sessions in the first week. This arm includes 6 additional sessions including SMT, activation and mobilizing exercises. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pain between the 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the examiner, originate from the lumbar region.
- Age 18 - 60 years
- Oswestry disability score > 20%
- Self-reported
Key exclusion criteria (4 listed)
- Prior surgery to the lumbosacral spine
- Currently pregnant
- Currently receiving mind-body or exercise treatment for LBP from a healthcare provider (e.g., chiropractic, physical therapy, massage therapy, etc.)
- Neurogenic signs including any of the following: positive ipsi- or contra-lateral straight leg raise test; reflex, sensory, or strength deficit in a pattern consistent with lumbar nerve root compression
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 |
|---|---|---|
| SMTAlso: spinal manipulative therapyThe subject is supine. The clinician stands opposite the side to be manipulated and side-bends the subject away from the side to manipulate. The side to be manipulated is the more painful. If the subject cannot identify a more painful side the clinician selects a side. The clinician rotates the subject, and delivers a high-velocity, low-amplitude (HVLA) thrust to the pelvis in a posterior/inferior direction. The clinician notes if a cavitation (ie, a "pop") occurred. If it does, SMT treatment is complete. If no cavitation occurs, the subject is repositioned and SMT is performed again. If no cavitation occurs on the second attempt, the clinician manipulates the opposite side. A maximum of 2 attempts per side is permitted. If no cavitation is noted by that time, SMT treatment is complete. Substitution with a side-posture HVLA technique is allowed if the preferred technique is not possible due to subject preference or comfort. | Behavioural | SMT Only, SMT extended, SMT extended with Activation Exercises, SMT extended with Mobilizing Exercises, SMT extended with Mobilizing and Activation Exercises, SMT with Activation Exercises, SMT with Mobilizing Exercises, SMT with Mobilizing and Activation Exercises |
| Activation ExercisesActivation exercises are designed to facilitate use of the lumbar multifidus muscle. Exercises will begin with isometric multifidus contractions in different positions with clinician feedback and exercises to isometrically co-contract the multifidus and deep abdominal muscles. Subjects will also perform lumbar extensor strengthening exercises shown to produce 20%-50% of multifidus maximum voluntary contraction. Subjects will continue to perform isometric exercises throughout treatment. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days. | Behavioural | SMT extended with Activation Exercises, SMT extended with Mobilizing and Activation Exercises, SMT with Activation Exercises, SMT with Mobilizing and Activation Exercises |
| Mobilizing ExercisesMobilizing exercises include a program of repeated movements progressing into end-ranges of spinal flexion and/or extension shown in past studies to improve ROM and reduce spinal stiffness. Patients will be instructed in mid-range exercises and will be further assessed for a directional preference. A directional preference is present if movement in a particular direction decreases LBP intensity or causes symptoms to centralize towards the midline. If a subject has a directional preference he or she will be prescribed exercises specifically in that direction along with mid-range exercise. Otherwise the subject will be assigned exercises moving into either flexion or extension based on the clinician's discretion. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days. | Behavioural | SMT extended with Mobilizing Exercises, SMT extended with Mobilizing and Activation Exercises, SMT with Mobilizing Exercises, SMT with Mobilizing and Activation Exercises |
| Extended SMTAdditional 6 SMT sessions provided | Behavioural | SMT extended, SMT extended with Activation Exercises, SMT extended with Mobilizing Exercises, SMT extended with Mobilizing and Activation Exercises |
Primary outcome
Oswestry
Time frame: 1 week
The Oswestry Index measures back pain-related disability. The scale contains 10 items with a final score ranging from 0-100. Higher numbers indicate more disability.
Pain intensity: 0-10 numeric pain rating
Time frame: 1 week
A 0-10 numeric pain rating is used to assess pain intensity. Higher numbers indicate greater pain intensity.
2 secondary outcomes
Multifidus Activation
Time frame: Baseline, 1-week, 4-weeks, 3 months
Spinal Stiffness
Time frame: Baseline, 1-week, 4-weeks, 3 months
Results and safety
The study was stopped early (reason given: COVID-19 restrictions on research activities). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMT, Activation Exercises and Mobilizing Exercises in people with Low Back Pain and Opioid Use, 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 22 Sep 2022. 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 was stopped early (reason given: COVID-19 restrictions on research activities). Results are not available in the source record.
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?
Oswestry (time frame: 1 week). The study lists 2 primary outcomes in all. 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 22 Sep 2022.