Low Back PainPhase 2NCT02868034

Optimization of Spinal Manipulative Therapy Protocols

A Phase 2 study testing SMT, Mobilizing Exercises and Activation Exercises in people with Low Back Pain, run by University of Utah at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Low Back Pain
What is being tested?: SMT, Mobilizing Exercises and Activation Exercises
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 273 participants
Where: 2 sitesin 2 countries
Study dates: 22 Feb 2017to 12 Jan 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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%

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

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

University of Utah, Department of Physical Therapy
Salt Lake City, Utah, 84112

Other trials in United States

Canada1 site

University of Alberta
Edmonton, Alberta

Other trials in Canada

About this study

Official title: Optimization of Spinal Manipulation Therapy (SMT) Protocols

Research on spinal manipulative therapy for individuals with low back pain has been hampered by a lack of understanding of which of the physiologic effects produced by spinal manipulation are related to clinical benefit, and how these effects can be used to optimize treatment outcomes. Prior research has identified physiologic effects that relate to the clinical benefits from spinal manipulation treatment. The goal of this project is to examine strategies to use these effects to identify optimized treatment protocols. The results of this project will provide critical information for future clinical trials related to spinal manipulation.

Read the detailed description

Low back pain (LBP) is a common and costly condition. Spinal manipulative therapy (SMT) is a common mind body intervention for individuals with LBP. Although SMT for LBP has been examined in numerous clinical studies, the literature on SMT remains unclear and even contradictory as to the effectiveness of this treatment. Studies that have supported SMT have generally found relatively small treatment effects. Many reasons have been offered for the inconsistent research literature and small effect sizes of SMT. A primary rationale offered is that the SMT protocols used in clinical research are not optimal, primarily due to a lack of understanding of the underlying mechanisms explaining the clinical benefits of SMT realized by some patients with LBP.

The prior work of this research team has identified two mechanisms explaining the therapeutic effects of SMT. These effects are a reduction in spinal stiffness and improved activation of the lumbar multifidus muscle. This research has also developed accurate, non-invasive methods to measure these effects and their response to SMT. The model identifying these two mechanisms has been validated in a second patient sample.

The overall goal of this proposal is to optimize SMT treatment protocols for patients with LBP. The optimization strategy in this study will evaluate SMT combined with other treatments known to modulate the same signals that underlie the clinical effects of SMT assessing both mechanistic (stiffness, lumbar multifidus activation) and patient-centered (function and pain) outcomes. This project will use innovative methodology to efficiently evaluate the effects of various individual treatment components towards an overall effect; identifying which components are contributing to the target outcomes and which, if any, may be discarded. All participants will be provided 2 sessions of SMT, and then will be randomized to a treatment group for an additional 3 weeks using a factorial design and stratified by responder status in order to evaluate different combinations of intervention components (muscle activation exercise, spinal mobilizing exercise, additional SMT) that work on the same pathways that modulate the same effects (spinal stiffness and muscle activation). Outcomes will include spinal stiffness and muscle activation measures as well as patient-reported outcomes assessed at baseline, and after 1 week, 4 weeks and 3 months. Results of this project will provide optimized SMT protocols that will be ready for application in future randomized controlled trials examining the efficacy and effectiveness of SMT.

Conditions: Low Back Pain
Being tested: SMT, Mobilizing Exercises, Activation Exercises, SMT extended
Keywords: Low Back Pain, Spinal Manipulation, Exercise
Medical subject headings: Low Back Pain, Motor Activity

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
All patients receive 2 SMT sessions in the first week. 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.
Mobilizing ExercisesBehavioural
Mobilizing exercises will 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.
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.
SMT extendedBehavioural
This treatment involves 6 additional SMT sessions. Each SMT session is conducted as described previously.

Study groups in NCT02868034
Study group	Role	What they receive
SMT Only	Experimental	Patients receive 2 sessions on SMT during week 1, no additional treatment. Receives: Behavioral: SMT
SMT extended	Experimental	2 sessions of SMT in week 1 and 6 additional sessions of SMT during weeks 2-4. Receives: Behavioral: SMT; Behavioral: SMT extended
SMT with Activation Exercises	Experimental	2 sessions of SMT during week 1 and 6 additional sessions of lumbar multifidus activating exercises during weeks 2-4. Receives: Behavioral: SMT; Behavioral: Activation Exercises
SMT with Mobilizing Exercises	Experimental	2 sessions of SMT during week 1; 6 sessions of spinal mobilizing exercises during weeks 2-4. Receives: Behavioral: SMT; Behavioral: Mobilizing Exercises
SMT with Mobilizing and Activation Exercises	Experimental	2 sessions of SMT during week 1; 6 sessions of lumbar multifidus activating exercises and spinal mobilizing exercises during weeks 2-4. Receives: Behavioral: SMT; Behavioral: Mobilizing Exercises; Behavioral: Activation Exercises
SMT extended with Mobilizing Exercises	Experimental	2 sessions of SMT during week 1; 6 sessions of SMT and spinal mobilizing exercises during weeks 2-4. Receives: Behavioral: SMT; Behavioral: Mobilizing Exercises; Behavioral: SMT extended
SMT extended with Activation Exercises	Experimental	2 sessions of SMT during week 1; 6 sessions of SMT and lumbar multifidus activating exercises during weeks 2-4. Receives: Behavioral: SMT; Behavioral: Activation Exercises; Behavioral: SMT extended
SMT extended with Activation and Mobilizing Exercises	Experimental	2 sessions of SMT during week 1; 6 sessions of SMT, multifidus activating and spinal mobilizing exercises during weeks 2-4. Receives: Behavioral: SMT; Behavioral: Mobilizing Exercises; Behavioral: Activation Exercises; Behavioral: SMT extended

What is being measured

The primary outcome is the main question the study is designed to answer.

Spinal Stiffness
Spinal stiffness is assessed with the VerteTrack device that applies a vertical load along the lumbar spine of a prone participant. The indenter houses a sensor to provide continuous, real-time quantification of spinal deformation in response to a defined load. Stiffness was determined as the ratio of the maximum applied force to the resultant displacement in N/mm. Higher numbers indicate greater amounts of stiffness.
Measured: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Multifidus Activation
Multifidus activation was measured with brightness-mode ultrasound images using a 60mm, 2-5 MHz curvilinear array. Images are acquired with the multifidus at rest and during submaximal contraction. Three images in each state are acquired and averaged. Muscle activation is calculated as the change in thickness at rest and submaximal contraction and expressed as a percentage change. Greater numbers indicate higher muscle activation.
Measured: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.

Secondary outcomes (2)

Oswestry Disability Index
The Oswestry Disability Index measures back pain-related disability. The scale contains 10 items with a minimum score of zero and maximum score of 100. Higher numbers indicate more disability. There are no subscales.
Measured: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Pain Intensity
A 0-10 numeric pain rating is used to assess pain intensity. The minimum score is zero, maximum score is 10. Higher numbers indicate greater pain intensity. There are no subscales.
Measured: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Feb 201712 Jan 2019

First posted16 Aug 2016 (estimated)
Study start22 Feb 2017
Primary completion12 Jan 2019
Study completion12 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 273 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02868034
Sponsor's protocol ID: 1UH3AT009293-01
Status last verified: Apr 2023
First submitted: 11 Aug 2016
Last updated: 17 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Fritz JM, Sharpe JA, Lane E, Santillo D, Greene T, Kawchuk G. Optimizing treatment protocols for spinal manipulative therapy: study protocol for a randomized trial. Trials. 2018 Jun 4;19(1):306. doi: 10.1186/s13063-018-2692-6.
PubMed 29866131

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimization of Spinal Manipulation Therapy (SMT) Protocols
ClinicalTrials.gov ID: NCT02868034
Acronym / sponsor ID: 1UH3AT009293-01
Conditions: Low Back Pain
Keywords: Low Back Pain, Spinal Manipulation, Exercise
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 273 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Collaborators: University of Alberta
Study start: 22 Feb 2017 (actual)
Primary completion: 12 Jan 2019 (actual)
Study completion: 12 Jan 2019 (actual)
First posted: 16 Aug 2016 (estimated)
Results: Posted 17 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
SMT Only	Experimental	Behavioral: SMTPatients receive 2 sessions on SMT during week 1, no additional treatment.
SMT extended	Experimental	Behavioral: SMT, Behavioral: SMT extended2 sessions of SMT in week 1 and 6 additional sessions of SMT during weeks 2-4.
SMT with Activation Exercises	Experimental	Behavioral: SMT, Behavioral: Activation Exercises2 sessions of SMT during week 1 and 6 additional sessions of lumbar multifidus activating exercises during weeks 2-4.
SMT with Mobilizing Exercises	Experimental	Behavioral: SMT, Behavioral: Mobilizing Exercises2 sessions of SMT during week 1; 6 sessions of spinal mobilizing exercises during weeks 2-4.
SMT with Mobilizing and Activation Exercises	Experimental	Behavioral: SMT, Behavioral: Mobilizing Exercises, Behavioral: Activation Exercises2 sessions of SMT during week 1; 6 sessions of lumbar multifidus activating exercises and spinal mobilizing exercises during weeks 2-4.
SMT extended with Mobilizing Exercises	Experimental	Behavioral: SMT, Behavioral: Mobilizing Exercises, Behavioral: SMT extended2 sessions of SMT during week 1; 6 sessions of SMT and spinal mobilizing exercises during weeks 2-4.
SMT extended with Activation Exercises	Experimental	Behavioral: SMT, Behavioral: Activation Exercises, Behavioral: SMT extended2 sessions of SMT during week 1; 6 sessions of SMT and lumbar multifidus activating exercises during weeks 2-4.
SMT extended with Activation and Mobilizing Exercises	Experimental	Behavioral: SMT, Behavioral: Mobilizing Exercises, Behavioral: Activation Exercises, Behavioral: SMT extended2 sessions of SMT during week 1; 6 sessions of SMT, multifidus activating and spinal mobilizing exercises during weeks 2-4.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 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%

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 TherapyAll patients receive 2 SMT sessions in the first week. 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.	Behavioural	SMT Only, SMT extended, SMT extended with Activation Exercises, SMT extended with Activation and Mobilizing Exercises, SMT extended with Mobilizing Exercises, SMT with Activation Exercises, SMT with Mobilizing Exercises, SMT with Mobilizing and Activation Exercises
Mobilizing ExercisesMobilizing exercises will 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 Activation and Mobilizing Exercises, SMT extended with Mobilizing 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 Activation and Mobilizing Exercises, SMT with Activation Exercises, SMT with Mobilizing and Activation Exercises
SMT extendedThis treatment involves 6 additional SMT sessions. Each SMT session is conducted as described previously.	Behavioural	SMT extended, SMT extended with Activation Exercises, SMT extended with Activation and Mobilizing Exercises, SMT extended with Mobilizing Exercises

Primary outcome

Spinal Stiffness
Time frame: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Spinal stiffness is assessed with the VerteTrack device that applies a vertical load along the lumbar spine of a prone participant. The indenter houses a sensor to provide continuous, real-time quantification of spinal deformation in response to a defined load. Stiffness was determined as the ratio of the maximum applied force to the resultant displacement in N/mm. Higher numbers indicate greater amounts of stiffness.
Multifidus Activation
Time frame: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Multifidus activation was measured with brightness-mode ultrasound images using a 60mm, 2-5 MHz curvilinear array. Images are acquired with the multifidus at rest and during submaximal contraction. Three images in each state are acquired and averaged. Muscle activation is calculated as the change in thickness at rest and submaximal contraction and expressed as a percentage change. Greater numbers indicate higher muscle activation.

2 secondary outcomes

Oswestry Disability Index
Time frame: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.
Pain Intensity
Time frame: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.

Results and safety

Results posted to the registry on 17 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase II - SMT Only	30	22
Phase II - SMT Extended	29	23
Phase II - SMT With Activation Exercises	30	26
Phase II - SMT With Mobilizing Exercises	31	27
Phase II - SMT With Mobilizing and Activation Exercises	30	24
Phase II - SMT Extended With Mobilizing Exercises	29	26
Phase II - SMT Extended With Activation Exercises	30	24
Phase II - SMT Extended With Activation and Mobilizing Exercises	32	26

Primary outcome: Spinal Stiffness

Time frame: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.. Mean (97.5% Confidence Interval). Unit: N/mm

Measure	SMT Treatment Component n = 99	Mobilizing Exercise Component n = 108	Activating Exercise Component n = 106
Spinal Stiffness measure at 4 weeks	6.20 (5.98 to 6.41)	6.28 (6.07 to 6.48)	6.10 (5.90 to 6.31)
Spinal Stiffness measure at 12 weeks	6.07 (5.85 to 6.28)	6.16 (5.96 to 6.37)	6.06 (5.85 to 6.27)

SMT Treatment Component: Mean Difference (Final Values): -0.02 (97.5% CI -0.26 to 0.22), p = 0.025, Mixed Models Analysis
SMT Treatment Component: Mean Difference (Final Values): -0.17 (97.5% CI -0.43 to 0.09), p = 0.025, Mixed Models Analysis
Mobilizing Exercise Component: Mean Difference (Final Values): 0.14 (97.5% CI -0.11 to 0.38), p = 0.025, Mixed Models Analysis

Population analysed: Results were examined based on the main effects and interactions among the 3 treatment components in the factorial study design (SMT, Mobilizing Exercise, Activating Exercise). Scores were missing for participants in the SMT group (n=21 at 4 weeks and 12 weeks), Mobilizing exercise (n=14 at 4 weeks and n=19 at 12 weeks), and Activating exercise (n=16 at 4 weeks and n=22 at 12 weeks)

Primary outcome: Multifidus Activation

Measure	SMT Treatment Component n = 99	Mobilizing Exercise Component n = 108	Activating Exercise Component n = 106
Multifidus Activation 4 weeks	12.10 (10.20 to 14.0)	12.42 (10.56 to 14.28)	12.0 (10.09 to 13.84)
Multifidus Activation 12 weeks	12.20 (10.28 to 14.12)	12.74 (10.87 to 14.62)	12.10 (10.22 to 13.97)

SMT Treatment Component: Mean Difference (Final Values): -0.57 (97.5% CI -2.67 to 1.52), p = 0.025, Mixed Models Analysis
SMT Treatment Component: Mean Difference (Final Values): -0.37 (97.5% CI -2.76 to 2.02), p = 0.025, Mixed Models Analysis
Mobilizing Exercise Component: Mean Difference (Final Values): 0.06 (97.5% CI -2.03 to 2.16), p = 0.025, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected over the 12 week period from baseline to final assessment including both Phase I and Phase II (post-randomization). Events reported by Phase II treatment group may have occurred at any point over the 12-week study period. Among the 32 participants who withdrew before randomization, 4 participants reported 5 adverse events. All events were an increase in symptoms of back pain, spasm or stiffness.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
No Further Treatment	0 of 30 (0%)	3 of 30 (10%)	0 of 30
Extended SMT	0 of 29 (0%)	8 of 29 (27.6%)	0 of 29
Activating Exercise Component Only	0 of 30 (0%)	9 of 30 (30%)	0 of 30
Mobilizing Exercise Component Only	0 of 31 (0%)	10 of 31 (32.3%)	0 of 31
SMT With Activating Exercise Component	0 of 30 (0%)	12 of 30 (40%)	0 of 30
SMT With Mobilizing Exercise Component	0 of 29 (0%)	7 of 29 (24.1%)	0 of 29
Activating Exercise and Mobilizing Exercise Components	0 of 30 (0%)	5 of 30 (16.7%)	0 of 30
SMT With Activating Exercise and Mobilizing Exercise Components	0 of 32 (0%)	13 of 32 (40.6%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29866131Fritz JM, Sharpe JA, Lane E, Santillo D, Greene T, Kawchuk G. Optimizing treatment protocols for spinal manipulative therapy: study protocol for a randomized trial. Trials. 2018 Jun 4;19(1):306. doi: 10.1186/s13063-018-2692-6.

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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.

Julie M Fritz, PhD, PT principal investigator

University of Utah

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SMT, Mobilizing Exercises and Activation Exercises in people with Low Back Pain, run by University of Utah at 2 sites in 2 countries.

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 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: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Spinal Stiffness (time frame: Assessed at Phase II Baseline, 4 weeks, 12 weeks. 4 weeks and 12 weeks reported. Phase II baseline values were constrained to be equal to a common overall mean for analyses.). 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?

On the ClinicalTrials.gov record for NCT02868034, 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 17 May 2023.