Low Back PainNCT01854892
The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function
A study testing Manipulation, Mobilization and Laser Therapy in people with Low Back Pain, run by Ohio University at 1 site in United States.
Trial summary
Low back pain (LBP) is one of the most common reasons for seeking medical care and accounts for over 3.7 million physician visits/year in the U.S. alone. Ninety percent of adults will experience low back pain in their lifetime, 50% will experience recurrent LBP, and 10% will develop chronic pain and related… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Manipulation, Mobilization and Laser Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to 5 May 2017
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Report history consistent with chronic low back pain
- Average pain intensity at least mild when assessed with a numerical pain scale
- At least mild disability when assessed with a questionnaire
- Meets criteria for clinical prediction rule
Who cannot join
- A history of certain neurological, cardiorespiratory, and musculoskeletal disorders
- Have active cancer or be blind
- Report recent use of certain medications and treatments
- Report being pregnant, lactating, or that she anticipates becoming pregnant in the next 3-months
- Have too high body mass or unexplained weight loss
- Have clinical depression
- Have pending litigation related to the low back pain or are receiving any type of disability services
- Current drug or alcohol use that would interfere with adherence to study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Low back pain (LBP) is one of the most common reasons for seeking medical care and accounts for over 3.7 million physician visits/year in the U.S. alone. Ninety percent of adults will experience low back pain in their lifetime, 50% will experience recurrent LBP, and 10% will develop chronic pain and related disability.
While there is growing evidence for the clinical effectiveness of alternative and complementary therapies to treat low back pain, little is known on the physiologic consequences and effects of these treatments. Further, additional data is needed to understand how these different treatment techniques effect clinical changes in pain and disability. The lack of empirical data hinders acceptance by the wider scientific and health-care communities, and it also limits the development of rational strategies for using alternative and complementary therapies.
- Conditions
- Low Back Pain
- Being tested
- Manipulation, Mobilization, Laser Therapy
- Keywords
- low back pain, manipulation, laser therapy, osteopathic, chiropractic, mobilization, muscle energy, physical therapy, muscle, spine, adjustment, rehabilitation
- 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.
ManipulationOther
High velocity short amplitude thrust spinal manipulation applied to the lumbar spine.
MobilizationOther
Static isometric contractions of the lumbar spine to induce spinal mobilization
Laser TherapyOther
Cold laser applied to the paravertebral muscles in the lumbar region
| Study group | Role | What they receive |
|---|---|---|
| Manipulation | Experimental | Spinal manipulation Receives: Other: Manipulation |
| Mobilization | Experimental | Spinal mobilization Receives: Other: Mobilization |
| Laser Therapy | Experimental | Cold laser therapy Receives: Other: Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in numerical pain rating score
Measured: 48 hours post 3 week intervention
Change in disability score
Roland Morris disability questionnaire
Measured: 48 hours post 3 week intervention
Secondary outcomes (4)
Change in score on PROMIS Pain Behavior Survey
This survey was developed by the NIH to provide reliable and valid measures of pain behavior. We will exam the change in scores on this survey from visit 2 (initial testing session) to visit 8(48 hours post 3 week intervention)
Measured: 48 hours post 3 week intervention
Change in scores on PROMIS pain interference survey
This survey was developed by the NIH to provide reliable and valid measures of pain interference. We will exam the change in scores on this survey from visit 2 (initial testing session) to visit 8(48 hours post 3 week intervention)
Measured: 48 hours post 3 week interventions
Change in scores on PROMIS pain intensity survey
This survey was developed by the NIH to provide reliable and valid measures of pain intensity. We will exam the change in scores on this survey from visit 2 (initial testing session) to visit 8(48 hours post 3 week intervention)
Measured: 48 hours post 3 week intervention
Change in scores on PROMIS physical function survey
This survey was developed by the NIH to provide reliable and valid measures of physical function. We will exam the change in scores on this survey from visit 2 (initial testing session) to visit 8(48 hours post 3 week intervention).
Measured: 48 hours post 3 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2013 (estimated)
- Study startJun 2013
- Primary completion5 May 2017
- Study completion5 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Thomas, Ohio University
- Investigators
- James S Thomas, Ph.D., PT, Principal investigator, Ohio UniversityBrian C Clark, Ph.D., Principal investigator, Ohio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854892
- Sponsor's protocol ID
- AT006978
- Status last verified
- May 2017
- First submitted
- 3 May 2013
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stamenkovic A, Clark BC, Pidcoe PE, van der Veen SM, France CR, Russ DW, Kinser PA, Thomas JS. Distinguishing chronic low back pain in young adults with mild to moderate pain and disability using trunk compliance. Sci Rep. 2021 Apr 7;11(1):7592. doi: 10.1038/s41598-021-87138-6.
PubMed 33828171Thomas JS, Clark BC, Russ DW, France CR, Ploutz-Snyder R, Corcos DM; RELIEF Study Investigators. Effect of Spinal Manipulative and Mobilization Therapies in Young Adults With Mild to Moderate Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2012589. doi: 10.1001/jamanetworkopen.2020.12589.
PubMed 32756930Clark BC, Russ DW, Nakazawa M, France CR, Walkowski S, Law TD, Applegate M, Mahato N, Lietkam S, Odenthal J, Corcos D, Hain S, Sindelar B, Ploutz-Snyder RJ, Thomas JS. A randomized control trial to determine the effectiveness and physiological effects of spinal manipulation and spinal mobilization compared to each other and a sham condition in patients with chronic low back pain: Study protocol for The RELIEF Study. Contemp Clin Trials. 2018 Jul;70:41-52. doi: 10.1016/j.cct.2018.05.012. Epub 2018 May 21.
PubMed 29792940
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function
- ClinicalTrials.gov ID
- NCT01854892
- Acronym / sponsor ID
- AT006978
- Conditions
- Low Back Pain
- Keywords
- low back pain, manipulation, laser therapy, osteopathic, chiropractic, mobilization, muscle energy, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Ohio UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 5 May 2017 (actual)
- Study completion
- 5 May 2017 (actual)
- First posted
- 16 May 2013 (estimated)
- 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.
Low back pain (LBP) is one of the most common reasons for seeking medical care and accounts for over 3.7 million physician visits/year in the U.S. alone. Ninety percent of adults will experience low back pain in their lifetime, 50% will experience recurrent LBP, and 10% will develop chronic pain and related disability.
While there is growing evidence for the clinical effectiveness of alternative and complementary therapies to treat low back pain, little is known on the physiologic consequences and effects of these treatments. Further, additional data is needed to understand how these different treatment techniques effect clinical changes in pain and disability. The lack of empirical data hinders acceptance by the wider scientific and health-care communities, and it also limits the development of rational strategies for using alternative and complementary therapies.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manipulation | Experimental | Other: ManipulationSpinal manipulation |
| Mobilization | Experimental | Other: MobilizationSpinal mobilization |
| Laser Therapy | Experimental | Other: Laser TherapyCold laser therapy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Report history consistent with chronic low back pain
- Average pain intensity at least mild when assessed with a numerical pain scale
- At least mild disability when assessed with a questionnaire
- Meets criteria for clinical prediction rule
Key exclusion criteria (8 listed)
- A history of certain neurological, cardiorespiratory, and musculoskeletal disorders
- Have active cancer or be blind
- Report recent use of certain medications and treatments
- Report being pregnant, lactating, or that she anticipates becoming pregnant in the next 3-months
- Have too high body mass or unexplained weight loss
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 |
|---|---|---|
| ManipulationHigh velocity short amplitude thrust spinal manipulation applied to the lumbar spine. | Other | Manipulation |
| MobilizationStatic isometric contractions of the lumbar spine to induce spinal mobilization | Other | Mobilization |
| Laser TherapyCold laser applied to the paravertebral muscles in the lumbar region | Other | Laser Therapy |
Primary outcome
Change in numerical pain rating score
Time frame: 48 hours post 3 week intervention
Change in disability score
Time frame: 48 hours post 3 week intervention
Roland Morris disability questionnaire
4 secondary outcomes
Change in score on PROMIS Pain Behavior Survey
Time frame: 48 hours post 3 week intervention
Change in scores on PROMIS pain interference survey
Time frame: 48 hours post 3 week interventions
Change in scores on PROMIS pain intensity survey
Time frame: 48 hours post 3 week intervention
Change in scores on PROMIS physical function survey
Time frame: 48 hours post 3 week intervention
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 12 May 2017.
- Derived from this study: PubMed 33828171Stamenkovic A, Clark BC, Pidcoe PE, van der Veen SM, France CR, Russ DW, Kinser PA, Thomas JS. Distinguishing chronic low back pain in young adults with mild to moderate pain and disability using trunk compliance. Sci Rep. 2021 Apr 7;11(1):7592. doi: 10.1038/s41598-021-87138-6.
- Derived from this study: PubMed 32756930Thomas JS, Clark BC, Russ DW, France CR, Ploutz-Snyder R, Corcos DM; RELIEF Study Investigators. Effect of Spinal Manipulative and Mobilization Therapies in Young Adults With Mild to Moderate Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Netw Open. 2020 Aug 3;3(8):e2012589. doi: 10.1001/jamanetworkopen.2020.12589.
- Derived from this study: PubMed 29792940Clark BC, Russ DW, Nakazawa M, France CR, Walkowski S, Law TD, Applegate M, Mahato N, Lietkam S, Odenthal J, Corcos D, Hain S, Sindelar B, Ploutz-Snyder RJ, Thomas JS. A randomized control trial to determine the effectiveness and physiological effects of spinal manipulation and spinal mobilization compared to each other and a sham condition in patients with chronic low back pain: Study protocol for The RELIEF Study. Contemp Clin Trials. 2018 Jul;70:41-52. doi: 10.1016/j.cct.2018.05.012. Epub 2018 May 21.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
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
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
James S Thomas, Ph.D., PT principal investigator
Ohio University
Brian C Clark, Ph.D. principal investigator
Ohio 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 Manipulation, Mobilization and Laser Therapy in people with Low Back Pain, run by Ohio 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 4 inclusion and 8 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 12 May 2017. 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?
Change in numerical pain rating score (time frame: 48 hours post 3 week intervention). 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 NCT01854892, which also lists 3 linked publications.
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 May 2017.