Clinical trial NCT01854892: The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function
Official title: The RELIEF Study - Researching the Effectiveness of Lumbar Interventions for Enhancing Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
manipulation
laser therapy
osteopathic
chiropractic
mobilization
muscle energy
physical therapy
muscle
spine
adjustment
rehabilitation
Lead sponsor: Ohio University
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in numerical pain rating score
timeFrame: 48 hours post 3 week intervention
measure: Change in disability score
timeFrame: 48 hours post 3 week intervention
Secondary outcomes:
measure: Change in score on PROMIS Pain Behavior Survey
timeFrame: 48 hours post 3 week intervention
measure: Change in scores on PROMIS pain interference survey
timeFrame: 48 hours post 3 week interventions
measure: Change in scores on PROMIS pain intensity survey
timeFrame: 48 hours post 3 week intervention
measure: Change in scores on PROMIS physical function survey
timeFrame: 48 hours post 3 week intervention
Other outcomes:
Locations:
city: Athens
country: United States
facility: Ohio University
state: Ohio
Study officials:
affiliation: Ohio University
name: James S Thomas, Ph.D., PT
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio University
name: Brian C Clark, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Thomas 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.
citation: Clark 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.