Clinical trial NCT01943435: Study Comparing 3 Different Treatments for Arthritis of the Lower Back (Lumbar Spinal Stenosis)
Official title: A Comparison of Non-Surgical Treatment Methods for Patients With Lumbar Spinal Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Keywords: Spinal Stenosis
Spinal manipulation
Exercise
Epidural injection
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2013-09-17
Enrollment: 259
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Lumbar spinal stenosis - known by patients as "arthritis of the spine" - is a condition that is very common; found in about 30% of older adults. It is the most common reason for people over the age of 65 to have back surgery. Some patients with stenosis do not need back surgery and can be treated with other methods, such as physical therapy, chiropractic, exercise, and medication. But we just don't have enough good research to tell us which treatment works best for which patient and under which circumstances. This research study hopes to provide more information about the effectiveness of the various non-surgical choices for managing stenosis.

OBJECTIVES: This study will directly compare the effectiveness of three common non-surgical treatment approaches for stenosis:

1. Medical care that involves prescription medications and/or spinal injections (epidurals)
2. Group exercise in supervised classes given in a community center setting
3. Hands-on (manual) therapy and rehabilitative exercises given in a clinic setting by physical therapists and chiropractors

METHODS: This research study will involve 259 adults who are at least 60 years old and have been diagnosed with lumbar spinal stenosis. The research volunteers will be divided into three groups, each group receiving one of the 3 types of treatments listed above under "Objectives". The determination of which type of treatment each person receives will be determined by chance, using a computerized version of flipping a coin. This is a process known as randomization, which scientists think reduces the bias in research studies. A series of tests and questionnaires will be given to the patients before and after they get treatment and comparisons will be made to see how much improvement they made with each of the types of treatments. Finally, the researchers will compare the differences between the 3 treatment groups to see if certain types of treatment produced better results than others, and if there were any examination findings that could be used to predict which type of patient would do better with which type of treatment.

Detailed description: BACKGROUND: Lumbar spinal stenosis (LSS) is a condition that is highly prevalent in the senior citizen population. LSS is the most frequent indication for spinal surgery in patients over the age of 65 years. The fastest growth in lumbar surgery in the U.S. this past decade has occurred in older adults with LSS and the rate of complex fusion procedures has increased 15-fold. These surgical procedures are associated with significant health care costs, risks, complications, and re-hospitalization rates. Yet, evidence is lacking for the effectiveness of the various non-surgical treatments offered to patients with LSS. This knowledge gap has greatly hindered the development of clinical practice guidelines relevant to the non-surgical treatment approaches for LSS.

OBJECTIVES: This study will perform a comparison of three common approaches to the non-surgical management and treatment of patients with LSS. The specific research questions associated with this study are: (1) How do group exercise and manual therapy with rehabilitative exercise compare with medical care? (2) How do group exercise and manual therapy with rehabilitative exercise compare with each other? (3) Are there any baseline predictors associated with clinical improvement in any of these non-surgical treatment approaches? The long term objective of this study is to produce research evidence relevant to community stakeholders and to inform better decision making about non-surgical treatment options available to LSS patients.

METHODS: This will be a comparative effectiveness study utilizing the research design of a randomized controlled clinical trial (RCT). It will be a 3-group RCT that allows for pragmatic treatment approaches in each of the three study arms. The study sample will consist of 259 older adults (\>60 years) who have symptoms consistent with a diagnosis of LSS, which will be confirmed by clinical examination and diagnostic imaging. Eligible subjects will be randomized into one of three pragmatic treatment approaches: 1) medical care; 2) group exercise; or 3) manual therapy with rehabilitative exercise.

All subjects will be treated for a 6-week course of care. Primary outcome measures are two validated research measurement tools; the Swiss Spinal Stenosis Questionnaire (self-reported pain/function) and the Self Paced Walking Test (performance-based measure). We will also employ a novel secondary outcome measure; the Sense Wear Armband which provides a real-time measure of physical activity during normal daily living.

Eligibility criteria: Inclusion Criteria:

* Minimum age of 60 years
* Can read/write English and understand directions
* Diagnosis of lumbar spinal stenosis confirmed by CT or MRI scan
* Has limitation of standing and/or walking tolerance
* Willing to attend treatments 2 times per week for 6 weeks
* Ability to walk at least 50 feet without the need for a cane or walker

Exclusion Criteria:

* History of metastatic cancer
* Advised by a physician not to exercise
* History of lumbar surgery for spinal stenosis or previous lumbar fusion
* Presence of severe peripheral artery disease in legs
* Severe hypertension: Systolic \> 200 mm/hg or Diastolic \> 110 mm/hg
* Ankle brachial index \< 0.8
* Neurologic or neurodegenerative disease other than stenosis that severly impairs the ability to walk
* Presence of cauda equina symptoms (saddle paresthesia, progressive loss of bladder/bowel function, etc)

Primary outcomes:
measure: Swiss Spinal Stenosis (SSS) Questionnaire Score
timeFrame: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).
Secondary outcomes:
measure: Self Paced Walking Test (SPWT)
timeFrame: Primary end-point was 8 weeks ( 2 weeks after 6 week intervention is completed).
Other outcomes:
measure: Sense Wear Armband
timeFrame: Primary End-Point was 8 weeks ( 2 weeks after completion of 6-week intervention).
Locations:
city: Pittsburgh
country: United States
facility: UPMC Shadyside Center for Integrative Medicine
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Michael J Schneider, PhD, DC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneider M, Ammendolia C, Murphy D, Glick R, Piva S, Hile E, Tudorascu D, Morton SC. Comparison of non-surgical treatment methods for patients with lumbar spinal stenosis: protocol for a randomized controlled trial. Chiropr Man Therap. 2014 May 10;22:19. doi: 10.1186/2045-709X-22-19. eCollection 2014.
citation: Schneider MJ, Ammendolia C, Murphy DR, Glick RM, Hile E, Tudorascu DL, Morton SC, Smith C, Patterson CG, Piva SR. Comparative Clinical Effectiveness of Nonsurgical Treatment Methods in Patients With Lumbar Spinal Stenosis: A Randomized Clinical Trial. JAMA Netw Open. 2019 Jan 4;2(1):e186828. doi: 10.1001/jamanetworkopen.2018.6828.