Clinical trial NCT00942227: The Value of Traction in Treatment of Lumbar Radiculopathy
Official title: The Value of Traction in Treatment of Lumbar Radiculopathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sciatica
Radiculopathy
Spinal Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Intervertebral Disk Displacement
Keywords: Sciatica
Radiculopathy
Physical therapy modalities
Rehabilitation
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: University of Utah
name: 59th Medical Wing
name: Empi, A DJO Company
First posted: 2009-07-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with low back pain.

Detailed description: Despite the opinions of clinical experts that patients who might benefit from traction may represent distinct sub-groups of patients, most studies have not attempted to narrow their inclusion criteria beyond loose definitions of 'acute' or 'chronic' symptoms. While these studies seem to indicate that traction interventions will be of little benefit when administered to large groups of patients without a prior attempt to select which patients are most likely to benefit, they are not sufficient to preclude the possibility that a subgroup of patients may benefit substantially from the intervention. Recent preliminary studies suggest a there exists a subgroup of patients with LBP that is likely to benefit from traction.

The two primary aims of this study are:

1. Determine the validity of the previously-identified prediction criteria to identify patients highly likely to benefit from the addition of traction to a standard physical therapy intervention.
2. Compare the overall effectiveness of addition of a traction component to a standard physical therapy intervention.

Eligibility criteria: Inclusion Criteria:

* Chief complaint of pain and/or paresthesia in the lumbar spine with a distribution of symptoms that has extended distal to the gluteal fold on at least one lower extremity within the past 24 hours based on the patient's self-report.
* Oswestry disability score of at least 20%
* Age at least 18 years and less than 60 years
* At least one of the following signs of nerve root compression:

  1. Positive ipsilateral or contralateral straight leg raise test (reproduction of leg symptoms with straight leg raise \< 70 degrees)
  2. Sensory deficit to pinprick on the ipsilateral lower extremity
  3. Diminished strength of a myotome (hip flexion, knee extension, ankle dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower extremity
  4. Diminished lower extremity reflex (Quadriceps or Achilles) of the symptomatic lower extremity

Exclusion Criteria:

* Red flags noted in the patient's general medical screening questionnaire (i.e., tumor, metabolic diseases, RA, osteoporosis, spinal compression fracture, prolonged history of steroid use, etc.)
* Evidence of central nervous system involvement, to include symptoms of cauda equina syndrome (i.e., loss of bowel/bladder control or saddle region paresthesia) or the presence of pathological reflexes (i.e., positive Babinski)
* Patient reports the complete absence of low back and leg symptoms when seated
* Recent surgery (\< 6 months) to the lumbar spine or buttocks, or any fusion surgery of the lumbar spine or pelvis
* Recent (\< 2 weeks) epidural steroid injection for low back and/or leg pain
* Current pregnancy
* Inability to comply with the treatment schedule

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: Baseline, 6 weeks, 6 months, 1year
Secondary outcomes:
measure: Global Rating of Change
timeFrame: Baseline, 6 weeks, 6 months, 1 year
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Intermountain Healthcare, Rehab Agency
state: Utah
Study officials:
affiliation: Intermountain Healthcare; University of Utah
name: Julie M Fritz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thackeray A, Fritz JM, Childs JD, Brennan GP. The Effectiveness of Mechanical Traction Among Subgroups of Patients With Low Back Pain and Leg Pain: A Randomized Trial. J Orthop Sports Phys Ther. 2016 Mar;46(3):144-54. doi: 10.2519/jospt.2016.6238. Epub 2016 Jan 26.
citation: Fritz JM, Thackeray A, Childs JD, Brennan GP. A randomized clinical trial of the effectiveness of mechanical traction for sub-groups of patients with low back pain: study methods and rationale. BMC Musculoskelet Disord. 2010 Apr 30;11:81. doi: 10.1186/1471-2474-11-81.