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The Value of Traction in Treatment of Lumbar Radiculopathy

Primary Purpose

Sciatica, Radiculopathy, Spinal Diseases

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Physical therapy rehabilitation

About this trial

This is an interventional treatment trial for Sciatica focused on measuring Sciatica, Radiculopathy, Physical therapy modalities, Rehabilitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Intermountain Healthcare, Rehab Agency

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Extension oriented treatment approach

Mechanical traction plus extension-oriented treatment

Arm Description

Extension exercises. Subjects are instructed in a progression of extension oriented movements for the lumbar spine. Manual therapy may be added to further increase extension movement and/or reduction of symptoms.

Mechanical lumbar traction will be utilized in addition to extension oriented exercises. Subjects are also instructed in a progression of extension oriented movements for the lumbar spine. Manual therapy may be added to increase extension movement and/or reduce radicular symptoms.

Outcomes

Primary Outcome Measures

Oswestry Disability Index

Secondary Outcome Measures

Global Rating of Change

Full Information

NCT ID

NCT00942227

First Posted

July 16, 2009

Last Updated

January 11, 2013

Sponsor

Intermountain Health Care, Inc.

Collaborators

University of Utah, 59th Medical Wing, Empi, A DJO Company

1. Study Identification

Unique Protocol Identification Number

NCT00942227

Brief Title

The Value of Traction in Treatment of Lumbar Radiculopathy

Official Title

The Value of Traction in Treatment of Lumbar Radiculopathy.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Intermountain Health Care, Inc.

Collaborators

University of Utah, 59th Medical Wing, Empi, A DJO Company

4. Oversight

Data Monitoring Committee

5. Study Description

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: 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. Compare the overall effectiveness of addition of a traction component to a standard physical therapy intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sciatica, Radiculopathy, Spinal Diseases, Musculoskeletal Diseases, Neuromuscular Diseases, Intervertebral Disk Displacement

Keywords

Sciatica, Radiculopathy, Physical therapy modalities, Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Extension oriented treatment approach

Arm Type

Active Comparator

Arm Description

Arm Title

Mechanical traction plus extension-oriented treatment

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Physical therapy rehabilitation

Other Intervention Name(s)

McKenzie exercises, Directional preference, Specific exercise

Intervention Description

Extension oriented exercises. Subjects will be instructed in a progression of extension oriented exercises for the lumbar spine

Intervention Type

Other

Intervention Name(s)

Physical therapy rehabilitation

Other Intervention Name(s)

Saunders 3D Active Trac

Intervention Description

Mechanical lumbar traction will be applied with subjects in prone utilizing 40-60% of subject's body weight to create a distraction force in the lumbar spine. Following traction, subjects will be instructed in a progression of extension oriented exercises and manual therapy to increase extension as described for the comparator group.

Primary Outcome Measure Information:

Title

Oswestry Disability Index

Time Frame

Baseline, 6 weeks, 6 months, 1year

Secondary Outcome Measure Information:

Title

Global Rating of Change

Time Frame

Baseline, 6 weeks, 6 months, 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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: Positive ipsilateral or contralateral straight leg raise test (reproduction of leg symptoms with straight leg raise < 70 degrees) Sensory deficit to pinprick on the ipsilateral lower extremity Diminished strength of a myotome (hip flexion, knee extension, ankle dorsiflexion, great toe extension, or ankle eversion) of the ipsilateral lower extremity 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie M Fritz, PhD

Organizational Affiliation

Intermountain Healthcare; University of Utah

Official's Role

Principal Investigator

Facility Information:

Facility Name

Intermountain Healthcare, Rehab Agency

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84119

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26813755

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.

Results Reference

derived

PubMed Identifier

20433733

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.

Results Reference

derived

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The Value of Traction in Treatment of Lumbar Radiculopathy

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