NCT00979108

Brief Summary

The purpose of this study is to determine the effectiveness of adding mechanical traction to standard physical therapy treatments for patients with neck and arm pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2009

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

2.7 years

First QC Date

September 16, 2009

Last Update Submit

November 14, 2014

Conditions

RadiculopathyNeck PainSpinal DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesIntervertebral Disk Displacement

Keywords

RadiculopathyNeck painPhysical therapy modalitiesRehabilitation

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Questionnaire

    Baseline, 4 weeks, 6 months, 1year

Secondary Outcomes (1)

  • Global Rating of Change

    Baseline, 4 weeks, 6 months, 1 year

Study Arms (3)

Standard exercise

ACTIVE COMPARATOR

Subjects will be instructed in neck and postural exercises.

Other: Physical therapy rehabilitation

Over-door traction and exercise.

EXPERIMENTAL

Subjects will receive traction utilizing an over-the-door traction unit in addition to neck and postural exercises.

Other: Physical therapy rehabilitation

Mechanical traction and exercise

EXPERIMENTAL

Mechanical cervical traction will be utilized in addition to neck and postural exercises.

Other: Physical therapy rehabilitation

Interventions

Physical therapy rehabilitationOTHER

Mechanical cervical traction will be applied at a moderate force and adjusted based on symptom relief. In addition, subjects will be trained in cervical and postural exercises.

Also known as: Saunders 3D Active Trac
Mechanical traction and exercise

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary complaint of neck pain with symptoms (pain and/or numbness) extending distal to the acromioclavicular joint or caudal to the superior border of the scapula (may be unilateral or bilateral).
  • Age between 18-70 years old
  • Neck Disability Score score \>10 points

You may not qualify if:

  • Red flags indicative of a serious or non-musculoskeletal condition (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
  • Diagnosis of cervical spinal stenosis based on CT or MRI imaging
  • Evidence of cervical myelopathy or central nervous system involvement, (e.g., hyperreflexia, intrinsic muscle wasting of the hands, unsteadiness during gait, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathologic reflexes (i.e. positive Hoffman's or Babinski reflex).
  • Prior surgery to the neck or thoracic spine
  • Inability to comply with treatment and follow-up schedule

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78235, United States

Location

Intermountain Healthcare, Rehab Agency

Salt Lake City, Utah, 84119, United States

Location

Related Publications (1)

  • Fritz JM, Thackeray A, Brennan GP, Childs JD. Exercise only, exercise with mechanical traction, or exercise with over-door traction for patients with cervical radiculopathy, with or without consideration of status on a previously described subgrouping rule: a randomized clinical trial. J Orthop Sports Phys Ther. 2014 Feb;44(2):45-57. doi: 10.2519/jospt.2014.5065. Epub 2014 Jan 9.

    PMID: 24405257RESULT

MeSH Terms

Conditions

RadiculopathyNeck PainSpinal DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBone DiseasesHerniaPathological Conditions, Anatomical

Study Officials

  • Julie Fritz

    IHC Health Services, Inc., Dba: TOSH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Operations Coordinator

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 17, 2009

Study Start

July 1, 2009

Primary Completion

March 1, 2012

Study Completion

January 1, 2013

Last Updated

November 17, 2014

Record last verified: 2014-11

Locations

US(2)