NCT00695006

Brief Summary

To date, optimal strategies for the management of patients with Cervical Radiculopathy (CR) remain elusive. The purpose of this study was to compare the effects of manual therapy, exercise, and cervical traction to manual therapy, exercise, and sham traction on pain, function and disability in patients with CR.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

June 25, 2008

Status Verified

June 1, 2008

Enrollment Period

1.2 years

First QC Date

June 9, 2008

Last Update Submit

June 24, 2008

Conditions

Cervical Radiculopathy

Keywords

manual therapy, cervical traction, cervical radiculopathy

Outcome Measures

Primary Outcomes (3)

  • Neck Disability Index

    2wk, 4wk, 3mo, 6mo

  • Patient Specific Functional Scale

    2wk, 4wk, 3mo, 6mo

  • Numeric Pain Rating Scale

    2wk, 4wk, 3mo, 6mo

Secondary Outcomes (5)

  • Global Rating Of Change

    2wk, 4wk, 3mo, 6mo

  • Body Diagram

    2wk, 4wk, 3mo, 6mo

  • Fear Avoidance Belief Questionnaire

    2wk, 4wk, 3mo, 6mo

  • Satisfaction

    2wk, 4wk, 3mo, 6mo

  • Grip Strength

    2wk, 4wk

Study Arms (2)

II

SHAM COMPARATOR

Sham Traction

Other: Sham Traction

I

ACTIVE COMPARATOR

Traction

Other: Traction

Interventions

Sham TractionOTHER

Traction \<5lbs

II
TractionOTHER

Standard supine intermittent traction

I

Eligibility Criteria

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

You may qualify if:

  • of 4 positive on CPR, 18-70yrs

You may not qualify if:

  • history of previous cervical or thoracic spine surgery
  • bilateral upper extremity symptoms
  • signs or symptoms of UMN disease
  • medical "red flags"(tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use)
  • cervical spine injections (steroidal) in the past two weeks
  • current use of steroidal medication prescribed for their radiculopathy symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Advance Rehab at Fredericksburg Orthopaedics

Fredericksburg, Virginia, 22401, United States

Location

MeSH Terms

Conditions

Radiculopathy

Interventions

Traction

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Ian A Young, PT

    Advance Rehab at Fredericksburg Orthopaedics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 11, 2008

Study Start

September 1, 2006

Primary Completion

December 1, 2007

Study Completion

July 1, 2008

Last Updated

June 25, 2008

Record last verified: 2008-06

Locations

US(1)