NCT03015493

Brief Summary

The purpose of the study is to examine the effects of cervical traction with or without the addition of neural mobilization, in patients with cervical radiculopathy

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Status
unknown

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

May 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

January 16, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

January 6, 2017

Last Update Submit

January 13, 2017

Conditions

Keywords

Neck painNeurodynamicsSpinal manipulative therapy

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index

    Change from baseline after 4 weeks

Secondary Outcomes (4)

  • Numeric Pain Rating Scale

    Change from baseline after 4 weeks

  • Patient-Specific Functional Scale

    Change from baseline after 4 weeks

  • Grip strength measurement using a dynamometer

    Change from baseline after 4 weeks

  • Measurement of cervical spine active range of motion using a universal goniometer

    Change from baseline after 4 weeks

Study Arms (3)

Neural mobilization and traction

EXPERIMENTAL

Patients in this group are treated with neural mobilization techniques combined with cervical traction

Other: Neural mobilization combined with traction

Traction group

EXPERIMENTAL

Patients in this group are treated with cervical traction

Other: Traction

Control group

NO INTERVENTION

Patients in this group comprise the control group and are not treated with any intervention

Interventions

Neural mobilization techniques combined with cervical traction for the cervical nerve roots

Neural mobilization and traction

Traction techniques for the cervical spine

Traction group

Eligibility Criteria

Age22 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral sensory and motor deficits including sharp pain, muscle weakness and numbness in the upper arm
  • A positive result in a minimum three of four tests (Spurling's test, Distraction test, Upper Limb Neurodynamic Test 1 and ipsilateral cervical rotation of less than 60) of a clinical prediction rule. This clinical prediction rule has demonstrated 94% specificity (95% = 0.88 to 1.00), 24% sensitivity (95% = 0.05 to 0.43) and a positive likelihood ratio of 6.1 (95% = 2.0 to 18.6) when 3 of 4 items were positive

You may not qualify if:

  • A current history of cervical myelopathy or signs of upper motor neuron disease
  • Bilateral CR or other musculoskeletal conditions in the affected limb.
  • Receive of any prescription or over-the-counter analgesia or anti-inflammatory medication during the prior two weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Young IA, Michener LA, Cleland JA, Aguilera AJ, Snyder AR. Manual therapy, exercise, and traction for patients with cervical radiculopathy: a randomized clinical trial. Phys Ther. 2009 Jul;89(7):632-42. doi: 10.2522/ptj.20080283. Epub 2009 May 21.

MeSH Terms

Conditions

RadiculopathyNeck Pain

Interventions

Traction

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Chritos Savva, PhD

    European University Cyprus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 6, 2017

First Posted

January 10, 2017

Study Start

May 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

January 16, 2017

Record last verified: 2017-01