NCT02081430

Brief Summary

The purpose of this study is to determine the immediate effects of cervicothoracic manipulation and upper trapezius stretching on upper trapezius pressure pain threshold and cervical ROM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

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

May 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 7, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 5, 2014

Status Verified

November 1, 2014

Enrollment Period

1.3 years

First QC Date

March 4, 2014

Last Update Submit

November 3, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Pressure Threshold

    Using a standardized pain pressure algometer, subjects will have recordings of pressure at which onset of pain is noted

    up to 10 minutes

Secondary Outcomes (1)

  • Cervical Range of Motion

    up to 10 minutes

Study Arms (3)

CT Manipulation

EXPERIMENTAL

Prone cervicothoracic manipulation

Procedure: CT Manipulation

Upper trapezius stretch

ACTIVE COMPARATOR

Passive sustained stretch to upper trapezius muscle

Procedure: Upper trapezius stretch

Control

NO INTERVENTION

8 Minute wait

Interventions

CT Manipulation
Upper trapezius stretch

Eligibility Criteria

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

You may qualify if:

  • Absence of current neck pain
  • Aged 18 - 70 years
  • Able to lie on stomach or back without difficulty

You may not qualify if:

  • 'Red flag' items indicated in Neck Medical Screening Questionnaire such as history of a tumor, bone fracture, metabolic diseases, Rheumatoid Arthritis, osteoporosis, severe atherosclerosis, prolonged history of steroid use, etc.
  • History of neck whiplash injury
  • Diagnosis from physician of cervical spinal stenosis (narrowing of spinal canal) or presence of symptoms (pain, pins and needles, numbness) down both arms
  • Presence of central nervous system involvement such as exaggerated reflexes, changes in sensation in the hands, muscle wasting in the hands, impaired sensation of the face, altered taste, and presence of abnormal reflexes
  • Evidence of neurological signs consistent with nerve root entrapment (pinched nerve in the neck)
  • Prior surgery to neck or upper back
  • A medical condition which may influence assessment of pain or pressure pain thresholds (i.e. taking analgesics, sedatives, history of substance abuse, or cognitive deficiency)
  • Diagnosis from physician of fibromyalgia syndrome
  • Currently pregnant, or could be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nevada Las Vegas

Las Vegas, Nevada, 89154, United States

Location

Study Officials

  • Emilio J Puentedura, PT, DPT, PhD

    UNLV

    PRINCIPAL INVESTIGATOR
  • William J Hanney, PT, DPT, PhD

    UCF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 7, 2014

Study Start

May 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 5, 2014

Record last verified: 2014-11

Locations