NCT02552290

Brief Summary

The proposed project seeks to evaluate the influence of cervicothoracic (CT) manipulation and passive stretching to the upper trapezius on pressure pain thresholds and range of motion (ROM) in individuals without recent complain of neck pain.

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 Nov 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

November 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 17, 2015

Completed
Last Updated

September 17, 2015

Status Verified

September 1, 2015

Enrollment Period

1 year

First QC Date

September 14, 2015

Last Update Submit

September 16, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cervical Range of Motion

    Cervical Range of Motion in each cardinal plane (sagittal, coronal and transverse) will be measured in angular degrees using a CROM device

    Immediately after the intervention

Secondary Outcomes (1)

  • Pain Pressure Threshold

    Two minutes and 5 Minutes after the intervention

Study Arms (3)

Cervicothoracic manipulation

ACTIVE COMPARATOR

Description of a Right C7/T1 manipulation. The subject will lie prone. The therapist will stand on the L side of the subject facing in a cephalic direction (towards the patient's head). The therapist's right hand makes contact with the thumb on the right side of the spinous process of the first thoracic vertebra. The therapist left hand supports the head making contact on the temporal bone. The hand/neck is gently laterally flexed to the right, until slight tension is palpated in the tissues. A high-velocity low-amplitude thrust will be applied towards the subjects left side. If cavitation does not occur (an audible pop) the subject will be repositioned and the manipulation attempted a second time. A maximum of 2 attempts will be performed for each side of the neck.

Other: Cervicothoracic manipulation

Upper trapezius stretch

ACTIVE COMPARATOR

The subjects will be in a supine position. A researcher will passively place the subject's head into flexion, side-bending away and rotation towards the side to be stretched until the muscle barrier is met. The researcher will depress the subject's shoulder with 100 Newtons of force measured with a Micro FET pressure dynamometer (Hoggan Health Industries, Salt Lake City, UT).) Once this pressure amount is achieved the stretch will be held for 30 seconds. This will be repeated two times on each side. The subject will be asked to provide continuous feedback about the stretch felt and the degree of discomfort (if any) felt during the 30 second stretches.

Other: Upper Trapezius Stretch

Control group

OTHER

Subjects assigned to the control group will receive no intervention. They will stay behind the curtained research area for approximately 3 minutes in a seated position.

Other: No intervention

Interventions

Sustained stretch of upper trapezius muscle

Upper trapezius stretch

Manipulation to the cervicothoracic spine

Cervicothoracic manipulation

Wait

Control group

Eligibility Criteria

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

You may qualify if:

  • \. No current history or past history of neck pain; able to lie on back or stomach without difficulty

You may not qualify if:

  • 'Red flag' items indicated in your 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 your 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 your 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 your 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 - Department of Physical Therapy

Las Vegas, Nevada, 89154, United States

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Emilio J Puentedura, PT, DPT, PhD

    UNLV

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 17, 2015

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

September 17, 2015

Record last verified: 2015-09

Locations