NCT00128869

Brief Summary

This study aims to compare whether or not there is a difference in the effectiveness of upper back (thoracic spine) mobilizations versus manipulations used in a population of patients with mechanical neck pain. The investigators hypothesize that patients receiving a manipulative technique will experience better outcomes than patients receiving the mobilization techniques and these results will be evident at a 48-hour follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2005

Typical duration for phase_1

Geographic Reach
1 country

4 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

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 13, 2008

Status Verified

May 1, 2008

Enrollment Period

2.4 years

First QC Date

August 9, 2005

Last Update Submit

May 8, 2008

Conditions

Neck Pain

Keywords

ManipulationMobilizationNeck PainPhysical Therapy

Outcome Measures

Primary Outcomes (3)

  • Pain Diagram and Scale

  • Neck Disability Scale

  • Global Rating of Change Scale

Secondary Outcomes (1)

  • Side Effects Questionnaire

Interventions

spine mobilizationsPROCEDURE
spine manipulationsPROCEDURE

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primary complaint of neck pain with duration of symptoms greater than 4 weeks
  • Age between 18-60 years old

You may not qualify if:

  • Red flags from the medical neck screening questionnaire to include tumor, fracture, metabolic disease, rheumatoid arthritis (RA), osteoporosis, prolonged history of steroid use.
  • History of whiplash injury
  • Diagnosis of cervical spinal stenosis
  • Bilateral upper extremity symptoms
  • Evidence of central nervous system involvement to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathological reflexes
  • Two or more positive neurological signs consistent with nerve root compression to include muscle weakness involving a major muscle group of the upper extremity; diminished upper extremity muscle stretch reflex; diminished or absent sensation to pinprick in any upper extremity dermatome.
  • Prior surgery to the neck or thoracic spine
  • Pending legal action regarding neck pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sharp Rees-Stealy Medical Group

San Diego, California, 92123, United States

Location

Centennial Physical Therapy-Colorado Sport and Spine Centers

Colorado Springs, Colorado, 80919, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Groves Physical Therapy

Brooklyn Center, Minnesota, 55430, United States

Location

Related Publications (5)

  • Norlander S, Aste-Norlander U, Nordgren B, Sahlstedt B. Mobility in the cervico-thoracic motion segment: an indicative factor of musculo-skeletal neck-shoulder pain. Scand J Rehabil Med. 1996 Dec;28(4):183-92.

    PMID: 9122645BACKGROUND

  • Norlander S, Gustavsson BA, Lindell J, Nordgren B. Reduced mobility in the cervico-thoracic motion segment--a risk factor for musculoskeletal neck-shoulder pain: a two-year prospective follow-up study. Scand J Rehabil Med. 1997 Sep;29(3):167-74.

    PMID: 9271151BACKGROUND

  • Norlander S, Nordgren B. Clinical symptoms related to musculoskeletal neck-shoulder pain and mobility in the cervico-thoracic spine. Scand J Rehabil Med. 1998 Dec;30(4):243-51. doi: 10.1080/003655098443995.

    PMID: 9825389BACKGROUND

  • Flynn TW, Wainner RS, Whitman JM. Immediate effects of thoracic spine manipulation on cervical range of motion and pain. Journal or Manual and Manipulative Therapy. 9(3), 164-171. 2001

    RESULT

  • Cleland JA, Childs JD, McRae M, Palmer JA, Stowell T. Immediate effects of thoracic manipulation in patients with neck pain: a randomized clinical trial. Man Ther. 2005 May;10(2):127-35. doi: 10.1016/j.math.2004.08.005.

    PMID: 15922233RESULT

Related Links

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Paul E Glynn, DPT, OCS

    Newton-Wellesley Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2005

First Posted

August 10, 2005

Study Start

May 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 13, 2008

Record last verified: 2008-05

Locations

US(4)