Short-Term Effects of Combined Manual Therapy to the Cervical and Thoracic Spine

The recruitment status of this study is unknown because the information has not been verified recently.

Verified March 2011 by Masefield and Cavallaro Physical Therapy.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Masefield and Cavallaro Physical Therapy

ClinicalTrials.gov Identifier:

NCT01318720

First received: March 17, 2011

Last updated: NA

Last verified: March 2011

History: No changes posted

Purpose

Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on techniques for the treatment of neck pain is an intervention commonly implemented in clinical practice. Recently researchers and clinicians have implemented manual therapy techniques to the thoracic spine (midback) to treat patients with neck pain. To date no studies have examined the short-term combined effects of thoracic spine manual therapy and cervical spine manual therapy in the treatment of patients with mechanical neck pain. The purpose this study is to assess the combined effects of thoracic spine thrust manipulation with cervical spine non-thrust manipulation in patients with neck pain.

Condition	Intervention
Neck Pain	Other: Manual Therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Short-Term Combined Effects of Thoracic Spine Thrust Manipulation and Cervical Spine Non-Thrust Manipulation in Patients With Mechanical Neck Pain: A RCT

Resource links provided by NLM:

MedlinePlus related topics: Neck Injuries and Disorders

U.S. FDA Resources

Further study details as provided by Masefield and Cavallaro Physical Therapy:

Primary Outcome Measures:

Neck Disability Index (NDI) [ Time Frame: Short-term outcome 1 week ] [ Designated as safety issue: No ]
Neck Disability Index (NDI) is a disease-specific outcome measure specifically used in patients with neck pain. The NDI has been shown to be reliable and valid in individuals with mechanical neck pain.

Secondary Outcome Measures:

Global Rating of Change (GROC) [ Time Frame: Short-term outcome 1 week ] [ Designated as safety issue: No ]
The Global Rating of Change is a outcome measure used to assess patient perceived recovery following interventions.

Estimated Enrollment:	64
Study Start Date:	November 2009
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Manipulation The experimental group is receiving thoracic spine thrust manipulation and cervical spine non-thrust manipulation.	Other: Manual Therapy Thrust manipulation is a type of manual therapy that clinicians apply using a high-velocity, low-amplitude thrust directed at a joint(s)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Neck pain of less than 3 months
No symptoms below the shoulder
Baseline Neck Disability Index score of 10 or greater

Exclusion Criteria:

Red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, metabolic disease, rheumatoid arthritis, osteoporosis, prolonged use of steroid, etc)
History of whiplash injury within the past two months
Diagnosis of cervical spinal stenosis
Uni-lateral or bi-lateral upper extremity radicular symptoms
Evidence of central nervous system involvement
Two or more positive neurological signs consistent with nerve root involvement: myotomal muscle weakness, dermatomal sensory loss, diminished or absent reflexes
Prior surgery to the neck or thoracic spine
Pending legal action regarding their neck pain, or patients with no fault or workers compensation claims
Insufficient English language skills to complete the questionnaires
Inability to comply with treatment and follow-up schedule
Women who may be pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318720

Contacts

Contact: Michael Masaracchio, PT, DPT, PhD(c), OCS, SCS

718-259-0900

Locations

United States, New York
Masefield Cavallaro Physical Therapy	Recruiting
Brooklyn, New York, United States, 11228
Contact: Joy Masefield, PT, RN 718-259-0900 joymasefield@optimum.net
Contact: Vincent Cavallaro, PT 718-259-0900 vcavallaro@optimum.net
Principal Investigator: Michael Masaracchio, PT, DPT, PhD(c), OCS, SCS
Sub-Investigator: Elvira Kacaj, PT, DPT
Long Island University	Recruiting
Brooklyn, New York, United States, 11201
Contact: Cristiana Kahl Collins, PT, PhD, NCS 718-488-4521 ckahl@liu.edu
Contact: Stacy Gropack, PT, PhD 718-488-1496 sgropack@liu.edu
Principal Investigator: Michael Masaracchio, PT, DPT, PhD(c), OCS, SCS

Sponsors and Collaborators

Masefield and Cavallaro Physical Therapy

Investigators

Principal Investigator:

Michael Masaracchio, PT, DPT, PhD(c), OCS, SCS

Masefield Cavallaro Therapy

More Information

No publications provided

Responsible Party:	Joy Masefield, Owner, Masefield Cavallaro Physical Therapy
ClinicalTrials.gov Identifier:	NCT01318720 History of Changes
Other Study ID Numbers:	MCPT1
Study First Received:	March 17, 2011
Last Updated:	March 17, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Masefield and Cavallaro Physical Therapy:

Neck Pain
Thrust Manipulation
Non-Thrust Manipulation

Additional relevant MeSH terms:

Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013

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