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

Tracking Information

First Received Date ^ICMJE

March 17, 2011

Last Updated Date

March 17, 2011

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Short-Term Combined Effects of Thoracic Spine Thrust Manipulation and Cervical Spine Non-Thrust Manipulation in Patients With Mechanical Neck Pain: A RCT

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Neck Pain

Intervention ^ICMJE

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)

Study Arm (s)

Experimental: Manipulation

The experimental group is receiving thoracic spine thrust manipulation and cervical spine non-thrust manipulation.

Intervention: Other: Manual Therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2011

Estimated Primary Completion Date

April 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

718-259-0900

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01318720

Other Study ID Numbers ^ICMJE

MCPT1

Has Data Monitoring Committee

Responsible Party

Joy Masefield, Owner, Masefield Cavallaro Physical Therapy

Study Sponsor ^ICMJE

Masefield and Cavallaro Physical Therapy

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

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

Masefield Cavallaro Therapy

Information Provided By

Masefield and Cavallaro Physical Therapy

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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