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

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ClinicalTrials.gov Identifier: NCT01318720
Recruitment Status : Completed
First Posted : March 18, 2011
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):
Michael Masaracchio PT, DPT, PhD(c), OCS, SCS, Masefield and Cavallaro Physical Therapy

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.

Condition or disease Intervention/treatment
Neck Pain Other: Manual Therapy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : November 2009
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Neck Disability Index (NDI) [ Time Frame: Short-term outcome 1 week ]
    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 :
  1. Global Rating of Change (GROC) [ Time Frame: Short-term outcome 1 week ]
    The Global Rating of Change is a outcome measure used to assess patient perceived recovery following interventions.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318720

United States, New York
Long Island University
Brooklyn, New York, United States, 11201
Masefield Cavallaro Physical Therapy
Brooklyn, New York, United States, 11228
Sponsors and Collaborators
Masefield and Cavallaro Physical Therapy
Principal Investigator: Michael Masaracchio, PT, DPT, PhD(c), OCS, SCS Masefield Cavallaro Therapy

Responsible Party: Michael Masaracchio PT, DPT, PhD(c), OCS, SCS, Senior Staff Physical Therapist, Masefield and Cavallaro Physical Therapy
ClinicalTrials.gov Identifier: NCT01318720     History of Changes
Other Study ID Numbers: MCPT1
First Posted: March 18, 2011    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015

Keywords provided by Michael Masaracchio PT, DPT, PhD(c), OCS, SCS, Masefield and Cavallaro Physical Therapy:
Neck Pain
Thrust Manipulation
Non-Thrust Manipulation

Additional relevant MeSH terms:
Neck Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms