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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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         
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         
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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 28, 2014