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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Therapy
Sponsored by
Masefield and Cavallaro Physical Therapy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck Pain, Thrust Manipulation, Non-Thrust Manipulation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Long Island University
  • Masefield Cavallaro Physical Therapy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Manipulation

Arm Description

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

Outcomes

Primary Outcome Measures

Neck Disability Index (NDI)
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)
The Global Rating of Change is a outcome measure used to assess patient perceived recovery following interventions.

Full Information

First Posted
March 17, 2011
Last Updated
April 6, 2015
Sponsor
Masefield and Cavallaro Physical Therapy
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1. Study Identification

Unique Protocol Identification Number
NCT01318720
Brief Title
Short-Term Effects of Combined Manual Therapy to the Cervical and Thoracic Spine
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Masefield and Cavallaro Physical Therapy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Pain, Thrust Manipulation, Non-Thrust Manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manipulation
Arm Type
Experimental
Arm Description
The experimental group is receiving thoracic spine thrust manipulation and cervical spine non-thrust manipulation.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
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 Measure Information:
Title
Neck Disability Index (NDI)
Description
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.
Time Frame
Short-term outcome 1 week
Secondary Outcome Measure Information:
Title
Global Rating of Change (GROC)
Description
The Global Rating of Change is a outcome measure used to assess patient perceived recovery following interventions.
Time Frame
Short-term outcome 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Masaracchio, PT, DPT, PhD(c), OCS, SCS
Organizational Affiliation
Masefield Cavallaro Therapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island University
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11201
Country
United States
Facility Name
Masefield Cavallaro Physical Therapy
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11228
Country
United States

12. IPD Sharing Statement

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

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