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

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

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Other: Manual Therapy

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11201
      • Long Island University
    • Brooklyn, New York, United States, 11228
      • Masefield Cavallaro Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Short-term outcome 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Rating of Change (GROC)	The Global Rating of Change is a outcome measure used to assess patient perceived recovery following interventions.	Short-term outcome 1 week

Collaborators and Investigators

• Sponsor: Masefield and Cavallaro Physical Therapy
• Investigators: Principal Investigator: Michael Masaracchio, PT, DPT, PhD(c), OCS, SCS, Masefield Cavallaro Therapy

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: March 17, 2011
• First Submitted That Met QC Criteria: March 17, 2011
• First Posted (Estimate): March 18, 2011

Study Record Updates

• Last Update Posted (Estimate): April 7, 2015
• Last Update Submitted That Met QC Criteria: April 6, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Neck Pain; Thrust Manipulation; Non-Thrust Manipulation
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: MCPT1