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

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318720
• Other study ID #: MCPT1
• Status: Completed
• Phase: N/A
• First received: March 17, 2011
• Last updated: April 6, 2015
• Start date: November 2009
• Est. completion date: June 2012

Study information

• Verified date: April 2015
• Source: Masefield and Cavallaro Physical Therapy
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Neck Pain

Intervention

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)

Locations

Country	Name	City	State
United States	Long Island University	Brooklyn	New York
United States	Masefield Cavallaro Physical Therapy	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Masefield and Cavallaro Physical Therapy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No