Manual Therapy and Augmented Exercise for Neck Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Des Moines University
Sponsor:
Collaborators:
Walsh University
Youngstown State University
Information provided by (Responsible Party):
Shannon Petersen, Des Moines University
ClinicalTrials.gov Identifier:
NCT01750736
First received: December 11, 2012
Last updated: April 12, 2013
Last verified: April 2013
  Purpose

Manual therapy and exercise have shown to be beneficial for people with neck pain, however it is not clear how outcomes following a general exercise program compare to specific exercises intended to augment a specific manual/hands-on intervention. This study will compare outcomes following manual therapy and a specific exercise program with manual therapy and a general exercise program.


Condition Intervention
Neck Pain
Other: Augmented Exercise and Manual Therapy
Other: General Exercise and Manual Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of a Home Exercise Program to Augment a Manual Therapy Intervention: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Des Moines University:

Primary Outcome Measures:
  • Change in Neck Disability Index (NDI) [ Time Frame: baseline; 36-48 hours; 96 hours ] [ Designated as safety issue: No ]
    A functional questionnaire completed by the subject


Secondary Outcome Measures:
  • Change in Numeric Pain Rating Scale (NPRS) [ Time Frame: baseline; 36-48 hours; 96 hours ] [ Designated as safety issue: No ]
  • Change in Self Reported Activity Scale (SAA) [ Time Frame: Baseline; 36-48 hours; 96 hours ] [ Designated as safety issue: No ]
  • Change in Pressure Pain Threshold (PPT) [ Time Frame: Baseline; Immediate post intervention; 36-48 hours; 96 hours ] [ Designated as safety issue: No ]
  • Change in Vibratory Measure [ Time Frame: Baseline; Immediate post intervention; 36-48 hours; 96 hours ] [ Designated as safety issue: No ]

    A specialized tool is used to measure sensory threshold; it is a hand-held sensor with a small vibrating tip held against the skin.

    This device measures how the nerves react to vibration. The procedure is non-invasive. Little or no discomfort should be felt during the test.



Other Outcome Measures:
  • Change in Tampa Scale for Kinesiophobia [ Time Frame: Baseline; 36-48 hours; 96 hours ] [ Designated as safety issue: No ]
  • Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) [ Time Frame: Baseline; 36-48 hours; 96 hours ] [ Designated as safety issue: No ]
  • Clinical Equipoise [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Equipoise occurs when a given treatment has no evidence of being better than another and/or when the individual clinician has no preference of one treatment versus the other.Examiners will complete a form using an 11-point scale to quantify how much they believe the experimental group will have better outcomes or the control group will have better outcomes.

  • Change in Global Rating of Change (GROC) [ Time Frame: Baseline; 36-48 hours; 96 hours ] [ Designated as safety issue: No ]
  • Compliance Measure [ Time Frame: 96 hours ] [ Designated as safety issue: No ]
    Each patient will complete a daily exercise diary. The examiner will assign a score for compliance based on the patient's knowledge and proficiency of performing their home program and the information in the daily exercise diary.

  • Change in Range of Motion (ROM) [ Time Frame: Baseline; Immediate post intervention; 36-48 hours; 96 hours ] [ Designated as safety issue: No ]
  • Change in Strength [ Time Frame: Baseline; immediate post intervention; 36-48 hours; 96 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: November 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Augmented Exercise and Manual Therapy
Subjects will receive manual therapy according to clinical guidelines followed by instruction in a specific exercise to augment the specific manual treatment provided.
Other: Augmented Exercise and Manual Therapy
Session 1 will include the manual therapy intervention to cervical and or thoracic regions. Subjects will perform the augmented exercise at home and at each data collection session.
Other Names:
  • Manipulation
  • Mobilization
  • Self-Mobilization
Active Comparator: General Exercise and Manual Therapy
Subjects will receive manual therapy according to clinical guidelines followed by instruction in a general neck range of motion exercise.
Other: General Exercise and Manual Therapy
Session 1 will include the manual therapy intervention to cervical and or thoracic regions. Subjects will perform general range of motion exercises for the neck at home and at each data collection session.
Other Names:
  • Manipulation
  • Mobilization
  • Self-Mobilization

Detailed Description:

The purpose of this study is to determine if specific neck exercises intended to augment specific manual therapy treatments result in better outcomes than standard neck exercises in people with neck pain. Clinical tests and measurements as well as patient questionnaires will be completed and compared between groups.

A secondary purpose is to determine if self report of activity is correlated with functional improvements. We hypothesize that a specifically applied home exercise that augments the effects of the manual therapy intervention will lead to improvements in outcomes in patients with neck pain. We hypothesize that higher reports of self activity will be correlated with improvements in outcomes.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with complaint of neck pain, neck motion limitations, pain at end-range neck ROM, limited cervical/cervical and thoracic joint mobility, neck pain with manual segmental examination

Exclusion Criteria:

  • The presence of any red flags (i.e. tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, signs and symptoms of vertebrobasilar insufficiency, etc.), use of blood thinners, whiplash injury in the past 6 weeks, evidence of central nervous system involvement (such as hyperreflexia, sensory disturbances in the hands, unsteadiness during walking, etc.), history of spinal surgery, workers compensation or pending legal action regarding their neck pain, insufficient English language skills to complete questionnaires, unable to comply with schedule
  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: NCT01750736

Contacts
Contact: Shannon M Petersen, DScPT 515-271-1688 shannon.petersen@dmu.edu

Locations
United States, Iowa
Des Moines University Recruiting
Des Moines, Iowa, United States, 50325
Contact: Shannon M Petersen, DScPT    515-271-1688    shannon.petersen@dmu.edu   
United States, Ohio
Walsh University Recruiting
North Canton, Ohio, United States, 44720
Contact: Chad E Cook, PhD    330-490-7370    ccook@walsh.edu   
Principal Investigator: Chad E Cook, PhD         
Youngstown State University Recruiting
Youngstown, Ohio, United States, 44555
Contact: Ken E Learman, PhD    330-941-7125    klearman@ysu.edu   
Principal Investigator: Ken E Learman, PhD         
Sponsors and Collaborators
Des Moines University
Walsh University
Youngstown State University
Investigators
Principal Investigator: Shannon Petersen, DScPT Des Moines University
  More Information

No publications provided

Responsible Party: Shannon Petersen, Associate Professor, Des Moines University
ClinicalTrials.gov Identifier: NCT01750736     History of Changes
Other Study ID Numbers: DMUPT-001
Study First Received: December 11, 2012
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Des Moines University:
Augmented Exercise
Cervicalgia
Manual Therapy
Manipulation
Quantitative Sensory

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

ClinicalTrials.gov processed this record on October 19, 2014