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Manual Therapy and Augmented Exercise for Neck Pain

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ClinicalTrials.gov Identifier: NCT01750736
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : February 12, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

December 11, 2012
December 17, 2012
February 12, 2015
November 2011
June 2013   (Final data collection date for primary outcome measure)
Change in Neck Disability Index (NDI) [ Time Frame: baseline; 36-48 hours; 96 hours ]
A functional questionnaire completed by the subject
Same as current
Complete list of historical versions of study NCT01750736 on ClinicalTrials.gov Archive Site
  • Change in Numeric Pain Rating Scale (NPRS) [ Time Frame: baseline; 36-48 hours; 96 hours ]
  • Change in Self Reported Activity Scale (SAA) [ Time Frame: Baseline; 36-48 hours; 96 hours ]
  • Change in Pressure Pain Threshold (PPT) [ Time Frame: Baseline; Immediate post intervention; 36-48 hours; 96 hours ]
  • Change in Vibratory Measure [ Time Frame: Baseline; Immediate post intervention; 36-48 hours; 96 hours ]

    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.

Same as current
  • Change in Tampa Scale for Kinesiophobia [ Time Frame: Baseline; 36-48 hours; 96 hours ]
  • Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) [ Time Frame: Baseline; 36-48 hours; 96 hours ]
  • Clinical Equipoise [ Time Frame: Baseline ]
    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 ]
  • Compliance Measure [ Time Frame: 96 hours ]
    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 ]
  • Change in Strength [ Time Frame: Baseline; immediate post intervention; 36-48 hours; 96 hours ]
Same as current
 
Manual Therapy and Augmented Exercise for Neck Pain
The Use of a Home Exercise Program to Augment a Manual Therapy Intervention: a Randomized Controlled Trial
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Neck Pain
  • 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
  • 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
  • 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.
    Intervention: Other: Augmented Exercise and Manual Therapy
  • 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.
    Intervention: Other: General Exercise and Manual Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
June 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01750736
DMUPT-001
No
Not Provided
Not Provided
Shannon Petersen, Des Moines University
Des Moines University
  • Walsh University
  • Youngstown State University
Principal Investigator: Shannon Petersen, DScPT Des Moines University
Des Moines University
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP