search
Back to results

Manual Therapy and Augmented Exercise for Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Augmented Exercise and Manual Therapy
General Exercise and Manual Therapy
Sponsored by
Des Moines University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Augmented Exercise, Cervicalgia, Manual Therapy, Manipulation, Quantitative Sensory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Des Moines University
  • Walsh University
  • Youngstown State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Augmented Exercise and Manual Therapy

General Exercise and Manual Therapy

Arm Description

Subjects will receive manual therapy according to clinical guidelines followed by instruction in a specific exercise to augment the specific manual treatment provided.

Subjects will receive manual therapy according to clinical guidelines followed by instruction in a general neck range of motion exercise.

Outcomes

Primary Outcome Measures

Change in Neck Disability Index (NDI)
A functional questionnaire completed by the subject

Secondary Outcome Measures

Change in Numeric Pain Rating Scale (NPRS)
Change in Self Reported Activity Scale (SAA)
Change in Pressure Pain Threshold (PPT)
Change in Vibratory Measure
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.

Full Information

First Posted
December 11, 2012
Last Updated
February 10, 2015
Sponsor
Des Moines University
Collaborators
Walsh University, Youngstown State University
search

1. Study Identification

Unique Protocol Identification Number
NCT01750736
Brief Title
Manual Therapy and Augmented Exercise for Neck Pain
Official Title
The Use of a Home Exercise Program to Augment a Manual Therapy Intervention: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Des Moines University
Collaborators
Walsh University, Youngstown State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Augmented Exercise, Cervicalgia, Manual Therapy, Manipulation, Quantitative Sensory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Augmented Exercise and Manual Therapy
Arm Type
Experimental
Arm Description
Subjects will receive manual therapy according to clinical guidelines followed by instruction in a specific exercise to augment the specific manual treatment provided.
Arm Title
General Exercise and Manual Therapy
Arm Type
Active Comparator
Arm Description
Subjects will receive manual therapy according to clinical guidelines followed by instruction in a general neck range of motion exercise.
Intervention Type
Other
Intervention Name(s)
Augmented Exercise and Manual Therapy
Other Intervention Name(s)
Manipulation, Mobilization, Self-Mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
General Exercise and Manual Therapy
Other Intervention Name(s)
Manipulation, Mobilization, Self-Mobilization
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Neck Disability Index (NDI)
Description
A functional questionnaire completed by the subject
Time Frame
baseline; 36-48 hours; 96 hours
Secondary Outcome Measure Information:
Title
Change in Numeric Pain Rating Scale (NPRS)
Time Frame
baseline; 36-48 hours; 96 hours
Title
Change in Self Reported Activity Scale (SAA)
Time Frame
Baseline; 36-48 hours; 96 hours
Title
Change in Pressure Pain Threshold (PPT)
Time Frame
Baseline; Immediate post intervention; 36-48 hours; 96 hours
Title
Change in Vibratory Measure
Description
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.
Time Frame
Baseline; Immediate post intervention; 36-48 hours; 96 hours
Other Pre-specified Outcome Measures:
Title
Change in Tampa Scale for Kinesiophobia
Time Frame
Baseline; 36-48 hours; 96 hours
Title
Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
Time Frame
Baseline; 36-48 hours; 96 hours
Title
Clinical Equipoise
Description
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.
Time Frame
Baseline
Title
Change in Global Rating of Change (GROC)
Time Frame
Baseline; 36-48 hours; 96 hours
Title
Compliance Measure
Description
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.
Time Frame
96 hours
Title
Change in Range of Motion (ROM)
Time Frame
Baseline; Immediate post intervention; 36-48 hours; 96 hours
Title
Change in Strength
Time Frame
Baseline; immediate post intervention; 36-48 hours; 96 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Petersen, DScPT
Organizational Affiliation
Des Moines University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Des Moines University
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Walsh University
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
Country
United States
Facility Name
Youngstown State University
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44555
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Manual Therapy and Augmented Exercise for Neck Pain

We'll reach out to this number within 24 hrs