Trial record 19 of 1083 for:
senior [AGE-GROUP] AND exercise [TREATMENT] | Open Studies
Manual Therapy and Augmented Exercise for Neck Pain
This study is currently recruiting participants.
Verified April 2013 by Des Moines University
Sponsor:
Des Moines University
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
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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:
|
|
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:
|
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
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 May 23, 2013