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| Name | Class |
|---|---|
| Walsh University | OTHER |
| Youngstown State University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Augmented Exercise and Manual Therapy | Experimental | Subjects will receive manual therapy according to clinical guidelines followed by instruction in a specific exercise to augment the specific manual treatment provided. |
|
| General Exercise and Manual Therapy | Active Comparator | Subjects will receive manual therapy according to clinical guidelines followed by instruction in a general neck range of motion exercise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Augmented Exercise and Manual Therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neck Disability Index (NDI) | A functional questionnaire completed by the subject | baseline; 36-48 hours; 96 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numeric Pain Rating Scale (NPRS) | baseline; 36-48 hours; 96 hours | |
| Change in Self Reported Activity Scale (SAA) | Baseline; 36-48 hours; 96 hours | |
| Change in Pressure Pain Threshold (PPT) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tampa Scale for Kinesiophobia | Baseline; 36-48 hours; 96 hours | |
| Change in Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) | Baseline; 36-48 hours; 96 hours | |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shannon Petersen, DScPT | Des Moines University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Des Moines University | Des Moines | Iowa | 50325 | United States | ||
| Walsh University |
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| ID | Term |
|---|---|
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| General Exercise and Manual Therapy | Other | 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. |
|
|
| Baseline; Immediate post intervention; 36-48 hours; 96 hours |
| 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. | Baseline; Immediate post intervention; 36-48 hours; 96 hours |
| Clinical Equipoise |
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. |
| Baseline |
| Change in Global Rating of Change (GROC) | Baseline; 36-48 hours; 96 hours |
| Compliance Measure | 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. | 96 hours |
| Change in Range of Motion (ROM) | Baseline; Immediate post intervention; 36-48 hours; 96 hours |
| Change in Strength | Baseline; immediate post intervention; 36-48 hours; 96 hours |
| North Canton |
| Ohio |
| 44720 |
| United States |
| Youngstown State University | Youngstown | Ohio | 44555 | United States |