{
    "info": {
        "nct_id": "NCT01729065",
        "official_title": "A Randomized Study to Assess the Efficacy of Early Physical Therapy Intervention on Upper Quarter Strength and Mobility, and Reported Upper Extremity Disability and Quality of Life Measures Following a Modified Unilateral Neck Dissection for Treatment of Head and Neck Cancer",
        "inclusion_criteria": "* Adults age 18-85, able to give informed consent\n* Subject has provided written informed consent\n* Received Modified Unilateral Neck Dissection with sparing of the SAN\n* Not currently using transcutaneous electrical nerve stimulation (TENS) as a pain relieving modality\n* Not currently receiving acupuncture as a pain relieving modality\n* Able to participate with treatment group protocol including physical therapy appointment every other week\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "* History of prior shoulder injury or surgery including rotator cuff repair or total shoulder arthroplasty.\n* History of CVA with hemi paresis\n* Bilateral neck dissection\n* Known severed SAN",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Adults age 18-85, able to give informed consent",
            "criterions": [
                {
                    "exact_snippets": "Adults age 18-85",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 85,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "able to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has provided written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Subject has provided written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received Modified Unilateral Neck Dissection with sparing of the SAN",
            "criterions": [
                {
                    "exact_snippets": "Received Modified Unilateral Neck Dissection",
                    "criterion": "Modified Unilateral Neck Dissection",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sparing of the SAN",
                    "criterion": "sparing of the SAN",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not currently using transcutaneous electrical nerve stimulation (TENS) as a pain relieving modality",
            "criterions": [
                {
                    "exact_snippets": "Not currently using transcutaneous electrical nerve stimulation (TENS)",
                    "criterion": "transcutaneous electrical nerve stimulation (TENS) usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not currently receiving acupuncture as a pain relieving modality",
            "criterions": [
                {
                    "exact_snippets": "Not currently receiving acupuncture as a pain relieving modality",
                    "criterion": "acupuncture",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to participate with treatment group protocol including physical therapy appointment every other week",
            "criterions": [
                {
                    "exact_snippets": "Able to participate with treatment group protocol",
                    "criterion": "participation in treatment group protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "physical therapy appointment every other week",
                    "criterion": "physical therapy appointment frequency",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "every other week"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 85 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 85 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 85,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* History of prior shoulder injury or surgery including rotator cuff repair or total shoulder arthroplasty.",
            "criterions": [
                {
                    "exact_snippets": "History of prior shoulder injury",
                    "criterion": "shoulder injury",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of prior ... surgery including rotator cuff repair",
                    "criterion": "rotator cuff repair surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of prior ... surgery including ... total shoulder arthroplasty",
                    "criterion": "total shoulder arthroplasty surgery",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of CVA with hemi paresis",
            "criterions": [
                {
                    "exact_snippets": "History of CVA",
                    "criterion": "CVA (cerebrovascular accident)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hemi paresis",
                    "criterion": "hemi paresis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilateral neck dissection",
            "criterions": [
                {
                    "exact_snippets": "Bilateral neck dissection",
                    "criterion": "neck dissection",
                    "requirements": [
                        {
                            "requirement_type": "laterality",
                            "expected_value": "bilateral"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known severed SAN",
            "criterions": [
                {
                    "exact_snippets": "Known severed SAN",
                    "criterion": "severed SAN",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}