Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT00835302
Eligibility Criteria:
Inclusion Criteria:
* Primary complaint of shoulder pain (defined as pain between the neck and the elbow at rest or during movement of the upper arm, see diagram at right)
* Age between 18-65 years old
* Shoulder Pain and Disability Index (SPADI) score greater than 20 points (full description of this measure provided in self report measures section)
Exclusion criteria:
* Medical red flags noted in the patient's Medical Screening Questionnaire(i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, weight loss, fever, prolonged history of steroid use, etc.)
* Acute fractures in the shoulder region.
* Acute severe trauma to the cervical (neck) or thoracic (upper back) regions in the last 6 weeks.
* Contraindications to manipulative therapy (for example osteoporosis of the cervicothoracic spine).
* Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes), etc.
* Diagnosis of cervical spinal stenosis or bilateral upper extremity symptoms
* Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
Muscle weakness involving a major muscle group of the upper extremity Diminished upper extremity muscle stretch reflex (biceps brachii, brachioradialis, or triceps brachii reflexes) Diminished or absent sensation to pinprick in any upper extremity dermatome
* Prior surgery to the neck or thoracic spine involving fusion or open reduction internal fixation.
* Insufficient English language skills to complete all questionnaires as they have only been validated in English.
* Inability to comply with treatment and follow-up schedule
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00835302
Study Brief:
Protocol Section:
NCT00835302