Please select the eligibility criteria that correspond to the clinical trial below.
Title: Exploring Integrative Medicine for Back and Neck Pain - A Pragmatic Randomized Clinical Pilot Trial
Brief Summary: Research over the last years have reported an increased popularity of complementary therapies (CTs) and an integration of CTs into mainstream medical settings, health care organizations and insurance plans. These trends may present both new challenges and new opportunities for health care provision. In Sweden and elsewhere, major challenges include the great variety and quality of CT provision within health care and a lack of national and international recommendations of how integrations of CTs with conventional care should be modelled, i.e. lack of conceptual models for delivering integrative medicine (IM). This may partly be a result of a scarce evidence base in support of IM provision within public health care services, e.g. lack of IM compared to usual care in randomised clinical trials. It remains largely unknown whether comprehensive models of IM are clinically or cost effectively different from conventional care provision.

Back and neck pain are costly, conventionally managed in primary care and two of the most common conditions treated by CTs. We have developed a comprehensive collaborative consensus model for IM adapted to Swedish primary care. The aim of this pilot study was to explore the feasibility of a pragmatic randomised clinical trial to investigate the effectiveness of the IM model versus conventional primary care in the management of patients with non-specific back/neck pain.


Options:
A: Inclusion Criteria:

* over 18
* present myofascial trigger points in trapezius muscle

Exclusion Criteria:

* to be under anti-inflammatory, analgesic, anticoagulant, muscle relaxant or antidepressant medication at the start of the study or one week before it (Simons, 2004)
* to suffer from fibromyalgia syndrome, or to have any contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, fear of needles, wounds in the area of the puncture, metal allergy, cancer, systemic disease) (Baldry, 2005).
B: Inclusion Criteria:

* Back/neck pain with or without headache for at least two weeks and at least three times per week
* Resident of Stockholm County
* Literate in Swedish
* Willing and able to comply with study requirements

Exclusion Criteria:

* Specific pathology and severe causes of back/neck pain such as malignant disease, vertebral fractures and severe or progressive neurological symptoms.
C: Inclusion Criteria:

* Aged over 19 years with acute pain defined as pain occurring within 72 hours of ED presentation
* Acute neck pain with no evidence of neurological abnormality
* Acute headache which meets the classification criteria of a primary headache as described by the International Headache Society (code 1 to 4)
* Acute ankle injury with no evidence of fracture or complete tear of ligaments

Exclusion Criteria:

* Any suspected non-musculoskeletal cause (neoplasm or neurological complications) for neck or ankle pain
* Any suspected secondary headaches classified by codes 5 to 12 in the International Classification of Headache Disorders, 2nd edition
* Pain due to bone fracture or joint dislocation
* Pain with fever (defined by a temperature above 37.5 °C)
* Inappropriate at the ED physician's discretion
* Pain level of less than 4 points of pain intensity on the Numerical Rating Scale (NRS) (range 0 to 10) at the completion of observations after the standard ED management
* Pregnant women
D: Inclusion Criteria:

* A clinically relevant MFTrP of the upper Trapezius musculature
* Self-reported pain of ≥3 on an eleven-point numerical pain rating scale (NRS-101).
* BMI less than 31

Exclusion Criteria:

* a history of chronic, systemic pathology (e.g. hemophilia)
* pre-existing neck/shoulder pathology/surgical procedures,
* clinical depression
* health-related legal action
* pregnant
* anti-inflammatory and/or chronic pain medication
* had received dry needling for a shoulder/neck disorder within 6 months prior to the study (to raise the level of patient naiveté) suffered from needle phobia

Answer: B