Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Decision Support System for Self-management of Low Back Pain - a Randomized Controlled Trial for the selfBACK Project
Brief Summary: The intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain (LBP) via an smartphone app.


Options:
A: Inclusion Criteria:

Subjects will include those for whom a discontinuation trial of NSAIDs is most appropriate: 1) Veterans with knee pain despite NSAID use and/or 2) Veterans at relatively higher risk of NSAID toxicity 55-59 as ascertained by meeting 1 or more of the following 4 criteria:

* Answer affirmatively to the question: "Do you have some knee pain on most days over the past 3 months?"
* Have 1 or more risk factors for NSAID-induced nephrotoxicity (age greater than 60 years, atherosclerotic cardiovascular disease, current diuretic use, chronic renal insufficiency, congestive heart failure (New York Heart Association class I-II. Note, Class III and IV are excluded).
* Have 1 or more risk factors for NSAID-induced gastrointestinal toxicity (history of peptic ulcer disease, age \> 65 years, concurrent use of daily ASA or corticosteroids), and are currently on a gastro-protective agent.
* Have 1 or more risk factors for NSAID-induced cardiovascular toxicity (prevalent cardiovascular disease, hypertension, hypercholesterolemia, diabetes, smoking, family history of early heart disease or age greater than 55 years for women).

In addition, subjects must:

* Be age 20 years or older. While the usual cut off for knee OA is approximately 40 years, the investigators chose to lower the age cutoff as younger Veterans have a higher than expected risk of OA (see B.1).
* Have radiographic evidence of knee OA reported in the VistA electronic system.
* Be using an NSAID (other than daily ASA) for knee pain on most days of the month for at least the past 3 months.
* Be able to understand and speak English and have a telephone.
* Be willing to engage in a CBT program, to discontinue (or replace) their NSAID, and to restrict co-therapies to acetaminophen for 14 weeks.

Exclusion Criteria:

* Subjects desiring escalation of analgesics for their current level of knee pain as determined by endorsement of the following statement: "Is your knee pain bad enough that you want to talk to your doctor about taking stronger pain medications?"
* Current use of opioids and/or Celebrex.
* Current use of an NSAID (not including ASA) for a painful condition in addition to knee OA.
* Contraindications to chronic NSAID use: current use of warfarin or antiplatelet agent other than ASA, allergy to any NSAID, active upper gastrointestinal ulceration in the previous 30 days, upper gastrointestinal bleeding in the past year, history of gastroduodenal perforation or obstruction, cardiovascular event within the past 6 months (myocardial infarction, cerebrovascular event, coronary-artery bypass graft, invasive coronary revascularisation, or new-onset angina), severe congestive heart failure (New York Heart Association class III-IV), evidence of serious anemia, hepatic, renal (including nephrotic syndrome), or blood coagulation disorders, and pregnancy.

\*\*\*Though the investigators are proposing a RWT - and thus will not be initiating NSAID therapy - it would not be appropriate to continue NSAIDs (even when prescribed) in high-risk patients. The investigators acknowledge that these exclusion criteria limit generalizability, but the investigators feel justified to ensure subjects' safety.\*\*\*

* Previous hyaluronic acid knee injections (within 6 months) or corticosteroid knee injections (within 3 months).
* Scheduled knee hyaluronic acid or corticosteroid injections, arthroscopy, or knee surgery.
* Co-morbid conditions that include the following: known other causes of arthritis (infectious arthritis, rheumatoid arthritis, connective tissue disease, or psoriatic arthritis), gout or pseudogout attack within the last 12 months, peripheral neuropathy or cardiopulmonary disease that limits walking more than knee pain, bone metastases or Paget's disease involving the lower extremities, and history of drug or alcohol abuse within the past 2 years, bilateral knee replacements or knee pain in the replaced knee only.
* Current involvement in litigation or receiving workmen's compensation.
* Hearing, cognitive impairment or mental illness, as determined by chart review that would preclude participation in a CBT program.
* For Women of Childbearing Age: Must not currently be pregnant, agree to avoid getting pregnant during the course of the study and should inform the study team if pregnancy occurs at any time during study participation.
* Previous meloxicam use discontinued due to lack of effective symptom relief
* Contraindications to prolonged NSAID use, per PI discretion.
B: Inclusion Criteria:

* Seeking care from primary health-care practice (general practitioners, physiotherapists, chiropractors) or a local outpatient spinecenter (DK) for non-specific LBP within the past 8 weeks
* LBP of any duration
* Mild-to severe pain-related disability rated as 6 or above on the Roland Morris Disability Questionnaire
* Age: ≥18 years
* Own and regularly use a smart phone (with at least Android 7.0 or iOS11.0) with internet access (Wi-Fi and/or mobile data)
* Have a working email address and have access to a computer with internet access to complete questionnaires in a web browser.

Exclusion Criteria:

* Not interested,
* Unable to speak, read or understand the national language (Danish/ Norwegian),
* Cognitive impairments or learning disabilities limiting participation,
* Mental or physical illness or condition limiting participation,
* Inability to take part in exercise/physical activity,
* Fibromyalgia (diagnosed by a health care professional),
* Pregnancy,
* Previous back surgery
* Ongoing participation in other research trials for LBP management.
C: Inclusion Criteria:

* female or male
* 18-65 years of age
* chronic neck pain for at least 12 weeks
* if additional back pain is reported, neck pain has to be predominant
* intensity of the average neck pain ≥ 4 on the numeric rating scale (NRS) in the last week
* presence of a smartphone (iphone, Android phone) and willingness to do data entry through a smart phone application (App)
* physical and mental ability to participate in the study
* willingness to be randomized, to apply study intervention according to the protocol, to complete the baseline questionnaire in paper form and electronic questionnaires and diaries provided by a smart phone application
* written and oral informed consent

Exclusion Criteria:

* neck pain caused by a known malignant disease
* neck pain caused by trauma
* known rheumatic disorder
* history or planned surgery of the spinal column of the neck in the next 6 months
* known neurological symptoms e.g radicular symptoms because of prolapsed vertebral disc
* regular intake of analgesics (\>1x per week) because of additional diseases
* intake of centrally acting analgesics
* known severe acute or chronic disorder, that do not allow participation in the therapy
* other known diseases, that do not allow participation in the therapy
* known alcohol or substance abuse
* no sufficient German language skills
* current application for a benefit
* participation in another clinical trial during six months before the study and parallel to the study
* conducting regular relaxation techniques, mindfulness training or meditation six weeks before the study or planned in the next 6 months
D: Inclusion Criteria:

* The inclusion criteria for patients in this study were: patients ≥18 years of age presenting pain of any location, lasting ≥ 3 months, intensity ≥ 4 on the EVN (Numerical Visual Scale), and with one of the following characteristics: Continuous pain, Intermittent pain ≥ 5 days a week. Not be participating in another research project and with skills for the use of mobile telephony.

Exclusion Criteria:

* Exclusion criteria included cancer patients, bipolar or psychotic disorder, a history of brain injury, inability to complete study forms due to mental disability or language barrier.

Answer: B