[Federal Register Volume 82, Number 95 (Thursday, May 18, 2017)]
[Notices]
[Pages 22826-22828]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10067]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Noninvasive, 
Nonpharmacological Treatment for Chronic Pain

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

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SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review of Noninvasive, 
Nonpharmacological

[[Page 22827]]

Treatment for Chronic Pain, which is currently being conducted by the 
AHRQ's Evidence-based Practice Centers (EPC) Program. Access to 
published and unpublished pertinent scientific information will improve 
the quality of this review.

DATES: Submission Deadline on or before June 19, 2017.

ADDRESSES: Email submissions: src.org">SEADS@epc-src.org.
    Print submissions:
    Mailing Address: Portland VA Research Foundation, Scientific 
Resource Center, ATTN: Scientific Information Packet Coordinator, PO 
Box 69539, Portland, OR 97239.
    Shipping Address (FedEx, UPS, etc.): Portland VA Research 
Foundation, Scientific Resource Center, ATTN: Scientific Information 
Packet Coordinator, 3710 SW U.S. Veterans Hospital Road, Mail Code: R&D 
71, Portland, OR 97239.

FOR FURTHER INFORMATION CONTACT: Ryan McKenna, Telephone: 503-220-8262 
ext. 51723 or Email: src.org">SEADS@epc-src.org.

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Noninvasive, 
Nonpharmacological Treatment for Chronic Pain. AHRQ is conducting this 
systematic review pursuant to Section 902(a) of the Public Health 
Service Act, 42 U.S.C. 299a(a).
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Noninvasive, Nonpharmacological Treatment for Chronic 
Pain, including those that describe adverse events. The entire research 
protocol, including the key questions, is also available online at: 
https://www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2470.
    This is to notify the public that the EPC Program would find the 
following information on Noninvasive, Nonpharmacological Treatment for 
Chronic Pain helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, please provide a summary, including the following 
elements: Study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EPC Program. The 
contents of all submissions will be made available to the public upon 
request. Materials submitted must be publicly available or able to be 
made public. Materials that are considered confidential; marketing 
materials; study types not included in the review; or information on 
indications not included in the review cannot be used by the EPC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program Web 
site and available for public comment for a period of 4 weeks. If you 
would like to be notified when the draft is posted, please sign up for 
the EPC email list at: https://www.effectivehealthcare.ahrq.gov/index.cfm/join-the-email-list1/.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

The Key Questions

    I. In adults with chronic low back pain:
    A. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with sham treatment, no 
treatment, waitlist, attention control, or usual care?
    B. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with pharmacological therapy 
(e.g., opioids, NSAIDS, acetaminophen, anti-seizure medications, 
antidepressants)?
    C. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with exercise?
    II. In adults with chronic neck pain:
    A. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with sham treatment, no 
treatment, waitlist, attention control, or usual care?
    B. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with pharmacological therapy?
    C. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with exercise?
    III. In adults with osteoarthritis-related pain:
    A. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with sham treatment, no 
treatment, waitlist, attention control, or usual care?
    B. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with pharmacological therapy?
    C. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with exercise?
    IV. In adults with fibromyalgia:
    A. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with sham treatment, no 
treatment, waitlist, attention control, or usual care?
    B. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with pharmacological therapy?
    C. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with exercise?
    V. In adults with chronic tension headache:
    A. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with sham treatment, no 
treatment, waitlist, attention control, or usual care?
    B. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with pharmacological therapy?
    C. What are the benefits and harms of noninvasive 
nonpharmacological therapies compared with biofeedback?
    VI. Do estimates of benefits and harms differ by age, sex, or 
presence of comorbidities (e.g., emotional or mood disorders)?

[[Page 22828]]

PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, 
Settings)

Population(s): Adults with the following chronic pain (defined as pain 
lasting 12 weeks or longer or pain persisting past the time for normal 
tissue healing) conditions specified in the Key Questions:

Key Question 1: Nonradicular chronic low back pain
Key Question 2: Chronic neck pain without radiculopathy or myelopathy
Key Question 3: Pain related to primary or secondary osteoarthritis
Key Question 4: Fibromyalgia
Key Question 5: Primary chronic tension headache (defined as 15 or more 
headache days per month for at least 3 months)
Key Question 6: Patients with any of the five chronic pain conditions

Interventions (All Key Questions)

I. Exercise
II. Psychological therapies
III. Physical modalities
IV. Manual therapies
V. Mindfulness practices
VI. Mind-body practices
VII. Acupuncture
VIII. Functional restoration training
IX. Multidisciplinary/interdisciplinary rehabilitation

Comparators

I. For all Key Questions, subquestion ``a''
    A. Sham treatment
    B. Waitlist
    C. Usual care
    D. Attention control
    E. No treatment
II. For all Key Questions, subquestion ``b''
    A. Non-opioid pharmacological therapy (nonsteroidal anti-
inflammatory drugs, acetaminophen, antiseizure medications, 
antidepressants)
    B. Opioid analgesics
III. Key Questions 1-4, 6, subquestion ``c'': Exercise
IV. Key Question 5, 6, subquestion ``c'': Biofeedback

Outcomes

I. Primary efficacy outcomes (in priority order); we will focus on 
outcomes from validated measures
    A. Function/disability/pain interference
    B. Pain
II. Harms and adverse effects
III. Secondary outcomes
    A. Psychological distress (including depression and anxiety)
    B. Quality of life
    C. Opioid use
    D. Sleep quality, sleep disturbance
    E. Health care utilization

Timing

I. Duration of followup: Short term (up to 6 months), intermediate term 
(6-12 months) and long term (at least 1 year); we will focus on longer-
term (>1 year) effects where possible
II. Studies with <1 month followup after treatment will be excluded

Settings

I. Any nonhospital setting or setting of self-directed care
II. Exclusions: Hospital care, hospice care, emergency department care

Sharon B. Arnold,
Deputy Director.
[FR Doc. 2017-10067 Filed 5-17-17; 8:45 am]
 BILLING CODE 4160-90-P