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Fibromyalgia Pain & Function Protocol

The best supported part of Nancy Klimas's fibromyalgia approach is energy-envelope pacing with structured symptom tracking, and that is what this protocol leads with. Low-dose naltrexone (LDN) is covered honestly as an option some physicians use off-label: the early small trials looked promising, and every larger randomized trial since has failed to beat placebo. No dosing is given here, and nothing on this page is a treatment plan.

Pain management
Mixed: pacing is well supported, low-dose naltrexone is not
Not endorsed · based on the published work of Nancy Klimas
At a glance
Time
Ongoing, daily
Type
Recovery
Pacing is the well supported part of this protocol, and low-dose naltrexone is the part the larger evidence has turned against.
The protocol
Start here
Pace to your energy envelope: stay under your activity ceiling and stop before exhaustion Every day, on good days as well as bad ones. The same threshold-based method Klimas and exercise physiologist Connie Sol use in their ME/CFS work

Overexerting on a good day is what drives the boom and bust crash cycle. Holding activity steady is what limits flares, and it is the highest-value thing on this page.

Nancy Klimas / INIM
Ongoing
Track pain weekly on a 0-10 scale One rating a week, ideally the same day and time, alongside a note on how much activity that week held

Fibromyalgia fluctuates on its own, so a single good or bad week tells you nothing. A weekly number over a couple of months is what lets you and your physician separate a real change from normal variation, whatever you are trying.

Nancy Klimas / INIM
Honest limit
Give sleep its own physician-guided plan rather than expecting a pain treatment to fix it Discussed with a physician familiar with fibromyalgia, since some fast-acting sedatives can worsen non-restorative sleep

Even the trials that found a pain signal for LDN did not reliably show improvement in sleep or fatigue. Sleep is its own problem and needs its own plan.

Nancy Klimas / INIM
Safety, before naltrexone is even discussed
If you take opioid painkillers, or might need them, tell your doctor before any naltrexone conversation Informational only. This is a conversation to have with your prescriber, not a step to act on yourself

Naltrexone is an opioid antagonist. It blocks opioid painkillers and can precipitate acute withdrawal in someone who is opioid-dependent. Every fibromyalgia trial excluded opioid users, so there is no randomized evidence in people taking them, and they are a large share of chronic-pain patients. The antagonist effect also persists for roughly two to three days after the last dose, which matters for surgery and emergency pain relief.

StatPearls, Naltrexone (NCBI Bookshelf NBK534811)
⚠ Naltrexone blocks opioid painkillers and can trigger acute withdrawal in anyone opioid-dependent. Tell every clinician you see, including surgical and emergency teams, if naltrexone is ever prescribed.
If your physician raises it
Treat low-dose naltrexone as an unproven option to discuss, not a step to take No dosing is given on this page. Every low dose of naltrexone is compounded, since there is no FDA-approved low-dose product, and the decision belongs entirely to a prescribing physician

Klimas's clinical use of LDN is real and reported, and clinical practice is not the same thing as trial evidence. The larger randomized trials have not beaten placebo, and no guideline recommends it. It is generally well tolerated in trials, with vivid dreams the most consistent side effect, so the honest framing is low expected benefit rather than high risk.

Younger et al. 2013 / FINAL 2024 / INNOVA 2026
⚠ Prescription-only and off-label for fibromyalgia. Never self-source or self-dose naltrexone. Low-dose naltrexone is compounded, and the FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.
Ongoing
Reassess with your physician on a set schedule and agree in advance what would count as working Regular check-ins, with your weekly tracking in hand

Deciding upfront what a real response looks like, and by when, is what stops an unproven treatment continuing indefinitely on hope. Any off-label medication is monitored and adjusted by the prescriber, never independently.

Nancy Klimas / INIM
The evidence 11

Pacing is the well supported part of this protocol, and low-dose naltrexone is the part the larger evidence has turned against.

View sources
Ep 35: Finding Treatments for Fibromyalgia and ME/CFS Listen podcasts.apple.com
Finding Treatments for Fibromyalgia and ME/CFS Watch VuMedi
General Klimas / INIM clip (not fibromyalgia-specific) Watch youtube.com
Institute for Neuro-Immune Medicine (Nova Southeastern University) Read NSU INIM
FDA-approved fibromyalgia medications: pregabalin, duloxetine, milnacipran Read NCBI / PMC
Low-dose naltrexone for the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled, counterbalanced crossover trial (Younger, Noor, McCue & Mackey, Arthritis and Rheumatism, 2013) Read Arthritis Rheum, 2013
Low-dose naltrexone for treatment of pain in patients with fibromyalgia: a randomized, double-blind, placebo-controlled, crossover study (Bested et al., Pain Reports, 2023) Read Pain Rep, 2023
Efficacy and safety of low-dose naltrexone for fibromyalgia (FINAL): a randomised, double-blind, placebo-controlled trial (Lancet Rheumatology, 2024) Read Lancet Rheumatol, 2024
Low-dose naltrexone in fibromyalgia: a 12-month randomised, double-blind, placebo-controlled trial (INNOVA, European Journal of Pain, 2026) Read Eur J Pain, 2026
Efficacy of low-dose naltrexone in chronic pain: a systematic review and meta-analysis (Hegde et al., Current Pain and Headache Reports, 2025) Read Curr Pain Headache Rep, 2025
Amitriptyline for fibromyalgia in adults (Moore et al., Cochrane Database of Systematic Reviews, 2015) Read Cochrane Database Syst Rev, 2015

Not medical advice. This page is for education only and is not a substitute for professional medical care. Consult a qualified clinician before changing your health routine.
Independent curation. YourProtocol is an independent platform. This protocol is based on the publicly available work of Nancy Klimas and is not created, reviewed, endorsed by, or affiliated with Nancy Klimas or MD, Director, Institute for Neuro-Immune Medicine · Nova Southeastern University.

Is this for you
  • People diagnosed with fibromyalgia who want a pacing and tracking method they can start on their own, alongside their physician's care
  • Anyone who has read about low-dose naltrexone online and wants the honest evidence picture, including what the larger trials found
  • Caregivers helping someone manage activity limits and flares
  • Not a self-prescribing guide, and not a substitute for diagnosis and ongoing care from a physician
Cautions
  • Naltrexone is an opioid antagonist. It blocks opioid painkillers and can precipitate acute withdrawal in anyone who is opioid-dependent, and the effect persists for roughly two to three days after the last dose, which matters for surgery and emergency pain relief. Every fibromyalgia trial excluded opioid users, so there is no randomized evidence in people taking them. Tell every clinician you see.
  • Low-dose naltrexone is prescription-only and off-label for fibromyalgia. There is no FDA-approved product at any low dose, so every low dose is compounded, and the FDA does not verify the safety, effectiveness or quality of compounded drugs before they are marketed.
  • The larger randomized trials of low-dose naltrexone in fibromyalgia have not beaten placebo, and no major guideline recommends it. Treat it as unproven, not as an established treatment.
  • Never self-prescribe or source naltrexone. Tell your doctor about every medication and supplement you take.
  • Fibromyalgia requires diagnosis and ongoing care from a physician. This page is pacing and tracking support, not a treatment plan on its own.
  • Educational only, not medical advice.
Common questions
What supplements are actually worth it for fibromyalgia, honestly?
None of them clear our grade B bar. Magnesium is grade C: a plausible mechanism around muscle and nerve excitability, but only small, underpowered trials. Vitamin D is grade C and only helps people who are genuinely deficient, correcting a real deficiency is the supportable action, not supplementing above normal levels. CoQ10 is grade C: several small positive trials, no large confirmatory trial. The honest verdict: cheap, low risk, worth discussing with your doctor, but do not expect much, and do not spend real money expecting a result. This carries no product recommendation.
What is the best thing for fibromyalgia pain that is not an opioid?
Three drugs are FDA-approved specifically for fibromyalgia: pregabalin (2007), duloxetine (2008), and milnacipran (2009), grade B, resting on the approval basis plus randomized trials. Amitriptyline is guideline-recommended and widely used off-label, but it is not FDA-approved for fibromyalgia, and the 2015 Cochrane review (Moore et al.) found no first- or second-tier evidence for it and rated the supporting trials very low quality, so treat it as grade C and mixed, the same honest split this page already gives low-dose naltrexone. Non-drug: pacing, already the highest-value step on this page. Every drug named here is a conversation with your clinician, never a self-start.
Is fibromyalgia a real medical condition, or is it all in my head?
Fibromyalgia is real, and it is not in your head. It is a real, recognized disorder of how the nervous system processes pain, not a psychiatric condition and not a diagnosis of exclusion. The best-supported mechanism is central sensitization: the brain and spinal cord amplify pain signals. This is measurable with quantitative sensory testing, which consistently finds people with fibromyalgia are more sensitive to standardized pressure and heat than controls, grade B, a well-replicated finding across many independent studies. Brain imaging adds supporting but less settled evidence: a systematic review of structural and functional MRI studies (Cagnie et al., Seminars in Arthritis and Rheumatism, 2014) found moderate evidence of reduced grey matter in pain-processing regions like the anterior cingulate cortex, grade C, real but heterogeneous across studies and not a diagnostic scan. A subset of patients also show small-fiber neuropathy on skin biopsy, roughly 40 to 50 percent in pooled estimates (Oaklander et al., Pain, 2013; meta-analysis PMID 30314675), grade C, a real physical finding in a meaningful minority but not present in everyone and not required for diagnosis. Institutionally, fibromyalgia is formally recognized by the American College of Rheumatology, has its own World Health Organization ICD-11 code (MG30.01, chronic widespread pain), and has dedicated management guidelines from EULAR (2017) and NICE (NG193, 2021). None of that adds up to a cure, and no scan or blood test can diagnose it today, but the pain is physiologically real and it has a name every major medical body recognizes.
What are the actual diagnostic criteria for fibromyalgia? Has my doctor been using outdated ones?
The old 1990 American College of Rheumatology criteria (Wolfe et al., Arthritis and Rheumatism, 1990) required a doctor to press on 18 specific points and find tenderness in at least 11 of them. That exam was retired years ago. The current standard is the 2016 revision (Wolfe et al., Seminars in Arthritis and Rheumatism, 2016) of the 2010/2011 criteria, and it does not use tender-point pressing at all. It uses two scored scales: the Widespread Pain Index (WPI, 0 to 19, counting painful body areas) and the Symptom Severity Scale (SSS, 0 to 12, scoring fatigue, unrefreshing sleep, cognitive symptoms and other complaints). Criteria are met with WPI 7 or higher and SSS 5 or higher, or WPI 4 to 6 with SSS 9 or higher, plus generalized pain in at least 4 of 5 body regions, with symptoms present at a similar level for at least 3 months. One line matters most for a dismissive visit: the criteria state outright that a fibromyalgia diagnosis is valid irrespective of other diagnoses, and does not exclude the presence of other clinically important illness. It is not a last-resort label for when nothing else is found, and it can coexist with other conditions. A doctor is not applying the current standard if they are still pressing on 18 points or treating it as a diagnosis that only counts once everything else is ruled out. Meeting these numbers is not a diagnosis: only a clinician can diagnose fibromyalgia, using this criteria alongside your full clinical picture.
My doctor does not believe I have fibromyalgia, or dismisses it. What can I actually do?
Bring the criteria, not just your symptoms: ask specifically whether your pain and symptom pattern meet the 2016 ACR criteria (WPI and SSS scored, generalized pain in at least 4 of 5 regions, present at a similar level for 3 or more months), and ask whether the outdated 18-point tender-point exam is being used instead. A reasonable workup rules out other explanations for widespread pain, commonly thyroid function, inflammatory markers (ESR and CRP), and vitamin D, not to disprove your pain but to check for a treatable overlapping condition, since a fibromyalgia diagnosis does not exclude having something else too. If a clinician will not apply a named, published diagnostic standard to a real symptom pattern, asking for a rheumatology referral or a second opinion is a reasonable next step, not an overreaction. This is informational only, not a diagnosis; only a clinician can diagnose fibromyalgia.
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