Sciatica: acupuncture helps

 a recent study of patients with sciatica from a herniated lumbar disc found that acupuncture vs sham acupuncture was associated with significant improvements in pain and function (see sciatica acupuncture helps JAMAintmed2024 in dropbox, or doi:10.1001/jamainternmed.2024.5463)

 

Details:

-- 216 participants were randomly assigned to receive 10 sessions of acupuncture (n = 110) or sham acupuncture (n = 110) over 4 weeks, in a multicenter clinical trial conducted in 6 tertiary-level hospitals in China in 2021. all participants had pain for at least 3 months, with at least moderate leg pain intensity of >40mm on the visual analog scale

-- mean age 51.3 years; 147 females (68.1%)

-- BMI 24, duration of low back pain (LBP) 3 years

-- site of MRI- or CT-determined disk disease: L3-4 in 33%, L4-5 in 78%, L5-S1 in 70%

-- treatments received: NSAIDs 7%, steroids <1%, neurotropic drugs (mecobalamin, vitamin B1, vitamin B12) 4%, acupuncture 27%, Chinese herbal medicine 10%, other physiotherapy 6%

-- baseline VAS leg pain score (visual analog scale): 60 (scale 0-100mm, the higher the worse)

-- baseline ODI score (Oswestry Disability Index): 35 (10-item ODI scale ranging from 0 (no disability) to 100 points (maximum disability possible))

-- baseline VAS Back pain score: 55

-- SFBI (Sciatica Frequency and Bothersomeness Index) score: 14 for frequency, 14 for bothersomeness

-- baseline SF-36 (36-item Short Form Health Survey, a quality-of-life measurement, from 0-100, the higher the better): physical health 30, mental health 49

-- exclusion criteria: severe spinal disease or severe progressive neurological symptoms; cardiovascular, liver, kidney, or hematopoietic system disease; a mental health disorder or other severe coexisting disease; being pregnant, lactating, or planning to conceive; had undergone lumbar disc surgery; were taking medication that has a therapeutic effect on sciatica; or had received acupuncture for sciatica in the past year

 

--Both acupuncture and sham acupuncture were performed by licensed acupuncturists with at least 3 years of experience. Acupuncture points were the standard ones but that varied by the specific location and types of pain on an individual basis; the sham group had acupuncturists who used nonacupoints away from the meridians, which are considered to have no effect; this is common practice for sham controls in acupuncture research.

 

-- main outcomes and measures:

    -- the 2 coprimary outcomes: changes in visual analog scale (VAS) for leg pain and Oswestry Disability Index (ODI) from baseline to week 4 (though outcome measures were recorded at weeks 2, 4, 8, 26, and 52)

            -- Acupuncture was considered to be an effective therapy only if both primary outcomes achieved statistical significance

                 -- for these measurements, the minimal clinically important differences (MCIDs) on the VAS and ODI were preset at 15mm and 7 points, respectively; these are on the high end of what is considered minimally clinically important

    -- Secondary outcomes:

        -- VAS for low back pain, SFBI, SF-36, use of rescue medicines, and patient’s global assessment

        -- adverse events   

 

Results:

-- blinding test:

    -- at week 2 and week 4, assessment of the James blinding index found that patients were unaware of which group they were assigned to

 

-- VAS for leg pain at week 4:

    -- decreased 30.8 mm in the acupuncture group and 14.9 mm in the sham acupuncture group at week 4: mean difference −16.0 (−21.3 to −10.6), P < .001

-- ODI for leg pain at week 4:

    --decreased 13.0 points in the acupuncture group and 4.9 points in the sham acupuncture group at week 4: mean difference −8.1 (−11.1 to −5.1), P < .001

 

-- between-group difference of VAS and ODI: apparent starting at week 2, mean difference −7.8 (−13.0 to −2.5), P = .004 and −5.3 (−8.4 to −2.3), P = .001, respectively

    -- and this persisted through week 52, mean difference −10.8 (−16.3 to −5.2), P < .001; and −4.8 (−7.8 to −1.7), P = .003, respectively

        -- notably, acupuncture was significantly better than sham acupuncture at each measured time:

 

 

-- results of the per-protocol analysis at week 4 were consistent and a bit stronger for the mean difference between acupuncture and sham acupuncture:

    -- VAS: -17.4 (-22.7 to -12.1), P<0.001

    -- ODI: -9.2 (-12.4 to -6.1), P<0.001

 

-- SFBI frequency score: SFBI bothersomeness score and SF-36 physical health scores all had highly significant benefit of acupuncture at all of the time periods measured (essentially all had P<0.001)

-- SF-36 mental health score: no difference was found between the acupuncture vs sham acupuncture groups except at week 52, where the acupuncture group had a better score of 54.6 (52.9-56.2) vs 51.1 (49.4-52.8), P=0.004 (all other time periods had a strong trend to being better in the acupuncture group)

-- rescue analgesic medications: 17 patients in the acupuncture and 24 in the sham acupuncture group

 

--Adverse events (AEs):

    -- overall, found in 26 patients in the acupuncture group (24.1%) vs 5 in the sham acupuncture group (4.6%)

        -- most common ones were subcutaneous hemorrhage and minor bleeding, and all AEs wee considered to be mild and self-limiting, without need for special medical intervention

        -- no serious AEs leading to hospitalization or surgery or exacerbation of a pre-existing condition or death

 

Commentary:

-- back pain is a 2^nd most common reason for primary care visit, and costliest medical condition in the US ($134 billion spent in 2016) 

-- sciatica occurs in about 30% of people with low back pain, annual incidence of 1 to 5% 

-- overall prognosis of low back pain with sciatica is worse than just with regular axial low back pain 

    -- observationally, 45% of patients with low back pain with sciatica do not have significant improvement in disability at one year, 34% report chronic pain at 2 years

-- studies have found that gabapentinoids (gabapentin and pregabalin) are largely ineffective for both low back pain and lumbar radicular pain: https://gmodestmedblogs.blogspot.com/2018/07/gabapentinoids-still-not-help-low-back.html

 

--Most cases of sciatica are related to herniated lumbar discs that compress nerve roots and are associated with inflammation, on the order of 85% of the time. Most people get better with conservative treatment, leading to the accepted strategy for those without high-risk structural or inflammatory symptoms (eg cauda equina syndromes, fevers/night sweats, potentially active malignancy, immunosuppression, weight loss etc), of delaying imaging in most cases (excepting those with deteriorating conditions) by 6-8 weeks, prescribing analgesia (acetaminophen/NSAIDs) and conservative management (physical therapy, decreasing painful activities but maintaining activity to the extent possible/avoiding excessive bed rest). In fact, studies have suggested that in most cases, it is actually dangerous (ie getting more surgery) in patients who get MRIs in the first 6 weeks of low back pain (https://gmodestmedblogs.blogspot.com/2021/02/low-back-pain-dangerous-to-get-early.html )

-- a few prior articles of note in treating low back pain and sciatica:

    -- one found that initiating PT within 3 days of the initial sciatica symptoms led to self-reported dramatic decreases in back pain intensity and disability up to 1 year later: https://gmodestmedblogs.blogspot.com/2020/10/sciatica-early-pt-helps-longterm.html

    -- another found that opiates were relatively ineffective for acute back pain (https://gmodestmedblogs.blogspot.com/2023/08/acute-low-back-or-neck-pain-placebo-was.html )

    -- another that opiates were ineffective for chronic back/hip/knee pain (https://gmodestmedblogs.blogspot.com/2018/03/opioids-not-better-for-chronic.html )

    -- another study also found that opiates were ineffective and that topical diclofenac may well be better than oral NSAIDs (https://gmodestmedblogs.blogspot.com/2023/08/acute-low-back-or-neck-pain-placebo-was.html )

    -- and another found that a variety of nonpharmacologic interventions were beneficial (eg yoga, taichi, mindfulness, home-based CBT (see https://gmodestmedblogs.blogspot.com/2018/03/opioids-not-better-for-chronic.html for references to these blogs)

    -- there was a recent article on the benefit of virtual yoga (low back pain chronic virtual yoga JAMA2024 in dropbox, or doi:10.1001/jamanetworkopen.2024.42339); I will do a blog on that soon

 

-- This randomized clinical trial found that in patients with chronic sciatica from a herniated disk, acupuncture resulted in less pain and better function compared with sham acupuncture at week 4, and these benefits persisted through week 52. Acupuncture should be considered as a potential treatment option for patients with chronic sciatica from a herniated disk.

-- this was the largest study done on acupuncture vs sham acupuncture, had the most rigorous design and reaffirmed the results of several prior smaller studies.

 

Limitations:

-- this study was done in China where acupuncture more readily available and accepted, which may predispose these Chinese patients to having a more positive outcome from acupuncture

    -- however, the recipients were unable to differentiate whether they received the true or sham acupuncture therapy, confirming the conclusion that acupuncture really works and with quite impressive results

    — though the inclusion of participants from China could limit generalizability to other countries/cultures

-- the acupuncturists were aware of whether the participants received the true vs sham acupuncture, though they were trained to be discrete and the patients were unaware of which acupuncture they received when measured at weeks 2 and 4. so this was not (and could not be) a completely blinded study, but the likelihood of bias here is low

-- in the above trial the acupuncturists targeted 7 acupoints, though there is evidence mentioned in this study that there may be more benefit if more acupoints or more than the 10 sessions were involved in the treatment

-- this study did have a slew of exclusions for participation, many of which eliminated lots of potential patients from participating and limiting generalizability more broadly. also, we are not informed of the variety of psychosocial/medical conditions that might affect participants' perception of pain and affect the results of the study (eg, depression, stress, sleep deprivation, chronic medical conditions and medications, living conditions...)

 

So,

-- A pretty striking affirmation that acupuncture, well-known to help with pain, worked well in decreasing sciatica symptoms as well as the overall quality of life measures, and with less need for taking rescue medications

-- this benefit was not only highly statistically significant, but exceeded the preset cutpoints of being clinically significant

-- and, a short course of 10 sessions over 4 weeks led to long-term results for up to 52 weeks (the last time point measured)

    -- this long-term effect is pretty similar to the finding that PT initiated within the first 3 days of sciatica symptoms led to decreased pain and disability one year later, as noted above

    -- and both of these long-term effects of early interventions (I suspect) are related to the anti-inflammatory effects of both acupuncture (see acupuncture anti-inflammatory JInflamRes2021 in dropbox, or  https://www.dovepress.com/article/download/71691 ) and physical therapy (see physical therapy dec inflamm PhysTher2017 in dropbox, or doi: 10.1093/ptj/pzx056).

-- so acupuncture provides a safe and non-pharmacologic intervention that seems to work quite well in decreasing the short-term and long-term effects of sciatica

geoff

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