Hyperbaric Oxygen for Neuropathic Pain and ...

Hyperbaric Oxygen for Neuropathic Pain and Fibromyalgia

01-Jun-2015

Hyperbaric Oxygen for Neuropathic Pain and Fibromyalgia Review information Authors Geoff A Kirwood 1

1

[Empty affiliation]

FnMyalgia.com

Citation example: Kirwood GA. Hyperbaric Oxygen for Neuropathic Pain and Fibromyalgia. Cochrane Database of Systematic Reviews [Year], Issue [Issue]. DOI: 10.13140/2.1.1501.4402

Contact person Geoff A Kirwood Dates Assessed as Up-to-date: 27 May 2015 Date of Search:

24 September 2014

Next Stage Expected: Protocol First Published: Not specified Review First Published:

Not specified

Last Citation Issue:

Not specified

What's new Date / Event

Description

27 May 2015 Updated

Efrati & Buskila et al report published

History Date / Event

Description

Abstract Background Irreversible chronic non-cancer pain is frequently neuropathic, and pharmacotherapy is often palliative support. Relief regimes range from antiepileptic medicines (eg carbamazepine, pregabalin) with limited understanding of their pharmacodynamics, to opioids or conversely opioid receptor antagonists (eg naltrexone). This review considers the benefit afforded by HyperBaric Oxygen Therapy (HBOT) to a variety of conditions attributable to damaged nerves, continuing the approach historically taken by Cochrane's Pain, Palliative and Supportive Care group (PaPaS). Their future intent is segregation of fibromyalgia from neuralgia conditions, once sufficient evidence has accrued.

Objectives To assess pain relief following a course of HBOT, and enduring benefit where possible.

Search methods

Review Manager 5.3

1


01-Jun-2015

Search methods Medline, Embase, Cochrane Central, and the US Clinical Trial registry each yielded unique result(s) from search.

Selection criteria RCTs treating neuralgia with HBOT and reporting pain as a primary outcome, whether overall under central sensitisation or localised pain for focal damage.

Data collection and analysis Inadequate compliance with trial reporting standards constrained the data gathered for assessment of bias. Only two trials revealed information sufficient for CONSORT acceptability, and perhaps coincidentally the majority were conducted outside Europe or the United States.

Main results Pooling of results across conditions, done of necessity since just one condition studied was repeated in a synthesis, showed a consistent and significant improvement in subjective pain through a course of HBOT as short as two weeks. Limited availability of investigations reporting outcome of pain threshold does not detract from another consistent benefit being shown.

Authors' conclusions No result could be considered top-tier evidence, but significant benefit indicates that only a small group of participants is needed for future replication conducted with greater rigour. The potential for reversibility of the conditions is suggested by both enduring benefit and claims of amelioration due to rectified neural activity.

Plain language summary Hyperbaric Oxygen therapy (HBOT) for chronic neuropathic pain and fibromyalgia Studies on HBOT for Trigeminal Neuralgia (TN), Postherpetic Neuralgia (PHN), Complex Regional Pain Syndrome (CRPS), myofascial pain, radiation-induced brachial plexopathy (RIBP) and fibromyalgia (FM) are included in meta-analysis. The postulate of commonality apparent in overlap in symptoms, response to identical medications, and complications arising within these conditions is tested by a common intervention - regardless of pathophysiology.

Background Acute pain is the body's normal response to an aberrant stimulus of nociceptive sensors, but chronic pain commonly arises due to malfunctioning afferent nerves. Until mid-2014, the Cochrane Musculoskeletal (CMSG) and PaPaS groups jointly considered fibromyalgia and neuropathic pain under a category of chronic non-cancer pain. Carbamazepine for neuropathic pain and fibromyalgia [Wiffen 2014] was the last intervention reviewed prior to an editorial decision deeming availability of sufficient evidence specific to each condition. Hereupon CMSG and PaPaS reviews shall isolate FM and withhold reviews recently completed. Ongoing debate [Oaklander 2013, Üçeyler 2013] on the small-fibre pathology manifest in FM as being distinct from small-fibre neuropathy requires that an open-minded inclusiveness is currently warranted. This review evaluates the response to Hyperbaric Oxygenation in a multitude of conditions to determine any commonality. Appropriateness of meta-analysis is tested under heterogeneity in Summary of main results.

Description of the condition Neuropathic pain comes from damaged nerves, typically sensed as a burning or tingling, and several neuropathies are common in uncontrolled diabetes. Loss of epidermal endings and progressive denervation have been investigated at the Neuroscience Institute of Albany Medical College [Petersen 2010] in each of the conditions reviewed here. Dysautonomia is manifest in both Chronic Fatigue and FM syndromes, and multi-focal (or Wide Spread) pain is the

Review Manager 5.3

2


01-Jun-2015

Dysautonomia is manifest in both Chronic Fatigue and FM syndromes, and multi-focal (or Wide Spread) pain is the diagnostic for FM adopted by the American College of Rheumatology (ACR) in 2010. CRPS is characterised by oedema and peripheral pain, and within months vasoconstriction leads to irreversible ankylosis and osteoporosis. TN is idiopathic degeneration of the facial nerve causing stabbing pain radiating from the jaw. Confusion with temporo-mandibular joint disorder (TMJD), symptomatic in FM is to be expected since musculoskeletal disorders expertise belong neither to the domain of neurologists nor dentists. Myofascial pain pathophysiology is believed due to vasoconstriction at a muscular trigger point, again resulting in ischaemia. PHN results from 1 in 6 herpes zoster cases, arising due to viral invasion of nerves and inflammation of ganglions. Trigeminal and intercostal nerves are often affected long after any skin lesion has cleared. Radiation induced brachial plexopathy (RIBP) is irreversible limb paralysis resultant from treatment for breast cancer.

Description of the intervention HBOT chambers ordinarily used for diver decompression sickness deliver intermittent 100% oxygen by facial mask or hood over a half to two hour period at up to 3 ATA, corresponding to a 60ft dive. Five minute respite periods on normal air allow for conversation with the medical attendant. The brevity of hyperoxia leaves no residual oxidant concern, indeed is speculated to trigger anti-oxidant pathways [Thom 2009], elevating glutathione levels for adaptive protection. A common unexpected side-effect precluding treatment is barotrauma - due to inability or difficulty in equalising inner ear pressure. A screening for pulmonary risk is mandatory, as is specialist evaluation of the danger of oxygen toxicity in subjects.

How the intervention might work At 2ATA sufficient O 2 becomes dissolved in plasma as to meet all of a cell's needs without reliance upon haemoglobin. Denervation risk motivates urgent HBOT in order to prevent nerve necrosis in ischaemia/reperfusion injury, ischaemia lowering the concentration of adenosine triphosphate (ATP) concluding with irreversible loss of cell homeostasis. ATP elevation as being neuroprotective has been proposed [Sanchez 2007], alongside the concept of oxidative stress as in effect being a 'vaccinating'. Nitric oxide is a mediator in inflammatory hyperalgesia, its upregulation in HBOT being "paradoxical" in relief of pain. The anti-oxidant glutathione is dependent upon ATP for production. The rebound effect for glutathione in hyperoxidation was described a quarter century ago [Deneke 1989], but quality studies into HBOT for inflammatory or rheumatic disease are lacking. Insulin-like growth factor (IGF-1) plays an important role in vascular tone, in part by decreasing vasoconstrictor responses to agonists such as noradrenalin. An uncontrolled study of HBOT for diabetic foot ulcers, wound healing was associated with IGF-1 increase [Aydin 2013]. HBOT has been trialed for ulcers resultant from diabetic circulatory compromise, but a small uncontrolled HBOT trial for diabetic autonomic neuropathy (studying dysautonomia) hasn't yet been synthesised [Isguzar 2001].

Why it is important to do this review Fibromyalgia alone's diagnosed prevalence of 3%, with no promise of a cure and limited studies underway into medications which treat (rather than merely mitigate) the condition suggest that an active therapy has a niche opportunity to assist in disease turnaround. It is commonplace to find conditions passively treated by medications with questionable efficacy. A small (n=14) successful RCT of HBOT for cluster headache found immunoreactive substance P was halved in the intervention group [DiSabato 1996]. This trial is examined in review CDE005219, referenced in Agreements and disagreements with other studies or reviews. The speculative pathogenesis is of more densely innervated trigeminal fibers containing nociceptive and inflammatory substance P. This neuropeptide is overexpresed in rheumatoid arthritis and osteoarthritis, and upregulation is under investigation in psoriatic arthritis, systemic lupus erythematodes, systemic sclerosis, vasculitides, Sjogren syndrome, vasculitides, reflex sympathetic dystrophy, gouty arthritis, fibromyalgia syndrome, chronic fatigue syndrome and degenerative vertebral spine disorders [Seidel 2007]. The therapy's potential appears to be extensive. Diabetic neuropathy is treated by TCAs, SNRIs & SSRIs, and anti-convulsants are also prescribed for neuropathic pain. Comparisons are made with fibromyalgic pain by neurologists hypothesizing that similar sensory symptoms might be associated with similar mechanisms [Koroschetz 2011]. Approved fibromyalgia frontline medications are the

Review Manager 5.3

3


01-Jun-2015

might be associated with similar mechanisms [Koroschetz 2011]. Approved fibromyalgia frontline medications are the same - duloxetine, amitriptyline, and gabapentin. Meta-analysis of some of these anti-depressant therapies finds Number Needed to Treat (NNT) exceeds NN to Harm, with frequency of side-effects of weight gain, lethargy, and dizziness exceeding achievement of a cutpoint of a 50% reduction in pain [Hauser 2014]. This harm further constrains patient's participation in healthy activities. Since no resolution of FM has been found, medication remains palliative. Finding non-pharmacologic lasting benefit is vital to restoring individual empowerment for initiation of wellness strategies which can restore Quality of Life.

Objectives The aim of this review is to determine in which conditions analgesic efficacy is brought by HBOT.

Methods Criteria for considering studies for this review Types of studies Controlled trials, regardless of blinding, duration or reputation of journals in which published. Case studies or series weren't considered, and pilot studies using enriched enrolment designs were excluded due to overt selection bias. No determination specific to crossover trials was specified, nor was forethought given to Unit of Analysis issues which may arise.

Types of participants No age, gender or minimum participant numbers discrimination was applied.

Types of interventions A course of HBOT with comparator of either another physical therapy, pharmacotherapy, placebo or sham HBOT session. Therapy with O 2 at normal atmospheric pressure was excluded, as was a single session of HBOT on the rationale that tolerance of the therapy needs run-in testing.

Types of outcome measures An eclectic policy was applied to outcome selection, which reflected the exploratory nature of most trials. Study outcomes were particular to the condition being treated, and the uniqueness of disease prognosis led to secondary outcomes being gathered for meta-analysis wherever commonality was apparent. This review is focused on these two:

Primary outcomes No de-facto measures can be considered de rigueur in any trial's report for neuralgia outcomes, but selective reporting was assessed by checking differences between declared study protocols and results. Relief of pain as reported either collective score or NNT is a palliative benefit, albeit an impractical solution for reasons of cost and time commitment. NNH is a key adjunct to NNT in assessing comparative benefit of differing interventions for the one condition [Finnerup 2010] and although inapplicable to objectives in this situation, qualitative detail on adverse events is of interest.

Secondary outcomes The opportunity to resume activities which have potential for recovery of QoL at treatment conclusion is enhanced by a raised threshold to pain. Measurement of threshold by algometry, dolorimetry, or thermal tolerance was accepted. Also of interest is the enduring benefit from HBOT, the outcome measurements after however many months the subjects were followed up.

Search methods for identification of studies Review Manager 5.3

4


01-Jun-2015

Search methods for identification of studies Eligibility criteria was discussed with a hyperbaric chamber operator, per Acknowledgements.

Electronic searches - Medline MeSH search terms used Appendix 4: hyperbaric neuralgia pain pain management limit to (humans and (controlled clinical trial or randomized controlled trial)) ... 5/13 valid - EMBASE 'hyperbaric oxygenation'/exp OR 'hyperbaric oxygen' AND ('neuralgia'/exp OR 'neuralgia' OR 'pain') AND 'controlled trial' NOT ('cancer' OR 'headache') ... 3/47 valid - CENTRAL hyperbaric oxygen* AND (neuralgia OR fibromyalgia) ... 3/3 valid - ClinicalTrials.gov 'hyperbaric oxygen* pain' ... 2/13 valid Headache and migraine weren't used as arguments since there have been no new studies since Cochrane review CD005219 [Bennett 2008]. Comparing efficacy for these conditions alongside HBOT for Traumatic Brain Injury or stroke has more consistent therapy causality investigating the benefit of vasoconstriction, and again appropriate Cochrane reviews are available. CD005005 review of HBOT for the condition of Late Radiation Tissue Injury shares one study [Pritchard 2001] with this report.

Searching other resources The paucity of trials was the reason that cross-references cited by report authors duplicated those already found. Further handsearching of conference proceedings was unwarranted due to lack of their adherence to reporting standards.

Data collection and analysis Uncorrelated data gathering was a consequence of a lack of collaborators in this project.

Selection of studies No filtering criteria of participant age or locality, study size or duration was applied.

Data extraction and management The author takes sole responsibility for data entered into analyses, and objective assessments of quality. The secondary outcome of pain threshold was not pre-specified, but arose when found reported in four studies.

Assessment of risk of bias in included studies The assessment of bias in subjective pain studies requires even greater importance be placed on quality of the report [Moore 2010]. The standard tool RevMan5 bias dashboard has been modified to concatenate the two selection biases (Rsg: Random Sequence Generation and Acs: Allocation Concealment) into Sb. Randomised allocation will be further tested under review of baseline characteristics, since due to small participant numbers the elimination of bias due to imbalanced groups cannot be left to chance. Category Ob: Other bias has been replaced by Qc: Quality control and Cc: CONSORT compliance. Quality concerns are flagged wherever any errors of fact are apparent, by 'high risk' under Qc. If provided data demonstrates there was no opportunity for error then 'low risk' is given. The other inclusion, Cc scores 24 items (CONSORT checklist modified per Appendix 1) ranked by tertile for red/yellow/green rating.

Measures of treatment effect Review Manager 5.3

5


01-Jun-2015

Measures of treatment effect Mean difference in each group was by change in the average, pooled variance determined with Bessels correction. If dichotomous outcomes were evident, Odds Ratios are preferred in order to maintain compatibility with observational studies. Standardised Mean Difference (SMD) used in the forest plots, due to disparate scales.

Dealing with missing data There is no issue with Last or Baseline Observation Carried Forward since negligible dropout occurred. The commonest side-effect of the hyperbaric chamber is discomfort - intolerability of which would be apparent upon the first treatment.

Assessment of heterogeneity 2

Cochrane's Q as recalculated by I is chosen as the measure used to test the rationale of met-analysis across conditions. Since only the one condition of FM is studied twice for treatment by HBOT, then high inter-study variance of results is anticipated.

Assessment of reporting biases Coverage of CONSORT issues is included as a score in Bias-Cc above. Publication bias is unexpected because all trials are small in number, as a result of limited availability of the equipment.

Data synthesis Random effects model used in the meta-analysis, by virtue of disparate conditions being treated. Likewise, sensitivity analysis is precluded. Changes in continuous metrics are reported in outcome comparisons. The small number of small studies precluded sub-group analysis.

Results Description of studies All but one trial were parallel group Randomised Control Trials, the exception being a crossover RCT. Intention to Treat analysis considerations didn't arise since all control groups were placebo or sham treatments with HBOT.

Context of studies The team from Xijing hospital Dept of Anaesthesiology and Dallas Dept of Neurobiology focused on behavioral and neurochemical results on HBOT treated rats with induced sciatic nerve injury [Gu 2012]. Less detail is provided on their concurrent human trial of HBOT for TN patients. [Kiralp 2004], [Kiralp 2009], and [Yildiz 2004] teams from Gülhane Military Medical Academy Depts of Physical Medicine & Rehabilitation and Underwater & Hyperbaric Medicine (in various lineups of personnel) reported on CRPS, fibromyalgia and myofascial pain. [Peng 2012] from Dept of HBO at Xiangya hospital used HBOT as a preventative for PHN in conjunction with a standard, comprehensive medication regime. Primary outcomes specified for of all these trials were noncommittal declarations of 'general effect observation'. Israel's Assaf Harofeh Medical Center trialed HBOT for FM, in conjunction with Neuroimaging for verification of therapy's efficacy factored by subgroup of responders [Buskila 2013]. [Pritchard 2001] RIBP lobbyists within Radiotherapy Action Group Exposure in a collaboration with Institute of Naval Medicine, and Depts of Oncology and Radiotherapy from six English hospitals conducted the trial at Royal Hospital Haslar, of HBOT for a primary endpoint of sensory restoration.

Results of the search Figure 1 is the PRISMA flow diagram showing 12 records were reduced by 3 for ineligibility and another 2 for want of language translation.

Included studies

Review Manager 5.3

6


01-Jun-2015

Included studies Five studies treating with a pressure of 2.2 to 2.4ATA, one at 2ATA and one at 1.8 are less of a concern than the number of treatments ranging from 10 to 40. Considering that five conditions were investigated no conclusion can be drawn on intervention dosage, and variety in these factors awaits replicating studies. 117 males and 238 females reflects the higher or exclusive prevalence amongst women of fibromyalgia or RIPS. Of several assessor objective and patient subjective outcome metrics, five of the seven included studies shared a reported pain score. Three of these five performed a followup assessment after some months. Next most common outcome was the measuring of pain threshold - reported by four.

Excluded studies A positive trial of HBOT for diabetic neuropathic pain yielded positive results but English translation was unavailable [Mai 2007] (other than the abstract). It is filed as 'Awaiting Classification', and this limitation also applied to a Russian CRPS report with 35 participants [Tuter 1997]. Two studies on Chronic Fatigue Syndrome patients were uncontrolled or selectively controlled [Akarsu 2013; Van Hoof 2003], as was one on diabetic autonomic neuropathy [Isguzar 2001] measuring heartrate variability and cutaneous response by electromyelography.

Risk of bias in included studies The high quality of the RIBP report [Pritchard 2001] was of limited value, since only a secondary outcome was compatible with this review's purpose. This was also the only study to include result's median scores and a consideration of non-parametric analysis. Five other studies paid scant attention to reporting procedures regarding elimination of bias, but the one with highest grading compliance also provided self-report against CONSORT [Buskila 2013].

Allocation (selection bias) Pseudo-randomisation by alternate allocation was commonplace, and may be judged as prudent when participant numbers are low. Only the RIBP study adequately detailed procedures for randomisation sequence generation and measures taken to conceal allocation. Of the three other studies presenting patient baseline characteristics, a difference in pain threshold of the myofascial groups (p=0.07) is a concern [Kiralp 2009] regarding greater potential for recovery in the intervention arm. Significant differences in both education level and symptom severity could be found in FM patients [Buskila 2013]. The PHN groups appeared balanced.

Blinding (performance bias and detection bias) Sufficiency of participant's blinding in HBOT is unable to be examined in detail for placebo or nocebo effects due to limited empirical information for this intervention. Absence of any sham HBOT for the TN [Peng 2012] control group could result in attributing the majority of the effect to placebo, especially considering this study showed the least significant improvement in pain score among all trials. However the background four pharmacotherapies, ranging from opioids to anti-depressants confounds this issue also. [Buskila 2013] explains that oxygen saturation is increased 50% in normal air at 1.3ATA, hence they too opted against sham treatment. The control arm underwent the same therapy after the treatment arm concluded, following a crossover approach. Subjective reports were compared with SPECT imaging in order to detect performance bias.

Incomplete outcome data (attrition bias) A few dropouts among 355 participants is remarkably low attrition within the realm of chronic pain study [Moore 2010], particularly so when the personal disruption of attendance at a decompression centre is required for several weeks. No reply has been received to an author request sent Sept 2014 for both clarification of implied dropouts arising from subject numbers, and explanatory rationale of declared dropouts [Gu 2012, Kiralp 2004]. Two dropouts upon entry to the program due to side-effects [Peng 2012] of claustrophobia and facemask irritation is treated as an issue of Quality Control, since the numbers don't reflect this dropout.

Selective reporting (reporting bias)

Review Manager 5.3

7


01-Jun-2015

Selective reporting (reporting bias) Only two trials were registered and although the proposed McGill questionnaire was omitted the primary outcome measures corresponded to those reported, including pain VAS [Gu 2012]. McGill Pain was also a secondary outcome in the protocol for [Pritchard 2001] RIBP, which is cited for individual patients but missing in the collated results. The protocol attached as supplement to the PLoS report is datestamped over 1 year after the trial concluded [ Buskila 2013].

Inadequate reporting None of the studies offered interim measures during the treatment period, which is unfortunate since the number of treatments ranged from 10 to 40. Rather than being helpful in informing interim analyses, the benefit of progressive capture of effect is a vital input to duration and hence costing of a course of HBOT. This suggests a workaround to the impractical requirement for sham treatment of controls, by undertreating with reduced courses instead.

Other potential sources of bias Two major factual inconsistencies were evident from data audit, and a separate risk of Quality Control has been mod

created to draw attention here. The highest level of compliance with CONSORT was 16.5/24 items, rather poor overall but this was not perceived to have major bearing on results. The bias ranking was by tertile to draw attention to those reports' results having greater trustworthiness.

Effects of interventions Five of seven studies reported an outcome of pain by Visual Analogue Score (VAS), even if varied in their scale chosen. Self-evident forest plots are provided under Summary of main results. SMD and 95% CI for myofascial pain reduction was -2.11 (-3.06, -1.16), for FM -2.24 (-2.96, -1.52), for TN -1.35 (-2.03, -0.67), for CRPS -1.15 (-1.65, -0.64), and for PHN -0.59 (-1.08, -0.10). Concomitant pharmacotherapy by mecobalamin, IV antiviral, TriCyclic Anti-depressant and opioid [Peng 2012] as standard treatment on both PHN trial arms diluted the impact of the HBOT intervention adjunct. Nonetheless a statistically significant outcome was reported (p=0.046). The myofascial study [Kiralp 2009] still showed significant effect differences despite a control group's 100% O 2 treatment at 3/4 of the pressure of the lowest dosage HBOT intervention group for TN [Gu 2012]. This TN study was one to consider analgesia requests as an outcome, mean dosage of carbamazepine dropping from 320 at baseline to 200 mg/d for two months subsequent to the HBOT course. Another [Buskila 2013] was for FM, again demonstrating benefit in that after two months 11 among 19 users of analgaesic medication eliminated usage of at least one drug. Insufficient data is presented to permit calculation of NNT as sought in considering Why it is important to do this review.

Discussion Four comparisons are made under analyses, showing forest plots concatenating study outcomes of pain VAS reduction achieved consequent to HBOT and also after delayed followup, as well as pain threshold reported at treatment conclusion. A post-hoc decision was made to omit the fourth permutation of pain threshold after followup since there were only two studies and both the time periods and means of measurement were disparate. In brief, after 3 months a benefit was measured by algometry device [Kiralp 2009, p3 months sufferance of TN, MRI confirmation of diagnosis

Interventions

10 sessions by 1.8 ATA, 70min O2

Outcomes

VAS pain, analgesia requests

Notes

Investigation of HBOT for induced sciatic nerve injury in rats introduces TN trial on humans

Risk of bias table Bias

Authors' Support for judgement judgement

Selection bias

Unclear risk Baseline table missing

Blinding of participants and personnel (performance bias)

Unclear risk Sham pressure barely perceptible 1.1 ATA, otherwise good concealment

Blinding of outcome assessment Unclear risk Not described but claimed in protocol registration (detection bias) Incomplete outcome data (attrition bias)

High risk


Low risk

Quality control

High risk

mod

CONSORT

compliance

7 additional subject's data discarded due to unexplained incompleteness, and figure 5(c) legend shows data for only 22 patients? Close match between registered outcomes and reported. dose-response falsehood, SEM for age instead of SD error

Unclear risk 9.5/24

Kiralp 2004

Review Manager 5.3

12

Hyperbaric Oxygen for Neuropathic Pain and Fibromyalgia Methods

3 week treat, 1 month followup RCT

Participants

49 male, 22 female stage I or II CRPS (presumed military personnel)

Interventions

15 sessions at 2.4 ATA, ~90min O2

Outcomes

Pain, oedema and wrist Range Of Motion

Notes

Confounder treatments withheld. Atrophic stage III excluded.

01-Jun-2015


Authors' judgement

Support for judgement

Selection bias

Unclear risk

No baseline characteristics


Low risk

Blinding of outcome assessment (detection bias)

Unclear risk

Sham at full pressure Implied blinding by assessor

Incomplete outcome data (attrition bias) Unclear risk

Alternate allocation but unequal groups implies withdrawal due to contraindications


Low risk

Detailed outcome data provided

Quality control

Unclear risk

mod

CONSORT

High risk

compliance

6/24

Kiralp 2009 Methods

2 week, 3 month followup RCT

Participants

11 male, 19 female newly diagnosed with myofascial pain per Simons Criteria 1999

Interventions

Active 2.4 ATA / Control 1.3 ATA 100% O 2 for 10 sessions of 90mins each

Outcomes

Pain threshold & VAS, Pain Disability Index (& SF12)

Notes

Alternative medications withheld, exclusion: fibromyalgia, thoracic outlet syndromes


Authors' judgement

Support for judgement

Selection bias

Low risk

Baseline characteristics


Low risk

Controls not sham treated, instead administered a lowered dosage

Blinding of outcome assessment (detection bias)

Low risk

Independent

Incomplete outcome data (attrition bias) Low risk

Full participation


Mental & Physical factors for SF-12 analysed, and paired t-test shows statistical rigour

Review Manager 5.3

Low risk

13

Hyperbaric Oxygen for Neuropathic Pain and Fibromyalgia Quality control mod

CONSORT

01-Jun-2015

Unclear risk Low risk

compliance

10/24

Peng 2012 Methods

3 weeks, no followup RCT

Participants

34 male, 34 female herpes zoster duration