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    ABSTRACTHypothesis Plantar heel pain (plantar fasciitis) is acommon and disabling condition. A variety oftreatment options are available to patients withplantar heel, however the evidence for thesetreatments is generally weak and the best way tomanage plantar heel pain remains unclear. Triggerpoint dry needling is increasingly used as an adjuncttherapy for musculoskeletal pain. In patients withplantar heel pain this technique is thought toimprove muscle activation patterns, increase jointrange of motion and alleviate pain. However, therehave been no randomised controlled trials that haveevaluated the effectiveness of dry needling forplantar heel pain.Methods In order to develop a treatment protocolto evaluate the effectiveness of dry needling forplantar heel pain we conducted a three stagemodified Delphi process using a web-based surveytechnique. Over a series of three iterations,30 experts (participants) worldwide indicated theirlevel of agreement on specific issues relating to theuse of dry needling for plantar heel pain includingtheir treatment rationale, needling details andtreatment regimen. Consensus for a dry needling

    protocol for plantar heel pain was achieved when>60% of participants (IQR 1.0 category on 5-pointLikert scale) agreed the protocol was adequate.Results The response rate was 75% (n=30),100% (n=30) and 93% (n=28) in the first, secondand third rounds respectively. Round 1 helpedgenerate a list of 10 items that were deemedimportant for developing a dry needling protocol forplantar heel pain. These 10 items weresubsequently presented in Round 2. Of these, 5 ofthe 10 items met the criteria to be included in a dryneedling protocol for plantar heel pain that was

    presented in the final round, Round 3. Items that didnot meet the criteria were either removed oramended and then presented in Round 3. In the finalround, 93% of participants (IQR range = 1) agreedthe proposed dry needling protocol for plantar heelpain was adequate. The protocol can now be usedin future research projects designed to evaluate theeffectiveness of dry needling for plantar heel pain.

    BACKGROUND

    Despite the high prevalence of plantar heelpain13 and the detrimental impact it has on

    quality of life,4 the optimal treatment for this

    Consensus for dry needling for plantar heel pain(plantar fasciitis): a modified Delphi study

    Matthew P Cotchett, Karl B Landorf, Shannon E Munteanu, Anita M Raspovic

    Additional data are publishedonline only. To view these files

    please visit the journal online(http://aim.bmj.com).

    Department of Podiatry andMusculoskeletal ResearchCentre, La Trobe University,Melbourne, Victoria, Australia

    Correspondence toMatthew P Cotchett,Department of Podiatry andMusculoskeletal ResearchCentre, La Trobe University,Kingsbury Drive, Bundoora,Melbourne, VIC 3086, Australia;

    [email protected]

    Accepted 23 February 2011Published Online First18 April 2011

    disorder remains unclear.5

    Consequently, analternative adjunctive treatment such as trig-ger point dry needling is increasingly beingused by health practitioners.6

    Trigger point dry needling is an invasiveprocedure that involves stimulation of myo-fascial trigger points (MTrPs) using an acu-puncture needle.6

    The exact mechanism of action of dry nee-dling is still largely unknown; however, dryneedling has been shown to alter the biochem-ical environment surrounding a MTrP.7 In addi-tion, the elicitation of a local twitch responseusing dry needling has been shown to reducespontaneous electrical activity within theMTrP region of skeletal muscle in rabbits.8

    While these findings are important for under-standing how dry needling works, an equallyimportant question is whether dry needling iseffective in a clinical setting. A recent meta-analysis of randomised controlled trials foundthat dry needling and acupuncture of MTrPswas not significantly better than placebo.9However, the meta-analysis only included fourtrials and each trial scored poorly when assessed

    for quality.9 At this stage, therefore, the evi-dence for the effectiveness of dry needling formusculoskeletal pain is also uncertain.

    Clearly, there are few high-quality, ran-domised controlled trials that have evaluatedthe effectiveness of this intervention. With thisin mind, we recently conducted a systematicreview,10 but to widen the pool of informationwe included both randomised controlled trialsand quasi-experimental trials. Including non-randomised trials in systematic reviews can beappropriate when there are a limited number

    of randomised trials available.11 12

    Our reviewwas also different in that we focused on theuse of dry needling specifically for plantar heel.Our search identified two quasi-experimentaltrials that combined dry needling with acu-puncture.13 14 Both trials found a statisticallysignificant reduction in pain but the method-ological quality, as measured by the QualityIndex tool,15 was poor.

    Therefore, further good-quality evaluationsof dry needling are required to help informpractice. Importantly, to ensure these trialshave external validity, a treatment protocol is

    required that has a broad consensus from

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    experts practising in the area. Treatment protocols to eval-uate the effectiveness of acupuncture for tennis elbow16and depression17 have been developed by consensus,although at present no protocol for plantar heel pain hasbeen documented. The aim of this study was to seekinformation from experts who use dry needling for plan-tar heel pain, in order to develop a consensus-driven treat-

    ment protocol to be used in future clinical trials.

    METHODS

    Consensus methodApproval for this study was obtained from the La TrobeUniversity, Faculty of Health Sciences human ethics com-mittee (reference number FHEC09/200). A modifiedDelphi process was used to develop a consensus for use ofdry needling for plantar heel pain. This process attemptsto achieve a convergence of opinion among experts on aspecific topic, over a series of rounds or iterations.18 Theadvantage of this method is that participants remain anon-

    ymous during all rounds of the survey and can expressopinions without influence of dominant characters.18

    Selection of expertsLittle consensus exists for the definition of an expert andalso the criteria used to select experts for consensusstudies.19 We selected experts based on topics that havearisen in the literature, which have defined experts basedon knowledge, and the ability to influence policy.19 20

    Experts with knowledge of dry needling for plantar heelpain

    Therapists involved in the instruction and facilitation ofdry needling courses were considered leaders in the pro-fession with substantial knowledge of the study topic. Inaddition, the Delphi panellists also considered authors ofpeer-reviewed articles to be leaders within the profession,although there is no guideline to determine how manypeer-reviewed articles need to be published before anauthor is considered an expert.21 Nevertheless, someresearchers have used this criterion previously to selectexperts for consensus studies.22 For our study, we consid-ered the chief investigators of each of these publicationsto be experts and invited them to participate.

    Experts with the ability to influence policyTherapists who were members of a professional associa-tion and linked to an acupuncture and dry needling inter-est group were invited to participate. The Delphi panellistsconsidered these therapists to have first-hand experienceof dry needling with the potential to influence clinicalpractice guidelines within their profession.

    Methods to reduce bias in the selection of expertsTo minimise bias in selection of experts and increase theexternal validity of the study,19 we invited a heterogeneous

    sample consisting of therapists from multiple countries

    who practised varying treatment rationales. Invited partici-pants were also largely unknown to the Delphi panellists.23

    Expert identificationParticipants were identified in July 2009 using two meth-ods. First, a nomination process was used whereby well-respected individuals within the target population were

    chosen.24 For our study, a physical therapist with 17 yearsclinical experience, and the author of nine peer-reviewedarticles in the field of myofascial pain, nominated eighttherapists who she considered leaders within the profes-sion. Second, an internet search was performed by thechief investigator to locate dry needling courses taughtworld wide. The email address corresponding to thecourse and/or the course instructor(s) was identified andsaved for future correspondence. In addition, an internetsearch of acupuncture and dry needling special interestgroups within physiotherapy, osteopathy, myotherapy,podiatry and medical associations world wide, was con-

    ducted. Nominated experts and therapists linked to dryneedling courses and special interest groups were invitedby email to participate.

    The Delphi panellistsThe survey was constructed by two physical therapists,each with more than 8 years of dry needling experience andfour university-based podiatrists (the investigators on thisproject) with an average of 17 years of practice-related expe-rience, including the management of plantar heel pain.

    Procedure

    In order to develop a dry needling protocol, with specificdetails of needling techniques, we used a modified Delphiprocess that incorporated a structured questionnaire withthe opportunity for open-ended responses in round 1. Thisis a common method employed when there is adequateinformation about the issue of interest.25 Similar to a tradi-tional Delphi process, we developed a list of items inround 2 based on round 1 responses. However, instead ofasking participants to rank order or prioritise items inrounds 2 and 3 (ie, to develop consensus), we rephraseditems following round 2 based on highlighted themes.This approach is often undertaken in a modified Delphiprocess to move towards consensus.26

    Figure 1 highlights the flow of information throughoutthe study. The initial invitation contained a URL to theSurvey Monkey website (http://www.surveymonkey.com) that included the participant information sheet, con-sent form and round 1 of the survey. This website wasused to deliver the questionnaire in all rounds of the study.Participants were asked to complete the survey electroni-cally within 2 weeks of receiving the email. Up to tworeminders were sent to those participants who did notcomplete the survey in the prespecified time (2 weeks). Allparticipants provided electronic consent to participate.

    In round 1, participants answered a series of questions

    and provided comments relating to their use of dry nee-

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    dling for plantar heel pain (see online supplementaryfile 1). Each question related to a section of the STandardsfor Reporting Interventions in Controlled Trials ofAcupuncture (STRICTA) guidelines.27 After completedsurveys had been received by the chief investigator, thequantitative data and open-ended responses were analy-sed by the Delphi panel (see Data analysis below).

    In round 2, participants were presented with the results of

    round 1. The Delphi panel generated a list of 10 items con-

    sidered a priority for development of a dry needling protocolfor plantar heel pain taking into account round 1 responsesof the participants (see supplementary file 2). The 10 itemsselected were subjectively chosen by the panel; however,the items reflected the content of the STRICTA guidelines,which are heavily weighted toward reporting of needlingdetails and less to needling rationale, treatment regimenand use of co-interventions. Therefore, we asked partici-

    pants to answer eight statements relating to needling details

    Figure 1 Flow of information through the study.

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    and two to treatment regimen. No items relating to use ofco-interventions were incorporated because our plannedtrial was not designed to include alternative therapies.

    For nine of the 10 items, participants were required torate their level of agreement on a five-point Likert scale(from 1, indicating strongly disagree to 5, indicatingstrongly agree). For the 10th item, participants were asked

    to select the optimal needle retention time in minuteswhen dry needling for plantar heel pain.The findings of rounds 1 and 2 were used to form the

    round 3 questionnaire (see supplementary file 3). In thisfinal round (ie, round 3), a dry needling protocol for plan-tar heel pain was proposed. The protocol was presented inline with the STRICTA guidelines and included informa-tion relating to treatment rationale, needling details andtreatment regimen. Participants were asked to indicatetheir level of agreement with the proposed protocol.

    Data analysis

    In round 1, the Delphi panel analysed quantitative andqualitative data (ie, from the open-ended responses). Bothforms of data were exported to a Microsoft Excelspreadsheet and placed into a category linked to theSTRICTA guidelines. The categories included:

    Treatment rationale;1.Muscles dry needled;2.Depth of needle insertion;3.Number of needles inserted;4.Needle retention time;5.Manual needle stimulation;6.Needle response sought;7.Treatment regimen.8.

    For each category, the Delphi panel performed a thematicanalysis28 to identify and list key themes from open-endedresponses. In addition, data from the structured questionswere analysed for the percentage agreement for each state-ment. Items with >60% support were considered to have anacceptable level of agreement. The use of percentage mea-sures, to represent the collective responses of participants, isalso common in the Delphi process,21 although there is noconsensus on what percentage of participant responses con-stitutes an acceptable level of agreement.

    The combination of themes originating from open-ended responses and analysis of quantitative data from

    the structured questions helped form the round 2 ques-tionnaire, which was linked to the STRICTA guidelines.Items from round 1 that displayed >60% agreement wereincluded in the questionnaire while items with 60% of voteswithin the agree and strongly agree categories were

    considered to have an adequate level of consensus whileitems with an IQR>1.0 were considered to have a lowconsensus.2931 Item 10, which asked participants to dis-cuss needle retention time, was not analysed using an IQRbecause an answer to the question could not be measuredon a Likert scale (ie, an ordinal scale). Instead, the Delphipanellists analysed the percentage agreement in five time

    intervals (see supplementary file 2).At the end of round 2 consensus ratings and open-endedresponses were exported to a Microsoft Excel spreadsheetand placed into a category linked to the STRICTA guide-lines, similar to round 1. A thematic analysis wasundertaken to highlight the majority theme. Items thatdisplayed an adequate level of consensus (IQR1.0 and>60% of votes within the agree and strongly agree cat-egories) were considered an important component of adry needling treatment for plantar heel pain and were sub-sequently placed in a protocol presented to participants inround 3. The Delphi panel discussed items that displayeda low level of consensus and a decision was made to

    rephrase or remove each item so that a move towardsconsensus could be achieved. The rephrased item wasthen included in a protocol that was presented in round 3.The procedure to rephrase items between rounds is a pro-cess not uncommon to a Delphi process and has been usedin a study that explored the use of specific statistical teststo measure consensus among a group of participants.26

    The protocol presented in round 3, consisted of 10 items.Each item was based on sections outlined in the STRICTAguidelines. Consensus for the proposed dry needling pro-tocol for plantar heel pain was achieved if >60% of par-ticipants (IQR1) agreed that the protocol was adequate

    for a clinical trial to evaluate the effectiveness of dry nee-dling for plantar heel pain.

    RESULTS

    Round 1The response rate was 75% (n=30). Of the 75% who didrespond, the chief investigator knew four participantspersonally and the other three members of the Delphipanel knew none. Of the 30 participants, the majoritywere from Australia 53% (n=16) while nine othercountries were represented including the UK 10% (n=3),USA 10% (n=3), Spain 7% (n=2), Belgium 3% (n=1),

    Ireland 3% (n=1), Japan 3% (n=1), The Netherlands 3%(n=1), New Zealand 3% (n=1) and South Korea 3% (n=1).An invitation was also sent to therapists in Brazil, Canada,Denmark, Germany and Turkey but none responded.

    The results of round 1 are presented in table 1. In regardsto treatment rationale, 93% (n=28) of participants prac-tised dry needling according to the MTrP model. However,33% (n=10) of participants practised MTrP dry needling incombination with the radiculopathy model; 7% (n=2)with traditional Chinese acupuncture; 3% (n=1) withWestern medical acupuncture; 3% (n=1) with the Baldrytechnique and 3% (n=1) with a layering approach. Two

    participants did not employ the MTrP model but ratherapplied a neurophysiological approach.

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    Table 1 Round 1 findings*: a breakdown of participants responses to specific details relating to dry needling for plantar heel pain

    (N=30)

    Section of STRICTA guidelines Item from round 1 questionnaire Response to item n %

    Treatment rationale Model MTrP model 28 93.3

    Radiculopathy model 10 33.3

    Other 6 20

    Non-responders 0

    Dry needling details Muscles dry needled Soleus 24 80

    Quadratus plantae 22 73.3

    Gastrocnemius 21 70

    Abductor hallucis 17 56.7

    Flexor digitorum brevis 17 56.7

    Posterior tibial 10 33.3

    Flexor digitorum longus 10 33.3

    Abductor digiti minimi 9 30

    Multifidus 8 26.7

    Flexor hallucis longus 7 23.3

    Peroneus longus 7 23.3

    Non-responders 0

    Needle length and diameter Depends on muscle dry needled 27 90

    Other 3 10Number of insertions per muscle 1 2 6.7

    2 11 36.7

    3 8 26.7

    4 2 6.7

    5 3 10

    10 1 3.3

    Non-responders 3 10

    Needle response(s) sought Local twitch response 26 86.7

    Dull ache, heaviness, distension 28 93.3

    Needle grasp 26 86.7

    Jump sign 22 73.3

    Non-responders 1 3.3

    Needle retention time (minutes)

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    When questioned about needling details there was sub-stantial variability among participants for (1) muscles dryneedled (a total of 35 different muscles (mean=7, SD=6)were usually dry needled for plantar heel pain); (2) opti-

    mal needle retention time (range

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    were more consistent for depth of needle insertion; use ofmanual needle stimulation; type of response elicited andfrequency of treatment following the first consultation.

    Based on the results of round 1, participants in round 2were informed that the MTrP model would be adoptedfor use during subsequent development of the dry nee-dling treatment protocol as 93% of participants usedthis rationale. In addition, as the range of muscles dryneedled by participants was large (35 in total) it wouldnot be possible to effectively dry needle 35 different

    muscles in a standard consultation of 2030 min. As theaim of the study was to develop a treatment protocolthat could be pragmatically applied in a clinical setting,the Delphi panellists presented two items in round 2(items 1 and 2) to determine if participants would prefera trial that was (1) standardised,32 with a fixed numberof muscles to be dry needled; (2) semistandardised,33which would include a set number of muscles and anadditional prespecified list of muscles that could beassessed based on the participants presentation or(3) pragmatic,34 which would involve dry needling anymuscle that was clinically relevant. Participants werealso given the opportunity to respond to these items inan open-ended manner.

    Table 3 Explanation for amending items that did not meet consensus criteria in round 2 (amended for round 3)

    Item from round 2 to be amended for round 3 Explanation for amending the item

    Item 2

    To ensure that a total of five muscles are dry

    needled, assessment and dry needling of additional

    muscles including ADM, TP, FHL, FDL, PL, EHL, EDL,

    TA, PB, PT, G Med and/or G Min, would be adequate

    in the treatment of plantar heel pain?

    Participants were reluctant to standardise treatment and limit the total number of muscles to be

    dry needled to five, as this would not normally occur in clinical practice. Hence, to increase

    external validity of a clinical trial we proposed that synergists, antagonists and more proximal

    muscles, which might impact on Sol, Gastroc, QP, FDB and Abd H should be assessed and dry

    needled if MTrPs were present

    Item 6

    The intensity of needle stimulation should be

    increased if the patient has had a poor response and

    there was no exacerbation of symptoms following the

    previous visit?

    50% (IQR>1.0) of participantsagreedorstrongly agreedwith item 6. However, a number of

    participants stated that a poor response to treatment should be followed by a revision of the

    treatment plan rather than increasing the intensity of needle stimulation. Therefore, item 6 was not

    presented in the proposed treatment protocol. Instead, we suggested that if a patient has a poor

    response to dry needling, the patient should be reassessed and MTrPs in other muscles treated

    Item 8

    During the course of a clinical trial, treatment

    should be stopped if the participants symptoms

    resolve before the course of the dry needling

    treatment?

    63% (IQR>1.0) of participants agreed or strongly agreed with item 8, although some participants

    suggested that cessation of treatment should reflect resolution of symptoms and also clinical

    findings relevant to the presenting complaint. A statement in round 3 was generated to reflect this

    opinion

    Item 9

    The duration of needle insertion is shortened if thepatient is sensitive to needle stimulation?

    57% (IQR>1.0) of participantsagreedorstrongly agreedwith item 9. To accommodate a widerrange of opinions, we proposed that manual stimulation of the acupuncture needle should be

    reduced if the patient is sensitive to needle stimulation. If this action is insufficient to reduce the

    painful stimulus, the manipulation should be stopped and the needle left in situ for 5 min. If the

    painful stimulus is still not tolerated by the patient the needle should be removed

    Item 10

    On average, following manual stimulation of the

    acupuncture needle to produce an appropriate

    response, how long would you leave the needle

    in situ?

    As there was divergence of opinion in response to this statement and as there is no current

    recommendation for optimal needle retention time for dry needling MTrPs associated with plantar

    heel pain, we proposed that the needle remain in situ for 5 min, after an appropriate response had

    been achieved. This needle retention time would accommodate 75% of responses to item 10

    Item numbers displayed in table 3 correspond to the item numbers presented in table 2.

    Abd H, abductor hallucis; ADM, abductor digiti minimi; EDL, extensor digitorum longus; EHL, extensor hallucis longus; FDB, flexor digitorum brevis; FDL,

    flexor digitorum longus; FHL, flexor hallucis longus; G Med, gluteus medius; G Min, gluteus minimus; Gastroc, gastrocnemius; MTrP, myofascial trigger

    point; PB, peroneus brevis; PL , peroneus longus; PT, peroneus tertius; QP, quadratus plantae; Sol, soleus; TA, tib ialis anterior; TP, tibialis posterior.

    Round 2All 30 participants (100% response rate) completed thesurvey in round 2. Five of nine items (item numbers 1, 3, 4,5 and 7) met the criteria to be included in the dry needlingprotocol that was to be proposed in round 3 (table 2).

    Substantial variability was evident for the optimal nee-dle retention time. Based on the findings in round 2, a dryneedling protocol for plantar heel pain was presented inround 3 rather than a third structured survey. Items thatdid not meet the criteria for inclusion in the protocol

    proposed in round 2, were either removed or amendedand then presented in the final round, round 3. Table 3provides an explanation for amendment of items that dis-played substantial variability in responses.

    Round 3Twenty-eight participants (93% response rate) completedthe survey in round 3. One participant failed to respondand the Delphi panellists excluded another because theparticipant did not routinely use dry needling as a first-line management for plantar heel pain. The median levelof agreement was 4 on a five-point Likert scale (IQR=1).Ninety-six per cent of respondents either strongly agreed(29%, n=8) or agreed (68%, n=19)with the proposed pro-

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    tocol, which was developed with a clinical trial to evalu-ate the effectiveness of dry needling for plantar heel painin Mind. Only 4% (n=1) disagreedwith the proposed pro-tocol. Table 4 provides a detailed description of the dryneedling treatment protocol based on the results of theprevious two rounds. After completion of round 3, theDelphi panel decided to exclude the posterior tibial mus-cle as a structure to be dry needled owing to a recent pub-lication that highlighted the hazardous nature of needling

    the this muscle without ultrasound guidance.35

    DISCUSSION

    In preparation for future clinical trials to evaluate the effec-tiveness of dry needling for plantar heel pain, we con-ducted a modified Delphi process to develop and obtainconsensus for a dry needling protocol. Experts in the useof dry needling for plantar heel pain, from varying alliedhealth and medical backgrounds, participated in this proj-ect by indicating their level of agreement about specificdry needling topics. Questions put to the participants werein accordance with the STRICTA recommendations.27

    After a series of three rounds, 93% of the experts sur-veyed agreed that the dry needling protocol proposed

    would be adequate for a clinical trial to evaluate the effec-tiveness of dry needling for plantar heel pain. As far as weknow, this is the first study to have established a protocolfor the use of dry needling for plantar heel pain. The pro-tocol provides a detailed outline of a dry needling treat-ment, including treatment rationale; muscles to beassessed; type of acupuncture needle used; depth of needleinsertion; needle response elicited; use of manual needlestimulation; needle retention time; frequency and total

    duration of treatment.Although not a limitation, the final protocol established

    by consensus underwent one minor modification afterround 3 without approval from the Delphi participants.The Delphi panellists removed the posterior tibial muscleas a structure that might be assessed and if appropriate,dry needled. This was in response to a recent study rec-ommending that needle insertion into the tibialis posteriorshould only be undertaken using ultrasound guidanceowing to close proximity of neurovascular bundles.35

    The study also needs to be viewed in light of some limi-tations. First, the criteria used to select experts might nothave adequately identified participants with sufficientclinical experience. The criteria set were based on themes

    Table 4 Dry needling protocol for plantar heel pain that was presented in the final round, round 3

    Consultation Treatment will be conducted within a 30 min timeframe. The participant will be lying down.

    Rationale MTrP model

    MTrP diagnosis Criteria used to identify a MTrP will include a list of essential criteria and a list of observations that help confirm the presence of a

    MTrP.23 A flat palpation or pincer grip technique will be used to locate a MTrP24

    Dry needling details (1)Brand of acupuncture needle: Seirin J-Type or Hwa-To Ultraclean

    (2)Muscles to be dry needled. Muscles to be assessed first will include those harbouring MTrPs that might be responsible for the

    participants pain, including the Sol, QP, FDB and Abd H muscles. Synergists and antagonists of these muscles will also be

    assessed for MTrPs. These muscles will include the Gastroc, FDL, FHL, TP, PL, PB, TA, EHL, EDL, Add H, Abd Dig Min, Lb and

    Int. In addition a search will be undertaken for MTrPs in muscles which might be influencing the participants loading of the

    aforementioned muscles. These muscles will include the Pf, G Max, G Med, G Min, TFL, AL, AM, AB, ST, SM and BF

    (3)Needle length and diameter. Needle length will be determined by the location of the MTrP to be dry needled. Most commonly

    the needle length will range from 30 to 75 mm. The diameter of the needle will be 0.30 mm but will be varied depending on the

    participants tolerance to insertion of the needle. A smaller diameter needle may be used if needle insertion is uncomfortable

    (4)Needle insertions per muscle. The number of needle insertions per muscle will depend on the number of MTrPs to be dry

    needled; participants tolerance to needle insertion; responsiveness of the tissue to dry needling and level of postneedle

    soreness for a specific muscle

    (5)Response elicited. Dry needling of a MTrP will attempt to elicit an appropriate response such as a local twitch response;

    sensation such as a dull ache, heaviness, distension, pressure or bruising and/or a reproduction of the participants symptoms.

    If an appropriate response is not elicited the needle will be removed and the participant re-examined

    (6)Manipulation of the acupuncture needle. Following insertion, the acupuncture needle will be withdrawn partially and advancedrepeatedly to produce an appropriate response. If the participant is sensitive to insertion of the needle the manipulation will be

    reduced. If this action is insufficient to reduce the painful stimulus, the manipulation will be stopped and the needle left in situ.

    Alternatively, the needle may be replaced with a needle that has a smaller diameter

    (7)Needle retention time. The needle will remain in the muscle for as long as it takes to produce an appropriate response and is

    tolerated by the participant. Once this has occurred the needle will be left in situ for 5 min. This will allow sufficient time for

    the stimulus to subside in participants who are sensitive to the treatment

    Treatment regimen The clinical trial will involve one treatment a week for 6 weeks. Treatment will be stopped if a participants symptoms resolve

    before the course of the dry needling treatment. However, if a participant experiences a relapse within the 6-week treatment

    period they will be offered further weekly treatment (s) until the end of the 6-week course.

    AB, adductor brevis; Abd H, abductor hallucis; Add H, adductor hallucis; AL, adductor longus; AM, adductor magnus; BF, biceps femoris; EDL, extensor

    digitorum longus; EHL, extensor hallucis longus; FDB, flexor digitorum brevis; FDL, flexor digitorum longus; FHL, flexor hallucis longus; G Max, gluteus

    maximus; G Med, gluteus medius; G Min, gluteus minimus; Gastroc, gastrocnemius; Int, interossei; Lb, lumbricals; MTrP, myofascial trigger point;

    PB, peroneus brevis; Pf, piriformis; PL, peroneus longus; QP, quadratus plantae; SM, semimembranosus; Sol, soleus; ST, semitendinosus; TA, tibialis anterior;TFL, tensor fascia latae; TP, tibialis posterior.

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    that are commonly used to define experts.19 Although webelieve that the criteria were sufficient to identify experts,we did not set a criterion for the minimum number ofyears of clinical and/or research experience required forinclusion in the study. While 63% of participants hadpractised dry needling for >5 years, 37% of participantshad practised dry needling for less than this. It might be

    argued that practitioners with 1.0), it would have been shownby greater disagreement at this stage.

    CONCLUSION

    In preparation for future clinical trials, a modified Delphi

    process was used to develop and obtain consensus for adry needling protocol for plantar heel pain. The vast major-ity of participants agreed that the proposed protocol,including treatment rationale, needling details, frequencyand total duration of treatment was adequate for use in aclinical trial to evaluate the effectiveness of dry needlingfor plantar heel pain. The protocol can now be used infuture research projects designed to evaluate the effective-ness of dry needling for plantar heel pain.

    Competing interests None.

    Ethics approval This study was conducted with the approval of the La Trobe Univer-sity human ethics committee.

    Provenance and peer review Not commissioned; externally peer reviewed.

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    We plan a trial of dry needling acupuncture for plantar

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    We conducted a modified Delphi study to establish a

    consensus for treatment

    Three rounds of consultation generated a protocol with

    93% agreement

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