Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effects (benefits and harms) of acupuncture and related interventions (e.g. acupressure, electrotherapy and moxibustion) for treating plantar heel pain in adults.
Background
Description of the condition
Plantar heel pain is commonly known as heel spur syndrome, plantar fasciitis or plantar fasciosis. These terms describe the common pathology that results in pain and tenderness along the proximal plantar fascia (thick connective tissue which sustains the arch of the foot) and its attachment at the extremity of the heel bone (Thomas 2010). The pain is exacerbated by passive dorsiflexion of the toes, standing on tiptoes and weight bearing, especially immediately after a period of rest, such as when rising from bed in the morning (Barrett 1999; Perez‐Millan 2001). Chronic plantar heel pain can have a substantial negative effect on foot‐specific and general health‐related quality of life, regardless of age, gender or body mass index (Irving 2008).
Plantar heel pain is one of the most common complaints among patients who see foot and ankle specialists (McPoil 2008). It is estimated that 10% of the population will experience this condition at some time during their lives (Crawford 2005). Plantar heel pain leads to one million patient visits to office‐based physicians or hospital outpatient departments per year in the United States (Riddle 2004). Up to 8% of injuries due to sporting activities and 25% of all foot injuries in runners have been found to be related to plantar heel pain (Barrett 1999; Lysholm 1987).
The aetiology of plantar heel pain is unclear and is thought to be multifactorial. The most common cause is excessive biomechanical stress of the plantar fascia and the area at which the fascia inserts into the heel bone (Thomas 2010). The plantar fascia is a broad, fibrous tissue that spans the space between the tuberosity of the heel bone and the proximal phalanges of each toe. Repetitive micro‐trauma of the tissue, such as micro‐tears at the calcaneal enthesis (fascia insertion site at the heel bone), triggers inflammation and degeneration of the plantar fascia (Cornwall 1999; Cotchett 2010). Stress related to work habits, increased age and body mass index, decreased ankle and first metatarsophalangeal joint range of motion and excessive periods of weight‐bearing activity can aggravate the symptoms of heel pain (Irving 2006; Thomas 2010).
Initial treatment options for plantar heel pain include Achilles tendon and plantar fascia stretching exercises, padding and strapping of the foot, orthotic insoles, oral anti‐inflammatories and a corticosteroid injection (McPoil 2008; Thomas 2010). If patients notice improvements in their symptoms within six weeks, the initial therapy is continued until the remaining symptoms are eliminated. If little to no improvement is noted after several months, surgery may be considered (Thomas 2010).
Description of the intervention
Acupuncture is generally defined as an intervention that stimulates specific points on the body with needles (Mayor 2007). Acupuncture has a long history of use in eastern Asian countries, such as China and Korea. Traditionally, the use of acupuncture has been based primarily on the Qi theory, where the insertion of needles at appropriate acupuncture points correct imbalances of Qi, which is a 'substance' that flows through the human body, and thereby facilitate recovery from illness (White 2008;WHO 2007). Acupuncture treatment consists of two components: acupuncture points (from the perspective of traditional Chinese medicine) and needling. Acupuncture related interventions are defined according to these two components: i.e. use of acupuncture points alone (e.g. laser acupuncture, acupressure or moxibustion) and use of needling alone (e.g. dry needing at myofascial trigger points (MTrPs)).
How the intervention might work
The mechanism of acupuncture anaesthesia remains unclear. In Western medical acupuncture, the mechanisms of acupuncture are explained by five elements: local effects, segmental analgesia, extra‐segmental analgesia, central regulatory effects and MTrPs (White 2008). Mechanisms that could explain the effect of acupuncture on pain relief have been suggested by scientific research. 'Local effects' of acupuncture are thought to stimulate the free nerve endings that release several vasoactive neuropeptides (Carlsson 2002; White 2008) and the connective tissues that induce the mechanical signal transduction that causes cell secretion (Langevin 2006). Recently, a study reported that adenosine A1 receptors may mediate the local anti‐nociceptive effects of acupuncture (Goldman 2010). In terms of 'segmental analgesia', acupuncture stimulation in the same segmental region of the pain can induce segmental analgesia that is based on the pain gate control theory (White 2008). The pain relief associated with 'extra‐segmental analgesia' of acupuncture can be explained by release of opioid peptides such as β‐endorphin and descending inhibitory pain control that inhibits the nociceptive pathway by releasing serotonin and noradrenaline (Han 2004; White 2008). Another theory of acupuncture analgesia is that the limbic system, which is responsible for the affective component of pain, is 'centrally regulated' by acupuncture stimulation (White 2008). Lastly, the biochemical environment surrounding 'MTrPs' might be altered by needling, and reduced spontaneous electrical activity within the MTrPs has been shown by the elicitation of a local twitch response (Cotchett 2011a).
Why it is important to do this review
The effectiveness of acupuncture for treating plantar heel pain has recently been systematically reviewed with a focus on dry needling and/or injection of MTrPs (Cotchett 2010). The results of this review were inconclusive. However, in addition to MTrPs, various methods of stimulation (manual, electric, laser, pharmacologic and thermal) have been used at different acupuncture points (distal, local and MTrPs). The clinical usage of acupuncture for treating plantar heel pain is becoming more common; however, the effectiveness and safety of acupuncture for this purpose remain uncertain (Cotchett 2011). Therefore, this review aims to provide a critical examination of the evidence for the effectiveness of acupuncture and related interventions for treating plantar heel pain.
Objectives
To assess the effects (benefits and harms) of acupuncture and related interventions (e.g. acupressure, electrotherapy and moxibustion) for treating plantar heel pain in adults.
Methods
Criteria for considering studies for this review
Types of studies
Randomised and quasi‐randomised controlled trials (i.e. methods of allocating participants that are not strictly random such as patient's date of birth or hospital record number) in which acupuncture and related interventions were used to treat adults with plantar heel pain will be included. Non‐randomised controlled trials and uncontrolled trials (e.g. case studies) will be excluded.
Types of participants
Adults experiencing plantar heel pain will be included. We will include trials with children provided it is clear that the majority of the trial population were adults (over 18 years). We will exclude trials treating children only or aimed at treating traumatic pain, such as fracture, post‐operative pain and conditions such as benign and malignant tumours or posterior heel pain caused by insertional Achilles tendinopathy, enthesopathy or Haglund’s deformity.
Types of interventions
Acupuncture treatment using various types of stimulations, including handling (manual acupuncture), electricity (electroacupuncture) and heating (fire or warm needling), will be included. All types of acupuncture related interventions involving use of needling or acupuncture points, such as laser acupuncture, pharmaco‐acupuncture, moxibustion (heating the herb mugwort), dry needling at non‐acupuncture points (e.g. MTrPs) and non‐penetrating acupuncture point stimulation (e.g. acupressure and magnets), will be considered. Trials that compare acupuncture or acupuncture related interventions with the following regimens will be included.
Placebo (e.g. sham acupuncture) or no treatment
Oral inflammatory medication
Injection (e.g. local anaesthetics, corticosteroids, botulinum toxin, platelet rich plasma or autologous blood)
Achilles and plantar fascia stretching, or other exercises or manual therapy
Extracorporeal shock wave therapy
Therapeutic orthotic insoles or padding and strapping of the foot
Any combination of the above interventions
We will include trials irrespective of whether the participants of both comparison groups receive no other treatment or whether they receive other care, including usual adjunct care such as medication and education. We will exclude trials that compare different types of acupuncture or acupuncture related interventions.
Types of outcome measures
Primary outcomes
Heel pain: assessed using a validated scale (e.g. visual analogue scale (VAS), numeric rating scale (NRS) score). Where data are available, the primary assessment will be 'first‐step' pain.
Ability of physical functioning: will be assessed using the any standard validated scale. Preference will be given to the disability scale associated with the Foot Function Index (FFI) or the Foot Health Status Questionnaire (FHSQ).
Serious adverse events (e.g. plantar fascial rupture/tear, infection or nerve damage).
Secondary outcomes
Heath‐related quality of life (HRQoL), as assessed using any standard validated scale (e.g. the 36‐Item Short Form Health Survey (SF‐36)).
Other adverse events related to acupuncture treatment (e.g. bleeding, pain, bruising or allergic reactions).
Return to previous level of activities of daily living or to work.
Global measure of improvement (e.g. overall improvement or proportion of patients recovered).
Analgesic usage.
Search methods for identification of studies
Electronic searches
We will search the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (The Cochrane Library), MEDLINE, EMBASE, the Physiotherapy Evidence Database (PEDro), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED), China National Knowledge Infrastructure databases (CNKI) and Korean medical databases (Korean Association of Medical Journal Edition (KAMJE), Korean Medical Database (KMBASE), Korean Studies Information Service System (KISS), National Discovery for Science Leaders (NDSL), Korea Institute of Science and Technology Information (KISTI), DBpia, Korean National Assembly Digital Library (KNADL), Oriental Medicine Advanced Searching Integrated System (OASIS) and Korean Traditional Knowledge Portal). Search strategies for The Cochrane Library and MEDLINE are shown in Appendix 1.
We will also search the WHO International Clinical Trials Registry Platform (ICTRP) Search Portal for ongoing and recently completed studies.
No language or publication status restrictions will be applied.
Searching other resources
Bibliographic references in relevant publications (e.g. foot and ankle textbooks, clinical guidelines of plantar heel pain, review articles and included trials) will be examined.
Data collection and analysis
Selection of studies
Two review authors (SL and JK) will independently screen titles and abstracts for potentially eligible studies, for which full reports will be obtained. Based on these, the same two authors will independently perform study selection and record their decisions using a standard eligibility form. We will resolve disagreements through discussions with the other authors and with the arbiter (TK).
Data extraction and management
Two review authors (SL and JK) will independently extract the data using a standard data extraction form. The authors will use Review Manager (Revman 2011) for data entry and management. Any disagreement between the authors will be resolved by discussion or consultation with all authors. If there are insufficient or missing data, we will contact the corresponding authors of the trials.
Assessment of risk of bias in included studies
Two review authors (SL and JK) will independently evaluate the risk of bias in the included studies using The Cochrane Collaboration's 'Risk of bias' tool (Higgins 2011). Any disagreement between the authors will be resolved by discussion or consultation with all authors. The following domains will be evaluated: sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, completeness of outcome data reporting, selective outcome reporting and other sources of bias. The risk of bias for individual domains will be judged as 'low risk', 'high risk' or 'unclear'.
While it is difficult, although not impossible, to blind practitioners in acupuncture trials, the blinding of the participants and assessors is possible and should be considered to be the ideal (MacPherson 2007; White 2001). We will not give a low risk of bias judgement where a placebo has been used, unless other supporting evidence is provided for successful blinding.
Measures of treatment effect
For continuous data (e.g. VAS, NRS, functional improvement scores or HRQoL scores), we will use either the mean difference (MD) or, if the same outcome variables were calculated with different methods and scales, the standardised mean difference (SMD) to measure the treatment effect with 95% confidence intervals. For dichotomous outcomes (e.g. yes or no, improved or not improved), the risk ratio (RR) will be used to measure the treatment effect with 95% confidence intervals. For ordinal outcomes (e.g. none, mild, moderate or severe), if the number of categories increases, we will analyse outcomes that are similar to continuous outcomes; otherwise, ordinal outcomes will be converted to dichotomous outcomes (e.g. responder or non‐responder).
Unit of analysis issues
Unit of analysis issues may arise in studies that include participants with bilateral heel pain. Should these occur and no adjustments can be made, we will perform sensitivity analyses to explore the effects of including these data and trials in the review. If cross‐over trials (e.g. allocating each participant to a sequence of interventions) are included, we will only assess data from the first phase to prevent carry‐over effects. In the case of repeated observations at different follow‐up times, we will categorise the data into three periods of follow‐up, specifically: short‐term (within four weeks), middle‐term (up to six months) and long‐term (more than six months) and present these separately.
Dealing with missing data
In cases in which there are missing data, we will consider why the data are missing. Whenever possible, we will contact the original study authors to request missing data. Where possible, we will conduct intention‐to‐treat (ITT) analysis. Unless we can derive missing standard deviations from standard errors, exact P values or 95% confidence intervals, we will not impute these. Where possible, a sensitivity analysis will be conducted, and we will address the potential impact of missing data in the discussion section of the review (Higgins 2011).
Assessment of heterogeneity
Heterogeneity between different studies will be assessed by visually inspecting the forest plot, performing a Chi² test with a level of significance of P < 0.10 to determine statistical significance. To quantify inconsistency across trials, the I² statistic will be calculated. Our interpretation of the I² results will follow that as suggested in Higgins 2011: 0% to 40% might not be important; 30% to 60% may represent moderate heterogeneity; 50% to 90% may represent substantial heterogeneity; and 75% to 100% may represent considerable heterogeneity.
Assessment of reporting biases
If a sufficient number of included studies (at least 10 trials) are available, we will use funnel plots to detect reporting biases (Higgins 2011). Funnel plot asymmetry is not the same as publication bias; therefore, we will attempt to distinguish the different possible reasons for the asymmetry such as small‐study effects, poor methodological quality and true heterogeneity of included studies (Egger 1997; Higgins 2011).
Data synthesis
When considered appropriate, results of comparable groups of trials will be pooled using both fixed‐effect and random‐effects models. The choice of the model to report will be guided by a careful consideration of the extent of heterogeneity and whether it can be explained, in addition to other factors such as the number and size of studies that are included. Ninety‐five per cent confidence intervals will be used throughout. We will consider not pooling data where there is considerable heterogeneity (I² > 75%) that cannot be explained by the diversity of methodological or clinical features among the trials.
Subgroup analysis and investigation of heterogeneity
To interpret the heterogeneity between studies, subgroup analysis will be conducted if there is an adequate number of studies (at least 10 trials). We have prespecified the following subgroups and their characteristics to reduce the likelihood of misleading findings.
Duration of plantar heel pain (acute: up to three months; chronic: more than three months)
Type of intervention (e.g. manual acupuncture, electroacupuncture, laser acupuncture, acupress and moxibustion)
Type of acupuncture points (traditional acupuncture points based on the theory of traditional Chinese medicine or medical acupuncture points, such as MTrPs)
Type of control (sham/placebo acupuncture, conventional treatment/usual care or no treatment)
Duration of follow‐up (short‐term, medium‐term or long‐term). If a trial presents data from more than one follow‐up time, we will only include the final follow‐up data for that trial in the subgroup analysis.
The overlap of the confidence intervals for the summary estimates and the significance tests implemented in the RevMan software will be used to investigate differences between subgroups (Higgins 2011).
Sensitivity analysis
If a sufficient number of studies are available, we will conduct sensitivity analyses to identify whether the findings are robust to the decisions made in the review. Sensitivity analyses will be performed to assess the effects according to following study characteristics:
Sample size (e.g. more or less than 30 participants in each group)
Methodological qualities (sequence generation, allocation concealment and participants/assessors blinding)
Statistical method (random‐effects model versus fixed‐effect model)
Analysis‐related issues (processes to handle missing data, effects of including skewed data and adjusted or unadjusted estimates of treatment effect)
'Summary of findings' tables
Where there are sufficient data, we will summarise the results for the main comparisons described in Types of interventions in 'Summary of findings' tables. We shall use the GRADE approach to assess the quality of evidence related to each of the primary outcomes listed in Types of outcome measures (Higgins 2011; see 12.2).
Acknowledgements
The authors would like to express their appreciation of helpful comments from Judy David, Helen Handoll and Cathie Sherrington on drafts of this protocol. We would also like to thank Lindsey Elstub for her encouraging suggestions and for providing guidance for this protocol, and Catherine Deering and Joanne Elliott for assistance with the search strategies. Finally, we acknowledge Dr. Kun Hyung Kim for his helpful comments.
Appendices
Appendix 1. Search strategies
The Cochrane Library (Wiley Online Library)
#1 MeSH descriptor Fasciitis, Plantar explode all trees #2 MeSH descriptor Fasciitis explode all trees #3 MeSH descriptor Foot Diseases explode all trees #4 (#2 AND #3) #5 (plantar NEAR/3 fasci*):ti,ab,kw #6 (plantar or heel* or foot or feet or arch*) NEAR/3 (pain* or inflam*):ti,ab,kw #7 (calcaneodynia or calcaneal periosteitis or enthesopathy or heel spur):ti,ab,kw #8 (#1 OR #4 OR #5 OR #6 OR #7) #9 MeSH descriptor Acupuncture explode all trees #10 MeSH descriptor Acupuncture Therapy explode all trees #11 (acupuncture or electro‐acupuncture or electroacupuncture or pharmaco‐acupuncture or pharmacoacupuncture or needling or acupressure or moxibustion):ti,ab,kw #12 (ah shi point*):ti,ab,kw #13 acupuncturist*:ti,ab,kw #14 (#9 OR #10 OR #11 OR #12 OR #13) #15 (#8 AND #14) [Trials]
MEDLINE (Ovid Online)
1 exp Fasciitis, Plantar/ 2 exp Fasciitis/ 3 Foot Diseases/ 4 2 and 3 5 (plantar adj3 fasci$).tw. 6 ((plantar or heel$ or foot or feet or arch$) adj3 (pain$ or inflam$)).tw. 7 (calcaneodynia or calcaneal periosteitis or enthesopathy or heel spur).tw. 8 1 or 4 or 5 or 6 or 7 9 exp Acupuncture/ 10 exp Acupuncture Therapy/ 11 (acupuncture or electro‐acupuncture or electroacupuncture or pharmaco‐acupuncture or pharmacoacupuncture or needling or acupressure or moxibustion).tw. 12 ah shi point$.tw. 13 acupuncturist$.tw. 14 9 or 10 or 11 or 12 or 13 15 8 and 14
What's new
| Date | Event | Description |
|---|---|---|
| 29 October 2019 | Amended | This protocol was withdrawn due to lack of progress. |
Contributions of authors
The topic was conceived by Lee S. The protocol was drafted by Lee S, Kim J, Kim J‐H, Kim T‐H and Choi S‐M. Lee S is the guarantor for this protocol.
Sources of support
Internal sources
-
Korea Institute of Oriental Medicine, Korea, South.
All authors were supported by Korea Institute of Oriental Medicine (K12010)
External sources
No sources of support supplied
Declarations of interest
None known.
Notes
This protocol for a Cochrane Review has been withdrawn by the Bone, Joint and Muscle Trauma Group, with agreement from the authors, due to lack of progress. There are no plans to republish the protocol in future.
Withdrawn from publication for reasons stated in the review
References
Additional references
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