A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain: A Randomized Clinical Trial
Phase: NA
Conditions: Plantar Fascitis, Myofacial Pain Syndromes, Trigger Point Pain, Myofascial
Sponsor: Universidad de Zaragoza

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Comparing two dry needling interventions for 
plantar heel pain: a protocol for a randomized 
controlled trial  
 
 
 
Clinical Trials: NCT03236779  
 
 
 
Author: ZAID AL BOLOUSHI 
 
 
DATE: 23-1-2021  
 
 
 
 
 
 
 

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COMPARING TWO DRY NEEDLING INTERVENTIONS FOR PLANTAR HEEL 
PAIN: A RANDOMIZED CONTROLLED TRAIL  
Relevant scientific background  
Plantar heel pain (PHP) is a common problem affecting the foot, causing soreness or tenderness in 
the sole of the foot, and under the heel, sometimes extending into the medial arch.1 The frequency 
and incidence of PHP is uncertain, however it is estimated that over the course of a lifetime 10% 
of the population may suffer from this condition.2 3 Several pathologies may cause PHP, such as 
myofascial pain syndrome, plantar fasciitis or heel spur, amongst others.4 The clinical diagnosis is 
usually established based on the patient’s history and physical examination, including pain during 
the first steps in the morning or after prolonged rest, as well as pain during prolonged standing or 
walking.2 3 5 The identification of the main cause of pain can be challenging as this is often 
multifactorial,6 and despite its prevalence, the etiology of PHP is not well understood.2 3 The 
presence of myofascial trigger points (MTrPs) within the muscles of the foot and lower leg may 
play an important role in people in PHP,7 an implicit assumption underlying many recent studies.8-
11 In addition, there is a lack of consensus regarding the ideal management approach for PHP.12-14  
Clinical practice guidelines support the use of conservative treatment, such as joint and soft tissue 
mobilization or self-stretching home programs.2 3 In particular, self-stretching home programs 
have shown to be effective for addressing PHP.2 6 15 Furthermore, recent randomized clinical trials 
(RCTs) have shown that there is an additional effect of reduction of pain severity when self-
stretching home programs are combined with ischemic compression11 and with dry needling.9 
Physical therapy approaches continue to evolve and include the combination of dry needling and 
electrolysis, known as percutaneous needle electrolysis, with promising results for the treatment 
of tendon pathologies.16-18 The percutaneous needle electrolysis technique is a minimally invasive 

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treatment that consists of the application of a galvanic electrolytic current that causes a controlled 
local inflammatory process in the target tissue. This promotes phagocytosis and the subsequent 
regeneration of the affected tissue.16 17 Currently, percutaneous needle electrolysis is being used in 
clinical practice to manage MTrPs, however, there are no studies supporting any additional 
beneficial effects of the same over dry needling.  
From a biological point of view, it seems reasonable to hypothesize that subjects may display 
improvements thanks to the mechanical effects of the needle, and that patients may experience 
superior benefits when the electrolysis effect is added to the mechanical stimulus provided by the 
needle. Therefore, the aim of this RCT was to compare the effectiveness of dry needling versus 
percutaneous needle electrolysis for improving the level of pain, function and quality of life of 
patients suffering from PHP caused by MTrPs. 
 
METHODS 
Design 
This study was a prospective, parallel-group RCT with blinded outcome assessment. Participants 
were recruited from Kuwait City, Kuwait, and both the assessment and intervention were 
conducted at the Physical Medicine and Rehabilitation Hospital in Kuwait. The study was 
conducted in compliance with the Helsinki Declaration of Human Rights and ethical approval was 
obtained by the Medical Ethics Committee of the State of Kuwait Ministry of Health, with 
reference number 642/2017. The study protocol has been previously published19 and the trial is 
registered at Clinicaltrials.com, number NCT03236779. This RCT was reported in accordance 
with the CONSORT statement for non-pharmacological trials. 
 

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Participants 
The study subjects were male and female adults, enrolled at the Physical Therapy Department of 
the Physical Medicine and Rehabilitation Hospital in Kuwait City. Participants were included if 
they fulfilled the following criteria: 1) diagnosed of plantar heel pain in accordance with the 
Clinical Guidelines linked to the International Classification of Function, Disability and Health 
from the Orthopedic Section of the American Physical Therapy Association;2 3 8 9 2) aged 21 to 60 
years at admission to the study, according to the Kuwaiti Ethical Committee; 3) a history of PHP 
for over one month, showing no improvements with previous conservative treatment; 4) the ability 
to walk 50 meters without any support; 5) the presence of MTrPs on plantar and calf muscles based 
on an initial physical examination carried out by a physiotherapist (MA) with experience and 
training in MTrPs; 6) accepting treatment from a male physiotherapist; 7) the ability to understand 
the study and the informed consent, as well as having signed the consent form.  
The exclusion criteria were: 1) needle phobia; 2) needle allergy or hypersensitivity to metals; 3) 
the presence of coagulopathy or use of anticoagulants according to medical criteria; 4) the presence 
of peripheral arterial vascular disease; 5) pregnancy; 6) dermatological disease affecting the dry 
needling area; 7) the presence of any chronic medical condition which might preclude participation 
in the study, such as: malignancy, systemic inflammatory disorders (e.g., rheumatoid arthritis, 
psoriatic arthritis, ankylosing spondylitis, septic arthritis), neurological diseases, polyneuropathy, 
mononeuropathy, and sciatica; 8) treatment of plantar heel pain with needling or acupuncture 
during the last four weeks; 9) history of injection therapy in the heel over the previous three 
months; and 10) previous history of foot surgery or fracture. Receiving or implementing any form 
of treatment for the plantar heel pain (taping, night splints, massage therapy or footwear 
modifications) during the trial was considered withdrawal criteria.  

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The sample-size calculation initially estimated that 39 participants per group would provide 80% 
power to detect a minimally important difference of 13 points in the pain domain of the Foot Health 
Status Questionnaire with a standard deviation of 20 points20 and an alpha risk at 0.05. Allowing 
for a 20% loss to follow-up, a minimum of 47 participants was required in each group, equaling 
94 participants in total. Based on initial data collection, the drop-out rate was recalculated to be 
25% and the sample size was therefore increased to a total of 102 patients. 
 
Patient and public involvement 
No patients were involved in the design, recruitment or conduction of this study and the burden of 
the intervention was not assessed by patients themselves neither. 
 
Randomization 
Participants who fulfilled the inclusion criteria received standardized oral and written information, 
and, after consenting to participate in the trial, they were randomized using block randomization 
by blocks of 10 patients. Allocation was randomly assigned using a computer program 
(Randomizer, https://www.randomizer.org/) with random patient file number sequences generated 
by a third person not involved in the study.  
 
Procedure and interventions 
Two study groups were randomly formed. The first was treated with dry needling whereas the 
second group was treated with percutaneous needle electrolysis. In both groups, during the first 
session, all participants were taught a self-stretching protocol11 which has been demonstrated to 
be effective for the management of PHP,2 6 11 consisting of self-stretching of the calf muscles and 

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specific self-stretching for the plantar fascia.19 The frequency of calf and plantar fascia-specific 
self-stretching exercises was twice a day, using intermittent stretching lasting 20 seconds, followed 
by 20-second rest periods, for a total of three minutes per stretch.11 Compliance with the self-
stretching protocol was registered before each treatment session and at the four-week follow-up. 
The muscles considered for invasive physical therapy treatment were the soleus, gastrocnemius, 
quadratus plantae, flexor digitorum brevis and abductor hallucis. These muscles typically refer 
pain to the heel and are muscles than can be directly palpated or that can be needled precisely and 
safely without ultrasound guidance. The clinician performed a physical exam to find MTrPs 
following the criteria by Travell and Simons: 1) the presence of a taut band and 2) identification 
of an exquisite spot tenderness or a nodule.7 A flat palpation or pincer palpation technique was 
used to palpate the MTrPs, depending on the muscle being assessed. If a muscle contained more 
than one MTrP, the most sensitive MTrP was treated, according to the patient’s perceived pain 
upon palpation. If the patient presented bilateral pain, the clinician treated both sides. The patient’s 
position (supine, prone or lateral decubitus position) depended on each muscle examined and was 
the same for the assessment as well as for the intervention. 
Each participant received four individual physical therapy sessions, once a week. Participants was 
treated by one physical therapist registered at the Kuwait Ministry of Health (ZA) with five years 
of practical experience in the field of dry needling and appropriate training in the protocol. The 
duration of each session was approximately 30 minutes. 
Participants were instructed to use the appropriate dose of medication as prescribed by their  
Physical Medicine and Rehabilitation physician (analgesics and non-steroidal anti-inflammatory 
medications) and were required to report any changes to the assessor during the evaluations if they 
took any additional medication or underwent any treatment during the intervention. 

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Invasive Intervention Groups: Dry Needling and Percutaneous Needle Electrolysis 
Specific needles for dry needling were used during invasive treatments (Agu-punt, Spain). Needle 
length was determined by the location of the MTrP and ranged from 30 to 75mm in length (or 
longer if necessary, according to the patients’ characteristics). The diameter of the needle was 
0.25-0.30 mm. If the participant was sensitive to the needle insertion, the level of manipulation 
was reduced. If this measure proved insufficient for reducing the painful stimulus, needle 
manipulation ceased altogether and the needle was left in situ.21 22 
To maintain appropriate hygienic conditions during the invasive treatments, the clinician wore 
latex gloves and thoroughly cleaned the skin of the area to be needled with an antiseptic solution 
(70% Propan-2-ol, Skin-des). Upon removal of the needle, the area was firmly compressed for 10 
seconds. The needle was discarded after each single use. In both groups, the intervention was 
terminated in the case of severe adverse effects and if the participant did not wish to continue. 
 
Dry Needling Arm 
Once the clinician located the MTrP, the needle was inserted over the same and a rapid needle 
entry was performed. The chosen technique for manipulating the needle was the technique 
described by Hong, which consists of a rapid needle entry and exit (fast in/fast out), in order to 
obtain a local twitch response, lasting 5 seconds employing a rhythmic movement at approximately 
1Hz/sec (5 entries).  
 
Percutaneous Needle Electrolysis Arm 
The electrotherapy equipment used (Physio Invasiva, PRIM Fisioterapia, Spain) produced a 

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continuous galvanic current through the cathode while the patient held a hand-held anode.18 Once 
the needle reached the relevant treatment area, this was needled in exactly the same manner as in 
the dry needling group, with the only difference being that the needle was transmitting an electrical 
current with an intensity of 1.5 mA (intensity was adapted to patient´s characteristics according to 
their pain tolerance). 
 
Study Variables 
An independent assessor (MA) blinded to treatment group allocation conducted all assessments at 
baseline, and at the 4, 8, 12, 26 and 52-week follow-up. Demographic and disease data were 
collected at baseline. 
The primary outcome was the Foot Pain domain of the Foot Health Status Questionnaire (FHSQ), 
a validated measure of foot-health status23 that has been used in similar trials, which evaluated the 
effectiveness of different interventions for plantar heel pain.8 24 25 Individual item scores were 
inserted into a computer program (FHSQ V.1.03) which, after data transformation, provides a 
score ranging from 0 to 100 for each domain,26 with greater scores reflecting a better condition.27 
Secondary outcomes were the Foot Function, Footwear and General Foot Health domains of the 
Foot Health Status Questionnaire, as well as the average and maximum level of pain over the past 
48 hours using the visual analogue scale (VAS). Participants were explained that a score of 0 
indicated the absence of pain whereas a score of 10 represented the maximum tolerable pain. 
Additionally, before each treatment session, they were asked to complete the VAS and after each 
treatment session, participants were asked to score their current pain immediately upon standing 
up and walking a few steps. The VAS is widely used and is both valid and reliable.28-30 

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Quality of Life (QoL) was assessed with the EQ-5D-5L, which was completed by the participants 
at baseline and at the 4, 8, 12, 26 and 52-week assessments. The EQ-5D-5L self-report 
questionnaire is a descriptive system with five questions, each representing one dimension of 
Health-related Quality of Life, i.e. mobility, self-care, daily activities, pain/discomfort and 
depression/anxiety. Each dimension can be rated on five levels: no problems, slight problems, 
moderate problems, severe problems and extreme problems. Together, the results serve to classify 
people into 1 of 3125 possible health states.31 These health states are subsequently transformed to 
quality of life values with the EQ-5D-5L crosswalk value sets.32 
 
Statistical Analysis 
The statistical analysis was performed using IBM SPSS Statistics (version 25, IBM, Chicago, IL) 
by intention to treat, with the last observation carried forward. The investigator who performed the 
analyses was masked to group allocation. The significance level for all statistical tests was set at 
P ≤ 0.05. 
Chi-squared tests were used to analyse if there were differences in categorical variables between 
groups at baseline. In addition, independent Student’s t-tests and Mann-Whitney U tests were used 
for parametric and nonparametric quantitative variables, respectively. Chi-squared tests were used 
to evaluate the compliance of the self-stretching protocol.  
Following recommendations to estimate treatment effects in RCTs, linear mixed models adjusted 
for baseline values were used to test the mean effect of treatment interventions at the follow up at 
the 4, 8, 12, 26 and 52-week follow-up, for the Foot Health Status Questionnaire and EQ-5D-5L 
measures. Linear mixed models adjusted for baseline values were used to test the mean effect of 
treatment interventions at the second session, third session, fourth session, and at the 4, 8, 12, 26 

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and 52-week follow-ups, for measures of VAS (average and maximum). Individual repeated 
measures (RM) ANOVAs were used to test time effects within each treatment group for primary 
and secondary outcomes. Cross-sectionally, at all linear mixed models and RM-ANOVAs, the 
Bonferroni correction was used to test between-group time point differences or within-group time 
changes, respectively. The Greenhouse-Geisser correction was applied for correcting against 
violations of sphericity, whereas eta-squared (η²) was used to estimate the magnitude of the 
difference between both groups (0.01 small effect, 0.06 medium effect and 0.14 large effect).33 
Independent t-tests were used to determine any difference between groups for measures of level 
of pain immediately after each treatment session. 
 

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