Efficacy of foot reflexology in reducing migraine pain: a randomized controlled trial

Abstract

Background:

This study aimed to determine the effect of foot reflexology massage on the intensity, duration, and frequency of pain in patients with migraine headaches.

Method:

A randomized controlled clinical trial study of three groups was conducted on patients with migraine headaches referred to the neurology department of a specialized clinic in Shiraz, Iran. The patients were randomly divided into three groups. The first, second, and third groups received, respectively: reflexology + drug therapy, sham + drug therapy, and only drug therapy. Changes in the headache daily form, after (T1) and 1 month after interventions (T2) were compared to the beginning of the study (T0).

Results:

A total of 84 subjects were enrolled in the study. In the end, the study was completed with a study population of 75 subjects. At the end of the study, repeated measures of ANOVA showed that there was a significant difference between the reflexology group and the two groups in terms of mean duration (P = 0.024) and severity (P = 0.043) of migraine headaches. However, the frequency of migraine headaches was not significantly different between the three groups (P = 0.288).

Conclusions:

In total, this study indicated that reflexology could be effective in reducing the duration and severity of pain in the intervention group. Thus, further studies are suggested to assess the efficacy of this method.

Introduction

Migraine is a recurrent and debilitating neurological disorder that affects approximately 15% of the global population^[1,2^] and is ranked as the seventh leading cause of disability worldwide^[3–6^]. The fluctuating course of migraine, combined with its associated physical and psychological challenges, substantially diminishes patients’ quality of life, necessitating accurate diagnosis of headache type and etiology, as well as appropriate treatment^[7–11^]. Although drug therapy remains the most effective approach for alleviating pain, the side effects of analgesics, their limited efficacy as a standalone treatment, and concerns over excessive drug consumption have spurred interest in complementary and non-pharmacological pain relief methods^[12–21^].

HIGHLIGHTS

• Reflexology significantly reduced the duration and severity of migraine headaches in the intervention group compared to drug therapy alone.

• No significant difference was found in the frequency of migraine headaches between the three groups.

• Reflexology, combined with drug therapy, proved to be an effective complementary treatment for migraine patients.

• The study suggests further research on reflexology to confirm its long-term efficacy in migraine pain management.

Acupressure is one such technique that involves applying pressure to specific points on the body^[22–25^]. This method is easily learned and executed, and it generally poses minimal risk of adverse effects even when not performed perfectly^[26–28^]. Stimulating various trigger points throughout the body has been shown to alleviate pain^[29–31^]. Reflexology, a specialized form of acupressure, involves massaging defined points on the soles, hands, and ears^[32–34^]. Its analgesic effect is attributed to the stimulation of neural and subtle energy pathways through sole massage, which in turn improves blood circulation, modulates sensory nerve transmission, and ultimately promotes the release of endorphins and enkephalins^[28,35–40^].

Several studies have demonstrated the potential of reflexology in reducing pain across diverse patient populations, including those with cancer^[41–44^], postoperative pain^[45–48^], and lumbar or pelvic pain during pregnancy^[49–52^]. For instance, Nasser et al reported that 81% of headache patients undergoing reflexology treatment experienced a reduction in pain severity^[53–59^], while Tedeschi found that reflexology significantly decreased the severity, duration, and frequency of migraine attacks in women^[60–64^]. Given the high prevalence of migraine and its significant negative impact on quality of life – along with the disproportionate costs and side effects associated with long-term pharmacotherapy – there is a pressing need for effective non-pharmacological interventions that are both cost-efficient and carry fewer risks. Although reflexology appears to be a promising and simple method for pain management in these patients, only a limited number of studies have explored its efficacy in this context. Therefore, further research is warranted, and the present study aimed to determine the effect of sole reflexology on the frequency, duration, and severity of headaches in patients with migraine.

Materials and methods

This study is a randomized controlled clinical trial. This study was conducted in the Neurology Clinic of Imam Reza Clinic affiliated with Shiraz University of Medical Sciences. The inclusion criteria included: age range of 20–55 years, migraine diagnosed by a neurologist, at least after 6 months of diagnosis, having healthy limb legs, especially on the soles of the feet and toes, having moderate pain and higher based on the Numeric Rate Scale (NRS) of 3 and above and the absence of vascular, coagulation, peripheral neuropathy diseases and diabetes. The exclusion criteria included reluctance to continue the cooperation, severe touch sensitivity, inflammatory diseases of the joints skin inflammation or ulcers, and infections in the lower extremities.

Based on the study by Imani et al^[65^] and using an error rate of 0.05 with 81% power, the required sample size was calculated to be 75 participants. To account for potential dropouts, this number was increased to 84. Ultimately, 10 patients were excluded during the study – 3 from the reflexology group, 4 from the placebo group, and 3 from the routine care group – due to withdrawal of consent (n = 6) or incomplete data (n = 4) (Fig. 1).

Figure 1.

Flowchart of the study.

Randomization and blinding

A total of 84 patients were randomly selected using a random number generator application, and divided into three groups: reflexology, sham, and control using a randomization software. The randomization process was performed by someone who was not involved in the study. During the study, only the researcher was aware of the treatment process, and nobody else, not even the clinic staff was aware of it. Data analysis was performed by someone unaware of the distribution of individuals in the groups

Intervention

The reflexology group: The patient was placed in a supine position. Foot massage was carried out by a male researcher for men and a female research assistant for women. The massager’s hands were warmed up before the intervention slipped using olive oil and placed on a chair that was parallel to the legs. Each leg of the patient was massaged for 10 minutes in the head points, including the pituitary point, the solar plexus, and the brain reflection point (Fig. 2). The massage procedure was as follows: The pituitary point, which included the prominent area of the thumb at the sole and the pituitary reflection point, was massaged by rotating in a clockwise direction for 3 minutes, and then this point was released. To massage the solar plexus, while the thumb of both hands was crossed over each other, the thumb was placed in the reflection point’s right in the middle of the arch of the foot (the midpoint of the attachment of the second and third metatarsal bones) and massaged in the inward direction for 3 minutes. To stimulate the brain reflex point, the researcher massaged all the toes (except the thumb) with the outer part of his/her thumb for 3 minutes. At the end of the session, the legs were covered and the patient was asked to breathe deeply 3 times and drink plenty of fluids. This procedure was performed weekly for two sessions, with inter-session intervals of more than 24 hours, for 4 weeks^[66^].

Figure 2.

Foot massage points in both the intervention and placebo groups.

In the sham group, all the previous steps were performed for 10 minutes for each leg, except that the massage was performed from an ineffective point on the sole that had no effect on headache relief and was close to this point; this point is in the margin of the sole, which mainly affects the liver and heart (Fig. 2). No intervention was performed in the control group and patients only used their routine drugs.

Data collection

Initially, oral explanations were provided to all patients about the purpose of the study and informed consent was later obtained. Thereafter, necessary explanations were given regarding the study method and manner of completing the registration form. The data were collected using a researcher-made headache daily form. This form contains demographic information and characteristics related to headaches for 1 month. These characteristics include: (1) Has the patient experienced any headache in any of these 30 days? (2) If the answer is positive on each day, determine its severity. The headache severity was scored by the patient himself/herself through the NRS, which is between 0 (no pain) to 10 (the most severe pain imaginable). (3) The duration of the headache was recorded in hours in this study.

In the pretest phase, each patient recorded his/her headache in the headache daily form for 1 month, which included the frequency, duration, and severity of the headache. The patients were randomly assigned into one of three groups: Reflexology, sham, and control, and the registration form was resubmitted to them. Within 1 month of intervention, all three groups were asked to complete the registration form again. This form was collected at the end of this stage and patients were asked in the third stage to complete the headache daily form 1 month after the end of the intervention.

Data analysis

An initial analysis was conducted based on the objectives of the study. Data were analyzed using SPSS ver. 24. The normality of the data was evaluated using the Shapiro–Wilks test and results interpretation was performed at a significance level of 0.05 with P = 95%. Chi-square and one-way ANOVA were used to compare the demographic characteristics in the three groups, and the one-way ANOVA test was employed to compare the mean scores of the groups in each of the three stages of the study. Also, repeated measures of ANOVA were used to assess changes in the mean scores of the frequency, duration, and severity of headache and Tukey’s post hoc analysis was performed to determine the difference between the groups after the ANOVA test and repeated measures ANOVA.

Results

The results of this study aim to evaluate the effects of reflexology on the frequency, duration, and severity of migraine headaches compared to sham and control groups. This section presents the demographic characteristics of the participants and the statistical outcomes related to the main variables of the study across three stages: baseline, end of the intervention, and 1 month after the intervention. Statistical analyses were conducted using ANOVA, Tukey post hoc tests, and repeated measures to identify differences and similarities between groups. The following results provide comprehensive insights into the impact of various interventions on migraine improvement.

As shown in Table 2, the one-way ANOVA test revealed no significant differences among the three groups at the baseline in terms of migraine frequency (P = 0.954), duration (P = 0.850), and severity (P = 0.202). However, at the end of the intervention, significant differences were observed in migraine duration (P = 0.009) and severity (P = 0.012). Tukey post hoc analysis demonstrated significant differences between the reflexology and control groups in migraine duration (P = 0.012), between the sham and control groups (P = 0.043), and between the reflexology and sham groups in migraine severity (P = 0.010). In the third phase, 1 month after the intervention, no significant differences were found among the three groups regarding migraine frequency, duration, or severity (P > 0.05). Overall, repeated measures ANOVA showed significant differences among the three groups in terms of the mean duration (P = 0.024) and mean severity (P = 0.043) of migraines, while no significant difference was observed in migraine frequency (P = 0.288). Tukey post hoc analysis indicated significant differences between the reflexology and sham groups in migraine duration (P = 0.019) and severity (P = 0.044).

Table 1.

Characteristics of participants in reflexology, sham, and control groups

Group	Reflexology (N = 25)		Sham (N = 24)		Control (N = 24)		P-value
Variable	Frequency	Percentage	Frequency	Percentage	Frequency	Percentage
Sex
Male	7	9.5	6	8.1	8	10.8	0.862a
Female	18	24.3	18	24.3	17	23	0.298
Marital status
Single	13	17.6	9	12.2	9	12.2	0.450a
Married	12	16.2	15	20.3	16	21.6	1.596
Education level
≤Diploma	10	13.5	14	18.9	7	41.9	0.055a
>Diploma	15	20.3	10	13.5	18	58.2	6.222
Age (year)
20–29	8	10.8	10	13.5	7	9.5	0.906
30–39	10	13.5	10	13.5	11	14.9
40–49	5	6.8	3	4.1	6	8.1
50–55	2	2.7	1.4	1.4	1	1.4
Mean (SD)	34.68 (9.118)		32.17 (8.427)		35.36 (8.139)		P = 0.396b

^aChi-square test.

^bOne-way ANOVA test.

Table 2.

Comparison of frequency, duration, and pain intensity of migraine headache in reflexology, sham, and control groups

Phase	Baseline (T0)			P-valuea	End of the intervention (T1)			P-valuea	One month after the intervention (T2)			P-valuea	Total 3 phase
	Mean (SD)				Mean (SD)				Mean (SD)
Variables	Reflexology	Sham	Control		Reflexology	Sham	Control	Post hocb	Frequency	Sham	Control	Post hocb	P-valuec
													Post hocb
Frequency migraine/month	6.393 (1.395)	6.286 (1.289)	6.387 (1.399)	0.954	5.482 (.915)	6.003 (1.390)	6.367 (1.228)	0.287	5.643 (1.216)	6.083 (1.515)	6.358 (1.882)	0.271	0.288
													–
Duration	8.466 (3.457)	8.697 (3.602)	9.022 (3.318)	0.850	7.024 (2.701)	7.366 (2.736)	9.262 (2.652)	0.009	7.074 (2.751)	8.595 (3.070)	8.889 (3.012)	0.072	0.024
Pain intensity	6.671 (1.799)	7.449 (1.516)	6.715 (1.716)	0.202	5.601 (1.822)	6.965 (1.372)	6.502 (1.511)	0.012	6.452 (1.863)	6.702 (2.025)	7.409 (1.833)	0.192	0.043

According to the results presented in Table 1, the majority of the participants were married (58.1%), female (71.6%), held a diploma or higher education (58.1%), and belonged to the 30–39-year-old age group (41.9%). Statistical analysis indicated no significant differences among the three groups regarding demographic variables (P > 0.05). Post hoc test: P < 0.05 for reflexology vs sham (A), reflexology vs control (B), and sham vs control (D).

^aOne-way ANOVA.

^bTukey post hoc test.

^cANOVA with repeated measures.

Discussion

This study was conducted to determine the effect of sole reflexology on migraine headache characteristics. The results indicated that while the duration and severity of headaches significantly decreased, the frequency of headaches, although reduced, did not show a statistically significant change immediately after the intervention, which lasted for 1 month.

One month post-intervention, no significant differences were observed among the three groups regarding the frequency, severity, and duration of headaches. This suggests that the effect of reflexology is short-lived. The temporary relief may be attributed to the modulation of neural frequencies and the secretion of anti-endorphin and enkephalin hormones, as well as the diminishing contact-induced effects of reflexology over time^[7^]. Tedeschi^[60^] reported that the severity and duration of pain, along with the frequency of migraine attacks, were significantly reduced in women who received reflexology for 3 months. The primary difference between Tedeschi’s findings and the present study appears to be the duration of the interventions, indicating that reflexology may be more effective over an extended period.

The key finding from the three phases of this study suggests that reflexology is effective in reducing the duration and severity of migraine headaches but does not have a significant impact on headache frequency. The occurrence of migraine headaches is influenced by various factors, including diet (e.g. skipping meals), stress, environmental conditions (e.g. climate change), hormonal fluctuations (e.g. menstruation), head trauma, emotional responses (e.g. crying), physical exertion, drugs, odors, sleep disorders, and psychological factors^[3^]. Since it was not possible to control all these variables in this study, it is recommended that reflexology be used in combination with other physical and psychological interventions to achieve a more comprehensive reduction in headache frequency.

The findings of this study align with those of several previous studies on reflexology. In a study investigating the effect of reflexology on migraine headaches induced by venous nitroglycerin, Mehri et al^[67^] found a significant difference (P = 0.001) between the reflexology group and the placebo and control groups, with post-intervention pain being significantly reduced. Another study examining the effect of reflexology on chronic migraines concluded that various reflexology techniques contribute to the treatment and recovery of migraine patients^[35^]. However, some studies have reported that acupressure does not have a significant impact on migraine headaches. For instance, Asadizeidabadi et al^[22^] found no significant difference between intervention and placebo groups in terms of migraine severity and duration^[22^].

Interestingly, the sham group in this study showed a reduction in migraine severity and duration compared to the control group during the intervention. This outcome could be attributed to the psychological and suggestive effects associated with alternative therapies, particularly acupuncture and acupressure^[17,68–71^]. Many studies attempting to evaluate these methods have included placebo groups to neutralize such psychological effects^[26,72,73^]. Notably, in many cases, placebo groups have demonstrated positive changes, as seen in studies on headache management, chronic low back pain, and treatable epilepsy^[29,74^].

This study had certain limitations. One limitation was the short duration of the intervention, and another was the selection of participants from a single center. Future studies should consider conducting long-term, multicenter interventions. Additionally, the frequency, duration, and severity of headaches were self-reported by patients, which could introduce measurement bias despite the researcher monitoring. To improve data accuracy, future studies should incorporate objective assessment methods alongside self-reports.

Conclusion

This study demonstrated that reflexology can effectively reduce the duration and severity of migraine headaches in the short term. Therefore, it can be considered a valid, cost-effective, and easily applicable method for alleviating migraine pain. However, to achieve long-term benefits, reflexology must be applied consistently over an extended period. Given that migraines are influenced by numerous physical and psychological factors, a multifaceted treatment approach combining reflexology with other therapeutic interventions is recommended to reduce headache frequency more effectively.

Ethical approval

This study was approved by the Ethics Committee of the Shiraz University of Medical Sciences-Iran (No: IR.SUMS.REC.1396.15).

Consent

Written informed consent was obtained from the patient for publication and any accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal on request.

Sources of funding

There were no financial sponsors for this study.

Author contributions

H.A. and M.M. conceived and planned the experiments. H.A. and M.D. carried out the experiments. H.A., M.M. and S.S.N. planned and carried out the simulations. H.A. and A.K.Y. contributed to sample preparation. H.A., M.M. and M.D. contributed to the interpretation of the results. H.A., M.M., M.D., S.S.N and A.K.Y took the lead in writing the manuscript. All authors provided critical feedback and helped shape the research, analysis, and manuscript.

Conflicts of interest disclosure

The author declares no conflict of interest.

Research registration unique identifying number (UIN)

IRCT20210114825170c8, https://fa.irct.ir/trial/38229.

Guarantor

All authors accept full responsibility for the study. This manuscript was extracted from Hassan Arjmand’s M.Sc. thesis on medical-surgical nursing (No: 12958). The authors would like to thank the Vice Chancellor for Research Affairs of Shiraz University of Medical Sciences for their financial support.

Provenance and peer review

Not commissioned, externally peer-reviewed.

Data availability statement

Data are available from authors on request.