The effect of manual therapies on tension-type headache in patients who do not respond to drug therapy: a randomized clinical trial

ABSTRACT

Backgrounds

Tension-Type Headache (TTH) is one of the most common types of headache. In patients with TTH, manual therapy can be used to treat myofascial pain.

Objectives

This study aimed to evaluate the effect of manual therapy on TTH in patients who did not respond to drug therapy.

Methods

A total of 24 patients with TTH were randomly enrolled into this prospective trial. The participants were divided into an intervention and a control group. The intervention group received the common medication and manual therapy, while the control group only received the common medication. Headache pain intensity, frequency, and duration, tablet count, and Neck Disability Index (NDI) were measured in both groups before, after, and one week after the intervention.

Results

There were significant differences between the two groups (treatment, control) regarding pain intensity (3.04, 6.75, P = 0.0001; effect size (ES) = 1.85), headache frequency (2.33, 5, P = 0.004; ES = 1.48) and duration (91.29, 284.74, P = 0.002; ES = 1.48), tablet count (1.83, 4.91, P = 0.01; ES = 1.04), and NDI (7.33, 20.16, P = 0.003; ES = 1.37). Within group differences were recorded in intervention group only for all dependent variables immediately after intervention and one week after the intervention (p < 0.05).

Conclusion

Manual therapy reduced headache pain intensity, frequency and duration, tablet count, and NDI score in patients with TTH.

Introduction

Tension-Type Headache (TTH) is one of the most common types of headache worldwide [1]. The adverse effects of TTH are more significant compared to other types of headache due to the 42% prevalence of TTH [2] in society [3]. Patients with TTH simply suffer from pain, shortening of occipital and temporalis muscles, and cramp in the neck and upper back muscles [4]. TTH has multiple origins including environmental and central factors [5]. Trigger Points (TrPs) in the neck and shoulder muscles also contribute to TTH [6]. Thus, one of the most efficient treatments for TTH is to identify and treat the neck muscles TrPs [7–10]. Previous studies indicated that the TrPs of temporalis, sternocleidomastoid (SCM), upper trapezius, and suboccipital muscles were associated with chronic TTH [11]. Additionally, the pattern of TrPs pain referral in the head and neck muscles was similar to the pain pattern in patients with severe TTH [12]. Dysfunction of the cervical and head joints is common in patients with TTH. Evidence has demonstrated that patients with TTH are commonly more likely to display increased forward head posture [13,14], reduced cervical lordosis [15], reduced cervical range of motion, and temporomandibular joint dysfunction [16].

Drug therapy is a type of treatment for TTH. Generally, different types of drug exist for treating TTH. Aspirin, acetaminophen, naproxen sodium, ketoprofen, and diclofenac potassium are used for acute management and amitriptyline and mirtazapine are used for prophylactic management. Acute therapy is used in episodic and chronic headache attacks that are mild to moderate in severity. These patients manage this type of headache by using simple analgesic drugs. Analgesic drugs can reduce headache frequency. TTH is associated with stress, anxiety and depression so simple analgesic drugs aren’t effective for treating these problems. Prophylactic management is used to treat these problems [17]. Tricyclic antidepressants (Amitriptyline and Nortriptyline) drugs were more useful in TTH prophylactic management [18]. The side effects of Amitriptyline are greater than Nortriptyline. One side effect of Amitriptyline is increased risk of suicidal ideation [19]. However, these drugs should be used carefully, because consuming simple analgesics for more than 14 days per month increases the risk of Medication Overuse Headache (MOH) and reduces the effectiveness of these drugs [17]. The International Headache Society (HIS) has defined MOH as a daily headache that requires analgesics use 15 days a month for three months [20,21]. MOH is an important health problem that is highly prevalent in communities. It has been found that there is an association between MOH and low income, smoking, sleep problems and high body mass index. Depression and anxiety are common in these patients [22]. MOH has social and economic consequences. MOH put a lot of economic burden on society like absence from work, reduced workforce and lost productivity at home [23]. Addiction to antidepressant drug was prevalent in patients that used these types of drugs [24]. Hence, non-pharmacological treatments should always be considered for patients with TTH [25]. However, limited research has been done on non-pharmacological therapy among patients with TTH.

One of the common therapies for TTH is manual therapy [26]. Manual therapies include a wide range of techniques used for neuromuscular problems. This type of treatment is applied to connective tissues to relieve pain and increase joint motion [27]. The common manual therapies used for patients with TTH consist of massage, stretching, myofascial release, and vertebral mobilization [12,28]. The purpose of this study was to assess the effect of manual therapy on TTH in patients who did not respond to drug therapy.

Materials and methods

Study design

In this parallel design randomized clinical trial, the participants were randomly divided into an intervention group receiving manual therapy and the usual drug therapy and a control group continuing the usual drug therapy. The study was done in three phases, namely baseline, treatment, and follow-up, each lasting for one week. Daily notes on headaches that included such variables as pain intensity, duration, and frequency, tablet count, and Neck Disability Index (NDI) were evaluated at the end of baseline, intervention, and follow-up phases. The average pain intensity, duration, and frequency of pain as well as tablet count per person were determined and analyzed. The patients were treated by one physiotherapist and the assessments were performed by another physiotherapist. This study was performed in the rehabilitation clinic of Shiraz University of Medical Sciences.

Treating physiotherapist:

One physiotherapist with 4 years of clinical experience in manual therapy field treated the patients in this trial. Before starting the study, this physiotherapist underwent standard manual therapy training, which was provided by the lead investigator.

Assessment:

One physiotherapist (with 2 years of assessment expertise) blinded to the groups the patients were in collected the data. This physiotherapist was trained by lead investigator to ensure that the assessment was performed on standard type.

Measurements

The data were collected through a daily headache form including demographic characteristics, tablet count per day, and frequency, pain intensity, and duration of pain. The means of these variables were calculated during the three phases.

Primary outcome measures

Pain intensity: Pain intensity was determined based on a numerical rating scale. Accordingly, the intensity of pain was scored from 0 to 10 indicating the absence of pain and the highest level of pain, respectively.

Headache frequency: The frequency of pain was determined based on the number of days a person had suffered from headaches during one week.

Secondary outcome measures

Headache Duration: The duration of pain was determined based on the number of minutes with pain per day.

Tablet count: This represented the number of tablets consumed by a person per day.

NDI: This variable was assessed by a questionnaire for evaluation of musculoskeletal disorders in the neck [29] before and immediately after the treatment phase and at the end of the follow-up phase.

These outcomes (average tablet count per day, frequency, pain intensity, and duration of pain, and NDI) were measured at the end of each phase.

Randomization

Block randomization was performed to ensure that the participants were divided into two equal groups. In this way, the patients with TTH were randomly divided into an intervention and a control group by a computer-generated block randomization schedule (six blocks with four individuals per block).

Ethic

This study was approved by the Ethics Committee of Shiraz University of Medical Sciences (code: IR.SUMS.REC.1396.64). The participants were required to sign the written informed consent form before being entered into the first phase of the study.

Participants

The participants were recruited from Emam Reza clinic in Shiraz. TTH was diagnosed by neurologists based on the diagnostic criteria adopted by the IHS. Power analysis was performed using G-power sample size calculator .The sample size was estimated based on a previous study [30] and considering α = 0.05, β = 0.1, and effect size of 0.99 [30]. Samples were included in the study by convenient sampling method. Accordingly, 24 patients who did not respond to medications were randomly divided into two groups. The participants aged 21 to 62 years. The flow diagram of the participants has been presented in Figure 1.

Figure 1.

The flow diagram of the participants.

Inclusion criteria were having headaches lasting for several minutes to several hours according to the IHS criteria [31]. In other words, the patients had to present at least two of the following criteria: no throbbing mode, not aggravating by daily activities such as walking and climbing the stairs, lack of nausea, vomiting, photophobia, and phonophobia during the attack [32], and not responding to medication. Exclusion criteria were having undergone cervical surgery, presence of herniated disc in the neck, pregnancy, breastfeeding, cervical (cervicogenic) headache and migraine (these types of headache were diagnosed by a neurologist), and having a history of severe trauma in the cervical area, malignancy in the neck region, rheumatism, fibromyalgia, cardiovascular disease, physiotherapy, and massage during the past six months.

Intervention

The intervention was performed after the baseline stage, and the follow-up procedure was conducted after the intervention. The intervention group received three therapy sessions for one week. Each session included myofascial release of SCM, upper trapezius, and scalp muscles, cranial base release [33], vertebral mobilization [34], and release of the TrPs of SCM, upper trapezius, and suboccipital muscle therapies through friction massage (Appendix A). Each session lasted 30 minutes.

Drug therapy

Both groups received the same types and doses of drugs (nortriptyline 50 qsh and valporae Na 200 mg BID). Both groups did not respond favorably to the prophylactic drugs and simple analgesics.

Statistical methods

The data were analyzed using the SPSS 25 software. Kolmogorov-Smirnov test was used to determine the normality of the data. At first, two-way repeated measures ANOVA was used to assess the time-group effect, which revealed a statistically significant interaction between time and group. Therefore, repeated measures ANOVA could not be utilized and within-group and between-group comparisons were made by paired t-test and independent t-test, respectively. Effect size was calculated by Cohen’s effect size calculator.

Results

All the study variables showed a normal distribution. Demographic information is presented in Table 1.

Table 1.

Demographic information.

Group	Mean age	Number of females and males
		Female	Male
Control	41.41	8	4
Intervention	43.16	7	5

No significant differences were observed between the two groups at baseline (Table 2).

Table 2.

Comparison of the two groups regarding headache pain intensity (number), frequency (days per week), and duration (minute per day), tablet count (per day), and NDI at baseline (between-group differences 95% CI).

Variable	Group		P-value
	InterventionMean (±SD)	ControlMean (±SD)
Pain Intensity	7.37 (2.01)	6.70 (2.37)	0.46
Frequency	4.91 (2.39)	5.25 (2.05)	0.71
Duration	344.18 (333.39)	279.05 (165.66)	0.55
Tablet count	5.66 (3.77)	4.08 (2.87)	0.26
NDI	20.83 (9.35)	20.50 (11.17)	0.93

*NDI: Neck disability index

The results revealed no significant difference between the two groups regarding headache pain intensity (p = 0.43), frequency (p = 0.17), and duration (p = 0.15) and tablet count (p = 0.89) immediately after intervention phase. A significant difference was observed between the two groups in terms of the NDI score immediately after the intervention phase (p = 0.004). However, the two groups were significantly different with respect to headache pain intensity, frequency, and duration, tablet count and NDI score (P < 0.05)after the follow-up stage Table 3.

Table 3.

Comparison of the two groups regarding headache pain intensity (number), frequency (days per week), and duration (minutes per day), tablet count (per day) and NDI at the end of intervention phase and follow-up phase. (between-group differences 95% CI).

Variable	Intervention Group		Control Group		P-valuetreatment	P-Value follow up	Effect size
	treatmentMean(±SD)	Follow upMean(±SD)	treatmentMean(±SD)	Follow upMean(±SD)
Pain Intensity	4.97 (2.45)	3.04 (1.98)	5.91 (3.23)	6.75 (2.05)	0.43	0.0001	1.85
Frequency	3.25 (1.95)	2.33 (2.26)	4.50 (2.43)	5.00 (1.80)	0.17	0.004	1.48
Duration	141.36 (137.16)	91.29 (89.17)	239.91 (187.01)	284.74 (161.28)	0.15	0.002	1.48
Tablet count	3.58 (3.42)	1.83 (2.62)	3.41 (2.64)	4.91 (3.26)	0.89	0.01	1.04
NDI	7.33 (4.24)	7.33 (2.80)	17.58 (10.11)	20.16 (12.39)	0.004	0.003	1.37

NDI: Neck disability index

The within-group comparison showed a significant reduction in headache pain intensity, duration, and frequency, tablet count, and NDI in the intervention group at different phases of the study (p < 0.05). However, no significant difference was detected in this regard in the control group (Tables 4 and5).

Table 4.

Comparison of headache pain intensity (number), frequency (days per week), and duration (minutes per day), tablet count (per day) and NDI in the intervention group at different phases (within group differences).

Variable	Phase			P-valueBaseline-Treatment phase	P-valueBaseline- Follow up phase	Effect size
	BaselineMean (±SD)	TreatmentMean (±SD)	Follow-up
Pain Intensity	7.37 (2.01)	4.97 (2.45)	3.04 (1.98)	0.005	<0.001	2.17
Frequency	4.91 (2.39)	3.25 (1.95)	2.33 (2.26)	0.04	0.008	1.10
Duration	344.18 (333.39)	141.36 (137.16)	91.29 (89.17)	0.07	0.01	1.03
Tablet count	5.66 (3.77)	3.58 (3.42)	1.83 (2.62)	0.04	0.002	1.17
NDI	20.83 (9.35)	7.33 (4.24)	2.80 (7.33)	<0.001	<0.001	1.95

*NDI: Neck disability index

Table 5.

Comparison of headache pain intensity (number), frequency (days per week), and duration (minute per day), tablet count (per day) and NDI in the control group at different phases (within group differences).

Variable	Phase			P-value Baseline- treatment phase	P-value baseline-follow up phase	Effect size
	BaselineMean (±SD)	TreatmentMean (±SD)	Follow upMean(±SD)
Pain Intensity	6.70 (2.37)	5.91 (3.23)	6.75 (2.05)	0.24	0.93	0.01
Frequency	5.25 (2.05)	4.50 (2.43)	5.00 (1.80)	0.08	0.42	0.12
Duration	279.05 (165.66)	239.91 (187.01)	284.74 (161.28)	0.07	0.1	0.03
Tablet count	4.08 (2.87)	3.41 (2.64)	4.91 (3.26)	0.36	0.36	0.27
NDI	20.50 (11.17)	17.58 (10.11)	20.16 (12.93)	0.05	0.80	0.02

*NDI: Neck disability index

Discussion

Main results

Statistically significant and clinically meaningful between the groups differences with large effect sizes were recorded for pain intensity (decreased of more than 4/10, based on Minimally Clinically Important Difference (MCID) this reduction of pain showed the clinical meaningfulness of the results [35]), duration, and frequency (decreased of more than 50 percent, based on HIS guideline 50 % reduction in headache frequency is clinically meaningful [36] (, tablet count, and NDI (decreased by more than 18%, NDI score changed more than 10-point so based on MCID [37] this treatment was clinical meaningful.) in the follow-up phase in patient with TTH. Uthaikhup et al. stated that cervical mobilization and neck exercises reduced the NDI score in patients with TTH. They emphasized that since these patients had musculoskeletal problems in the neck, cervical mobilization might increase the circulation and range of motion in the cervical area, eventually reducing the NDI score [38]. Similarly, neck mobilizations and release of head, neck, and shoulders TrPs reduced the NDI in patients with TTH [39].

In the present study, the mean NDI score was approximately 20 before the intervention in both intervention and control groups, showing that the patients suffered from cervical complications. However, the NDI score was reduced to 7 after the manual therapy in the intervention group. Hence, it can be concluded that manual therapy simultaneously reduced cervical problems and headache among the patients.

Mesa-Jimenez et al. reported that manual therapy was effective in decreasing the frequency, duration, and pain intensity of TTH [28]. Furthermore, cervical mobilization reduced headache pain intensity, duration, and frequency in patients with TTH [38], while myofascial release of the neck and head muscles reduced headaches pain intensity [40]. All these techniques showed positive pain relieving effect amongst patients with TTH [41]. However, Ghanbari et al. showed no significant decline in the frequency and duration of headaches in the patients with TTH who received cervical TrPs manual therapy [42]. It is worth mentioning that Ganbari et al. used only positional release techniques to deactivate the TrPs, while cervical mobilization, TrPs release, and myofascial release therapy were employed in the current investigation.

Patients with TTH consume a wide range of drugs, which are accompanied by a variety of complications despite their high costs. A number of studies have assessed the effect of manual therapy on drugs usage in patients with TTH. The present study, for instance, revealed a clinical significant decrease in tablet count in between group comparison after follow up phase (effect size> 1).

Ghanbari conducted a research on patients with TTH where patients received NSAID as abortive drugs and antidepressant as prophylactic drugs. This study showed no significant difference in the amount of consumed drugs after positional release of muscle Trps [42]. Mobilization reduced medications dosage in patients with TTH [38]. Manual therapy was more effective than drug therapy (acute and prophylactic drugs) in some variables such as frequency, intensity and duration of headache in short term [28].

One of the common treatments for neck problems is cervical mobilization, which has been shown to improve muscle function, muscle spindle sensitivity, proprioceptive awareness [43] and relieve pain [44]. The neurophysiological mechanism of manual therapy in the spine can immediately reduce pain due to its mechanical effects on pain receptors [45], activation of pain relief mechanism, and increased endorphin secretion [46]. Furthermore, friction massage can increase the blood flow to the TrPs locations [47] .The effects of massage include the rapid reduction of local pain, increased blood flow, and delivery of nutrients to the treatment area. Therefore, massage is a suitable technique for TrPs deactivation [10]. Myofascial release technique reduces pain in patients with TTH by increasing blood flow and lymph drainage and improving flexibility of soft tissue [48]. In this study myofascial release, vertebral mobilization and friction massage were applied. Based on MCID and effect size number (above 1 in all variables), this treatment has high clinical effects. It is likely that the beneficial effects of these techniques mitigate the symptoms of these patients.

Limitations

Assessing the value of manual therapy was difficult because a variety of techniques were utilized. Contextual factors were not consider in this study. The follow-up period was limited in this study. Therefore, future research is recommended with longer follow-up periods and considering contextual factors.

Clinical application

In TTH, musculoskeletal problem like Trps, postural dysfunction exist. In TTH patients that do not respond to drug therapy for reducing the MOH and Drug abuse, physiotherapists can treat patients with TTH with manual therapy (mobilization, myofascial release, friction massage) to reduce symptoms, the social and economic burden.

Conclusion

Manual therapy reduced pain intensity, frequency and duration, tablet count, and NDI score in TTH patients. Manual therapy can mitigate TTH symptoms.

Funding Statement

The author(s) reported there is no funding associated with the work featured in this article.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Geolocation information

This study was conducted in Shiraz located in Iran.

Supplemental data

Supplemental data for this article can be accessed online at https://doi.org/10.1080/10669817.2022.2107446.