Study design
A prospective randomized clinical trial study was arranged between 1st July to 31st December 2019.
Sample Size
Initially, total sample size of the study was 48 , (experimental=24 and control group=24) that was calculated online using Open Epi tool with confidence interval 95%, power of 80% (5). And, a non-response rate of 10% was taken.
'Ethics approval and consent to participate'
Ethical approval was taken from Medcare Sports Injury Clinic, Medcare International Hospital, Gill Road, Gujranwala with reference No. MSIC/329. The written informed consent was obtained from all participants with the following consent statement.
Participants
A total of 48 patients were selected from Rehabilitation and Injury Management Department of Medcare International Hospital Gujranwala Figure 1. Patients of both gender of age 18-40 years with diagnosis of ETTH and CTTH were included. And other inclusion criteria regarding TTH were (1). At least 10 episodes occurring on ≥1 day per month for at least 3 months (2). Headache episodes lasting from 30 minutes to 7 days (6).Headaches has at least two of them; Bilateral location of pain, Pressing tightening (non-pulsating) quality, Mild or moderate intensity, Pain provocation on trigger point palpation, Headache that does not aggravate by routine physical activity, No nausea or vomiting in ETTH , Not attributed to another disorder, Subjects being under pharmacological control. Patients with Headache that is aggravated by head movements, musculoskeletal and metabolic disorders with symptoms homogenous to headache (rheumatoid arthritis), previous neck trauma, Vertigo, dizziness, arterial hypertension, Malignancy, infection, trauma, bone deformities were excluded from the study.
Randomization
Participants were selected through Non probability convenient sampling technique as per inclusion and exclusion criteria. Patients of TTH were randomly allocated into 2 equal groups (Group A=24 and Group B=24) and randomization was done by lottery method. It was single blinded study in which assessor of data was blinded.
Interventions
Muscle energy technique along with myofascial release technique on upper trapezius and sternocleidomastoid was applied on patients of group A. Only myofascial release technique was used on upper trapezius and sternocleidomastoid muscle to group B.
Treatment Protocols
Group A
Muscle energy technique along with myofascial release technique on upper trapezius and sternocleidomastoid was applied on patients of group A.
Protocol 1:
Muscle Energy Technique on upper trapezius
The patient places in a moderate opposed exertion (20% of the accessible solidarity) to convey the decent shoulder to the ear (a shrug movement) and the ear to the shoulder. There ought to be a moderate level of duty and no uneasiness ought to be experienced. The compression goes on for 7-10 seconds and when the exertion is totally loose (7).
Muscle energy technique on sternocleidomastoid
Patient is approached to lift a little degree to the roof the completely turned head and to hold the breath. There is no requirement for the professional to apply opposition when the head is raised as this is adequately given by gravity. Between 7-10 seconds of isometric constriction, the patient is advised to discharge the exertion (and breath) bit by bit and position the head on the table so that there is a little level of expansion (7). Moist heating pad is applied for 10 minutes before each session (8).
Protocol 2:
Myofascial release technique on upper trapezius
The muscle is put on a gentle leeway by moving the ear somewhat to the shoulder on a similar side with the patient recumbent, or presumably sitting. The whole mass of the upper trapezius is raised off the supraspinatus muscle and summit in a pincer grasp. The muscle at that point rolls firmly between the fingers and thumb to palpate for a knob and tight groups to discover Trigger point's spot delicacy (9). Treatment session longs for 10 minutes of myofascial release on each side (10).
Myofascial release technique on sternocleidomastoid
The patient sits in a low-upheld firm-sitting easy chair easily and loose with each hand's fingers snared under the seat or under the thigh. The patient's head might be supported in the administrator's hand to enable the patient to loosen up the neck muscles, with the administrator's head leaning against the administrator's arm or chest. The patient is encouraged to rest the administrator's head weight and utilize greatest profound stomach breathing, which likewise unwinds. Therapist applies pressure on trigger points located in sternal and clavicular divisions of muscle with pincer grip. Gradually increasing the pressure and releasing the trigger points one by one. This is followed by stretching of muscle by deep inhalation, rotation of head on opposite side and rotation of chin on same side (9). Treatment session longs for 10 minutes of myofascial release on each side (10).
Group B
Treatment applied in this group is myofascial release technique for upper trapezius and sternocleidomastoid muscle. This was applied in the same way mentioned in the protocol 2 of group A interventions.
Outcome measures
Outcome variables of pain, range of motion and functional level of patients were measured at Baseline, 4th and 8th week by measuring scales of NPRS, inclinometer, Headache disability index and headache impact test respectively.
Numerical pain Rating scale (NPRS)
NPRS value is 0-10 and each number describes the level of discomfort and pain, “0” indicates no pain and “10” show worst or maximum pain.
Headache Disability Index (HDI)
HDI is a reliable and valid tool (12) to measure the disability due to headache.
Headache Impact Test (HIT-6)
HIT-6 is a valid and reliable tool for the impact of headache on activities of daily life (ADLs) (13).
Cervical range of motion (CROM Inclinometer)
CROM inclinometer is used to assess cervical range of motion.
Statistical analysis
The data were entered and analyzed using SPSS (Version 21.) Shapiro Wilk test was applied to check the normality of data. Non-Parametric test were applied for the significance. Mann Whitney U test was applied for the comparison of between groups for variable of pain, headache impact test, headache disability index and flexion, extension and lateral flexion at cervical spine. For within group analysis at 3 different levels (Baseline, 4th and 8th week) Friedman test was applied. Wilcoxon signed rank test was used within group comparison analysis in control group and experimental group for the variable of pain and all variables mentioned above. All results were calculated at 95% confidence level and p-value ≤0.05 was considered as significant value.
Ethical approval
The research was completed after the Ethical approval of institutional review board at Medcare International Hospital, Gill Road, Gujranwala.
Informed consent
Informed consent was taken from all the participants which were part of this study.