Effectiveness of different physiotherapy interventions in the management of cervicogenic headache: a pilot randomized controlled trial

ABSTRACT

Background

Cervicogenic headache is a secondary headache which leads to decreased functional activity, quality of life and functional disability.

Objective

To determine the feasibility and acceptability of different physiotherapy interventions in the management of cervicogenic headache and to determine sample size for a full trial.

Trial design

A pilot randomized controlled trial.

Settings

Various physiotherapy outpatient department.

Methods

Participants suffering from cervicogenic headache with age 20- 60 years were randomly allocated into four groups. Sessions were given over 4 weeks 4 times a week (16 sessions). The primary outcomes were feasibility of participant recruitment, assessment procedure, retention, adherence, and acceptability. The secondary outcomes were headache impact test-6 for a headache disability, headache diary for headache intensity, frequency, duration, and neck disability index for neck pain, disability measured at baseline, 4th week, and follow up after 1 month.

Result

178 subjects were screened based on selection criteria. Out of them, 93 (52%) were eligible and 80 (86%) participated in the study. 96.25% of participants completed the final 8-week assessment. Overall 93.75% of participants completed the entire assessment item across all time points. 95% completed all treatment sessions. 97.5–100% of participants were satisfied with the treatment protocol. No adverse effects were reported by participants. Based on the data obtained from the pilot trial, sample size was determined as 35 participants in each group.

Conclusion

The results indicate that the trial methodology and intervention are feasible for implementing a full-powered randomized controlled trial to determine the effectiveness of physiotherapy intervention in the management of cervicogenic headache.

Introduction

Cervicogenic headache (CGH) is a secondary headache caused by a disorder of the cervical spine and its components which may include bony, disc, and/or soft tissue elements [1]. It accounts for 15–20% of all chronic and recurrent headaches [2]. The prevalence rate of CGH varies from 4.1%–21% based on studies conducted on various sample populations, age groups, and diagnostic criteria [2–5]. The pain is usually present in the temporal region and may be referred to the occipital, frontal, and orbital regions with reduced cervical range of motion [6]. It is usually, not necessarily, accompanied by neck pain [1].

The research indicates that deep neck flexors and lower neck extensors assist neck motor control. Further, atrophy of these muscles can lead to head-neck instability ultimately leading to headache or vice-versa (pain-spasm-pain cycle or pain-atrophy-pain cycle) [7]. Such pain can reduce functional activity, work efficiency, and quality of life, which is a burden on public health and financial outcomes [8].

Previous literature documents various treatment options for CGH like spinal manipulation, massage, stretching, dry needling, spinal mobilization, etc. [9]. Drugs used in the management of headaches have several side effects and invasive treatments are difficult to administer as they require a lot of skill and knowledge. Non-pharmacological approaches are effective for the management of CGH particularly in mild to moderate intensity. Among these, physiotherapy is the best treatment option available [10]. According to Jull et al., the causes of CGH are postural abnormalities, muscle tightness, and neural tissue mechano-sensitivity which are dependent on the presence of articular (C₀–C₃ segments) and muscular impairment accompanied by an acute or long-term manifestation of poor neuromotor control [11]. These three sources of pain among CGH patients from our physiotherapy treatment selection, i.e. spinal mobilization to correct articular impairment, postural correction exercises for muscular impairments, and neural mobilization for neural tissue mechanosensitivity. Thus, in the present study, spinal mobilization, neural mobilization, and postural correction exercises techniques are physiotherapy interventions used for managing CGH symptoms. There is a paucity of research done to evaluate the efficacy of spinal mobilization on CGH as most studies used sustained natural apophyseal glide (SNAG) [12]. Various studies document that exercises have a positive effect on CGH, however, most of the research is done using craniocervical exercises [13]. There is a scarcity of work done on postural correction exercises. To the best of our knowledge, none of the trial evaluated the effect of neural mobilization on CGH. There was only one study that showed the beneficial effect of a combination of soft tissue and neural mobilization technique on tension-type headache (TTH) [14]. Before proceeding to the fully powered randomized control trial to evaluate the effectiveness of these three physiotherapy interventions i.e. spinal mobilization, neural mobilization, and postural correction exercises in the management of CGH, we aimed to conduct a pilot study to determine the feasibility and acceptability of conducting such a trial.

The primary aim of this pilot study was to determine the feasibility of participant recruitment, the feasibility of outcome measure, retention rate, adherence rate, and acceptability of treatment process. The secondary aim was to obtain pilot data on the difference in key outcomes to calculate the sample size for a definite randomized control trial.

Methodology

This pilot study followed the Consolidated Standards of Reporting Trials (CONSORT) for randomized pilot or feasibility trials [15].

Study design

A participant-blinded, parallel-group (1:1 allocation ratio), active, pilot randomized controlled trial was used to investigate the effects of spinal mobilization, neural mobilization, and postural correction exercises in the management of CGH.

Participants

Eligibility criteria

Inclusion criteria were (1) participants of age from 20 to 60 years with a history of CGH; (2) average score of at least three on the 10-point pain intensity scale in the last 4 weeks (pre-intervention). Exclusion criteria were (1) any other types of headache (migraine, TTH and occipital neuralgia, etc.); (2) vertebrobasilar insufficiency; (3) neck or head trauma in the past 2 years; (4) any head or neck surgery in the past 2 years; (5) spinal infection or diseases; (6) any history of neurological, cardiovascular, cardiopulmonary, and cervical discal disorders; (7) long term corticosteroid use or on anti-coagulant therapy (from last 6 months); (8) severe osteoporosis and pregnancy.

Settings: This study was conducted in various physiotherapy outpatient departments.

Participant identification: Participants were recruited through door to door survey from a nearby locality (community setting). During the baseline visit, verbal informed consent was taken along with musculoskeletal/headache history using questionnaire [16]. The second visit was done to only those houses where headache participants were living. Primary and secondary headaches were ruled out using the HARDSHIP questionnaire (headache-attributed restriction, disability, social handicap, and impaired participation) [17] and IHS criteria [1]. Further, CGH was assessed using Sjaastad criteria [18]. The IHS criterion was not adopted for CGH because we did not have resources to evaluate anesthetic blockade and post hoc headache resolution. Participants with CGH were contacted through phone for obtaining their consent to participate in this trial. If patients agreed to participate, they were invited to visit the OPD through appointment (time-allotment) and a brief confirmatory physical examination was done according to CGH diagnostic criteria. All patients were explained about the trial in local vernacular language and written informed consent was taken from them according to the declaration of Helsinki, 2013. The intervention was started after randomization. All participants received reminder calls to fill the headache diary and regarding the appointment.

Interventions

The interventions were given by a trained physiotherapist. The eligible participants were randomly allocated into four groups. After allocated to intervention groups all participants were examined for joint dysfunction, mechanical neural sensitivity, and muscle weakness or tightness [19]. The total duration of treatment was for 4 weeks, 4 times a week (16 sessions) and each treatment session lasted for approximately 30 minutes.

The spinal mobilization group received posteroanterior glide at the spinous and transverse process of C₂ and C₃ vertebra, lateral glide at affected side of the spinous process of C₂ and C₃ vertebra [20] and translatoric glide [21] at the transverse process of C₁ vertebrae and SNAG. Three sets of 30 oscillations were given at 2 Hz frequency with 10 seconds rest in between techniques/glides [20].

The neural mobilization group received neural mobilization of meninges, brachial plexus, and trigeminal nerve [14], along with neural mobilization for headache at three levels (Table 1) [22].

Table 1.

Procedure and dosage of neural mobilization technique

Technique	Procedure	Dosage
Level 1 Neutral sliders	Patient is in supine position with neck held in upper cervical neural flexion/ extension or slightly extended. Bilateral SLR is done if bilateral pain present. For unilateral head pain ipsilateral SLR/MNT1 was given.	The neurodynamic position was maintained for 30–60 s. One set of 5–10 repetitions were given in one session. Given in first week
Level 2 Sliders Tensioner	Patient is in supine position. Ipsilateral SLR/ MNT1 were given with upper cervical flexion in unilateral pain. SLR was given with upper cervical extension for distal slider and with upper cervical flexion for proximal slider was given if bilateral pain present. Combination of upper cervical flexion and contralateral lateral flexion with SLR/MNT1 was given in supine position.	5–20 repetitions of 2–3 sets given according to patient response in first week with 10-s rest in between sets.
Level 3 Neurodynamically sensitization	Level 3a – patient is in sitting position. First do ankle dorsiflexion then knee extension then lumbar flexion followed by thoracic flexion then cervical flexion then add sensitizing maneover (contralateral lateral flexion of upper cervical spine) Level 3b – patient is in lying position instruct patient to immediately sit after the head moves toward your chest. Then therapist passively flex the upper cervical then lower cervical and assist the patient while thoracic and lumbar flexion end with hip flexion. Level 3c – same as level 3b. Once the end range upper cervical slump position reached the therapist performs contralateral lateral flexion of upper cervical joint first with knee extension then with knee flexion.	Level 3a and 3b was given in third week and level 3c given in fourth week. 4–5 sets of 5–30 repetition was done according to patient’s response in level 2, 3a and 3b with 10-s rests in between the sets

MNT1 – median nerve tension test-1, SLR – straight leg raise.

In postural correction exercises group stretching of tight muscles (rectus capitus posterior, suboccipital, upper trapezeius, scalene, levator scapulae, sternocleidomastoid, pectoralis major/minor muscles) [23] were given 10 times with 6–10 second hold. Strengthening and endurance exercises for weak muscles (cervical flexors and deep cervical flexor, rhomboidus, and lower trapezeius muscles) were given 10–20 repetitions for strengthening exercises and 3 sets of 30 repetitions for endurance exercise [24,25].

The control group was given normal range of motion exercises for the neck and shoulder region, 10 repetitions 4 times a week for 4 weeks [26].

Outcomes

Feasibility and acceptability of physiotherapy interventions (spinal mobilization, neural mobilization, and postural correction exercise) by participants were the primary outcome measures. The feasibility of the recruitment rate was assessed by a number of participants recruited in the study according to eligibility criteria, the retention rate was assessed by the number of participants who completed the trial, and the adherence rate was assessed by the number of intervention sessions attended by participants by maintaining their attendance record daily. The feasibility of outcome measures was assessed by the number of participants completing the baseline, post-intervention and follow-up data. The acceptability of interventions was assessed by answering some basic questions regarding the treatment process in a yes and no manner (Table 2). At least, 70% participants recruitment, 90% of participants completing the trial, and 95% giving post and follow-up data as well as 75% participants attendance in treatment sessions were considered as key parameters for feasibility for the main trial [27]. Treatment interventions were acceptable if participants answered yes in at least 80% of questions (4 out of 5).

Table 2.

Acceptability of physiotherapy intervention (n = 80)

S.No.	Questions	Yes	No
1	Are you satisfied by the treatment received	78(97.5%)	2(2.5%)
2	Are you satisfied by the number of session given	80(100%)	–
3	Are you satisfied by the time of intervention	80(100%)	–
4	Are you satisfied by the intensity of intervention	79(98.8%)	1(1.4%)
5	Are you satisfied by giving assessment form	74(92.5%)	6(7.5%)

The secondary outcome was headache impact test-6 (HIT-6) for a headache disability. It consists of six items with a total score ranging from 36 to 78 points on 5 response options: never (6 points), rarely (8 points), sometimes (10 points), very often (11 points), and always (13 points) [28]. Another secondary outcome was headache diary [29]. As the participants agreed to participate in the study a set of paper diaries was given to them 4 weeks before the start of the intervention to maintain their headache records before, during, and after the treatment. Headache intensity was calculated by a numeric pain rating scale ranging from 0 as no pain to 10 as maximum pain. Headache frequency was calculated by a number of headache episodes in a month. Headache duration was calculated by time of headache start to end per episode (in minutes) divide by a number of episodes in a month [30]. The third secondary outcome was the neck disability index (NDI) for neck pain and disability. It consists of 10 items and each item was measured with 0 as no disability to 5 as a maximum disability. Overall score out of 100 was calculated by adding each item score together and multiplying it by two [31].

Sample size

As this was a pilot study a formal sample size calculation was not conducted. The main aim of the pilot study was to determine feasibility for the main study and to estimate the effect size to inform a future sample size calculation for the main trial. Therefore, a sample of 80 participants was chosen (20 participants per arm). This was recommended by Whitehead et al. that a minimum of 20 participants per arm has to be taken when estimating the variance for sample size calculation for a future trial design with 80% power, 5% significant difference, and small effect size [32].

Randomization and allocation concealment

Participants were randomized by using a computer-based random sequence generator with a 1:1 allocation ratio. A research assistant who was not involved in the trial did randomization before allocation to treating therapist after baseline assessment. The research assistant prepared consecutive numbered, sealed, opaque envelopes containing group allocation from 1 to 4 without knowing which type of intervention was given to which group.

Blinding

Participants were blinded to the treatment. Informed consent did not disclose the type of physiotherapy intervention provided to participants. We simply wrote a statement that a physiotherapy intervention would be given.

Statistical methods

Statistical analysis was conducted using IBM-SPSS version 21 software (SPSS Inc, Chicago, IL, USA). Intention-to-treat analysis was done to analyze missing data by using the last observation value carried forward. The primary outcome measure (feasibility) was calculated using descriptive statistics. All categorical variables were presented as number and percentage whereas continuous variables were presented as median and interquartile range (IQR). The baseline characteristics of the groups were compared with one-way ANOVA. All secondary outcomes were compared with Friedmann and Kruskal–Wallis test for within group and between groups respectively as data were non-normally distributed.

Results

Participant flow: A total of 80 participants were included in the study. The data from all 80 participants were analyzed. Four participants did not return the headache diary of follow-up period, one from the SM group (transferable job), and three from the control group for reasons not known. Figure 1 shows the participant’s flow.

Figure 1.

Participant flow (detail of included participant in the study).

Baseline data

The mean age of the participants was 39.56 ± 11.94. The majority of participants were female 81.3% (65/80). The baseline characteristics across the four groups were similar and no significant difference was found between the groups. The socio-demographic details and p-value of baseline data for all four groups are shown in Table 3.

Table 3.

Socio-demographic detail and p value of baseline data

Variables	SM group	NM group	PC group	Control	p value
Gender (frequency, percentage)	M = 5(25%), F = 15 (75%)	M = 1(5%), F = 19 (95%)	M = 4(20%), F = 16(80%)	M = 5(25%), F = 15(75%)
Age	41.45 ± 13.21	38.55 ± 9.28	38.65 ± 13.89	39.40 ± 11.63	0.075
Height	159.80 ± 22.01	155.40 ± 23.02	157.25 ± 20.10	154.25 ± 26.97	0.121
Weight	63.09 ± 15.69	66.10 ± 15.76	64.03 ± 13.45	64.42 ± 17.09	0.947
BMI	22.91 ± 7.06	25.33 ± 6.99	24.14 ± 6.94	24.45 ± 7.58	0.627
HIT −6 pre	74.5(66.25–78)	71(65.25–76)	72.5(69.25–78)	72(67.5–74.5)	0.448
HI pre	7.78(7.22–9.01)	6.58(5.65–8.1)	6.4(5.77–7.59)	6.7(5.08–7.95)	0.889
HD pre	1234.28(361.60–1440)	640.62(341.65–1440)	818.57(268.09–1440)	488.57(199.12–1440)	0.658
HF pre	28(9.5–30)	12(8–30)	17.5(11.5–28)	7.5(5.25–14)	0.135
NDI pre	43(28–58.75)	36.66(25.2–58.5)	41(35.12–56.2)	36.5(28.5–47.5)	0.179

BMI – body mass index, F – female, HD – headache duration, HF – headache frequency, HI – headache intensity, HIT-6 – headache impact test-6, M – Male, NDI – neck disability index, NM – neural mobilization group, PC – postural correction exercises group, SD – standard deviation, SM – spinal mobilization group.

Data are expressed in median (interquartile range).

Age, height, weight and BMI data are expressed in mean ± SD.

Outcomes

Primary outcomes

Feasibility of recruitment rate: Between February 2019 to October 2019, 178 participants were identified, of these 93 met the inclusion criteria and 13 refused to participate in the study some due to long-distance (7 participants) and other unknown reasons (5 participants). Therefore, a total of 80 participants out of 93 (86%) gave their consent and agreed to participate in the study. They were randomly allocated to three intervention groups (n = 20 each for spinal mobilization, neural mobilization, and postural correction exercises group) and one control group (n = 20).

Feasibility of outcome measures: All participants gave baseline data and post-intervention data; 76 participants (93.75%) completed the headache diary and 77 participants (96.25%) completed all other outcome measures (headache impact test-6 and neck disability index). Five participants did not return headache diary (one from the spinal mobilization group, two from the postural correction group, and two from the control group) and three did not give follow-up data for all outcome measures (one from the spinal mobilization group and two from the control group). Therefore, the overall feasibility of the outcome measure was 95%.

Retention rate: Attrition rate of 3.75% was documented at the end of the study. 80/80 (100%) completed the 4th-week assessment and 77/80 participants (96.25%) completed the 8th-week follow-up assessment.

Adherence rate: 76 out of 80 participants (95%) completed all 16 visits. Four participants did not complete all visits. One participant from the neural mobilization group skipped one visit to attend a marriage; one participant from the postural correction exercises group skipped three visits for going outside the city due to unknown reason and two participants from the spinal mobilization group: one skipped five visits due to the death of a family member and another skipped two visits due to illness (fever).

Acceptability: The acceptability of the treatment process and response of the questionnaire is shown in Table 2. Most patients were satisfied with the physiotherapy treatment except for two participants from the control group. All participants were satisfied with a number of treatment sessions and time of intervention received. One participant was not satisfied with the intensity of treatment given and six participants were not satisfied with giving assessment data of follow-up. Overall participants were satisfied with positive feedback about pilot intervention.

Secondary outcomes

The median and interquartile range of all secondary outcomes were measured using chi-square and p-value of Friedmann and Kruskal–Wallis test of all the four groups (Table 4). The result of the Friedmann test showed that all three groups were statistically significant at repeated time points with p < 0.001 for all outcome measures except headache duration in the spinal mobilization group with a significant p-value of 0.003. The control group also showed statistically significant improvement in headache disability (p = 0.026) and neck pain-related disability (p = 0.03). The result of the Kruskal–Wallis test showed a greater reduction in headache disability and neck pain-related disability at p < 0.001 for both post and follow-up period time in between-group comparisons. Headache intensity showed significant results at p = 0.031, <0.001 for post-intervention and follow-up period time, respectively. Headache duration and headache frequency showed significant results at p = <0.001 and p = 0.007 for follow-up period, respectively. However, headache duration and frequency showed non-significant improvement after post-treatment (Table 4).

Table 4.

Median and Interquartile range of all primary and secondary outcomes measures with their chi square and p value of Freidman and Kruskal–Wallis test of all four groups

With-in group	Groups				Between groups
Variables	SM	NM	PC	Control	ϰ2(p)*
HIT-6 (pre)	74.5(66.25–78)	71(62.25–76)	72.5(69.25–78)	72(67.5–74.5)	2.709(0.439)
HIT-6 (post)	59(50.5–63)	51.5(46.5–57)	58(50.5–61)	69(63–73.75)	27.782(<0.001)
HIT-6 (follow up)	44(36–58.75)	38(36–53.75)	42.5(36–49.5)	68.5(58.25–72)	23.538(<0.001)
ϰ2(p)#	37.795(<0.001)	31.063(<0.001)	30.5(<0.001)	7.314(0.026)
HI (pre)	7.78(7.22–9.01)	6.58(5.65–8.1)	6.4(5.77–7.59)	6.7(5.08–7.95)	7.897(0.048)
HI (post)	4.78(3.55–5.15)	4.9(2.54–6.54)	4.08(2.51–5.52)	6(4.7–7.9)	8.889(0.031)
HI (follow up)	3.65(1.7–5.37)	2.8(0–4.16)	3.2(0–5.92)	6.44(5.35–7.77)	16.776(0.001)
ϰ2(p)#	26.347(<0.001)	23.863(<0.001)	16.88(<0.001)	0.473(0.789)
HD (pre)	1234.28(361.6–1440)	640.62(341.65–1440)	818.57(268.09–1440)	488.57(199.12–1440)	2.229(0.526)
HD (post)	258.64(73.17–907.5)	267(48.75–554.87)	241.66(66.37–1027.5)	784(241.53–1350)	7.326(0.062)
HD (follow up)	277.5(52.83–1440)	36(0–356.25)	25.2(0–234)	604.61(270–1350)	17.911(<0.001)
ϰ2(p)#	11.662(<0.003)	23.147(<0.001)	29.51(<0.001)	0.259(0.878)
HF (pre)	28(9.5–30)	12(8–30)	17.5(11.5–28)	7.5(5.25–14)	10.194(0.017)
HF (post)	6(3.25–12.25)	6(2.25–10)	6.5(4–9)	8(5.25–12.25)	2.653(0.448)
HF (follow up)	5(2–8.75)	3(0–4.75)	3.5(0–9)	8(6–12)	12.023(0.007)
ϰ2(p)#	31.506(<0.001)	26.057(<0.001)	28.029(<0.001)	0.456(0.796)
NDI (pre)	43(28–58.75)	36.66(25.2–58.5)	41(35.12–56.2)	36.5(28.5–47.5)	1.362(0.714)
NDI (post)	18(8.77–23.92)	11.5(4.87–19.5)	12.15(2.38–21.15)	34.5(29–47.5)	27.762(<0.001)
NDI (follow up)	11.25(4–25.6)	7.75(0.5–15.87)	8(4–19)	34(27.62–47.5)	25.796(<0.001)
ϰ2(p)#	25.914(<0.001)	29.183(<0.001)	31.44(<0.001)	7(0.030)

HD – headache duration; HF – headache frequency; HI – headache intensity; HIT-6 – headache impact test-6; NDI – neck disability index; NM – neural mobilization; PC – postural correction exercises; SD – standard deviation; SM – spinal mobilization.

Data were expressed in median (Interquartile range).

*- Chi square and p value for Kruskal–Wallis test (in between groups).

#- Chi square and p value for Freidman test (with-in group).

The sample size for full trial

The standard deviation from these results will help in the calculation of sample size for a full trial. A total of 140 participants were included after calculation of sample size (32 participants in each group) based on 99% confidence interval and 90% power of study, pooled standard deviation of 8.45 with minimal clinical important differences (MCID) of 8 points for primary outcome measure that is headache disability (HIT-6) [33]. The sample size was 35 participants per group with an estimated dropout rate of 10%.

The aim of this pilot study was not to find the efficacy of treatment intervention. That’s why we are not reporting the significant result in detail.

Participants did not report any adverse effects of the treatment protocols.

Discussion

The results suggest that a future randomized control trial evaluating the effectiveness of different physiotherapy interventions (i.e. spinal mobilization, neural mobilization, and postural correction exercises) in the management of CGH is feasible. We have achieved a recruitment rate of 86%. At this rate, a fully powered randomized controlled trial is feasible. The retention rate of 96.25% was achieved at the end of the study (8th week) and 100% at the 4th week. The overall assessment rate was 96.25% which exceeds our prior target for proceeding with a full trial. 95% of participants completed all 16 visits which can be attributed as a good adherence rate of treatment. One of the reasons behind this success rate could be the scheduling treatment sessions according to the patient’s convenience. The participants were contacted on phone and then their appointment was fixed. This pilot study demonstrated strong treatment acceptability and all the participants were satisfied with a number of sessions and time of treatment. 98.75% of participants were satisfied with the intensity of intervention received and 97.5% were satisfied with the type of treatment received. Overall patients were satisfied with our treatment process. Regarding the feasibility of outcome measure, 96.25% of participants completed all outcome measures except headache diary. Our challenge in this pilot study was to collect headache diaries from participants 4 weeks before, during, and after treatment. We succeeded to collect a headache diary before and after treatment. However, only 93.75% of participants returned the headache diary in the follow-up period. However, it was a great number but less than our prior estimation rate of 95%. To increase the assessment rate we shall include some strategies in the main trial. First, we will try to recruit participants from places near to the clinic/OPD so that the geographical barrier can be reduced or to treat participants in local physiotherapy clinics in different societies of the city. Secondly, we can follow patients to mail their headache diary if they convey their inability to deposit it by hand at post-intervention or follow-up visit the OPD. Thirdly, we may adjust the sample size for a 20% dropout rate. These three strategies will be implemented in future RCT for high assessment completion rates. Although our aim was not to found the efficacy of physiotherapy intervention still we analyzed the data. Results showed the effectiveness of all three physiotherapy interventions for headache intensity, headache-related disability, and neck pain-related disability at different time points as well as comparisons between groups for both post and follow-up periods. However, headache duration and frequency show effectiveness for follow-up period only. The possible mechanism of improvement by spinal mobilization can be stimulation of mechanoreceptor in cervical facet joints that in turn inhibits pain by activating the descending pain inhibitory system [34]. Postural correction exercises can address muscular imbalances by holding the cervical spine in better alignment and maintaining head-neck stability, thus reducing the headache [7]. Neural mobilization could improve neural adaptability and reduce mechano-sensitivity by stimulating the nerves with elongation, sliding, and tension thus produces an analgesic effect [21].

Limitations

Regarding the recruitment process we excluded the participants having neck/head trauma. It causes greater than 50% of CGH and helps us to recruit more participants. We did not blind the treating therapist and assessor. We did not instruct participants to avoid other co-interventions like medications which may influence the result of the study. We did not record whether the participants were taking medication or not; if yes, then the dosage of medication taken before, during, and after the treatment. Our fully powered trial will include a medication record. Follow-up was done only 1-month post-intervention. Therefore, we were unable to monitor the long-term effects of treatment. In our RCT, we plan to increase the follow-up period.

Future scope: future trials can be performed with a combination of spinal mobilization, neural mobilization, and postural correction exercises techniques as well as optimization of exercise protocols. Further, the combination of three techniques can be compared with the individual technique.

Conclusion

The result of this pilot study suggests that it is feasible to do a fully powered randomized controlled trial to evaluate the efficacy of physiotherapy interventions (i.e. spinal mobilization, neural mobilization, and postural correction exercises) on pain and functional disability in patients suffering from CGH. Additionally, applying any of the three modalities randomly in groups of patients with established CGH resulted in improvements of measured outcomes compared to a control group.

Biographies

Monika Rani is a research scholar physiotherapy student in Guru Jambheshwar University of Science & Technology, Hisar(A grade NAAC accredited, state government university). Her interest in research is neurological physiotherapy and evidence based practice. she has published articles in peer reviewed journals and presents papers in national and international conferences.

Jaspreet Kaur is presently working as associate professor in Department of Physiotherapy, Guru Jambheshwar University of Science and technology (A grade NAAC accredited, state government university). She has done PhD in Physiotherapy and has more than 15 years of teaching and research experience. Presently she is supervising 05 PhD research scholars. She has guided more than 30 MPT dissertations. she has more than 41 publications and number of paper presentations. she has also delivered lectures as resource person in many national and international conferences.

Funding Statement

This trial did not receive any grant from funding agencies in the public, commercial, or not-for-profit sector.

Ethical approval and clinical trial registration

This study was approved by the Institutional Ethical Committee vide letter number (PTY/2018/710A), and was registered in the trials registry of India (CTRI) (Registration Number CTRI/2018/12/016717).

Disclosure statement

No potential conflict of interest was reported by the authors.