FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093716 [Registered on: 26/08/2025] Trial Registered Prospectively
Last Modified On: 12/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to compare manual therapy with breathing exercise and noninvasive nerve stimulation in reducing migraine symptoms in patients with migraine. 
Scientific Title of Study   Comparing the effect of transcutaneous nerve stimulation and craniosacral therapy with breathing exercises on neck musculature in migraine patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NAVPREET KAUR 
Designation  POST GRADUATE STUDENT 
Affiliation  GURU NANAK DEV UNIVERSITY 
Address  DEPARTMENT OF PHYSIOTHERAPY, GURU NANAK DEV UNIVERSITY, GRAND TRUNK ROAD OFF NH1, AMRITSAR, PUNJAB-143005, INDIA

Amritsar
PUNJAB
143005
India 
Phone  7888386378  
Fax    
Email  navvinav50@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  RAMANDEEP KAUR 
Designation  ASSISTANT PROFESSOR 
Affiliation  GURU NANAK DEV UNIVERSITY 
Address  DEPARTMENT OF PHYSIOTHERAPY, GURU NANAK DEV UNIVERSITY, GRAND TRUNK ROAD OFF NH1, AMRITSAR, PUNJAB-143005, INDIA

Amritsar
PUNJAB
143005
India 
Phone  8837504493  
Fax    
Email  ramangoraya14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  RAMANDEEP KAUR 
Designation  ASSISTANT PROFESSOR 
Affiliation  GURU NANAK DEV UNIVERSITY 
Address  DEPARTMENT OF PHYSIOTHERAPY, GURU NANAK DEV UNIVERSITY, GRAND TRUNK ROAD OFF NH1, AMRITSAR, PUNJAB-143005, INDIA

Amritsar
PUNJAB
143005
India 
Phone  8837504493  
Fax    
Email  ramangoraya14@gmail.com  
 
Source of Monetary or Material Support  
GURU NANAK DEV UNIVERSITY OFF NH1, AMRITSAR, PUNJAB-143005, INDIA 
 
Primary Sponsor  
Name  NAVPREET KAUR 
Address  VILL. PASSARIAN PO AKBARPUR KALAN, DIST. JALANDHAR-144041 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
NAVPREET KAUR  HEALTH CENTRE,GURU NANAK DEV UNIVERSITY  DEPARTMENT OF PHYSIOTHERAPY, GURU NANAK DEV UNIVERSITY, GRAND TRUNK ROAD OFF NH1, AMRITSAR, PUNJAB-143005, INDIA
Amritsar
PUNJAB 
7888386378

navvinav50@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE OF GURU NANAK DEV UNIVERSITYE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CRANIOSACRAL THERAPY WITH BREATHING EXERCISES  Craniosacral therapy (CST) is a well-established approach that involves gentle fascia traction and release, tailored to individual palpation restrictions, and has also been utilized as a treatment for headaches and migraines. thoracic breathing seems to explicate the negative impact of stress on the brain, body muscles, and the rate and depth of breathing.  
Comparator Agent  TRANSCUTANEOUS NERVE STIMULATION  Non-invasive neurostimulation for the treatment of migraine has become popular in recent years, which includes transcutaneous electrical nerve stimulation of different nerves (tNS). Transcutaneous occipital nerve stimulation (tONS) and supraorbital transcutaneous stimulation (STS) are effectively accepted peripheral nerve stimulations for migraine. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Subjects aged 18 to 45years
Both males and females.
Meet ICHD 3rd edition criteria for migraine
Headache frequency/month: 3-7
Subjects with occipital and neck pain
Migraine patients with either episodic migraine or chronic migraine
 
 
ExclusionCriteria 
Details  Head or neck injury in past 2 years
Head or neck implanted device
History of head, neck and spine surgery
Pregnancy
History of medicine overuse headaches
Skin lesions in the location of stimulating electrodes
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Age
2. Height
3. Weight
4. Pain
5. Frequency and intensity of migraine
6. Quality of life
7. Neck range of motion
8. Quality of sleep
 
4 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/09/2025 
Date of Study Completion (India) 13/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 13/11/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Migraine is a neurological condition that impacts approximately worldwide 15% of the global population and regarded as principal cause of disability (Antonio et al., 2023). Over last 32 years, its incidence is highest in the 10–14 years age group, while both prevalence and DALYs(disability-adjusted life years) begin to rise in 40–44 years age group subsequently arrive at their peak (Dong et al., 2024). Migraine is identified by recurring headaches usually unilateral or bilateral, pulsating in nature, and often presented symptoms like nausea, vomiting, sensitivity to light, and sensitivity to sound (Abo-Elghiet et al., 2025). Moreover, individuals with migraine may experience suboccipital muscle tension which causes neck pain along with neck disabilities, which can progress the condition. In a study examining episodic migraine, 70% of patients reported neck pain prior to the onset of a migraine attack, suggesting that neck pain might serve as a trigger for migraine. Additionally, active trigger points are considered a peripheral source of nociceptive stimuli that aggravate the pain. (Aoyama et al.,2021) The Neck Disability Index (NDI) indicated that 69% of patients with episodic migraine (EM) and 92% of those with chronic migraine (CM) experienced disabilities. (Abo-Elghiet et al., 2025).

Craniosacral therapy (CST) is a well-established approach that involves gentle fascia traction and release, tailored to individual palpation restrictions has also been utilised as a treatment for headaches and migraines (Muñoz-Gómez et al.,2022). CST was developed to release restrictions and regulate the balance of the cranium and the spine using standardized applications. Although, Non-invasive neurostimulation for the treatment of migraine has become popular in recent years which include transcutaneous electrical nerve stimulation of different nerves (tNS) (Evers et al., 2021). Transcutaneous occipital nerve stimulation (tONS), and supraorbital transcutaneous stimulation (STS) are effectively accepted peripheral nerve stimulations for migraine (Cheng et al.,2022).  Top of FormBottom of FormFurthermore, migraine is associated with impaired oxygen utilization and cerebrovascular dysfunction (Singhal et al., 2017). Since 1998, numerous studies have shown that high-flow oxygen therapy (HFOT) is a safe and effective acute treatment for migraines(Çöme et al.,2025). In this context, Diaphragmatic breathing seems to explicate the negative impact of stress on the brain, body muscles, and the rate and depth of breathing (Rahimi et al.,2021).

Need of study

Due to risk ratio of medication of migraine such as chest pain, throat tightness, skin irritations and possible contraindications including heart diseases, hypertension and pregnancy emphasize the requirement for alternative treatment options like neurostimulation therapies, patient education, guided physical activity, and manual techniques. (Abo-Elghiet et al., 2025). Till now, the literature stated the individual effect of transcutaneous nerve stimulation and craniosacral therapy on migraine but there is no study comparing the effectiveness of both treatments along with breathing exercises.


Aim and objectives

1.     To assess the effectiveness of transcutaneous nerve stimulation in comparison to craniosacral therapy combined with breathing exercises on neck pain in migraine patients.

2.     To assess the effect of both treatments on degree of neck disability in migraine.

3.     To compare the impact of both treatments on the frequency and severity of migraine episodes.

4.     To examine the effect of these interventions on the quality of life of migraine patients.

5.     To assess the effectiveness of transcutaneous nerve stimulation and craniosacral therapy on neck range of motion.

6.     To assess the effectiveness of both treatments on sleep quality.

Hypothesis

Alternative hypothesis: There is a remarkable difference in the effectiveness of transcutaneous nerve stimulation (tNS) and craniosacral therapy with breathing exercises in improving musculoskeletal impairments like pain relief, muscle tension reduction, and improvement in cervical mobility among migraine patients.

Null hypothesis: There is no notable difference in the effectiveness of transcutaneous nerve stimulation (tNS) and craniosacral therapy with breathing exercises in improving musculoskeletal impairments in migraine patients, including pain relief, muscle tension reduction, and improvement in cervical mobility.

Methodology

Study design: Experimental comparison study design

Study population: Adult population (18 to 50 years) with symptoms of migraine and neck pain

Source of data collection:  Health centre Guru Nanak Dev University and RG sports rehabilitation and physiotherapy clinic, Amritsar.

Sampling method: Simple random sampling technique

Sample size: 66; calculated by G power 3.1.9.4, with the effect size is 0.4 and power of study is 0.80.

Inclusion criteria

·       Subjects aged 18 to 50 years

·       Both male and females.

·       Meet ICHD 3rd edition criteria for migraine ( Jiang et al., 2023)

·       Headache frequency/month 3-7

·       Subjects with occipital and neck pain

·       Migraine patients with either episodic migraine or chronic migraine

Exclusion criteria

·       Head or neck injury in past 2 years

·       Head or neck implanted device

·       History of head, neck and spine surgery

·       Pregnancy

·       History of medicine overuse headaches

·       Skin lesions in the location of stimulating electrodes

Measurement tools

1.     NPRS(Numeric Pain Rating Scale)                                     

2.     MIDAS(Migraine Disability Assessment) (Araci et al., 2024)                                                                    

3.     NDI(Neck Disability Index)                                            

4.     SF-36(Short Form 36 health survey)                                 

5.     GONIOMETER                                                             

6.     FRT(Flexion Rotation Test)( Anarte-Lazo et al., 2021)

7.     PSQI(Pittsburg Sleep Quality Index)

 Outcomes variables

1.     Age

2.     Height

3.     Weight

4.     Pain

5.     Frequency and intensity of migraine

6.     Quality of life

7.     Neck range of motion

8.     Quality of sleep

·       Pain intensity : NPRS will be used to measure in intensity of neck pain in migraine patients

·       Migraine intensity and frequency: MIDAS is used to assess the frequency and intensity of migraine of episodic attacks

·       Quality of life :  The quality of life affected by migraine epispdes will be assessed by SF-36 health survey questionnaire.

·       Range of motion: The cervical range of motion ( extension, flexion, rotation ) will be examined with goniometer by the process goniometery .

·       Quality of sleep: The sleep quality in migraine patients is to be assessed by PSQI during assessment.

Interventions

The intervention techniques will be applied in a total of 8 sessions, 2 days a week for 6 weeks with session duration of 20 to 30 minutes.

Group 1: Patients will be given electrical stimulation with parameters of symmetrical biphasic waveform, phase width 400 us, pulse frequency 80 Hz for 10 minutes and 2 days a week.

·       Supraorbital nerve stimulation intensity up to 6 mA and electrode placement will be over the forehead just above eyebrows.

·       Occipital nerve stimulation intensity up to 12 mA and electrode placement would be at back of the head near base of skull.

Group 2:

·       Patients will be treated with atlanto-occipital release and cranial base release for 20 minutes with 10 minutes of each.

·        The therapist put 2 thumbs behind the patient’s ears, overlapped the palms, wrapped the patient neck, and slowly and regularly adjusted the frequency of traction and release of fascia.

·       Thoracic breathing will be performed with expansion and contraction of chest rather than the diaphragm along with CST.

 

Group 3:

·       Patients included will follow the regular drug regimens and conventional physiotherapy treatment which includes neck muscle stretching and ultrasound therapy.

 

Procedure

Study participants will be recruited on the basis of selection criteria of the study.

                                  

All possible procedures, techniques and interventions would be demonstrated to the subjects and a written consent will be taken from the patients.

 

Demographic data of study participants will be recorded prior to the assessment and treatment sessions

 

                    For assessment, one subject will be taken at a time.

 

                         Participants will be recruited into treatment and control groups

 

Pre-data of the variables (aforementioned) will be collected and interventions will be given to participants

 

         Post data will be collected after treatment and follow up sessions

 

 

Clinical implications

The findings of this study may help to expand the treatment options for migraine as well as enhancing the evidence based practice. These may be incorporated in clinical practice to improve the quality of life of patients with migraine.

 
Close