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CTRI Number  CTRI/2025/09/094547 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Combined Therapy on Adults with Tension-Type Headaches and Balance Problems 
Scientific Title of Study   Efficacy of Integrative Therapy Combining Vestibular Rehabilitation, Vagus Nerve Stimulation, and Craniofacial Release for Tension-Type Headache with Coexisting Vestibular Dysfunction: A Randomized Controlled Trial 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramesh Chandra Patra 
Designation  Professor 
Affiliation  Lovely Professional University Faculty of Applied Medical Sciences 
Address  Uni-Hospital Department of Physiotherapy, Block 3, Room no 105. Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, PIN-144411

Kapurthala
PUNJAB
144411
India 
Phone  09653174563  
Fax    
Email  ramesh.19500@lpu.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Ramesh Chandra Patra 
Designation  Professor 
Affiliation  Lovely Professional University Faculty of Applied Medical Sciences 
Address  Uni-Hospital Department of Physiotherapy, Block 3, Room no 105. Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, PIN-144411


PUNJAB
144411
India 
Phone  09653174563  
Fax    
Email  ramesh.19500@lpu.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Ramesh Chandra Patra 
Designation  Professor 
Affiliation  Lovely Professional University Faculty of Applied Medical Sciences 
Address  Uni-Hospital Department of Physiotherapy, Block 3, Room no 105. Lovely Professional University, Jalandhar-Delhi, G.T. Road, Phagwara, PIN-144411


PUNJAB
144411
India 
Phone  09653174563  
Fax    
Email  ramesh.19500@lpu.co.in  
 
Source of Monetary or Material Support  
Uni-Hospital, Block-3, Room no-105, Department of Physiotherapy, Lovely Professional University, Phagwara, Punjab, INDIA. 144411. 
 
Primary Sponsor  
Name  Dr Ramesh Chandra Patra 
Address  Uni-Hospital, Block-3, Room no-105, Department of Physiotherapy, Lovely Professional University, Phagwara, Punjab, INDIA. 144411. 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nill   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ramesh Chandra Patra  Lovely Professional University  Block-3, Room No-1056, Uni Hospital, Department of Physiotherapy, Division of Applied Medical Sciences, Lovely Professional University, Punjab, India. PIN-144411
Kapurthala
PUNJAB 		 09653174563

ramesh.19500@lpu.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Lovely Professional University, Punjab  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M279||Disease of jaws, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Integrative Neuromusculoskeletal Therapy (INMT)  Integrative Neuromusculoskeletal Therapy (INMT) combines three synergistic components aimed at addressing both the neurological and musculoskeletal contributors of tension-type headache with vestibular dysfunction and the total treatment duration is 12 weeks: Vestibular Rehabilitation (VT): Structured exercise program targeting vestibular compensation, balance retraining, gaze stabilization, and postural control. Administered by certified physiotherapists. Frequency: 40-minute sessions, twice weekly for 12 weeks. Transcutaneous Vagus Nerve Stimulation (tcVNS): Transcutaneous vagus nerve stimulation (tcVNS) was delivered using a medically approved, CE-marked auricular stimulator device (e.g., Nemos®). The stimulation targeted the auricular concha region, which corresponds to the auricular branch of the vagus nerve. Stimulation intensity was individually adjusted for each participant to produce a mild tingling sensation without causing discomfort or pain. Each stimulation session lasted for 20 minutes and was administered twice weekly over a period of 12 weeks. This non-invasive neuromodulatory intervention was designed to modulate the trigeminocervical complex, restore autonomic balance, and reduce central sensitization contributing to tension-type headache and vestibular dysfunction. Craniofacial Release (CFR): Craniofacial Release (CFR) involved manual myofascial release therapy specifically targeting the pericranial and cervical musculature. The therapy was administered by trained physiotherapists certified in craniofacial release techniques, ensuring a standardized and safe approach. The procedure consisted of applying gentle, sustained pressure to release fascial restrictions in key regions, including the temporal, suboccipital, masseter, and cervical areas. Each session lasted for 20 minutes and focused on areas identified as having maximal tenderness or restricted mobility during assessment. Treatments were delivered twice weekly over a period of 12 weeks, aiming to reduce pericranial muscle tension, improve local circulation, restore normal fascial mobility, and alleviate headache symptoms related to musculoskeletal dysfunction.  
Comparator Agent  Vestibular Rehabilitation (VT) Alone  Comparator (Control) Agent – Vestibular Rehabilitation (VT) Alone: The comparator intervention consisted of a standardized Vestibular Rehabilitation (VT) program, designed to improve vestibular function, postural control, and gaze stability in patients with coexisting vestibular dysfunction and tension-type headache. The VT program was delivered by certified physiotherapists and included a combination of balance retraining exercises, gaze stabilization exercises, habituation protocols, and postural control tasks. Each session lasted approximately 40 minutes and was administered twice weekly over a 12-week period. The control group did not receive adjunct therapies such as Vagus Nerve Stimulation or Craniofacial Release, allowing the study to isolate the specific contribution of these additional modalities in the experimental intervention. The VT-only arm served as the active comparator to assess the incremental benefit of integrating VNS and CFR into standard vestibular care. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Participants eligible for inclusion in the study were adults aged between 18 and 65 years with a clinical diagnosis of chronic tension-type headache according to the International Classification of Headache Disorders, third edition (ICHD-3) criteria. In addition, participants were required to have coexisting vestibular dysfunction, confirmed by clinical assessment and a Dizziness Handicap Inventory (DHI) score greater than 30. All participants were required to provide written informed consent and express willingness to comply with the study protocol. 
 
ExclusionCriteria 
Details  Participants were excluded if they had secondary headache disorders, a history of epilepsy, severe psychiatric illness, or the presence of a cardiac pacemaker. Pregnant or lactating women were also excluded due to unknown effects of the interventions on fetal and neonatal health. Individuals with recent head trauma within the past six months or those currently enrolled in other clinical trials were not eligible to participate, to avoid confounding factors and ensure the safety and scientific validity of the study results. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in number of headache days per month from baseline to 12 weeks  Change in number of headache days per month from baseline to 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in headache intensity (VAS scale, 0–10)

Change in DHI score

Change in SF-36 quality of life scores

Pericranial muscle tenderness scores (standardized scale) 		 Baseline, Week 6, Week 12 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   This randomized controlled trial aims to evaluate the clinical efficacy and safety of an integrative non-pharmacological intervention combining Vestibular Rehabilitation (VT), Transcutaneous Vagus Nerve Stimulation (tcVNS), and Craniofacial Release (CFR) in patients with chronic tension-type headache and coexisting vestibular dysfunction. A total of 135 participants aged 18–65 years will be randomly allocated into three groups: (1) VT alone (control), (2) VT + tcVNS, and (3) VT + tcVNS + CFR (experimental group). The primary outcome is the reduction in headache frequency after 12 weeks of intervention. Secondary outcomes include headache intensity, dizziness handicap, quality of life, pericranial muscle tenderness, autonomic balance (measured by HRV), and safety assessment. The study will follow a single-blinded, parallel-arm design, with all interventions delivered twice weekly for 12 weeks. This trial seeks to establish the added benefit of integrative therapy over standard vestibular rehabilitation in managing tension-type headache with vestibular dysfunction. 
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