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CTRI Number  CTRI/2026/04/108337 [Registered on: 13/04/2026] Trial Registered Prospectively
Last Modified On: 02/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effectiveness of music therapy and conventional program on pain, negative pain thoughts, and brain functioning in non specific chronic neck pain: a randomized controlled trial 
Scientific Title of Study   Effectiveness of Theta Binaural Beat Therapy and Conventional Program on Pain Intensity, Catastrophizing, and Event Related Potential in chronic non specific neck pain A randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sahar Zaidi 
Designation  Assistant professor, Department of physiotherapy, jamia hamdard 
Affiliation  Jamia Hamdard, New Delhi 
Address  Central library building,5th floor, Department of physiotherapy Jamia Hamdard, New Delhi-110062

South
DELHI
110062
India 
Phone  8178071369  
Fax    
Email  sahar@jamiahamdard.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Iram Fatima 
Designation  MPT student 
Affiliation  Department of Physiotherapy, Jamia Hamdard, New Delhi 
Address  Jamia Hamdard, Hamdard Nagar New Delhi-110062

South
DELHI
110062
India 
Phone  9625825710  
Fax    
Email  firam7116@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sahar Zaidi 
Designation  Assistant professor, Department of physiotherapy, jamia hamdard 
Affiliation  Jamia Hamdard, New Delhi 
Address  Central library building,5th floor, Department of physiotherapy Jamia Hamdard, New Delhi-110062

South
DELHI
110062
India 
Phone  8178071369  
Fax    
Email  sahar@jamiahamdard.ac.in  
 
Source of Monetary or Material Support  
self funded 
 
Primary Sponsor  
Name  Jamia Hamdard 
Address  Jamia Hamdard,Hamdard nagar , new delhi-110062, india 
Type of Sponsor  Research institution 
 
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 
Iram Fatima  Jamia Hamdard  Rehabilitation centre, Room no 9, Department of Physiotherapy, Hamdard nagar, New Delhi-110062
South
DELHI 		 9625825710

firam7116@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The jamia hamdard Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  chronic non specific neck pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  exercise therapy with sham intervention  sham intervention (ie, a single tone at 300 Hz) for 20 minutes with conventional physiotherapy, which included 10 minutes of hot fomentation followed by cervical isometric strengthening to facilitate deep neck muscle contraction and scapular strengthening.[24] Additionally, gentle stretching of neck muscles including the upper trapezius, sternocleidomastoid, and levator scapulae was performed, each held for 10 seconds and repeated three times  
Intervention  Theta binaural beat therapy with excercise therapy  theta binaural beat therapy (TBBT) The TBB was created using a combination of 300 Hz and 306 Hz were generated using the open-source software application Gnaural (GNU General Public License, GNU Project) The treatment with TBB consisted of a 300-Hz frequency applied to the left ear and a 306-Hz frequency applied to the right ear at the same time by noise free stereotype headphones . As a result, the brain internally perceived a TBB at a frequency of 6 Hz. During the intervention, participants were lying comfortably in a quiet room and instructed to relax with eyes closed while listening to binaural beats of 6Hz (theta frequency). the binaural beats were delivered for 20 minutes prior to conventional program per session, ensuring equal and safe sound intensity (60 – 70 dB) in both ears. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Chronic non-specific neck pain for a duration of more than three months.[14]
2.Age: 18 to 40 years.
3.Both male and female.
4. Score of 3 to 8 on a visual analog scale.
5.Mild visual impairment that are correctable with glasses 
 
ExclusionCriteria 
Details  1.Subjects with a history of (Whiplash injury or neurologic disease, Signs of radiculopathy,
Cervical myelopathy, Tumors, Cervical spine infection, Cervical spine surgery, Rheumatic
disorders).[15]
2.Had known hearing damage or loss.[6]
3.Had known vision loss
4.Had a psychiatric or substance abuse disorder. [6]
5.Any history of epilepsy, seizures, or neurological conditions.[6]
6.Use of medications (strong analgesics, muscle relaxants, or psychotropic drugs).
7.Pregnancy.[15]
8.Previous experience with binaural beat therapy.
9.Participants with pain in any joint other than the neck. 
 
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 Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Pain- Visual analog scale (VAS).
2. Pain Catastrophizing- Pain Catastrophizing Scale.
3. Event Related Potentials- EEG (ERP P-300)  		 baseline
after 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
norwick park neck pain questionnaire  baseline
after 4 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/05/2026 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   Chronic neck pain is a common musculoskeletal condition affecting functional ability and quality of life. Theta binaural beat therapy has been suggested to influence brain wave activity and pain perception. The present randomized parallel group placebo controlled trial aims to evaluate the effectiveness of theta binaural beat therapy on pain, physical function, sleep quality and pain catastrophizing in individuals with chronic non specific neck pain. Participants will be randomly allocated into two groups. The experimental group will receive theta binaural beat therapy along with conventional exercises, while the control group will receive sham intervention along with conventional exercises. Outcome measures include Visual Analog Scale, Pain Catastrophizing Scale and Event Related Potential P300. The findings of this study may provide evidence for the use of binaural beat therapy as an adjunct in physiotherapy management of chronic neck pain. 
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