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CTRI Number  CTRI/2024/10/074827 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 06/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Ease Your Neck Discomfort: Simple Techniques for Fast Results 
Scientific Title of Study   Short term effects of positional release technique deep transverse friction massage and hold relax on pain and range of motion in patients with sub acute trapezitis- A comparative study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parekh Maitri Pankajbhai 
Designation  Post graduate student 
Affiliation  SPB physiotherapy college 
Address  OPD no 6 Musculoskeletal physiotherapy department, SPB physiotherapy college, Ugat bhesan road, near bhestan jakatnaka, jahangirabad, Morabhagal, Surat. 395005. Gujarat, India.

Surat
GUJARAT
395005
India 
Phone  8758782934  
Fax    
Email  maitriparekh08@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Neha Modi PT 
Designation  Assistant professor 
Affiliation  SPB physiotherapy college 
Address  OPD no 6 Musculoskeletal physiotherapy department, SPB physiotherapy college, Ugat bhesan road, near bhestan jakatnaka, jahangirabad, Morabhagal, Surat. 395005. Gujarat, India

Surat
GUJARAT
395005
India 
Phone  9898936121  
Fax    
Email  mdneha1990@gmail.com  
 
Details of Contact Person
Public Query  
Name  Parekh Maitri Pankajbhai 
Designation  Post graduate student 
Affiliation  SPB physiotherapy college 
Address  OPD no 6 Musculoskeletal physiotherapy department, SPB physiotherapy college, Ugat bhesan road, near bhestan jakatnaka, jahangirabad, Morabhagal, Surat. 395005. Gujarat, India.

Surat
GUJARAT
395005
India 
Phone  8758782934  
Fax    
Email  maitriparekh08@gmail.com  
 
Source of Monetary or Material Support  
OPD no 6 Musculoskeletal physiotherapy department, SPB physiotherapy college, Ugat bhesan road, near bhestan jakatnaka, jahangirabad, Morabhagal, Surat. 395005. Gujarat, India. 
 
Primary Sponsor  
Name  SPB physiotherapy college 
Address  OPD no 6 Musculoskeletal physiotherapy department, SPB physiotherapy college, Ugat bhesan road, near bhestan jakatnaka, jahangirabad, Morabhagal, Surat. 395005. Gujarat, India. 
Type of Sponsor  Private medical college 
 
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 
Dr Maitri Parekh  SPB physiotherapy college   OPD no 6 Musculoskeletal physiotherapy department, SPB physiotherapy college, Ugat bhesan road, near bhestan jakatnaka, jahangirabad, Morabhagal, Surat. 395005. Gujarat, India.
Surat
GUJARAT 		 8758782934

maitriparekh08@ggmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee South Gujarat Medical Education and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A Conventional physiotherapy and Positional release technique  Conventional physiotherapy exercises Neck isometrics 10 repetitions Scapular strengthening 10 repetitions stretching of trapezius with 30 sec hold 3 repetitions Positional release technique Participants in a supine position received the strain counterstrain technique. Moderate digital pressure was applied to identify and maintain contact with the tender point on trapezius muscle. The muscle was positioned in a shortened, relaxed state by having the participant side-bend their head toward the affected side, while the therapist positioned the ipsilateral arm in flexion, abduction, and external rotation. This reduced the tender point pain by approximately 70%. The position was held for 20–30 seconds and repeated for 3 to 5 repetitions. 
Comparator Agent  Group B Conventional physiotherapy and Deep Transverse Friction Massage  Conventional physiotherapy exercises Neck isometrics 10 repetitions Scapular strengthening 10 repetitions stretching of trapezius with 30 sec hold 3 repetitions Deep Transverse Friction Massage will be given to affected part of trapezius muscle by thumb or index finger or by using of index and middle finger both. Skin should be moisture less. The Deep Transverse Friction Massage (DTFM) will be applied using two fingers or the therapists thumb, moving back and forth over the patients skin to separate muscle fibers at the affected tissue depth. The patient will be informed that the treatment may cause temporary pain, which will subside afterward. The massage will last for 3 to 5 minutes. 
Comparator Agent  Group C Conventional physiotherapy and Hold Relax  Conventional physiotherapy exercises Neck isometrics 10 repetitions Scapular strengthening 10 repetitions stretching of trapezius with 30 sec hold 3 repetitions Hold relax Patient will be in sitting position. The therapist will hold the back of the patients head, moving it in the opposite direction of the affected side to stretch the trapezius muscle, while rotating the face toward the affected side. After a 10-second isometric contraction, the muscle will relax for 10 seconds. This process will be repeated 5 times. 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  NPRS: 3 to 8
Unilateral subacute trapezitis 
 
ExclusionCriteria 
Details  PIVD in cervical region
History of spondylosis and spondylolisthesis
Cervical radiculopathy
Fracture affecting the clavicle, vertebrae and scapula.
Other inflammatory disease
Patients who are taking medication for pain
Any deformity of spine
Psychological disorders 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) NPRS for measuring the pain
2) Cervical goniometry for measuring the range of motion of neck 		 Baseline and on 6th session 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   20/10/2024 
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 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   Patients with acute and sub-acute trapezitis meeting the inclusion criteria will be recruited for the study. After explaining the procedure and obtaining informed consent, demographic data will be collected. Participants will be randomly assigned to one of three groups: Group A (Positional release technique), Group B (Deep Transverse Friction Massage), and Group C (Hold Relax), all receiving conventional physiotherapy. Each group will undergo three sessions per week for two weeks, with assessments before and after treatment. 
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