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CTRI Number  CTRI/2025/08/093769 [Registered on: 27/08/2025] Trial Registered Prospectively
Last Modified On: 26/08/2025
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   Effect of manual therapy and cupping therapy on thoracolumbar fascia 
Scientific Title of Study   Effect of myofascial release and cupping therapy of thoracolumbar fascia on flexibility of hamstring and cervical in forward head posture 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ramandeep Kaur 
Designation  Post graduated student 
Affiliation  Guru Nanak Dev University 
Address  Department of Physiotherapy, Guru Nanak Dev University, Grand Trunk Road Off NH1, Amritsar

Amritsar
PUNJAB
143005
India 
Phone  7087901768  
Fax    
Email  ramandeepkaur99376@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ramandeep Kaur 
Designation  Post graduated student 
Affiliation  Guru Nanak Dev University 
Address  Department of Physiotherapy, Guru Nanak Dev University, Grand Trunk Road Off NH1, Amritsar

Amritsar
PUNJAB
143005
India 
Phone  7087901768  
Fax    
Email  ramandeepkaur99376@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

Amritsar
PUNJAB
143005
India 
Phone  8837504493  
Fax    
Email  ramangoraya14@gmail.com  
 
Source of Monetary or Material Support  
Guru Nanak Dev University, Amritsar 
 
Primary Sponsor  
Name  Ramandeep Kaur 
Address  Rangar Nangal, Tehsil Batala, District Gurdaspur, 143505 
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 
Ramandeep Kaur  Health Center, Guru Nanak Dev University  Grand Trunk Road Off NH1, Amritsar
Amritsar
PUNJAB 
7087901768

ramandeepkaur99376@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe Guru Nanak Dev University  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 
Comparator Agent  CUPPING THERAPY  Cupping is a technique that includes the application of a vacuum to a localized area of the skin which is alternative medicine for pain relief. 
Intervention  MYOFASCIAL RELEASE  Myofascial release (MFR) techniques used to decrease tension in the myofascial tissues, and also reduce pain 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects between age group 22 to 60
2. Male and female both will be taken
3. Population with CVA of less than 49degree
4. Subjects with hamstring tightness
 
 
ExclusionCriteria 
Details  1. Neurological problems
2. Rheumatological problems
3. Fracture and surgery history
4. Disc disease
5. Open wound
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
• Muscle Strength
• Hamstring Flexibility
• Neck Disability
• Height
• Weight
• Body Mass Index (BMI).
• Cranio vertebral angle (CVA)
• Cervical Range of Motion
• Sleep Quality
 
4 weeks
 
 
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)   10/09/2025 
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="0"
Months="6"
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  

            Forward Head Posture (FHP) is most commonly observed spinal deformity in which the head of body is translated anteriorly in front of the vertical line of gravity by 5 cm. The prevalence of FHP is 66% worldwide, and is increasing in population who are using electronic devices for extended periods. The thoracolumbar fascia (TLF), has a significant role in maintaining postural control. A recent study focused on thoracolumbar fascia release techniques can improve range of motion, hamstring flexibility and muscle endurance. Myofascial release (MFR) techniques of manual therapy have become best known for treating musculoskeletal conditions and used to decrease tension in the myofascial tissues, increase function, and also reduce pain. Cupping therapy reportedly maintains normal physiological function through an immediate reaction by skin and fascia. 

  Need of study

 Recent studies state that forward head posture has correlation with hamstring flexibility and also cervical mobility due to the disturbance of myofascial chain connections. Moreover, literature suggested that the myofascial release technique applied to TLF were effective in improving the lumbar range of motion and  hamstring flexibility in the acute period in healthy young adults. So, there is need  to conduct more researches for affected population and  to explore the effect of thoracolumbar fascia release on hamstring flexibility and cervical mobility in forward head posture population.

 

Aims and objectivities

 

1.     To assess the effect of thoracolumbar myofascial release on the hamstring flexibility.

2.     To determine the result of thoracolumbar myofascial release on the cervical range of motion.

3.     To analyse the effect of cupping therapy of the thoracolumbar fascia on cervical range of motion.

4.     To evaluate the consequences of cupping therapy of the thoracolumbar fascia on hamstring flexibility.

5.     To investigate the combine effects of myofascial release and cupping therapy of thoracolumbar fascia on flexibility of hamstring and cervical in forward head posture population.

Hypothesis

1.     Alternating hypothesis – There is significant effects of thoracolumbar fascia release on hamstring flexibility and cervical mobility in forward head posture.

2.     Null hypothesis – There is no significant effects of the thoracolumbar release on hamstring flexibility and cervical mobility in forward head posture.

 

Methodology

Study design – Experimental study design.

Study population - Subjects with forward head posture and hamstring tightness.

Source of data – Health Centre at Guru Nanak Dev University and OPD patients of RG Sports Rehab physiotherapy clinic airport road Amritsar.

Sampling Technique- simple random sampling.

Sample size- 45; calculated by G power 3.1.9.4 with effect size 0.5 and power of study 0.83.

Study duration – 4 weeks

Selection criteria:

Inclusion

·       Subjects between age group 22– 60

·       Male and female both will be taken.

·       Population with CVA of less than 49degree.

·       Subjects with hamstring tightness (Raza, A. et al., 2022).

 

 

Exclusion

·       Neurological problems

·       Rheumatological problems

·       Fracture and surgery history

·       Disc disease

·       Open wound

Variables

·       Muscle Strength

·       Hamstring Flexibility

·       Neck Disability

·       Height

·       Weight

·       Body Mass Index (BMI).

·       Cranio vertebral angle (CVA)

·       Cervical Range of Motion

·       Sleep Quality

 

Tools for measurements

·       Goniometer

·       Cupping set

·       Examination couch

·       Smartphone

·       Measuring tape

·       Straight Leg Raise (SLR) test

·       Finger floor distance

·       2D Kinovea software

·       Pittsburgh Sleep Quality Index (PSQI)

·       Neck Disability Index

·       Manual Muscle Testing

 

2D Kinovea: The 2D Kinovea software will be used to measure craniovertebral angle. In this software, the lateral view picture of participant will be uploaded to measure angle between head and neck.

Finger Floor Distance: In the Finger Floor Distance test the subject bends forward and moves toward the toes. Then measured the distance between the middle finger and the floor using a measuring tape.

 Fleche test: In the fleche test, ask the patient to stand against a wall with straight back, heels, buttocks, calf, shoulders and head touch the wall. Measure the distance between the back of the head and the wall.

Pittsburgh Sleep Quality Index: The Pittsburgh Sleep Quality Index is widely used self-reported questionnaire that assesses sleep quality over a one- month time interval.

Neck Disability Index scale: The Neck disability Index is a scale that measures the severity of disability during activities of daily life.

 

INTERVENTION

GROUP A - Thoracolumbar Myofascial Release Treatment duration for 10 minutes till about 4 weeks and 3 sessions per week.

GROUP B – Cupping therapy. Treatment duration for 8 minutes till about 4 weeks and 2 session per week.

GROUP C- Combination of thoracolumbar myofascial release and cupping therapy. Treatment duration for each 5 minutes till about 4 weeks and 2 session per week.

Thoracolumbar Myofascial Release

The group A will be received thoraco-lumbar direct myofascial release technique.  The subjects will be positioned in prone direct force was applied to the skin in the direction of the limitation until the tissue barriers started to resist. Once the collagenous barrier was located, it was activated for 90–120 seconds without moving over the skin or pulling on the tissues, resulting in the fascia complex starting to give way and a feeling of softening. For each subject, this stage was repeated up to five times (Raza et al.,2022).

Cupping therapy

The group B will be received cupping therapy for thoracolumbar fascia release. The subject will in prone position, glass cups will be applied on thoracolumbar area with a suction pump. When the glass cup is applied to the skin for 8 minutes, the negative pressure within the cup causes myofascial decompression (Kim et al.,2017).

Combination of thoracolumbar myofascial release and cupping therapy

To group C, both thoracolumbar myofascial release and cupping therapy techniques will be applied each for 5 minutes till 4 weeks.

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, written consent will be taken from subjects prior to participation.

 

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

 

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

 

Participants will be recruited into the treatment groups.

 

Pre data of variables (aforementioned) will be collected and intervention will be given to the participants.

 

Post data will be collected after treatment and follow up sessions.

 

 

Clinical implications

As there is relationship between hamstring tightness and altered posture due to kinetic chain imbalances. The finding of this study may help to expands the vision of clinician to work with patients have forward head posture may address thoracolumbar fascia as treatment plan to improve flexibility of hamstring and cervical.

 
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