FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/01/022934 [Registered on: 24/01/2020] Trial Registered Prospectively
Last Modified On: 21/01/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of deep tissue massage of neck and yoga on pain and vision in people with neck pain. 
Scientific Title of Study   “Effectiveness of Deep Cervical Fascial manipulation and Yoga postures on pain, function and oculomotor control in mechanical neck pain: A pragmatic, parallel group, randomized, controlled trial” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prabu Raja G 
Designation  Assistant Professor 
Affiliation  Manipal college of health professions 
Address  Assistant Professor, 2nd floor, Department of Exercise and Sports Sciences, Manipal College of Health Professions Manipal Academy of Higher Education, Manipal, Udupi District.
Centre for Sports Medicine ,science and Research, Basement -5, Marena indoor sports complex, Manipal Academy of Higher Education, Manipal-576 104
Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  prabu.raja@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Prabu Raja G 
Designation  Assistant Professor 
Affiliation  Manipal college of health professions 
Address  Assistant Professor, Department of Exercise and Sports Sciences, Manipal Academy of Higher Education, Manipal, Udupi District.

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  prabu.raja@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Prabu Raja G 
Designation  Assistant Professor 
Affiliation  Manipal college of health professions 
Address  Assistant Professor, Department of Exercise and Sports Sciences, Manipal Academy of Higher Education, Manipal, Udupi District.

Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  prabu.raja@manipal.edu  
 
Source of Monetary or Material Support  
Department of Exercise and Sports sciences, Kasturba Hospital, Department of Speech and Hearing 
 
Primary Sponsor  
Name  Department of Exercise and Sports sciences 
Address  Manipal College of Heath Professions, Manipal Academy of Higher Education, Manipal 
Type of Sponsor  Research institution and hospital 
 
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 
Fiddy Davis  Kasturba Hospital / Manipal Academy of Higher Education  Department of Exercise and Sports science, Department of Speech and Hearing, Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA 		 9448252299

fiddy.davis@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  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  Cervical Joint mobilisation and thoracic/ Cervicothoracic manipulation and therapeutic exercises  Cervical mobilisation and thoracic manipulation: Rhythm: Smooth oscillatory movements will be performed. When treating pain, the large amplitude of movement will be used based on the symptom response. While treating stiffness and slight pain at the end range technique will be of small amplitude at the limit of their range. When treating muscle spasm, the rhythm is mainly a sustained position at a point where further movement is restricted by muscle spasm for a duration of 1 minute in the order of 10-20 seconds. These progressive sustained position is interspersed with oscillatory movements. If the joint is very painful and/or presence of protective muscle spasm, manipulation will be avoided. Therapeutic exercises: Participants will be taught upper cervical spine self-mobilisation and stretching of neck musculature to improve the mobility and the flexibility. Following this, re-education of the CCF and progressive training of deep neck flexors and extensors as well as axio-scapular muscles will be taught. Specific muscle lengthening exercise (Stretching): Stretching of muscles of the neck region such as suboccipital muscle, levator scapulae, upper trapezius and sternocleidomastoid will be taught. To elongate the muscle tissue, the participants will be advised to hold the stretch position for 20–30 seconds, and to perform the exercises for 3–5 times in a day. After re-educating the cranio-cervical movement, training the deep neck flexors and extensors will be done to improve the recruitment of the deep stabilizing musculature. Retraining scapular control: After retraining the scapular orientation, training to improve the endurance of the synergistic muscles of the scapula will be done in prone to achieve scapular control. Progressive retraining of the scapular control can be done using different positions and movement of the arms.  
Intervention  Fascial Manipulation and Sequential Yoga Poses  Fascial Manipulation: After the identification of densified and rigid Centre of co-ordination (CCs) and Centre of fusion (CFs) the interventions will be given in the form of fascial manipulation on the densified CCs. This includes deep friction massage using elbows or knuckles for a duration of 5-8 minutes. Antagonistic myofascial sequences will be targeted. Sequential Yoga Poses: Sequential Yoga Poses focusses on the myofascial continuum in the following sequence: Triangle pose, Extended Side Angle pose, Seated Eagle pose, Cow face pose, Child pose, Reverse Prayer pose, Camel Pose, Bow pose and Child pose. Each pose will be held for a period of 5 breath cycles which will be progressed by increasing the number of breaths during these asana. The participant will receive treatment on the first day following initial assessment of all outcome measures. The participants will be recalled thrice for the second and third and fourth treatment sessions. These sessions of interventions will be done within a span of 4 weeks with atleast an interval of 6 days in between the sessions. The participants will be asked to perform these unsupervised yoga poses atleast 5 days in a week for 3 months. Supervised poses has to be performed following FM during all three sessions.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Participants:
Patients with sub-acute and chronic mechanical neck pain for more than 3 weeks.
Study setting
Outpatient clinics at Kasturba hospital and its allied centres (Recruitment)
Department of Exercise and sports sciences - Centre for sports science, medicine and research (Interventions and Outcome measures)
Outpatient clinic - Department of Speech and Hearing (Outcome measures)
 
 
ExclusionCriteria 
Details 
1) History of trauma to the upper quarter region in the last one year.
2) Diagnosed diabetic neuropathy
3) Vestibular balance disorders
4) Medical conditions (speech and hearing and visual disorders)
5) Any previous surgical interventions to the upper quarter in last 1 year.
6) Diagnosed bony lesions/ systemic diseases/ cancer
7) Systemic inflammatory diseases like rheumatoid arthritis.
8) Infections and Skin lesions localized to the symptomatic head, neck and upper limb.
•Signs of neurological involvement such as positive ULNT, positive spurlings test, diminished sensation and reflexes, as well as strength deficits at the nerve root level of C5 to T1.
9) Any signs suggestive of myelopathy
10) Pregnant women
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
•Numeric pain rating scale (NPRS).

•Patient specific functional scale (PSFS)

•Oculomotor control tests
Smooth pursuit neck torsion test, saccades using Videonystagmography
Near point convergence (NPC) test using RAF ruler
 		 NPRS- Baseline,1st,2nd, 3rd 4th week, 3rd month and 6th month following 1st intervention

PSFS: Baseline,4th week, 3rd month and 6th month following 1st intervention

Oculomotor Control: Baseline,4th week, 3rd month following 1st intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
Myofascial stiffness,
Elbow extension range of motion(EEROM) during upper limb neurodynamics test 1
Fear avoidance Behaviour Questionnaire (FABQ) 		 EEROM- Baseline,1st,2nd, 3rd 4th week, 3rd month following 1st intervention

Myofascial stiffness: Baseline,4th week, 3rd month following 1st intervention

FABQ: Baseline, 3rd month and 6th month following 1st intervention


 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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)   29/01/2020 
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="4"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Purpose: 
The pathological modifications of deep fascia are considered to be one of the sources of musculoskeletal pain. Mechanical Neck pain (MNP) is usually treated symptomatically and the involvement of the deep cervical fascia (DCF) and its continuum is often ignored which may be involved in the presence of plethora of symptoms.The associated symptoms of the upper quarter with MNP, leads to an extensive treatment without any positive treatment effect. This mandates the need for treatment, focusing on the anatomical myofascial continuum (DCF and its continuum) of the upper quarter which may help in relieving MNP. There is a dearth of literature on the anatomical continuity of deep cervical fascia and their potential implications in patients with MNP. A well-designed pragmatic study investigating the role of deep fascia and incorporating manipulation of the fascia in MNP is needed.
Aim of the study:
To study the effectiveness of deep cervical fascial manipulation and it’s continuum on pain, patient-specific functions, oculomotor control, and myofascial stiffness in sub-acute and chronic mechanical neck pain.
Primary objective: 
To study the effectiveness of fascia directed approach that includes fascial manipulation (4 sessions in 3-4 weeks) and sequential yoga poses (12 weeks) as compared to usual care.  The objective is to study effects on function, oculomotor control and pain in patients with subacute and chronic mechanical neck pain.
Primary research hypothesis
Secondary objectives
1. To study the effectiveness of fascia directed treatment approaches (FM & SYP), in comparison to usual care on elbow extension ROM angle during ULNT 
2. To examine the modifying effects on the viscoelastic properties (tone, stiffness, elasticity) of myofascia by combining FM and SYP, compared to usual care in patients with MNP.
3. To investigate if there is any change in the patient-reported fear avoidance behavior with interventions such as FM and SYP when compared with the routine treatment of patients with MNP.
The hypothesis of this study is fascia directed treatment approaches (FM and SYP) will be better to usual care (Therapeutic exercises, mobilisation, manipulation) for improving pain, functions and oculomotor control in subjects with MNP.

 
Close