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CTRI Number  CTRI/2019/11/022019 [Registered on: 15/11/2019] Trial Registered Prospectively
Last Modified On: 24/11/2020
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   Manual therapies in non-specific neck with upper limb pain 
Scientific Title of Study   Short-term effects of mobilization or manipulation of thoracic spine in chronic nonspecific neck arm pain: a randomized clinical trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Agrawal 
Designation  Professor, Neurosurgery 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  7th floor, Department of Neurosurgery, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9811282043  
Fax    
Email  drdeepak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Pradeep Kumar Sahu 
Designation  Physiotherapist 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no- 17, 6th floor, Neurosciences Centre, AIIMS

South
DELHI
110029
India 
Phone  8384065426  
Fax    
Email  pksahu9938@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Pradeep Kumar Sahu 
Designation  Physiotherapist 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room no- 17, 6th floor, Neurosciences Centre, AIIMS

South
DELHI
110029
India 
Phone  8384065426  
Fax    
Email  pksahu9938@gmail.com  
 
Source of Monetary or Material Support  
Non-funded study 
 
Primary Sponsor  
Name  Pradeep Kumar Sahu 
Address  Room no-17, 6th floor, Neurosciences centre, AIIMS, 110029 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Deepak Agrawal  7th floor, Department of Neurosurgery, AIIMS, New Delhi,110029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Pradeep kumar sahu  All India Institute of Medical Sciences, New Delhi   Room no-23,Physiotherapy room, Neurosciences centre, AIIMS, New Delhi
South
DELHI 
8384065426

pksahu9938@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
All India Institute of Medical Sciences, New Delhi  Submittted/Under Review 
All India Institute of Medical Sciences, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M999||Biomechanical lesion, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Thoracic spine manipulation  Subjects in this group will receive manipulation targeting the upper thoracic spine as described by Cleland etal.,2007. It will be performed with the subject in the supine position. The clinician will target between segments T1 and T4 with this technique. The subject will be instructed to clasp his or her hands across the base of the neck. The subjects arms then will be pulled downward to create spinal flexion down to the upper thoracic spine. The therapists manipulative hand will be used to stabilize the inferior vertebra of the targeted motion segment, and his or her body applied force through the subjects arms to produce a high-velocity, low-amplitude thrust. If a pop occurred, then the therapist moved on to the next procedure. If not, the subject will be repositioned, and the technique will be performed again. This procedure will be performed for a maximum of 2 attempts. 
Intervention  Thoracic spine mobilization  Subjects will be positioned in prone. The clinician will perform one 30-second bout of grade III or IV central posterior-anterior mobilization at the T1 spinous process as described by Maitland et al,2001. After the 30-second bout, the therapist will proceed to T2 and will perform the same technique. This process will be continued sequentially in a caudal direction to T4. A frequency of 3-4 mobilization will be given with 1 minute rest in between for an overall intervention time of approximately 8-10 minutes. This technique is non-thrust in nature.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age- 18-65 years
2. Unilateral neck and arm pain below elbow
3. No evidence of nerve root compression i.e absence signs of radiculopathy(subjects should have normal sensory and motor function, negative foraminal compression test)
4. Absence of a specific diagnosis
5. Symptom duration more than 3 months
6. Pain intensity ≥ 3 on a VAS
7. Neck disability index ≥ 10 on 50 point scale
8. Evidence of increased peripheral nerve sensitivity to mechanical stimuli ( pain with nerve palpation reveal highly sensitized nerve to mechanical stimuli)
9. Pain in response to a nerve provocation test in the upper limb (will be performed in supine lying that involves the following: gentle scapular depression, shoulder abduction, forearm supination combined with wrist and finger extension, shoulder external rotation, and elbow extension. The test was considered positive with the reproduction of arm symptoms.
 
 
ExclusionCriteria 
Details  1. Any definite pathology resulting neck and arm pain
2. Concussion, loss of consciousness, or head injury as a result of the accident
3. Presence of any signs of nerve root dysfunction, ie, features of radiculopathy
4. Evidence of metabolic, Other neurological, psychiatric and cardiovascular disorder
5. Previous neck and shoulder girdle surgery
6. History of lumbar surgery and/or sciatica or other musculoskeletal disorders that potentially might affect the sensation in the lower limb to be tested
7. Inflammatory conditions; fibromyalgia; chronic fatigue syndrome
8. Other contraindications for manual therapy
9. Withdrawal of consent
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Intensity of pain on visual analogue scale (VAS)
2. Pressure pain sensitivity:Pressure pain thresholds (PPT) will be measured using a pressure algometer (Greenwich, USA). PPT will be measured over trapezius,1st webspace for primary hyperalgesia and over tibialis anterior muscle belly(homolateral) for widespread hyperalgesia.
3. Neural tissue sensitization:It will be measured using the upper limb neurodynamic test 1(median nerve) and PPT over median nerve will be taken.
 
1. Before intervention
2. Immediately after intervention
3. 48hr post-intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
a. Global rate of change(GOC)  1. Before intervention
2. Immediately after intervention
3. 48hr post-intervention
 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "49"
Final Enrollment numbers achieved (India)="49" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/11/2019 
Date of Study Completion (India) 23/11/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study will be a randomized clinical trial aimed to find and compare the short-term effects of mobilization and manipulation of thoracic spine in chronic non-specific neck arm pain individuals.Interventions will be done on a single day and outcome measures such as intensity of pain on VAS, pressure pain sensitivity and neural tissue sensitivity will be evaluated before intervention, immediately after intervention and 48hr post-intervention. 


 
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