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
|
|
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
|
|
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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