| CTRI Number |
CTRI/2020/06/026090 [Registered on: 24/06/2020] Trial Registered Prospectively |
| Last Modified On: |
11/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of a physiotherapy in neck pain |
|
Scientific Title of Study
|
Effectiveness of Upper and Mid Thoracic Spine Mobilization in Individuals with Mechanical Neck 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 |
Md Nazmul Hassan |
| Designation |
Clinical Physiotherapist |
| Affiliation |
Centre for the Rehabilitation of the Paralysed |
| Address |
Musculoskeletal Unit, Department of Physiotherapy
Savar, Dhaka, 1343
1343
Other |
| Phone |
01918032333 |
| Fax |
|
| Email |
hassan.crp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohammad Anwar Hossain |
| Designation |
Senior Consultant |
| Affiliation |
Centre for the Rehabilitation of the Paralysed |
| Address |
Department of Physiotherapy, centre for the Rehabilitation of the Paralysed (CRP),Savar, Dhaka-1343
1343
Other |
| Phone |
8801753559949 |
| Fax |
|
| Email |
anwar_physiobd@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Anwar Hossain |
| Designation |
Senior Consultant & Associate Professor |
| Affiliation |
Centre for the Rehabilitation of the Paralysed |
| Address |
Department of physiotherapy
Savar, Dhaka, 1343
1343
Other |
| Phone |
|
| Fax |
|
| Email |
anwar_physiobd@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Musculoskeletal Unit, Department of Physiotherapy, CRP, Savar, Dhaka-1343 |
|
|
Primary Sponsor
|
| Name |
Md Nazmul Hassan |
| Address |
CRP-Savar, Dhaka-1343 |
| Type of Sponsor |
Other [Self-funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mohammad Anwar Hossain |
Centre for the Rehabilitation of the Paralysed |
Musculoskeletal Unit, Department of Physiotherapy, CRP-Savar
|
8801753559949
anwar_physiobd@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
Conventional Physiotherapy |
Mckenzie Therapy, Manual Therapy, Maitland, Exercise therapy, electrotherapy for 30 minutes for 3 weeks |
| Intervention |
Thoracic Mobilization |
Oscillatory Thoracic Spine Mobilization
60 to 120 Hz per seconds |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Age range between 20 to 55 years: (Chiu, et al., 2012; Gautam, et al., 2014).
Male and female both will be included (Schopflocher, et al., 2011)
Patient who will be diagnosed as mechanical neck pain (El-Sodany, et al., 2014). |
|
| ExclusionCriteria |
| Details |
Age below 20 years and above 55 years (Ummar, et al., 2012)
Sustaining red flags of neck pain (McColl, 2013).
Associated pathology of the upper cervical region or upper limb (El-Sodany, et al., 2014).
Unwilling to participate (Halvorsen, et al., 2014).
Post-operative subjects.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, Range of Motion |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Disability and daily activities |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="0"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/06/2020 |
| 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)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Not Applicable |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Mechanical neck pain is worldwide health problem. Most often, it is the result of a compression or inflammatory pathology from a space occupying lesion such as disc herniation, spondylitic spur, or cervical osteophyte (Rai, Ajith, Bhagavan, & Pinto, 2013). The average annual incidence rate of cervical radiculopathy is 85 per 100,000 for the population in its entirety, with an increased prevalence occurring in the fifth decade of life, 203 per 100,000 (priya Vishnu, 2015). The most frequently involved nerve roots are the cervical 6 (C6) and cervical 7 (C7) cervical roots which are typically caused by C5-C6 or C6-C7 disc herniation or spondylosis (Sambyal and Kumar, 2013). It’s estimated that 50% of the population experienced neck and upper extremity pain at some time in their lifetime (Sambyal and Kumar, 2013). |