| CTRI Number |
CTRI/2025/01/079689 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of PosturePals® in Cervicothoracic Pain. |
|
Scientific Title of Study
|
Effects of PosturePals® on Pressure Pain Threshold, Cervicothoracic Muscle Activity, Craniovertebral Angle and Quality of Life among adults with Cervicothoracic Pain Syndrome: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shikha Malik |
| Designation |
PhD Scholar |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Plot No. 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9779761606 |
| Fax |
|
| Email |
shinny00720@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shikha Malik |
| Designation |
PhD Scholar |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Plot No. 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9779761606 |
| Fax |
|
| Email |
shinny00720@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammad Sidiq |
| Designation |
Associate Professor |
| Affiliation |
Galgotias University |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Plot No. 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
6006204628 |
| Fax |
|
| Email |
sidufatima@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Development Cell, Galgotias University, Plot No. 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, 203201 |
|
|
Primary Sponsor
|
| Name |
Galgotias University |
| Address |
Galgotias University, Plot No. 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida, 203201 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shikha Malik |
Galgotias University |
Room No. E003, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No. 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9779761606
shinny00720@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| School Ethical Committee Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PosturePals® |
Participants in the intervention group will receive PosturePals®, and it will be there for 5 days/week for 4 weeks. Along with PosturePals®, a standard physiotherapy protocol will be given that includes a moist heat pack for 15 minutes over the cervicothoracic region, followed by cervical and upper back exercises of 2-3 sets of 10-15 repetitions for three days per week for 4 weeks. The total duration of the study will be 4 weeks. |
| Comparator Agent |
Standard Physiotherapy Care |
The control group will receive standard physiotherapy for cervicothoracic pain syndrome. It will include a moist heat pack for 15 minutes over the cervicothoracic region, followed by cervical and upper back exercises of 2-3 sets of 10-15 repetitions for three days per week for 4 weeks. The total duration of the study will be 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Pain duration at least 6 weeks or more
2. Pain intensity score of 3 and above on NPRS at cervicothoracic region
3. Individual who has functional limitation or decreased ROM in cervicothoracic region
4. Individuals with sitting time more than 6-8 hours
5. BMI: 18.5–24.9 Kg/m2
6. Chest Circumference will be measured before the application of PosturePals®
7. Participants willing to participate and provide duly signed informed consent form
|
|
| ExclusionCriteria |
| Details |
i) History of whiplash injury, cervical and thoracic spine fracture
ii) Presence of inflammatory condition such as rheumatoid arthritis, ankylosing spondylitis
iii) Presence of any skin condition involving cervical and thoracic region,
iv) Presence of neurological conditions such as radiculopathy, myelopathy, and epilepsy
v) History of chronic pain syndrome such as fibromyalgia
vi) History of psychiatric condition that might influence with study requirements
vii) Tape-related allergies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Pressure pain threshold using algometer
2.Electromyography
3.Craniovertebral angle |
Baseline, immediately after 4-week intervention and 2-week follow-up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline, immediately after 4-week intervention and 2-week follow-up. |
|
|
Target Sample Size
|
Total Sample Size="57"
Sample Size from India="57"
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 3 |
|
Date of First Enrollment (India)
|
09/02/2025 |
| 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="1"
Months="0"
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
|
Cervicothoracic pain syndrome is a common musculoskeletal condition that affects the neck and upper back, leading to pain, stiffness, and limited range of motion. Conventional treatment methods, such as physical therapy and ergonomic interventions, have shown varying degrees of effectiveness in managing CTPS. The PosturePals® technique is a specialized form of dynamic taping designed to promote optimal posture and movement patterns. Unlike traditional taping methods, the PosturePals® provide continuous feedback to the body, reminding the individual to maintain correct posture throughout daily activities. Despite the potential benefits of the PosturePals®, there is limited evidence specifically evaluating its effectiveness in managing cervicothoracic pain syndrome. Addressing this gap is essential for establishing the clinical utility of the PosturePals®. Therefore, there is a critical need for research that specifically investigates the impact of PosturePals® on pressure pain threshold, muscle activity, posture, and quality of life in individuals with cervicothoracic pain syndrome. |