| CTRI Number |
CTRI/2025/02/080358 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
The Role of Advanced Therapies in Spinal Health: A Comparison of Vacuum IFT, Cryotherapy, Tecar Therapy, and Laser Therapy |
|
Scientific Title of Study
|
To study the Clinical outcomes of Vacuum IFT,Cryotherapy,Tecar or Laser Therapy combinations on patients with Spinal Ailments |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SSHRI/CS/NS/Combi2024/AD/75/07.24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akruti Dave |
| Designation |
Principal investigator and Chief physiotherapist |
| Affiliation |
Stavya Spine Hospital and Research Institute |
| Address |
Room No.0, third floor Annexe, Research Department, Stavya Spine hospital
and Research Institute ,Ellisbridge, Mithakhali ,Ahmedabad 380006,India
Ahmadabad
GUJARAT
380006
India |
| Phone |
9512829717 |
| Fax |
|
| Email |
akruti@stavyaspine.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akruti Dave |
| Designation |
Principal investigator and Chief physiotherapist |
| Affiliation |
Stavya Spine Hospital and Research Institute |
| Address |
Room No.0, third floor Annexe, Research Department, Stavya Spine hospital
and Research Institute ,Ellisbridge, Mithakhali ,Ahmedabad 380006,India
Ahmadabad
GUJARAT
380006
India |
| Phone |
9512829717 |
| Fax |
|
| Email |
akruti@stavyaspine.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akruti Dave |
| Designation |
Principal investigator and Chief physiotherapist |
| Affiliation |
Stavya Spine Hospital and Research Institute |
| Address |
Room No.0, third floor Annexe, Research Department, Stavya Spine hospital
and Research Institute ,Ellisbridge, Mithakhali ,Ahmedabad 380006,India
Ahmadabad
GUJARAT
380006
India |
| Phone |
9512829717 |
| Fax |
|
| Email |
akruti@stavyaspine.com |
|
|
Source of Monetary or Material Support
|
| Stavya Spine hospital and Research Institute Ellisbridge Mithakhali Ahmedabad 380006 |
|
|
Primary Sponsor
|
| Name |
Stavya Spine Hospital and Research Institute |
| Address |
Stavya Spine hospital and Research Institute Ellisbridge Mithakhali
Ahmedabad 380006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Akruti Dave |
Stavya Spine Hospital & Research Institute Pvt. Ltd. |
No. 8, Third floor Annexe,Stavya Spine hospital and Research Institute,Ellisbridge ,Mithakhali,Ahmedabad 380006,GUJARAT
Ahmadabad
GUJARAT |
9512829717
07926408174
akruti053@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Stavya Spine hospital & Research Institute IEC |
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 |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18-95 years.
2.Male and Female patients.
3.Pain duration greater than 3 months.
4.NPRS score greater or equal to 3.
5.Diagnosed with:
Postural problems
Postural low back pain (LBP)
Postural neck pain
Trapezius muscle spasm
Paraspinal muscle spasm
Dorsal spine pain
6.Diagnosed by medical doctors or orthopaedic/spine surgeons.
7.Occupational spine ailments included.
8.Multivitamins permitted.
9.Willingness to participate and comply with the study protocol
|
|
| ExclusionCriteria |
| Details |
1. Neuropathic pain due to nerve root compression.
2. Diabetes mellitus.
3. Severe comorbidity
4. History of acute trauma or fracture.
5. Implanted pacemakers.
6. Pregnancy.
7. History of malignancy or infection.
8. Systemic musculoskeletal disease.
9. Epilepsy.
10. Recent Spinal surgery (within the last 6 months)
11. Psychiatric disorders.
12. Neurodegenerative diseases.
13. Deep Vein Thrombosis (DVT).
14. Tuberculosis.
15. Spinal instability or deformities (PIVD, lumbar canal stenosis, scoliosis, cervical canal ste-nosis, lysis).
16.Diabetic neuropathy.
17. Osteoporosis.
18. Current use of NSAIDs or muscle relaxants.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Assessment:
- Visual Analogue Scale (VAS)
- Numeric Pain Rating Scale (NPRS)
Disability and Functional Assessment:
- Modified Oswestry Disability Index (ODI)
- Roland Morris Disability Questionnaire
- Neck Disability Index (NDI)
Range of Motion (ROM):
- Lumbar flexion and extension
- Neck flexion and extension
Quality of Life Assessment:
- SF-36 Health Survey
- Socioeconomic status via Kuppuswamy scale
|
This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
23/02/2025 |
| 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="2"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a prospective study involves 100
patients with spine ailments undergoing physiotherapy treatments, including
Vacuum IFT, Localized Cryotherapy, Laser Therapy, and TECAR Therapy. Patients
will be randomly assigned to either a control or interventional group. The
study aims to evaluate the effectiveness of combining these therapies to
enhance pain management, functional recovery, and patient satisfaction. By
determining the most effective therapy combinations, the study seeks to improve
non-surgical treatment protocols for spinal disorders. The treatment phase will
last 3-4 weeks, followed by a 1–2-month follow-up period to assess outcomes and
patient satisfaction.
|