| CTRI Number |
CTRI/2025/05/087754 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| 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
|
using Ultrasound with High-Voltage Galvanic Current vs. Ultrasound with Medium-Frequency Current and recording Reduction in Pain and Improving Function in Mechanical Back Pain: A Randomized Trial |
|
Scientific Title of Study
|
Efficacy of ultrasound combined with high-voltage galvanic current versus ultrasound with medium-frequency current in reducing pain and improving function in patients with mechanical back pain: 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 |
Abhishek Kanojia |
| Designation |
PG Scholer |
| Affiliation |
Uttar Pradesh University Of Medical Sciences |
| Address |
868 sector 6k Vrindavan yojna gopeskunj telibagh
uttar pradesh university of medical sciences saifai etawah
Etawah
UTTAR PRADESH
226029
India |
| Phone |
9807909169 |
| Fax |
|
| Email |
drabhishekkanojiaupums@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
KB Ranjeet Singh Chaudhary |
| Designation |
Faculty at UPUMS PARAMEDICAL |
| Affiliation |
Uttar Pradesh University Of Medical Sciences |
| Address |
Uttar Pradesh University Of Medical Sciences Faculty Of Paramedical Sciences SAIFAI ETAWAH
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9760690454 |
| Fax |
|
| Email |
chaudhary.ranjeet@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KB Ranjeet Singh Chaudhary |
| Designation |
Faculty FPS |
| Affiliation |
Uttar Pradesh University Of Medical Sciences |
| Address |
Uttar Pradesh University Of Medical Sciences Faculty Of Paramedical Sciences
UTTAR PRADESH
206130
India |
| Phone |
9760690454 |
| Fax |
|
| Email |
chaudhary.ranjeet@rediffmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Abhishek Kanojia |
Uttar Pradesh University Of Medical Sciences |
Room no. 114
Department of Physiotherapy Faculty Of Paramedical Sciences
UPUMS Saifai Etawah
Etawah
UTTAR PRADESH |
9807909169
drabhishekkanojiaupums@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M998||Other biomechanical lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound + High Voltage Pulsed Galvanic Current (HVPGC) |
Details: This group received therapeutic ultrasound along with HVPGC, which is a type of electrical stimulation using high-voltage, low-average current pulsed stimulation. |
| Comparator Agent |
Ultrasound + Medium Frequency Current (MFC) |
Details: This group received ultrasound therapy combined with Medium Frequency Current, often used in interferential or Russian stimulation forms. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with mechanical back pain lasting between 4 and 12 weeks
Not currently receiving other physical therapy modalities
No history of significant spinal pathology, surgery, or contraindications to electrical stimulation or ultrasound therapy
|
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women
Patients with pacemakers or other implanted electrical devices
Those with neurological disorders affecting balance or gait
Patients with cognitive impairments that prevent informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in pain intensity and improvement in functional mobility in patients with mechanical low back pain.
|
Reduction in pain intensity and improvement in functional mobility in patients with mechanical low back pain.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in disability scores (Oswestry Disability Index)
|
Baseline, end of 2 weeks (post-intervention), and 4 weeks follow-up.
|
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
09/06/2025 |
| 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)
|
Open to Recruitment |
| 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
|
This randomized controlled trial aims to compare the efficacy of two physiotherapeutic interventions—ultrasound combined with high-voltage pulsed galvanic current (HVPC) versus ultrasound with medium-frequency current (MFC)—in reducing pain and improving functional independence in patients with mechanical back pain. A total of 74 participants aged 18–65 years with subacute mechanical back pain (4–12 weeks) will be recruited from the physiotherapy OPD at UPUMS, Saifai. Participants will be randomly allocated into two groups: Group A will receive ultrasound + HVPC; Group B will receive ultrasound + MFC. Both interventions will be administered 3 times per week for 2 weeks. Pain intensity (measured using the Global Pain Scale and Algometer) and functional independence (measured using the Oswestry Disability Index) will be assessed pre- and post-treatment, and at a 2-week follow-up. Data will be analyzed using repeated measures ANOVA. The study seeks to generate evidence on the comparative effectiveness of combining ultrasound with different electrical stimulation modalities for optimal clinical management of mechanical back pain. |