| CTRI Number |
CTRI/2025/07/090328 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Super Inductive System Therapy and Conventional Physiotherapy in Treating Upper Cross Syndrome: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Efficacy of Super Inductive System Therapy and Conventional Therapy in subjects with Upper Cross Syndrome - Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjana A Pammannavar |
| Designation |
Assistant Professor |
| Affiliation |
K.L.E Institute of Physiotherapy |
| Address |
KLE Dr Prabhakar Kore Hospital and Research Center Advance Physiotherapy Sports department OPD no. 8 Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9380358281 |
| Fax |
|
| Email |
sanjanapammannavar@klekipt.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Santosh Metgud |
| Designation |
Vice Principal and Professor |
| Affiliation |
K.L.E Institute of Physiotherapy |
| Address |
KLE Dr Prabhakar Kore Hospital and Research Center Advance Physiotherapy Sports department OPD number 8 Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9164646484 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Santosh Metgud |
| Designation |
Vice Principal and Professor |
| Affiliation |
K.L.E Institute of Physiotherapy |
| Address |
KLE Dr Prabhakar Kore Hospital and Research Center Advance Physiotherapy Sports department OPD number 8 Belagavi
Belgaum KARNATAKA 590010 India |
| Phone |
9164646484 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLEs Dr. Prabhakar Kore Hospital and medical Research Center Neharu Nagar Belagavi Karnataka India 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Sanjana A Pammannavar |
| Address |
KLEs Dr Prabhakar hospital and research center Neharu nagar Belagavi Karnataka India 590010 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sanjana A Pammannavar |
Advance Physiotherapy OPD room number 8 sports department |
KLEs hospital and research center,
Neharu nagar Belagavi 590010 Belgaum KARNATAKA |
09380358281
sanjanapammannavar@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional therapy Group B |
•Hot Moist Pack: 10 min
•Therapeutic Ultra sound: 3 sessions per week
•Postural Education: 10 minutes (corrective posture training)
•Stretching Exercises And Soft tissue Release: Upper trapezius, levator scapulae, pectoralis major/minor, SCM, Rhomboids
•Hold for 30 seconds, repeat 3 times
•Strengthening Exercises: deep cervical flexors, rhomboids, and lower trapezius
•Home Exercise Plan: Recommended 10–15 minutes daily
|
| Intervention |
Super Inductive System plus Conventional therapy Group A |
Frequency: 3 sessions per week
Duration: 15 minutes per session
Intensity: As per tolerance, starting at low intensity and gradually increasing based on participant feedback
Placement: Focus on Upper and lower trapezius, Levator scapule, Pectoralis major and minor, Sternocleidomastoid, Rhomboids
Conventional Therapy Protocol
Hot Moist Pack: 10 min
Therapeutic Ultra sound: 3 sessions per week
Postural Education: 10 minutes (corrective posture training)
Stretching Exercises And Soft tissue Release: Upper trapezius, levator scapulae, pectoralis major/minor, Sternocleniod muscle, Rhomboids
Hold for 30 seconds, repeat 3 times
Strengthening Exercises: deep cervical flexors, rhomboids, and lower trapezius
Home Exercise Plan: Recommended 10–15 minutes daily
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18–45 years diagnosed with Upper Cross Syndrome based on clinical assessment.
Complaints of neck pain for at least three months.
Pain Pressure Threshold more or equal 2.5 N per cm2 over UCS-affected muscles.
Craniovertebral angle more or equal48 degrees indicating forward head posture.
Neck Disability Index score less or equal 10 percent, indicating functional limitations.
Willingness to participate in the study.
|
|
| ExclusionCriteria |
| Details |
History and recent diagnosis of cervical spine pathology such as herniated disc, cervical spondylosis, or spinal fractures.
Neurological disorders affecting muscle function.
Recent trauma, surgery, or injury to the neck, shoulder, or upper back within the last six months.
Severe musculoskeletal conditions such as rheumatoid arthritis, ankylosing spondylitis.
Pregnant or lactating women.
Implants or Pacemaker in the Upper quadrant of the body.
Skin infections, open wounds, or dermatological conditions in the treatment area.
Uncontrolled metabolic disorders.
Presently on any other Alternative therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Pain
2)ROM
3)Craniovertebral angle
4)Strength. |
Day of intervention and post intervention 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Posture
2)Kyphotic angle
3)Shoulder angle
4)Functional mobility. |
On Day 1 of intervention and 4th week of intervention |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
26/08/2025 |
| 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="3" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 evaluate the efficacy of Super Inductive System (SIS) therapy combined with conventional physiotherapy, compared to conventional therapy alone, in individuals diagnosed with Upper Cross Syndrome (UCS). UCS is a postural disorder characterized by muscle imbalances, including tightness in the upper trapezius and pectoral muscles and weakness in deep neck flexors and scapular stabilizers, leading to neck pain, postural deviations, and functional limitations. A total of 66 participants aged 18–45 years with UCS will be randomly assigned to either the SIS + conventional therapy group or the conventional therapy-only group. Interventions will be conducted over four weeks, and outcomes will be assessed pre- and post-intervention using electromyography (EMG), pain pressure threshold, craniovertebral angle, postural assessment, kyphotic and shoulder angles, functional mobility (NDI), and cervical ROM. The study aims to provide objective evidence on the effectiveness of SIS in improving muscle activation, posture, and reducing pain in UCS patients. |