| CTRI Number |
CTRI/2026/02/102913 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out the effect of shockwave therapy and class- IV Laser therapy in coccydynia in adult males
|
|
Scientific Title of Study
|
A comparative study to find out the effect of shockwave therapy and class- IV Laser therapy in coccydynia in adult males: A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shahnawaz Hussain |
| Designation |
Undergraduate Physiotherapy Student |
| Affiliation |
Galgotias University |
| Address |
J68/B3 Abul Fazal Enclave Jamia Nagar
South
DELHI
110025
India |
| Phone |
9911057313 |
| Fax |
|
| Email |
shahnawazhussain415@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Kumar PT |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
E003 Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9810434830 |
| Fax |
|
| Email |
neerajkumar@galgotiasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj Kumar PT |
| Designation |
Assistant Professor |
| Affiliation |
Galgotias University |
| Address |
E003 Galgotias University Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9810434830 |
| Fax |
|
| Email |
neerajkumar@galgotiasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy,Galgotias University, Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201 |
|
|
Primary Sponsor
|
| Name |
Shahnawaz Hussain |
| Address |
J68/B3 Abul Fazal Enclave, Jamia Nagar, New Delhi-110025, India |
| Type of Sponsor |
Other [My 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 Neeraj Kumar PT |
Galgotias University |
Department of Physiotherapy,E003, Galgotias University
Gautam Buddha Nagar
UTTAR PRADESH |
98104 34830
neerajkumar@galgotiasuniversity.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M533||Sacrococcygeal disorders, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Class-IV Laser Therapy |
Dosage/Form: High-intensity Laser (Class IV), Continuous Mode, Energy density:6-10J/cm2, Power:8-12W, 5-8 min per session, 2 times a week for one month |
| Intervention |
Shockwave therapy |
Dosage/Form: Radial Shockwaves, Freq:8-15Hz, NO.of Pulses: 1500-3000, 2 times a week for one month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Adults diagnosed with chronic coccydynia for more than 3 months.
Pain intensity rated is more than 5 on the Visual Analogue Scale (VAS).
No structural abnormalities like fractures or infections.
|
|
| ExclusionCriteria |
| Details |
Pregnancy or breastfeeding.
Patients with pacemakers or other electronic implants.
Malignancy or infection in the treatment area.
Severe psychiatric disorders or substance abuse.
Recent surgery on the coccyx.
Menstruation.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain Reduction.
|
Baseline, Week 2, Week 4, End of treatment, Follow-up at Week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life. |
Pre-Initial assessment, Post - after one month intervention |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
14/02/2026 |
| 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="0"
Months="2"
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
|
Coccydynia, a term originally used by Simpson in the middle of the 1900s, describes pain symptoms around the coccyx. While this disorder can affect anyone of any age or gender, research indicates that the typical age of onset is 40 years old, and women are five times more likely than males to have it. With the exception of the first coccygeal segment, coccydynia is made up of three to five primitive vertebral units that are usually fused together. With transverse grooves that identify the areas where the vestigial coccygeal units had previously joined, the ventral side of the coccyx is somewhat concave. A somewhat convex dorsal aspect with comparable transverse markings and many paired tubercles, called coccygeal articular processes, with the superior ones called coccygeal cornu, are features of the dorsal aspect.
|