| CTRI Number |
CTRI/2025/07/091513 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing Cold and Vibration to reduce Pain during Injections for hair loss |
|
Scientific Title of Study
|
Efficacy of cold vs vibratory analgesia for pain relief in Platelet-Rich Plasma therapy: a randomized split scalp 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 |
Dr Rudrani Mukherjee |
| Designation |
Junior Resident, MD Dermatology |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room no. 21, OPD Block,
Department of Dermatology,
Kasturba Medical College,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9836863999 |
| Fax |
|
| Email |
rudranimukherjee1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mihika Noronha |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room no. 21, OPD Block,
Department of Dermatology,
Kasturba Medical College,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105045938 |
| Fax |
|
| Email |
mihika.noronha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mihika Noronha |
| Designation |
Senior Resident |
| Affiliation |
Kasturba Medical College Manipal |
| Address |
Room no. 21, OPD Block,
Department of Dermatology,
Kasturba Medical College,
Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8105045938 |
| Fax |
|
| Email |
mihika.noronha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College
Madhavnagar (Madhava Nagar), Manipal – 576104
Udupi District, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Dr Rudrani Mukherjee |
| Address |
Room no. 21, OPD Block,
Department of Dermatology,
Kasturba Medical College, Manipal-576104,
Karnataka, India |
| 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 Rudrani Mukherjee |
Kasturba Hospital |
Room no. 21, OPD Block,
Department of Dermatology,
Kasturba Medical College, Manipal
Udupi
KARNATAKA |
9836863999
rudranimukherjee1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L649||Androgenic alopecia, unspecified, (2) ICD-10 Condition: L650||Telogen effluvium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ice pack (cold analgesia) |
Ice pack will be applied with gentle pressure on the injection site of the scalp for 2–3 seconds prior to each injection. |
| Intervention |
Kinetic Anaesthetic Device (vibratory analgesia) |
Kinetic Anaesthetic Device will be covered with a disposable, sterile plastic film and applied 2 cm from the scalp injection site before PRP administration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. People aged 18 years or more than 18 years undergoing scalp Platelet Rich Plasma therapy
2. Willingness to receive either cold therapy or vibratory analgesia as a pain management technique during PRP
3. Intact scalp sensation
4. Ability to provide informed consent and comply with study protocols, including pain assessments |
|
| ExclusionCriteria |
| Details |
1. Contraindications to cold therapy including previous history of Raynaud’s disease or phenomenon, cold urticaria, cryoglobulinemia
2. Use of systemic or local analgesics, anesthetics, or sedatives within 24 hours before PRP injection
3. Neurological disorders affecting scalp sensation including scalp neuropathy, trigeminal neuralgia
4. Active scalp infections
5. Pregnant or lactating patients
6. Cognitive impairment, psychiatric disorders, or communication barriers preventing accurate pain reporting |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison between mean Pain Scores using the Visual Analogue Scale of Cold versus Vibratory analgesia during PRP |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment and comparison of mean Ease of Administration Scores using the Likert Scale for Cold versus Vibratory analgesia during PRP |
6 months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/08/2025 |
| Date of Study Completion (India) |
16/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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, split-scalp clinical trial aims to compare the analgesic efficacy of cold versus vibratory analgesia during platelet-rich plasma (PRP) injections over the scalp for conditions including androgenetic alopecia, telogen effluvium. Fifty-two adult patients undergoing PRP as a standard of care, will receive 2 different analgesia methods - cold analgesia (ice pack) on one half of the scalp and vibratory analgesia using a kinetic anesthetic device (KAD) on the other. Side allocation will be randomized using a computer-generated list, with allocation concealed and the statistician blinded to the intervention. Pain will be measured immediately after each side using a Visual Analogue Scale (VAS), and ease of administration will be assessed by the performing dermatology residents using a structured Ease of Administration questionnaire. Statistical analysis will include paired t-tests for continuous variables and McNemar’s test for categorical outcomes. The study is designed to evaluate both patient-reported pain relief and clinician-reported feasibility of each analgesic method. Risk mitigation includes immediate discontinuation of the analgesic method if adverse reactions occur, with symptomatic management provided. Results will inform evidence-based, non-pharmacological pain management during PRP therapy. |