| CTRI Number |
CTRI/2025/02/081291 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
24/02/2025 |
| 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
|
To compare the effect of cryoair therapy versus cryo massage in Reliving pain among individual with acute trapezitis |
|
Scientific Title of Study
|
Effect of cryoair therapy versus cryo massage in acute trapezitis- A randomized controlled trail |
| 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 Nirav Vaghela |
| Designation |
Professor- department of Physiotherapy |
| Affiliation |
K. M. Patel Institute of Physiotherapy, Bhaikaka University |
| Address |
Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad Anand Gujarat India 388325
Anand
GUJARAT
388325
India |
| Phone |
9428647304 |
| Fax |
|
| Email |
niravpv@charutarhealth.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Khushi Popat |
| Designation |
MPT Student |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad Anand Gujarat India 388325
Anand
GUJARAT
388325
India |
| Phone |
9924646763 |
| Fax |
|
| Email |
kpopat67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khushi Popat |
| Designation |
MPT Student |
| Affiliation |
K M Patel Institute of Physiotherapy |
| Address |
Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152, Karamsad Anand Gujarat India 388325
Anand
GUJARAT
388325
India |
| Phone |
9924646763 |
| Fax |
|
| Email |
kpopat67@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kinesiotherapy and Electrotherapy unit of
physiotherapy department of K. M. Patel Institute of Physiotherapy, Shree krishna hospital, Karamsad, Gujarat, India 388325
|
|
|
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 |
| Dr Nirav Vaghela |
K M Patel Institute of Physiotherapy |
Shree Krishna Hospital, K M Patel Institute of Physiotherapy, OPD no. 152 , Karamsad, Anand , India 388325
Anand
GUJARAT |
9428647304
niravpv@charutarhealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE - 2 Bhaikaka University, Karamsad, Anand, Gujarat-388325 [DHR Reg. No. EC/NEW/INST/2021/592][OHRP Reg. No. IRB00014178] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
cryo massage with conventional therapy |
In circular motion massage will be given with ice pack.
It will be given with frequency-4 sessions consecutively and duration 10 minutes.
conventional therapy will include Scapular exercises and active neck exercises Frequency: 4 Sessions and Intensity: 2 Set × 10 Repetitions With 5 Sec Hold.
Total duration for conventional therapy: Approximately 8 minutes
Total duration for Group B ( Cryo massage with conventional therapy): Approximately 18 minutes |
| Intervention |
Cryoair therapy with conventional therapy |
It is a modality of cryo therapy which allows evenly distribute the cold air flow over surface of the skin and controlled dosage to achieve the desire effect.
It will be given with Frequency- 4 sessions consecutively, intensity according to patient’s tolerance, temperature- 12 degree Celsius and duration-10 minutes.
conventional therapy will include scapular exercises and active neck exercises
Frequency: 4 Sessions and Intensity: 2 Set × 10 Repetitions With 5 Sec Hold
Total duration for conventional therapy: Approximately 8 minutes
Total duration for Group A ( Cryoair with conventional therapy): Approximately 18 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Participants with age group of 18-26 years.
Both male and female will be included.
Unilateral or Bilateral Acute onset of Trapezitis.
Palpable tender points present over upper trapezius muscle.
Spasm present over trapezius muscle.
Restricted cervical lateral flexion of ROM. |
|
| ExclusionCriteria |
| Details |
Recent history of trauma, fracture, cervical spine surgery, PIVD, cervical radiculopathy, myopathy.
Sensory disturbance near treating part.
Allergy to cold. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Goniometer measurements |
Pre and post interventional assessment will be taken before and after each session in both experimental and control group.
Total 4 sessions will be carried out consecutively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numerical pain rating scale |
Pre & post interventional assessment will be taken before & after each session in both experimental & control group
Total 4 sessions will be carried out consecutively |
| Neck disability index(NDI) |
Pre & post interventional assessment will be taken before & after each session in both experimental & control group
Total 4 sessions will be carried out consecutively |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
11/03/2025 |
| 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)
|
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
|
NEED OF STUDY: Cryoair therapy and Cryo massage are already proven effective individually in acute trapezitis but there are no such studies who have compared this both techniques so there is need of study.
NPRS, NDI, and goniometry measurements will be taken pre test and post test after each session. Consecutively total 4 sessions will be conducted and the effect will seen. |