| CTRI Number |
CTRI/2026/02/104457 [Registered on: 20/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [cranio-sacral therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Craniosacral therapy for quality of life improvement in patients with cervical pain |
|
Scientific Title of Study
|
THE IMPACT OF CRANIOSACRAL THERAPY ON THE QUALITY OF LIFE OF PATIENTS WITH CERVICAL PAIN - PROSPECTIVE CONTROLLED EXPERIMENTAL 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 |
Anca Maria Oltean |
| Designation |
Lecturer, PhD |
| Affiliation |
University of Oradea |
| Address |
str. Universitatii nr.1, corp C, etaj 1, camera 117
Oradea, Bihor, Romania
410087
Other |
| Phone |
0722839150 |
| Fax |
|
| Email |
anca.dragan@uoradea.ro |
|
Details of Contact Person
Scientific Query
|
| Name |
Doriana Ioana Ciobanu |
| Designation |
Assoc.Prof.PhD, PhD |
| Affiliation |
University of Oradea |
| Address |
str. Universitatii, nr.1, corp C, etaj 1, Oradea, Bihor, Romania
410087
Other |
| Phone |
0722839150 |
| Fax |
|
| Email |
dciobanu@uoradea.ro |
|
Details of Contact Person
Public Query
|
| Name |
Anca Maria Oltean |
| Designation |
Lecturer, PhD |
| Affiliation |
University of Oradea |
| Address |
str. Universitatii, nr.1, corp C, etaj 1, Oradea, Bihor, Romania
410087
Other |
| Phone |
0722839150 |
| Fax |
|
| Email |
anca.dragan@uoradea.ro |
|
|
Source of Monetary or Material Support
|
| Osteokinetomedica SRL, str. Anatole France nr.41, Oradea, Bihor, Romania, 410842 |
|
|
Primary Sponsor
|
| Name |
Osteokinetomedica |
| Address |
str. Anatole France nr.41, Oradea, Bihor, Romania, 410842 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Romania |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anca Maria Dragan |
Osteokinetomedica Clinic |
str. Anatole France nr.41, Oradea, Bihor, Romania, Department of Physical Therapy, romm no.1
|
0040722839150
anca.dragan@uoradea.ro |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Committee on Scientific Reserch Conduct and Ethics, Faculty of Geography, Tourism and Sport |
Approved |
| Osteokinetomedica |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
cervicalgia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
physiotherapy |
the control group will will receive 12 therapy sessions (3 session/week) of physiotherapy, with a total duration of 4 weeks |
| Intervention |
physiotherapy and craniosacral therapy |
experimental group will receive 12 therapy sessions (3 session/week) of physiotherapy and craniosacral therapy, with a total duration of 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
age between 35 and 55 years; presence of cervical pain; absence of major associated comorbidities; attendance of at least 85% of the scheduled therapy sessions; absence of current pharmacological treatment; and no acute medical conditions. |
|
| ExclusionCriteria |
| Details |
fibromyalgia, spinal tumors, prior cervical spine surgery, significant cervical trauma (e.g., whiplash injuries or cervical fractures), infections, and inflammatory rheumatic diseases. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study aims to highlight the role of Cranio-Sacral Therapy in achieving faster pain reduction, thereby influencing stress levels and improving the quality of life of patients with cervical pain. |
baseline and at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="0"
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)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
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 study aims to highlight the role of Cranio-Sacral Therapy in achieving faster pain reduction, thereby influencing stress levels and improving the quality of life of patients with cervical pain. The patients will be recruited from OSTEOKINETOMEDICA Clinic in Romania, during the next months. The patients will be randomized into two groups, one experimental and one control. Both groups will follow a physiotherapy program, but patients from the experimental group will follow cranioscaral therapy sessions.
|