| CTRI Number |
CTRI/2022/12/047914 [Registered on: 06/12/2022] Trial Registered Prospectively |
| Last Modified On: |
05/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of dry needling
and fascial manipulation in treating Central Sensitization
related to Chronic knee OA patients |
|
Scientific Title of Study
|
Effectiveness of Dry Needling
and Fascial Manipulation On
Chronic Knee OA Patients with
Central Sensitization: A single
group pre post design |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chaudhary Jhanvi Ketanbhai |
| Designation |
PG student |
| Affiliation |
Srinivas institute of physiotherapy |
| Address |
Srinivas University, Institute of physiotherapy , City campus pandeshwar,mangaluru,575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9316546653 |
| Fax |
|
| Email |
jhanvichaudhary60@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajasekar S |
| Designation |
Dean |
| Affiliation |
Srinivas institute of physiotherapy |
| Address |
Srinivas University, Institute of physiotherapy , City campus pandeshwar,mangaluru,575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9448156719 |
| Fax |
|
| Email |
rajasekar@srinivasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Chaudhary Jhanvi Ketanbhai |
| Designation |
PG student |
| Affiliation |
Srinivas institute of physiotherapy |
| Address |
Srinivas University, Institute of physiotherapy , City campus pandeshwar,mangaluru,575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9316546653 |
| Fax |
|
| Email |
jhanvichaudhary60@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self-sponsered
Srinivas institute of physiotherapy and Hospital, City campus, pandeshwar mangaluru |
|
|
Primary Sponsor
|
| Name |
Chaudhary Jhanvi Ketanbhai |
| Address |
Srinivas institute of physiotherapy, City campus pandeshwar mangaluru,575001 |
| 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 |
| Chaudhary Jhanvi Ketanbhai |
Srinivas institute of physiotherapy and Srinivas hospital, Mangaluru |
Srinivas institute of physiotherapy and Hospital City campus pandeshwar mangaluru 575001
Dakshina Kannada
KARNATAKA |
9316546653
jhanvichaudhary60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srinivas institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry needling and Fascial Manipulation |
DRY NEEDLING:
Directly behind the trigger points near the knee joint, a headless needle will be placed. The guide tube will be taken out after the MTrp has been found between the subdominant hands fingers. The dominant hand’s first and second metacarpophalangeal fingers will be used to probe the area in various directions until at least one local twitch response, a local pain response, and usually the referral pain pattern of MTrP are acquired
FASCIAL MANIPULATION:
A defined assessment technique will be undertaken, FM refers to this as movement and palpation verification. In order to identify the most uncomfortable and impaired movement, as well as to highlight the myofascial units that are impacted, movement verifications will be carried out in three spatial planes. The severity of the patient’s symptoms or functional impairment for the knee segment under investigation will be described in the chart. Palpation verification, or verifying the gliding of the fascial tissue, is performed on the knee, hip, foot, leg, and pelvis of the chosen myofascial segments talus, pes, genu, and pelvis in that knee to identify which center of coordination [CC] is densified and painful and those referring pain to the symptomatic area as reported by the patient
Treatment will be given
once a week for four weeks
Post treatment assessment will be done after 4 weeks, follow up will be taken on 3 month and 6 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Knee osteoarthritis as defined by the American College of Rheumatology (knee discomfort and at least three of the following: 50 years or older, bony enlargement, crepitus on active motion, bony soreness, 30 minutes of morning stiffness, and no perceptible warmth of synovial)
Based on radiological findings, Kellgren and Lawrence grade2,3, and 4
The ideal CSI score is under 40.
|
|
| ExclusionCriteria |
| Details |
Knee arthroplasty
Intra-articular steroid injection and/or oral steroid treatment within the last six months
Total Meniscectomy
Neurological deficits in the lower limb
Cancer, rheumatoid arthritis, severe cognitive deficit
Lymph edema, peripheral vascular disease
Infection and allergy present in lower limb [ Skin Ulcer]
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •WOMAC Scale |
Pre intervention(1st day)
Post intervention(4th week)
Follow up(3rd month 6th month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TAMPA scale of Kinesio phobia
NPRS
Pain Self- efficacy questionnaire
Pain pressure threshold
Goniometer (ROM)
Patient satisfactory scale(6-point Likert Scale) |
Pre intervention (1st day)
Post intervention (4th week)
Follow up (3rd month & 6th month)
Only Central Sensitization Inventory scale is used as a screening tool and who have score 40 or greater than 40) |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
10/12/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/12/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After submitting informed consent, criteria for inclusion and exclusion are checked, patients who meet inclusion criteria, pre intervention outcome measure assessment will be measured using WOMAC, NPRS, Range of Motion, PPT, TAMPA Scale, Pain- self efficacy scale and CSI will be measured as screening tool. After assessing knee OA with central sensitization dry needling and fascial manipulation will be given to subjects once a week for four weeks. Post treatment assessment will be done after 4 weeks, follow up will be taken on 3 month and 6 months. |