| CTRI Number |
CTRI/2022/10/046654 [Registered on: 20/10/2022] Trial Registered Prospectively |
| Last Modified On: |
19/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Study to find the Effect of Kaltenborn Traction Mobilization technique in patient with Osteoarthritis knee. |
|
Scientific Title of Study
|
The Effect of Kaltenborn Traction Mobilization technique on Pain and Function in patient with Osteoarthritis (OA) knee: An Interventional Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishali Gohil PT |
| Designation |
PG Student |
| Affiliation |
Government Physiotherapy College, Jamnagar |
| Address |
Room no 33, Exercise Therapy Department, Physiotherapy OPD, Government Physiotherapy College, Old TB Hospital Building, Near Government Dental Hostel, Rameshwar Nagar, Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
vaishali.gohil.1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Sorani PT |
| Designation |
Incharge Principal |
| Affiliation |
Government Physiotherapy College, Jamnagar |
| Address |
Room no 33, Exercise Therapy Department, Physiotherapy OPD, Government Physiotherapy College, Old TB Hospital Building, Near Government Dental Hostel, Rameshwar Nagar, Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
soranidinesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Gohil PT |
| Designation |
PG Student |
| Affiliation |
Government Physiotherapy College, Jamnagar |
| Address |
Room no 33, Exercise Therapy Department, Physiotherapy OPD, Government Physiotherapy College, Old TB Hospital Building, Near Government Dental Hostel, Rameshwar Nagar, Jamnagar 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
|
| Fax |
|
| Email |
vaishali.gohil.1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Physiotherapy College, Old TB Hospital, Near Dental College, Rameshwar Nagar, Jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Dr Vaishali Gohil PT |
| Address |
Government Physiotherapy College, Old TB Hospital, Near Dental College, Rameshwar Nagar, Jamnagar 361008 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NOT APPLICABLE |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaishali Gohil PT |
Government Physiotherapy College, Jamnagar |
Room no 33, Exercise Therapy Department, Physiotherapy OPD, Government Physiotherapy College, Old TB Hospital Building, Near Government Dental Hostel, Rameshwar Nagar, Jamnagar 361008
Jamnagar
GUJARAT |
9727185588
vaishali.gohil.1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, M.P.SHAH GOVERNMENT MEDICAL COLLEGE AND GURU GOBINDSINGH HOSPITAL, JAMNAGAR |
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 |
| Comparator Agent |
CONVENTIONAL PHYSIOTHERAPY
1 Quadriceps Setting exercises
2 Short-Arc terminal knee
extension exercises
3 Straight-Leg Raise exercises
4 Full-Arc Knee Extension
exercises
5 Rowing machine exercises
6 Standing wall slides
7 Lunges
8 Step up-step down exercises
|
1 QUADRICEPS SETTING EXERCISES
2 SHORT-ARC TERMINAL KNEE EXTENSION EXERCISES
3 STRAIGHT-LEG RAISE EXERCISES
4 FULL-ARC KNEE EXTENSION EXERCISES.
THESE EXERCISES ARE OPEN-KINETIC CHAIN EXERCISES. IT OCCURS WHEN MOVEMENT ALLOWS THE DISTAL PART OF LIMB TO MOVE FREELY WHILE THE PROXIMAL PART IS FIXED. OPEN-KINETIC CHAIN EXERCISES PLAYS IMPORTANT ROLE IN ISOLATING INDIVIDUAL MUSCLE GROUPS. IT TENDS TO GENERATE MORE DISTRACTION AND ROTATIONAL FORCES AND IS USED WITH CONCENTRIC MUSCLE CONTRACTION.
5 ROWING MACHINE EXERCISES
6 STANDING WALL SLIDES
7 LUNGES
8 STEP UP-STEP DOWN EXERCISES.
THESE ARE THE CLOSED-KINETIC CHAIN EXERCISES FOR LOWER LIMB IN WHICH PHYSICAL EXERCISES ARE PERFORMED WHERE THE FOOT IS FIXED IN SPACE AND CANNOT MOVE. THE EXTREMITY REMAINS IN CONSTANT CONTACT WITH THE IMMOBILE SURFACE, USUALLY THE GROUND OR THE BASE OF A MACHINE. CLOSED-KINETIC CHAIN EXERCISES PRODUCE SUPERIOR ECCENTRIC CONTRACTION AND CO-CONTRACTION OF MUSCLES, AS WELL AS REDUCE SHEAR FORCES WHILE ADDING COMPRESSIVE FORCES TO JOINTS, THERE BY INCREASING JOINT STABILITY.
TREATMENT DURATION: EACH EXERCISE WILL BE DONE IN 3 SETS OF 5 REPETITIONS. THE SUBJECT RESTS FOR 1 MINUTE AFTER THE END OF EACH SET.TREATMENT WILL BE GIVEN FOR 15 DAYS AND OUTCOME MEASURES WILL BE TAKEN AT DAY 1, AT 7TH DAY AND AT 15TH DAY.
|
| Intervention |
KALTENBORN TRACTION MOBILIZATION TECHNIQUE |
KALTENBORN MANUAL THERAPY IS BASED ON THE CONCEPT OF MOBILIZATION WITH GENERAL MOVEMENT. HUMAN JOINT SURFACES ARE NOT FULLY CONGRUENT THEREFORE PHYSIOLOGIC MOVEMENTS ARE A COMBINATION OF A ROTATION AND A GLIDE.IN WHICH TRACTION IS A TECHNIQUE THET USES DISTRACTION OF ONE ARTICULAR SURFACE PERPENDICULAR TO ANOTHER THAT IMPROVE THE LIMITED RANGE OF MOTION AND THEREFORE REDUCED PAIN.TIME DURATION: 3 MIN WITH 1 MIN PAUSE REPEAT 3 TIMES.TREATMENT WILL BE GIVEN FOR 15 DAYSAND OUTCOME MEASURES WILL BE TAKEN AT DAY 1, AT 7TH DAY AND AT 15TH DAY. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient fulfilling the clinical criteria of
American College of Rheumatology for OA knee
2 Patients with primary OA of knee joint
3 Willingness to participate |
|
| ExclusionCriteria |
| Details |
1 Any surgical procedure done on either of lower
extremity in the past 6 months
2 Traumatic injury and post traumatic stiffness
over knee joint
3 Any infection/neoplastic disorder
4 Any neurological condition
5 Any skin condition
6 Non co-operative patient |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Numerical pain rating scale
(NPRS)
2 Western Ontario and McMaster
Universities Osteoarthritis
Index (WOMAC)
3 Pain Pressure Threshold
(PPT) |
1 Numerical pain rating scale
(NPRS): Baseline, at 7 days
and at 14 days of
intervention
2 Western Ontario and McMaster
Universities Osteoarthritis
Index (WOMAC): Baseline, at
7 days and at 14 days of
intervention
3 Pain Pressure Threshold
(PPT): Baseline, at 7 days
and at 14 days of
intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NOT APPLICABLE |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
25/10/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- It
is studied that the kaltenborn mobilization technique is effective in pain
and physical function in osteoarthritis of joints.
- There
are studies on effect of kaltenborn mobilization technique on
osteoarthritis of carpometacarpal joint of thumb and hip joint and the
studies are done with grade-3 gliding technique of kaltenborn mobilization
technique which is mainly for improving range of motion.
- But
there is lack of evidence for effectiveness of kaltenborn mobilization
technique in knee osteoarthritis and also with traction mobilization
technique of kaltenborn.
- NULL
HYPOTHESIS (ho): There is no improvement in pain and function
status in knee OA patient treated with Kaltenborn Traction mobilization
technique.
- So
two groups will be taken and one group will be given kaltenborn traction
mobilization technique with conventional physiotherapy and second group
will be given conventional physiotherapy.
- 38(19
in each group) sample size will be taken.
- Following
things will be checked pre and post intervention :
- Numerical
pain rating scale (NPRS)
- Western
ontario and mcmaster universities arthritis index (WOMAC)
- Pain
pressure threshold (PPT)s
|