| CTRI Number |
CTRI/2024/04/065751 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
12/04/2024 |
| 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 check the effects of manual therapy (cyriax therapy) in patients with lower back pain. |
|
Scientific Title of Study
|
Efficacy of cyriax therapy on pain, lumbar strength and joint position sense in individual’s with chronic low back pain |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Paramananda Roy |
| Designation |
Research scholar |
| Affiliation |
Manav rachna international institute of research and studies |
| Address |
manav rachna international institute of research and studies
physiotherapy department
division - Q block
room number - QG 07
Faridabad
Manav rachna campus road, gadakhor basti village, sector 43, faridabad, haryana, pincode - 121004
Faridabad
HARYANA
121004
India |
| Phone |
9560656683 |
| Fax |
|
| Email |
paramanandaroy9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Sethi |
| Designation |
Assistant Professor |
| Affiliation |
manav rachna international institute of research and studies |
| Address |
manav rachna international institute of research and studies
physiotherapy department
division - Q block
room number - QG 07
Faridabad
Faridabad
HARYANA
121004
India |
| Phone |
7042637002 |
| Fax |
|
| Email |
priyankasethi.sahs@mriu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Sethi |
| Designation |
Assistant Professor |
| Affiliation |
manav rachna international institute of research and studies |
| Address |
manav rachna international institute of research and studies
physiotherapy department
division - Q block
room number - QG 07
Faridabad
HARYANA
121004
India |
| Phone |
7042637002 |
| Fax |
|
| Email |
priyankasethi.sahs@mriu.edu.in |
|
|
Source of Monetary or Material Support
|
| Manav Rachna International Institute of Research and Studies
manav rachna campus rd, gadakhor basti village, sector 43, faridabad, haryana, pincode - 121004 india |
|
|
Primary Sponsor
|
| Name |
nManav Rachna International Institute of Research And Studies |
| Address |
nonegadakhor basti village,sector 43,faridabad,haryana,pin-121004 india |
| Type of Sponsor |
Other [Private institute] |
|
|
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 Priyanka Sethi |
manav rachna international institute of research and studies |
department of physiotherapy neurology physiotherapy lab Q-block room number- QG 07 , MRIIRS sector 43 aravalli hills surajkund road faridabad haryana
Faridabad
HARYANA |
7042637002
priyankasethi.sahs@mriu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, school of allied health sciences, manav rachna institute of research and studies, faridabad, haryana, india |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M545||Low back pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A- Control group (Conventional group) |
Group A- Control group (Conventional group). while the controlled group will undergo standard treatments for chronic low back pain with selective exercises and hot pack, TENS. |
| Intervention |
Group B - Experimental group (Cyriax Therapy group). |
Group B - Experimental group (Cyriax Therapy group). The Cyriax Therapy group will receive manual therapy sessions based on the Cyriax approach ( DTFM, Stretching and Mobilization),and Selective Exercises.
Treatment will be given 4 times/week for 4 weeks duration in both the groups.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. History of chronic pain ≥ 12 weeks
2. With or without Radiating pain
3. MMT of Lower Back and lower limb ≥ 3
|
|
| ExclusionCriteria |
| Details |
1. Recurrent low back pain
2. Neurological, Psycho-cognitive and Psychosomatic disorders
3. Any previous history of fracture in the spine or lower limb, muscular degenerative disorder
4. cardiopulmonary or endocrine disorders with contraindication to physical exercise
5. Any previous history of systemic infection
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. VAS- Pain
2. Goniometer – range of motion for lower limbs and lumber region
3. MMT- for lower back and lower limb Strength
4. Lumbar joint position sense (LJPS)- For joint position sense
|
1. Baseline (Day 0)
2. Post intervention-1 (after two weeks) day 14
3. Post intervention -II (after 4 weeks) day 28
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Oswestry disability scale- for quality of life
2. Tampa Scale for Kinesiophobia(TSK)- For fear of movement
|
1. Baseline (Day 0)
2. Post intervention-1 (after two weeks) day 14
3. Post intervention -II (after 4 weeks) day 28
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
24/04/2024 |
| 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 Yet Recruiting |
| 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
|
This study will be conducted in the department of physiotherapy, Manav Rachna International University of Research and Studies in Haryana. Study details and risks will be explained to all the participants and they will voluntarily participate in the study by signing the consent form after the initial assessment and screening through the selection criteria. The subjects will be divided into 2 groups by using convenient sampling techniques. Group A- Control group (Conventional group). while the controlled group will undergo standard treatments for chronic low back pain with selective exercises and hot pack, TENS. Group B - Experimental group (Cyriax Therapy group). The Cyriax Therapy group will receive manual therapy sessions based on the Cyriax approach( DTFM, Stretching and Mobilization),and Selective Exercises. Treatment will be given 4 times/week for 4 weeks duration in both the groups. |