| CTRI Number |
CTRI/2024/03/064905 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
effect of spinal manipulation and hamstring stretching on foot pressure in patients with low back pain |
|
Scientific Title of Study
|
Efficacy of spinal manipulation versus hamstring stretching on foot pressure in patients with 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 |
Ankush |
| Designation |
Student |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of science and technology Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
7082883713 |
| Fax |
|
| Email |
ankushmorkhi65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Jaspreet Kaur |
| Designation |
Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of science and technology Hisar Haryana
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet_physio@gjust.org |
|
Details of Contact Person
Public Query
|
| Name |
Prof Jaspreet Kaur |
| Designation |
Professor |
| Affiliation |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of Physiotherapy Guru Jambheshwar University of science and technology hisar haryana
Hisar
HARYANA
125001
India |
| Phone |
9466092657 |
| Fax |
|
| Email |
jaspreet_physio@gjust.org |
|
|
Source of Monetary or Material Support
|
| Ankush BPT student Department of Physiotherapy Guru Jambheshwar University of Science and
Technology Hisar |
|
|
Primary Sponsor
|
| Name |
Guru Jambheshwar University of Science and Technology |
| Address |
Department of physiotherapy Guru Jambheshwar University of
Science and Technology New Delhi-Sirsa Highway Hisar-125001 Haryana India
Haryana |
| Type of Sponsor |
Other [government University] |
|
|
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 |
| Ankush |
room no 5 OPD Department of Physiotherapy |
room no 5 OPD Department of Physiotherapy Guru Jambheshwar University of Science and Technology Hisar Haryana
Hisar
HARYANA |
7082883713
ankushmorkhi65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of GJUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hamstring stretching |
Hamstring stretching will be given with 5 repetitions and stretch hold for 30 seconds . given on alternate days for 4 weeks. |
| Intervention |
spinal manipulation |
spinal manipulation will be given on alternate days for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
low back pain
consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Acute injury .
Any neurological disorder.
Any disorder related to spine.
Any cardiovascular disorder.
Uncooperative individuals |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| foot pressure |
foot pressure will be measured for 2 times: at the baseline of treatment and after 4 weeks of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/04/2024 |
| 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="4"
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
|
Low back pain is most common musculoskeletal disorder in adult population. Low back pain further hampers the daily activities of an individual. Risk factors for low back include sedentary lifestyle, obesity, sitting in slouch posture for long period. This affects the person’s life physically, psychologically, socially and economically. Hence, this condition needs to be treated. Various treatment options available for low back pain such as conservative, physiotherapy and surgical treatment are available. Physiotherapy treatment include manual therapy like stretching and strengthening exercises. Physiotherapic modalities can also be use to treat the low back pain. Manual therapy and physiotherapy modalities can be effective method in the treatment of neck pain. Evidences shows the effect of hamstring stretching and Spinal manipulation in the treatment of low back pain. Hence, the rationale of the present study is to evaluate the efficacy of spinal manipulation and hamstring stretching in patients with low back pain. |