| CTRI Number |
CTRI/2025/03/082252 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| 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
|
comparing two exercises namely stretching and strengthening of tight hip muscle to reduce low back pain |
|
Scientific Title of Study
|
A comparative analysis of stretching and strengthening exercises for alleviating iliopsoas tightness misdiagnosed as low back pain in athletes |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pravallika Ambati |
| Designation |
PG Student |
| Affiliation |
Lovely Professional University |
| Address |
Room no 105,LPU OPD,3rd block, School of Allied Medical Sciences ,Lovely Professional university, Jalandhar,-Delhi Grand Trunk (GT)road, Near Chaheru,Phagwara
Kapurthala PUNJAB 144411 India |
| Phone |
7286906307 |
| Fax |
|
| Email |
pravallika3800@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bishlesh |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Cabin 24, Room 213, Block 4, School of Allied Medical Sciences,
Lovely Professional University, Jalandhar -Delhi, Grand trunk (GT)
road, Near Chaheru, Phagwara- Punjab.
Kapurthala PUNJAB 144411, India |
| Phone |
8054686814 |
| Fax |
|
| Email |
bishlesh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bishlesh |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Cabin 24, Room 213, Block 4, School of Allied Medical Sciences,
Lovely Professional University, Jalandhar -Delhi, Grand trunk (GT)
road, Near Chaheru, Phagwara- Punjab.
Kapurthala PUNJAB 14411 India |
| Phone |
8054686814 |
| Fax |
|
| Email |
bishlesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lovely Professional University, Jalandhar-Delhi, Grand trunk (GT) road, Near Chaheru,
Phagwara-144411, Punjab, India. |
|
|
Primary Sponsor
|
| Name |
Pravallika Ambati |
| Address |
Room no 105,LPU OPD,3rd block, School of Allied Medical Sciences, Lovely Professional University ,Jalandhar,-Delhi Grand Trunk (GT)Road ,Near Chaheru, Phagwara, Kapurthala 144411,Punjab,India |
| 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 |
| Dr Pravallika Ambati PT |
Lovely Professional University |
Room no 105, LPU
OPD, block 3, School of
Allied Medical
Sciences, Lovely
Professional University,
Jalandhar-Delhi, Grand
trunk (GT) road, Near
Chaheru,
Phagwara-144411,
Punjab.
Kapurthala PUNJAB |
7286906307
pravallika3800@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Lovely Professional University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Strengthening exercise for hip flexor muscle(Iliopsoas) |
Strengthening exercises are a safe and low-cost intervention to improve low back pain and disability. As such, hip strengthening may be an important adjunct to trunk muscle strength training which well supported for persons with low back pain and the three strengthening exercises for the hip flexors are given for two to five times a week and once a day |
| Intervention |
Stretching exercise for hip flexor muscle(Iliopsoas) |
Stretching is a therapeutic exercise technique designed to improve iliopsoas muscle. This stretch is done to relieve tension and tightness in the iliopsoas muscle, which is a major hip flexor, thereby improving hip mobility, alleviating lower back pain. This technique will be maintained for 30 seconds and performs one time for 6 days in a week and once in
a day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and Female players
2.Players who practice regularly
3.Aged between 18-25 years
4.Players who suffered back pain
5.Athletes who have 10 or more than 10 degree of iliopsoas tightness
|
|
| ExclusionCriteria |
| Details |
1.History of trauma of lumber spine and pelvic
2.Inflammatory condition that affect motion
3.Cardiac problem
4.Presence of tumors that can restrict the hip range of motion
5.Spinal deformity
6.Recent injury and surgery
7.Off season
8.Hamstring tightness
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oswestry Disability Index (ODI) |
T1 and T2
T1 Pre intervention (baseline)
T2 Post intervention (after 1 week of treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MODIFIED THOMAS TEST |
T1 & T2
T1-Pre intervention (baseline)
T2-Post intervention (after1 week of treatment) |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
12/03/2025 |
| 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="1" Months="0" 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
|
After evaluating the subjects based on the inclusion and exclusion criteria ,those who qualify will be enrolled in the study. Participants will then fill out a consent form and be provided with a detailed explanation of the procedure .Participants will be assigned to one of two groups: either the stretching exercises Group (Group A) or the strengthening exercises for hip flexors Group (Group B) . Each group will receive instructions on how to perform the exercises and how the testing will be conducted. Prior to the commencement of the protocol, the subjects will be assessed using various outcome measures, including the Oswestry Disability Index (ODI) ,Modifies Thomas test and Goniometer measurements for range of motion. Group A Experimental group- Subjects in Group A will receive a protocol of stretching exercise subjects will undergo stretching exercise the patient position is close to the edge of the treatment table so the hip being stretched can be beyond the neutral position. The opposite hip and knee are flexed towards the patients chest to stabilize the pelvis during the stretching. Stabilize the opposite leg against the patients chest with one hand or if possible assist patient by grasping around the thigh and hold it to prevent tilt of the pelvis during the stretch. Move the hip to be stretched into extension or hyper extension by placing downward pressure on the anterior aspect of distal thigh with your other hand. Allow the knee into extension so the two joint rectus Femoris does not restrict the range. The stretch was maintained by 30 seconds and perform one time. Perform this method for 6 days in a week and once in a day.
Group B - Experimental Group- Subjects in Group B will receive strengthening exercises for hip flexors the individual will be performing 3 strengthening exercises. The three strengthening exercises are Seated leg raise where the Subject place a kettlebell on the ground and sit behind it while bracing core , legs extended places hands on the floor just behind the hips then patient Lift the foot closest to the kettlebell up and over it, keeping the leg extended with no knee bend, and place it on the floor on the other side of the kettlebell and Repeat for 6 reps, then switch legs by moving the other leg closest to the kettlebell and repeating the same movement. The second exercises Psoas March (Banded ) Subject in supine position places a light-resistance band around both feet with legs up at a 90-degree angle while bracing core subject slowly extend one leg out, leading with your heel and keeping the other leg fixed in position. Once the leg is fully extended, bring it back to the starting position. Extend the opposite leg out, then back to the starting position. Repeat ‘march’ for 20 reps, keeping the movement slow and controlled. The third exercise is Weighted Standing Psoas March While standing on the step with one foot, placing it near the edge of the step on the same side as the kettlebell. With the foot that isn’t placed on the step, bring it down and hook the kettlebell handle over it. Subject Keeping the standing leg straight, bend the knee of the leg with the kettlebell upwards towards your torso, bracing the core to keep the body stable. Then subject Lift the knee until it is in line with the hip, bent at a 90-degree angle, then lower it back down. Repeat for 10 reps, then switch to perform the psoas march on the other leg. All the three exercises are performed for 2- 5 times a week. |