| CTRI Number |
CTRI/2026/02/104894 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Immediate effects of upper back versus mid-lower back manual therapy on hamstring flexibility in individuals with tight hamstrings: A randomized controlled trial |
|
Scientific Title of Study
|
Immediate effect of cervicothoracic vs thoracolumbar manipulation on hamstring flexibility in subjects with asymptomatic hamstring tightness : A Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Santosh Metgud |
| Designation |
Vice Principal and Professor |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
OPD NO 13 , Orthopedic Manual Therapy department,Dr Prabhakar Kore Hospital ,JNMC Campus , Nehru Nagar , Belagavi
JNMC CAMPUS , NEHRU NAGAR
Belgaum
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
MANOJ PAPPU |
| Designation |
POST-GRADUATE STUDENT |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
KLE Institute of Physiotherapy, JNMC campus, nehru nagar, Belagaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9449735254 |
| Fax |
|
| Email |
manojpappu2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MANOJ PAPPU |
| Designation |
POST-GRADUATE STUDENT |
| Affiliation |
KLE INSTITUTE OF PHYSIOTHERAPY |
| Address |
KLE Institute of Physiotherapy, JNMC campus, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9449735254 |
| Fax |
|
| Email |
manojpappu2014@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MANOJ PAPPU |
| Address |
OPD No. 13,OMT Department,Dr.Prabhakar Kore Hospital and Medical Research Centre,Nehru Nagar,Belagavi-590010 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| MANOJ PAPPU |
KLE Prabhakar Kore Hospital And Medical Research Centre |
OPD No.13,OMT Department,Dr.Prabhakar Kore Hospital and Medical Research Centre,Nehru Nagar,Belagavi-590010
Belgaum
KARNATAKA |
9449735254
manojpappu2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethics commitee,KAHER Institute of Physiotherapy,Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic Hamstring Tightness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A – Cervical and Thoracic Manipulation with Hamstring and Soleus Stretch
|
Cervical Spine Manipulation (C3 - C7):
1] Subject is in supine position.
2] Therapist performs a rotational and lateral flexion pre-thrust position localized to the restricted segment.
Thoracic Spine Manipulation (T4 - T9):
1] Subject is in prone position.
2] A high-velocity, low-amplitude thrust manipulation technique directed mid-thoracic (T4-T9) spine.
Hamstring Stretch for 30 seconds – 3 stretches with 15 seconds of interval.
1] If there would be no audible cavitation, a second attempt will be performed.
2] An audible cavitation would be expected for each manipulation to be considered a success.
3] Audible cavitations will be recorded for each group.
Duration for Each Group -With patient positioning it will last for 10-15 minutes.
|
| Intervention |
GROUP B – Thoraco Lumbar Manipulation with Hamstring and Soleus Stretch
|
Thoraco-Lumbar Manipulation (T12–L2)
1]The patient lies prone or side-lying.
2]The therapist contacts the spinous process or transverse processes of T12–L2 (thoracolumbar junction) using a hypothenar or pisiform contact while stabilizing the opposite shoulder or pelvis.
3]HVLA Thrust will be applied
Hamstring Stretch for 30 seconds – 3 stretches with 15 seconds of interval.
1] If there would be no audible cavitation, a second attempt will be performed.
2] An audible cavitation would be expected for each manipulation to be considered a success.
3] Audible cavitations will be recorded for each group.
Duration for Each Group -With patient positioning it will last for 10-15 minutes. |
| Comparator Agent |
GROUP C – Hamstring and Soleus Stretch |
1] 3 stretches with 15 seconds of interval for 30 seconds each.
2] If there would be no audible cavitation, a second attempt will be performed.
3] An audible cavitation would be expected for each manipulation to be considered a success.
4] Audible cavitations will be recorded for each group.
Duration for Each Group -With patient positioning it will last for 10-15 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1] Bilateral hamstring tightness with Straight Leg Raise (SLR) Greater than 70 Degree
2] Active Knee Extension Test Lesser than 20 Degree from full extension.
|
|
| ExclusionCriteria |
| Details |
1] History of shoulder or spinal surgery in the past year.
2] Partial or full-thickness rotator cuff tear, adhesive capsulitis, neurogenic radiculopathy, or other diagnosed shoulder pathology requiring surgery.
3] Contraindications to spinal manipulation: known osteoporosis, vertebral fracture, spinal infection, malignancy, bleeding disorder or current anticoagulant therapy, uncontrolled systemic disease, signs of upper motor neuron lesion.
4] Received spinal or shoulder manipulation within last 4 weeks.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hamstring flexibility will be assessed by measuring the knee extension angle (in degrees) using the Active Knee Extension Test. A higher knee extension angle indicates improved hamstring flexibility. |
4 weeks |
|
|
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)
|
15/03/2026 |
| 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)
|
Open to Recruitment |
| 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
|
| Hamstring tightness is a common musculoskeletal problem associated with decreased flexibility, altered biomechanics, and increased risk of lower-limb injuries.[1] Hamstring tightness is relatively common among college students aged 18 to 25 years.[1] Tight hamstrings are associated with dysfunction in the lumbar spine, pelvis, and lower limb, as well as conditions such as low back pain and abnormal gait.[1] Apart from causing a reduced range of motion, hamstring tightness can contribute to various orthopedic conditions, such as hamstring strain, plantar fasciitis, and low back pain.[1] Muscle tightness affects the ability of the hamstring muscles to maintain a constant length-tension relationship and absorb stress.[1] This decreased flexibility creates a cycle of a limited range of motion and increased postural abnormalities.[1] Conventional management strategies such as stretching, soft tissue release, and exercise therapy are widely employed to improve flexibility; however, their effects may be transient or require repeated sessions for optimal results.[1,2] Spinal manipulation is therefore aimed at restoring joint mobility and has shown potential to enhance neuromuscular excitability and muscle strength in experimental settings.[2] Given the interrelationship between spinal mobility and lower-limb muscle function, this study aims to evaluate the immediate and short-term effect of spinal manipulation on hamstring flexibility in individuals with hamstring tightness through a randomized controlled trial design. | |