Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2026-01-02 @ 4:59 AM
Study NCT ID:
NCT06888895
Status:
RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Immediate Effect of Passive vs. Passive-Active Hamstring Stretching on Flexibility in Patients With Chronic Low Back Pain
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Comparison of the Immediate Effect of Passive vs. Passive-Active Hamstring Stretching on Flexibility in Patients With Chronic Low Back Pain: Protocol for a Randomized Controlled Trial: EFIM2
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFIM2
Brief Summary:
The goal of this clinical trial is to determine whether a combination of passive and active hamstring stretching (PAS) is more effective than passive stretching alone (PS) in improving flexibility in patients with chronic low back pain (CLBP).
The main questions it aims to answer are:
Does PAS lead to greater improvements in active flexibility compared to PS? Does PAS provide additional benefits in passive flexibility, hamstring stiffness, and pelvic tilt? Researchers will compare the PAS group and the PS group to see if combining passive and active stretching results in greater improvements in flexibility and movement control.
Participants will:
Perform either PAS or PS stretching exercises as assigned. Undergo measurements of flexibility, hamstring stiffness, and pelvic tilt before and after the intervention.
Answer a question about their perceived change in flexibility following the intervention.
This study aims to improve rehabilitation strategies for people with CLBP, helping them achieve better movement and pain relief.
The main questions it aims to answer are:
Does PAS lead to greater improvements in active flexibility compared to PS? Does PAS provide additional benefits in passive flexibility, hamstring stiffness, and pelvic tilt? Researchers will compare the PAS group and the PS group to see if combining passive and active stretching results in greater improvements in flexibility and movement control.
Participants will:
Perform either PAS or PS stretching exercises as assigned. Undergo measurements of flexibility, hamstring stiffness, and pelvic tilt before and after the intervention.
Answer a question about their perceived change in flexibility following the intervention.
This study aims to improve rehabilitation strategies for people with CLBP, helping them achieve better movement and pain relief.
Detailed Description:
Individuals with chronic low back pain (CLBP) are affected by deficits in hamstring flexibility and lumbopelvic neuromuscular control. While passive hamstring stretching immediately improves passive hamstring flexibility, no clinically important difference in active range of motion has been observed.
The primary objective of the present randomized controlled study protocol is to compare the immediate effects of a novel combination of passive and active stretching (PAS) exercises with passive hamstring stretching (PS) alone on active flexibility.
The secondary objectives include conducting a similar comparison for passive flexibility, hamstring stiffness, and pelvic tilt, as well as estimating the Minimal Clinically Important Difference (MCID) for hamstring flexibility measures. Ninety CLBP patients will be randomized into PAS or PS group and will receive respective interventions. Primary outcome will be the mean value of two measurements of Active Knee Extension taken before and immediately after the intervention. Secondary outcomes, Fingertip-to-Floor distance, Straight Leg Raise, hamstring stiffness and pelvic tilt will be recorded and compared in the same manner. A group-by-time comparison will be conducted for primary and secondary outcomes. An anchor question about perceived by participants change in flexibility following intervention will serve to estimate MCID.
This study protocol is the first opportunity to assess whether combining passive and active hamstring stretching is better than passive stretching alone for achieving an immediate and clinically important improvement in active flexibility among CLBP patients. The results will provide valuable and time-efficient insights for the development of more comprehensive rehabilitation programs in both clinical and research settings.
The primary objective of the present randomized controlled study protocol is to compare the immediate effects of a novel combination of passive and active stretching (PAS) exercises with passive hamstring stretching (PS) alone on active flexibility.
The secondary objectives include conducting a similar comparison for passive flexibility, hamstring stiffness, and pelvic tilt, as well as estimating the Minimal Clinically Important Difference (MCID) for hamstring flexibility measures. Ninety CLBP patients will be randomized into PAS or PS group and will receive respective interventions. Primary outcome will be the mean value of two measurements of Active Knee Extension taken before and immediately after the intervention. Secondary outcomes, Fingertip-to-Floor distance, Straight Leg Raise, hamstring stiffness and pelvic tilt will be recorded and compared in the same manner. A group-by-time comparison will be conducted for primary and secondary outcomes. An anchor question about perceived by participants change in flexibility following intervention will serve to estimate MCID.
This study protocol is the first opportunity to assess whether combining passive and active hamstring stretching is better than passive stretching alone for achieving an immediate and clinically important improvement in active flexibility among CLBP patients. The results will provide valuable and time-efficient insights for the development of more comprehensive rehabilitation programs in both clinical and research settings.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2024-A02351-46 | OTHER | ANSM | View |