Comparison of the Immediate Effect of Passive vs. Passive-Active Hamstring Stretching on Flexibility in Patients With Chronic Low Back Pain

NCT ID: NCT06888895

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-04-30

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.

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.

Conditions

Chronic Low Back Pain (CLBP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Passive stretching (PS)

In the control group, participants will receive one minute of passive hamstring stretching applied three times for each lower limb, with a 30-second rest time between stretches. This ensures that the intervention time is consistent across both groups, totaling approximately 15-20 minutes.

Group Type: ACTIVE_COMPARATOR

Passive hamstring stretching

Intervention Type: OTHER

Participants will receive one minute of passive hamstring stretching applied three times for each lower limb, with a 30-second rest time between stretches.

Passive-Active Stretching (PAS)

The passive-active stretching (PAS) intervention has two phases. In the first, a physiotherapist performs bilateral passive hamstring stretching, followed by a 30-second walk. The second phase includes three exercises with 30-second rest intervals between them.

Active Knee Extension: The participant lies on their back with one thigh vertical (hip at 90°). A Stabilizer® Pressure Bio-feedback device is placed behind the lumbar spine to help maintain neutral position. The participant maintains 40 mmHg pressure while extending the knee to its maximum. Ten repetitions with a 3-second hold are performed.

One-Leg Deadlift: While balancing on one leg, the participant bends forward and lifts the opposite leg, targeting hamstring elongation. Ten repetitions with a 5-second hold are performed.

Bear-Squat Exercise: Starting in all-fours, participants shift weight onto toes and hands, moving the pelvis backward to elongate the hamstrings. Ten repetitions are performed.

Group Type: EXPERIMENTAL

Passive-active stretching (PAS)

Intervention Type: OTHER

Passive-active stretching (PAS) combines conventional passive stretching with active exercises designed to activate muscles that promote hamstring elongation. On the other hand, passive stretching (PS) is a commonly administered intervention to improve hamstring flexibility.

Interventions

Passive-active stretching (PAS)

Passive-active stretching (PAS) combines conventional passive stretching with active exercises designed to activate muscles that promote hamstring elongation. On the other hand, passive stretching (PS) is a commonly administered intervention to improve hamstring flexibility.

Intervention Type: OTHER

Passive hamstring stretching

Participants will receive one minute of passive hamstring stretching applied three times for each lower limb, with a 30-second rest time between stretches.

Intervention Type: OTHER

Other Intervention Names

Passive stretching (PS)

Eligibility Criteria

Inclusion Criteria

• Male or female patients aged between 18 and 65 years
• Suffering from low-back pain for at least 3 months
• Presenting with hamstring flexibility deficit (Straight Leg Raise <85°, Fingertip-to-Floor distance >5 cm)

Exclusion Criteria

• Patients with radicular pain
• Disc inflammation (MODIC Type 1)
• Other relevant pathologies (neurological, cardiovascular, respiratory, or oncological diseases)
• Significant surgical history (e.g., lumbar arthrodesis, knee or hip arthroplasty)
• Pregnancy or breastfeeding
• Patients under protective legal measures

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lech DOBIJA

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Clermont Ferrand Univbersity HOspital, Louise Michel site

Cébazat, France, France

Site Status: RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

334-73-754-963

Facility Contacts

Lech Dobija, PhD, PT

Role: primary

ldobija@chu-clermontferrand.fr

+33 4 73 75 08 39

Other Identifiers

2024-A02351-46

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2024 DOBIJA

Identifier Type: -

Identifier Source: org_study_id