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

NCT06888895 | Recruiting

• 2 other identifiers: RBHP 2024 DOBIJA2024-A02351-46
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Low Back Pain (CLBP)

Keywords

hamstring; chronic low back pain; extensibility deficit; passive stretching

Outcome Measures

Primary Outcomes (1)

• Active Knee Extension (AKE)

  The Active Knee Extension (AKE) angle will be evaluated at baseline and immediately after the intervention. The mean value of the two measurements taken before the intervention will be compared with the mean value of two measurements taken immediately after the intervention. The change in AKE values of the less flexible lower limb, expressed as a percentage relative to the initial value, will be used to compare the effect between the PS and PAS groups. The participants will extend the tested knee as much as possible while keeping their thigh vertical against a plastic stick placed along the anterior surface of their thigh (maintaining 90° hip flexion). The rater will position the EasyAngle® digital inclinometer on the tibial crest, just below the tibial tuberosity, to record the maximal knee extension angle.

  Before and immediately after the intervention

Secondary Outcomes (9)

• Fingertip-to-Floor distance (FTF)

  Before and immediately after the intervention

• Pelvic tilt angle

  Before and immediately after intervention

• Straight Leg Raise (SLR) angle

  Before and immediately after the intervention

• Hamstring stiffness

  Before and immediately after the intervention

• Pain Visual Analogue Scale (VAS)

  Before and immediately after intervention

Study Arms (2)

Passive stretching (PS)

ACTIVE COMPARATOR

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.

Other: Passive hamstring stretching

Passive-Active Stretching (PAS)

EXPERIMENTAL

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.

Other: Passive-active stretching (PAS)

Interventions

Passive-active stretching (PAS) 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.

Also known as: Passive stretching (PS)

Passive-Active Stretching (PAS)

Passive hamstring stretching 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 stretching (PS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (2)

Clermont Ferrand Univbersity HOspital, Louise Michel site

Cébazat, France, 63118, France

RECRUITING

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lech DOBIJA

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334-73-754-963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The same investigator will conduct both pre- and post-intervention assessments but will not be involved in administering the intervention for any patient, ensuring they remain blinded to patient allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 21, 2025
• Study Start: September 30, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The IPD will be shared on demand, starting from the publication of the primary study results, for up to 10 years after study completion.
• Access Criteria: The anonymized IPD will be sent on demand to qualified researchers or institutions.

Locations

FR (2)