Chronic Low Back Pain (CLBP)EFIM2NCT06888895
Comparison of the Immediate Effect of Passive vs. Passive-Active Hamstring Stretching on Flexibility in Patients With Chronic Low Back Pain
A study testing Passive-active stretching (PAS) and Passive hamstring stretching in people with Chronic Low Back Pain (CLBP), run by University Hospital, Clermont-Ferrand at 2 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Passive-active stretching (PAS) and Passive hamstring stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesFrance
- Study dates
- 30 Sep 2025to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Clermont Ferrand Univbersity HOspital, Louise Michel site
Cébazat, France, 63118
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lech Dobija, PhD, PT, +33 4 73 75 08 39, ldobija@chu-clermontferrand.fr
Lech DOBIJA, PhD, PT
About this study
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
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:
Read more
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.
Read the 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)
- Being tested
- Passive-active stretching (PAS), Passive hamstring stretching
- Keywords
- hamstring, chronic low back pain, extensibility deficit, passive stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive-active stretching (PAS)Other
Also called Passive stretching (PS)
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.
Passive hamstring stretchingOther
Participants will receive one minute of passive hamstring stretching applied three times for each lower limb, with a 30-second rest time between stretches.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Passive-active stretching (PAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and immediately after the intervention
Secondary outcomes (9)
Fingertip-to-Floor distance (FTF)
The FTF distance 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 FTF values, expressed as a percentage relative to the initial value, will be used to compare the effect between the PS and PAS groups.
The FTF measurement will be conducted in the standard manner by measuring the distance between the fingertips and the floor using a measuring tape at the end of the forward bending range, with knees fully extended.
Measured: Before and immediately after the intervention
Pelvic tilt angle
The pelvic tilt angle will be measured 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 pelvic tilt angle values, expressed as a percentage relative to the initial value, will be used to compare the effect between the PS and PAS groups.
The EasyAngle® inclinometer will be placed on the sacrum to measure the sagittal plane angle between the pelvis position in the erect standing posture and its position at the end of forward trunk bending, as in the FTF measurement.
Measured: Before and immediately after intervention
Straight Leg Raise (SLR) angle
The SLR 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 SLR angle 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 rater will raise the participant's lower limb with the knee fully extended until the first sensation of stretch or pain is felt. The angle will then be recorded using the EasyAngle® digital inclinometer, which will be secured with a Velcro strap to the lateral side of the lower limb at the level of the tibial tuberosity.
Measured: Before and immediately after the intervention
Hamstring stiffness
Hamstring stiffness during the SLR maneuver will be measured 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 hamstring stiffness 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 pulling force applied during the SLR maneuver will be recorded in Newtons using the EasyForce® digital dynamometer.
Measured: Before and immediately after the intervention
Pain Visual Analogue Scale (VAS)
Pain will be assessed using the Visual Analogue Scale (VAS), where 0 represents no pain and 100 represents the maximum imaginable pain, at the end of the SLR angle before the intervention. The post-intervention assessment will be recorded at the initial SLR angle or, if the range decreases, at the new end of the SLR angle.
Measured: Before and immediately after intervention
Tampa Scale of Kinesiophobia (TSK-17)
The Tampa Scale of Kinesiophobia (TSK-17) questionnaire will be used to assess fear of movement (kinesiophobia) at baseline. This questionnaire is commonly used for patients with chronic low back pain and demonstrates good psychometric properties. The TSK-17 score ranges from 17 to 68, with higher scores indicating worse outcomes (greater fear of movement) and lower scores indicating better outcomes (less fear of movement).
Measured: At baseline
Score of perceived harmfulness of the movements
Participants will complete a questionnaire assessing their perceived harmfulness of the movements presented in the videos, using a numerical scale (0 - Not harmful at all, 100 - Extremely harmful). A total of seven movements, corresponding to the AKE, SLR, FTF measurements, passive stretching, and three active stretching exercises, will be presented in the videos. The total score and individual scores for each movement will be analyzed.
Measured: At baseline
Skin conductance
Skin conductance will be measured using a NeuLog device, placed on the fingers of the participant's dominant hand. Fear-related sweat production increases skin conductance and can thus objectively indicate the participant's emotional state.
The average amplitude of the Skin Conductance Response will be recorded during both the pre-intervention evaluation and the intervention, measured in µS.
Measured: During pre-intervention evaluation and during intervention.
Perceived change in flexibility.
The participant's declaration of the perceived change in flexibility immediately after the intervention on the movements assessed (AKE, SLR, FTF) will be recorded. The following question will be asked: 'Do you feel a gain in flexibility?' The participant will choose from the following responses: 'No, I feel less flexible,' 'No, I feel no difference,' 'Yes, I feel a little more flexible,' or 'Yes, I feel much more flexible'.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start30 Sep 2025
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lech DOBIJA, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06888895
- Sponsor's protocol ID
- RBHP 2024 DOBIJA
- Other IDs
- 2024-A02351-46
- Acronym
- EFIM2
- Status last verified
- Nov 2025
- First submitted
- 6 Mar 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymised individual participant data (IPD) will be sheared on demande.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06888895
- Acronym / sponsor ID
- EFIM2 / RBHP 2024 DOBIJA
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- hamstring, chronic low back pain, extensibility deficit, passive stretching
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive stretching (PS) | Active comparator | Other: Passive hamstring stretchingIn 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. |
| Passive-Active Stretching (PAS) | Experimental | Other: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive-active stretching (PAS)Also: Passive stretching (PS)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. | Other | Passive-Active Stretching (PAS) |
| Passive hamstring stretchingParticipants will receive one minute of passive hamstring stretching applied three times for each lower limb, with a 30-second rest time between stretches. | Other | Passive stretching (PS) |
Primary outcome
Active Knee Extension (AKE)
Time frame: Before and immediately after the intervention
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.
9 secondary outcomes
Fingertip-to-Floor distance (FTF)
Time frame: Before and immediately after the intervention
Pelvic tilt angle
Time frame: Before and immediately after intervention
Straight Leg Raise (SLR) angle
Time frame: Before and immediately after the intervention
Hamstring stiffness
Time frame: Before and immediately after the intervention
Pain Visual Analogue Scale (VAS)
Time frame: Before and immediately after intervention
Tampa Scale of Kinesiophobia (TSK-17)
Time frame: At baseline
Score of perceived harmfulness of the movements
Time frame: At baseline
Skin conductance
Time frame: During pre-intervention evaluation and during intervention.
Perceived change in flexibility.
Time frame: Immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Individual participant dataSharing planned: Yes. The anonymised individual participant data (IPD) will be sheared on demande.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lech DOBIJA principal investigator
University Hospital, Clermont-Ferrand
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive-active stretching (PAS) and Passive hamstring stretching in people with Chronic Low Back Pain (CLBP), run by University Hospital, Clermont-Ferrand at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334-73-754-963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Knee Extension (AKE) (time frame: Before and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.