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Chronic Low-back PainEFIM1NCT04551326

Immediate Effect of Hamstring Stretching in Patients With Chronic Low Back Pain

A study testing manual hamstring stretching in people with Chronic Low-back Pain, run by University Hospital, Clermont-Ferrand at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Thigh muscles flexibility deficits contribute to handicap in chronic low back pain patients. The study aims to evaluate the immediate effect of thigh muscles stretching in patients with chronic low back pain. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Chronic Low-back Pain
What is being tested?
manual hamstring stretching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesFrance
Study dates
3 Jul 2020to 9 May 2022
Phase
Interventional
Are there results?
None posted in the registry

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age between 18 and 60 years
  • Chronic low back pain (>3 months) with or without pain irradiation to lower limb
  • Hamstring flexibility deficit (AKE <80° and FTF>5cm)

Who cannot join

  • Pregnancy or breastfeeding,
  • Condition of restricted mental/legal autonomy (ex. guardianship) ,
  • No social security insurance,

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • University Hospital, Clermont Ferrand

    Clermont-Ferrand, 63000

  • CHu de Nîmes

    Nîmes

Other trials in France

About this study

Thigh muscles flexibility deficits contribute to handicap in chronic low back pain patients. The study aims to evaluate the immediate effect of thigh muscles stretching in patients with chronic low back pain. The investigation team suppose that flexibility improvement could be detected by instrumented clinical measurements and such difference could be related to psycho-social factors evaluated by questionnaires.

Read the detailed description

The primary objective of the study is to evaluate the immediate effect of the hamstring muscle stretching in patients presenting chronic low back pain. The secondary objectives are: (1) to evaluate intra- and interrater reliability, construct validity and responsiveness of the hamstring flexibility measurements (Active Knee Extension [AKE], Straight Leg Rise [SLR]) realised with digital inclinometer, (2) to evaluate factors that potentially could influence immediate effect of the hamstring stretching, specifically psycho-social factors Fear Avoidance Belief Questionnaire (FABQ), Hospital Anxiety and Depression scale (HAD), neuropathic pain presence (DN4).

Being tested
manual hamstring stretching
Keywords
Chronic low back pain, Hamstring flexibility, Hamstring stretching, Immediate stretching effect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • manual hamstring stretchingOther

    Participants' lower limb will be positioned in maximal hip flexion and gradually moved to maximal knee extension by physical therapist. The procedure will take one minute for each lower limb.

Study groups in NCT04551326
Study groupRoleWhat they receive
hamstring stretchingExperimentalParticipants' lower limb will be positioned in maximal hip flexion and gradually moved to maximal knee extension by physical therapist. The procedure will take one minute for each lower limb.
Receives: Other: manual hamstring stretching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Active Knee Extension test (AKE)

    Description: Participant positioned in supine lying will actively extend his knee while keeping his hip joint in 90 degrees of flexion. Hip position will be verified by digital inclinometer and maintained with a barre indicating vertical position of the participants' thigh. The range of motion will be recorded with digital inclinometer positioned on the tibial craft of the exanimated limb.

    Measured: Day 1

Secondary outcomes (6)

  1. Straight Leg Rise test (SLR)

    Participant positioned in supine lying, examiner rise his lower limb, with knee extended. Examiner stops the movement when participant declare pain or tension onset than the range of motion is recorded in degree with digital inclinometer positioned on the tibial craft of the exanimated limb.

    Measured: Day 1 before stretching, Day 1 after stretching

  2. Fingertip-to-floor distance (FTF)

    Participant try to reach the floor with his fingertip by bending forward in the same time knees are kept extended. The distance between fingertips and floor are measured in centimetres by examiner.

    Measured: Day 1 before stretching, Day 1 after stretching

  3. Fear Avoidance Belief Questionnaire (FABQ)

    Questionnaire evaluating belief about physical activity and work activity. The The FABQ is divided into 2 parts, (1)physical activity (minimum score 0, maximum score 24) and (2) work (minimum score 0, maximum score 42). A higher score indicates more strongly held fear avoidance beliefs.

    Measured: Day 1

  4. Ostwestry Disability Index

    Questionnaire evaluating pain and function in low back pain patients. Maximum score 100%, minimum score 0%, A higher score indicates greater disability.

    Measured: Day 1

  5. Anxiety and Depression scale

    Questionnaire evaluating anxiety and depression, Hospital Anxiety and Depression scale. The scale is devided into 2 parts: (1) anxiety (minimum score 0, maximum sore 21) and (2) depression (minimum score 0, maximum sore 21). A higher score indicates greater anxiety or greater depression.

    Measured: Day 1

  6. Neuropathic pain presence

    Questionnaire evaluating existence of the neuropathic pain, Neuropathic pain presence (DN4). Minimum score 0, maximum sore 10. The score equal or superior to 4 indicate the presence of neuropathic pain.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start3 Jul 2020
  3. Primary completion9 May 2022
  4. Study completion9 May 2022

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04551326
Sponsor's protocol ID
RBHP 2019 DOBIJA
Other IDs
2019-A03000-57
Acronym
EFIM1
Status last verified
Jul 2026
First submitted
3 Sep 2020
Last updated
3 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dobija L, Pereira B, Cohen-Aknine G, Roren A, Dupeyron A, Coudeyre E. Immediate effect of passive hamstring stretching on flexibility and relationship with psychosocial factors in people with chronic low back pain. Heliyon. 2023 Sep 4;9(9):e19753. doi: 10.1016/j.heliyon.2023.e19753. eCollection 2023 Sep.

    PubMed 37810115

Questions about this trial

What is this clinical trial studying?

A study testing manual hamstring stretching in people with Chronic Low-back Pain, 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 3 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: finished, as of the sponsor's last update on 3 Aug 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Active Knee Extension test (AKE) (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04551326, which also lists 1 linked publication.

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 3 Aug 2026.

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