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

Chronic Low-back Pain Clinical Trial

— EFIM1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551326
• Other study ID #: RBHP 2019 DOBIJA
• Secondary ID: 2019-A03000-57
• Status: Completed
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: May 9, 2022

Study information

• Verified date: February 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Other:
• manual hamstring stretching
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.

Locations

Country	Name	City	State
France	University Hospital, Clermont Ferrand	Clermont-Ferrand
France	CHu de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1
Secondary	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.	Day 1 before stretching, Day 1 after stretching
Secondary	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.	Day 1 before stretching, Day 1 after stretching
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1