Effects of a Protocol of Hip Flexor Stretching on Chronic Mechanical, Non-specific LBP.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWroclaw University of Health and Sport Sciences

About this trial

The goal of this clinical trial is to compare the effectiveness of a stretching, exercise and education protocol versus usual care in improving pain, function and disability in patients with non-specific mechanical chronic low back pain (CLBP). The research hypothesis is: A combination of hip flexors stretching, exercise and education is more effective than usual care to improve pain, function and disability in patients with CLBP.

Participants will be randomly allocated in one of the two treatment groups. Pain, function and disability will be assessed before starting treatment, after the end of the treatment and one month , three months and one year after the end of the treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years

Medical diagnosis of chronic, mechanical, non-specific pain in the lumbar spine (M54, M51) - chronic low back pain.

Obtaining written consent to conduct research

Must be able to swallow tablets

Disqualifiers

Pregnancy

Pacemaker

Active cancer

To consent to conduct research

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling)

    Other intervention

    Hip flexors stretching (Adaptation from Evjenth and Hamberg) Strengthening Exercise * Deep squats * Flexo-extension of the ankle on a step over the head of metatarsal bones * Plank * Strengthening knee flexors and hip extensors * Lunges with a stick behind the patient back Education Pain relieving positions identified will be taught to the patient to use when they feel their pain. Identifying and learning to avoid pain positions or activities that increase pain. When the pain occur self stretching of hip flexors on the couch or the chair must be done

  • Medical treatment.

    Drug

    A medical doctor will prescribe the treatment following the standard of care in Polish public health services. Treatment will consist of medication and counseling.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Numeric Pain Rating Scale (NPRS)

Numeric Pain Rating Scale (NPRS) The NPRS will be used to ask the patient about the level of pain that he/she feels considering from 0 to 10, where 0 represents the absence of pain and 10 represents the most intense pain, used to measure the pain experienced by the patient. The participant will answer the NPRS, responding to the average, maximum and minimum pain experienced throughout its duration.

Time frame
Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment

Secondary outcomes

1

Lumbar Range of Motion

The MyoMotion( Noraxon, USA) is a device used to measure degrees of range of motion (ROM) in the lumbar spine. It consists of accelerometers and a program. The range of flexion, extension, will be measured in degrees.

Time frame
Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
2

ROM in Thomas test

The MyoMotion( Noraxon, USA) is a device used to measure degrees of range of motion (ROM) in the lumbar spine. It consists of accelerometers and a program. The range of flexion, extension, will be measured in degrees.

Time frame
Baseline,to complete the treatments, on average 2 weeks, 1 month after the end of treatment
3

Clinical Measure of extension.

To assess a patient's ability to extend their spine, a clinical method will be used and recorded. This method involves asking the patient how far they can reach while looking at a measuring tape.

Time frame
Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
4

Anatomical distribution of pain

Patients will draw on a body silhouette the region where they feel pain.

Time frame
Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wroclaw University of Health and Sport Sciences

Lead sponsor

Universidad de Zaragoza

Collaborator

Universitat Internacional de Catalunya

Collaborator

This trial is not recruiting at the moment. You can still explore other options: