Clinical trial NCT06975345: Effects of a Protocol of Hip Flexor Stretching on Chronic Mechanical, Non-specific LBP.
Official title: Short, Medium and Long Term Effects of a Protocol of Hip Flexor Stretching, Exercise and Pain Managment Education, Function and Disability in Patients With Chronic, Mechanical, Non-specific Low Back Pain. Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Musculoskeletal Manipulations
Low Back Pain, Mechanical
Keywords: manual therapy,
spine,
low back pain,
Chronic Low Back Pain,
Muscle Stretching Exercises,
Range of Motion, Articular,
Body composition,
Numeric Pain Rating Scale (NPRS)
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: Universidad de Zaragoza
name: Universitat Internacional de Catalunya
First posted: 2025-05-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Study design: the study is a randomized controlled study that will be conducted in a physiotherapy center in Poland. Potential subjects will be identified in public and private health services by a medicine doctor who will be responsible for screening subjects for eligibility and enrolling into the study.

Men and Women between 18 and 75 years old that will fulfill the criteria and will sign the informed consent will be randomly assigned to one of the two treatment groups. Randomization will be 1:1 ratio and the method to generate random allocation will be a random computer generated numbers table.

Evaluator, outcome assessor, will be blinded to the participant's group assignment.

The study has been approved by the research ethics committee of Wroclaw University of Health Sciences and Sports. The study will be conducted in accordance with ethical principles of the declaration of Helsinki (75th World Medical Association General Assembly , Helsinki, Finland, October 2024)

Treatment Groups:

Experimental group: Participants will receive a protocol of hip flexors stretching, exercise and education for chronic low back pain added to the standard of care in the Polish public health services prescribed by the medicine doctor.

Control group: Participants will receive only the standard of care in the Polish public health services prescribed by a medicine doctor.

The treatment period will consist of two weeks. Experimental group will receive 3 treatment sessions during this period of time. Control group will receive medication and counsels under medical doctor criteria.

The patients will be assessed at baseline (t0), after the treatment period (t1), 1 month after the end of the treatment (t2), three months after the end of the treatment (t3), and one year after the end of the treatment (t4).The variables that will be collected will be: Pain (NPRS), function (ROM), disability (ODI) and other descriptive and sociodemographic variables.

Statistical analysis will be performed to describe the sample, groups and comparison between groups.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnancy
* Pacemaker
* Active cancer
* To consent to conduct research
* Difficulty communicating
* The presence of a metal plate in the head and metal screws in the body
* Condition after operations in the area of the lumbar spine
* Condition after fractures in the lumbar spine
* Contraindications to manual therapy or exercise
* Has participated in a lumbar spine exercise or manual therapy program in the last three months
* Present clear signs of having suffered a significant lumbar injury
* Inability to maintain standing or a supine or prone position
* No possibility to perform the stretching of hip flexors

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
Secondary outcomes:
measure: Lumbar Range of Motion
timeFrame: Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
measure: ROM in Thomas test
timeFrame: Baseline,to complete the treatments, on average 2 weeks, 1 month after the end of treatment
measure: Clinical Measure of extension.
timeFrame: Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
measure: Anatomical distribution of pain
timeFrame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
measure: ROM in Straight Leg Raise Test
timeFrame: Baseline, to complete the treatments, on average 2 weeks, 1 month after the end of treatment.
measure: Quality of Life level
timeFrame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
measure: Kinesiophobia
timeFrame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
measure: Degree of Functional Disability
timeFrame: Baseline,to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
measure: Physical activity level
timeFrame: Baseline, to complete the treatments, on average 2 weeks, 1, 3 and 12 months after the end of treatment
measure: Body composition analysis
timeFrame: Baseline
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: Rehasport Wroclaw
state: Dolnośląskie
Study officials:
References: