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

Wroclaw University of Health and Sport Sciences

Status: Not yet enrolling

Conditions: Low Back Pain, Mechanical; Musculoskeletal Manipulations; Pain

Treatments: Drug: Medical treatment.; Other: Multicomponent intervention. Hip flexors stretching, Strengthening exercises and education and medical treatment (Medication and medical counselling)

Study type: Interventional

Funder types: Other

Identifiers

NCT06975345

AWFWroclawUNIZAR.PhDAlek

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Experimental group

Experimental group

Description:

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.

Treatment:

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

Drug: Medical treatment.

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Medical treatment.