An Exercise Program in Patients With Chronic Low Back Pain

NCT05524129 | Completed

• 1 other identifier: Vertebro-RHB_RHO/NK2022
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise intervention aims to improve the function of the deep back muscles and spine stabilizers, which appear to be an essential factor in preventing low back pain recurrences. In order to achieve the best possible effect of exercise, the patient should exercise for a long time even after finishing the exercise program, and it is also essential that exercises improve the function of the deep back muscles and become a regular part of the patient's life. In cooperation with the Neurological Clinic and physiotherapists from the Rehabilitation Department of the Brno University Hospital, the investigators put together a rehabilitation program to improve the function of the deep back muscles and spine stabilizers (group I). This program contains commonly used exercises; the patient can perform the exercises himself at home after the training, and no special aids are needed. The rehabilitation program is based on daily independent exercise, while the patient keeps a record of his activity in an exercise diary, which should contribute to motivation for regular exercise. At the same time, the physiotherapist will contact the patients by phone at regular weekly intervals, thereby maintaining their motivation. A total of 3 exercises were created, in which the patient will be taught gradually, according to his abilities and exercise tolerance. Regular checks with a physiotherapist are established to evaluate the correctness of the exercises, frequency, and effect and to increase the difficulty of the exercises. At the end of the exercise program, the patient will be instructed that it is desirable to continue the regular exercise. That exercise should become a part of everyday life to prevent the recurrence of vertebral disorders. As part of our previous study entitled "Changes in the lumbar paraspinal muscles in patients with lower back pain," preliminary results showed a positive effect on the clinical condition of the patients, good tolerance of the exercises on the part of the patients, and satisfaction with completing the rehabilitation program.

Conditions

Low Back Pain

Keywords

Low Back Pain; Physiotherapy; Telerehabilitation

Outcome Measures

Primary Outcomes (3)

• Change from baseline Functioning and disability score at 18 weeks and 6 months

  Patient functioning and disability will be measured by the Roland-Morris Disability Questionnaire. Values ranges from 0-24, lower scores mean a better outcome.

  Baseline, 18 weeks, 6 months

• Change from baseline Health-related quality of life score at 18 weeks and 6 months

  Short Form Survey (SF-36) - 36-item. Maximum value is 100 points, minimum value is 36 point. Higher score mean a better outcome.

  Baseline, 18 weeks, 6 months

• Change from baseline Endurance of the trunk extensors value at 18 weeks and 6 months

  With the Biering-Sorensen Test, the patient's trunk extensors' endurance will be evaluated. Patients will be positioned in the prone position with the pelvis, hips, and knees in complete contact with the treatment bed. The patient's pelvis will be supported with a belt and fixed by the physiotherapist. The patients were asked to extend their upper body straight forward from the edge of the table and stay in this position. The time able to hold position properly will be recorded in seconds.

  Baseline, 18 weeks, 6 months

Secondary Outcomes (2)

• Satisfaction - self-completed questionnaire

  18 week

• Exercise adherence

  18 week

Study Arms (2)

Interventional (Group I)

EXPERIMENTAL

It will be a hybrid form of rehabilitation, i.e. home exercises according to brochures in combination with regular visits to the ambulance for check-ups according to a precisely set schedule, the authorized physiotherapist will also contact the patients by phone at regular weekly intervals, thereby maintaining their motivation.

Other: rehabilitation exercise

Control (Group II)

ACTIVE COMPARATOR

These patients will undergo regular rehabilitation only in the outpatient center with the normally indicated frequency visits twice a week for 4 weeks.

Other: rehabilitation exercise; Other: electrotherapy

Interventions

rehabilitation exercise OTHER

Conventional rehabilitation exercise.

Control (Group II); Interventional (Group I)

electrotherapy OTHER

A middle frequency electro-therapy

Control (Group II)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The cause of the problems most likely lies in the back area (e.g., dysfunction of trunk stabilization, faulty posture, inappropriate movement habits, beginning mild degenerative changes of the spine)
• age over 18 years (upper limit not determined)
• chronic lower back pain (pain duration of at least 12 weeks) - especially non-specific pain (pain localized in the lumbar spine or pain with propagation above the knee at the most), chronic radicular pain of vertebral etiology (not requiring rehabilitation aimed at paresis) can also be present.
• All patients enrolled in the study must have had an imaging examination of the lumbar spine.

You may not qualify if:

• overall poor physical condition, it should be noted that the patient must undergo entrance and exit examinations with a physiotherapist as part of the study, which requires a certain level of physical fitness
• involvement of the lumbar spine by another pathology (fracture, inflammation, tumor)
• the presence of comorbidity affecting the overall mobility of the patient (e.g., the presence of paresis after a stroke, severe heart failure leading to immobilization)
• significant impairment of cognitive functions (restricting cooperation in the study and filling out questionnaires)
• the patient is not motivated to exercise regularly to strengthen the paraspinal muscles
• back pain arose acutely (e.g., acute disc herniation, injury, acute blockage
• lower limb problems cause back pain (arthrosis, dysplasia, longer lower limb, one-sided flat feet) and problems with internal organs (inflammation of the bladder, kidneys, genitals)
• arthrosis of the hip, knee, and shoulder joints higher than grade II
• cachexia, obesity grade II to III,
• Comment:
• the presence of milder chronic radiculopathy does not matter for entry into the study (muscle strength of lower limbs in individual segments should be at least IV grade)
• the exercise program can be adjusted individually according to the patient's condition
• it is necessary to have a signed informed consent

Sponsors & Collaborators

• Brno University Hospital: lead

Study Sites (1)

Michaela Sládečková

Brno, Czech Republic, 625 00, Czechia

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise Therapy; Electric Stimulation Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Blanka Adamova, MD., PhD

  Department of Neurology, University Hospital Brno, Czech Republic

  STUDY CHAIR

• Peter Krkoška, MD

  Department of Neurology, University Hospital Brno, Czech Republic

  STUDY DIRECTOR

• Filip Dosbaba, PT., PhD

  Department of Rehabilitation, University Hospital Brno, Czech Republic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 1, 2022
• Study Start: September 1, 2022
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)