Clinical trial NCT05784168: The Effect of Manual Therapy and Therapeutic Exercises on Pain and Functional Status in Persons With Low Back Pain
Official title: The Effect of Manual Therapy and Therapeutic Exercises on Pain and Functional Status in Persons With Chronic Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
manual therapy
exercise therapy
Lead sponsor: Lithuanian Sports University
Sponsor class: OTHER
First posted: 2023-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-specific chronic low back pain (LBP) can be managed with a variety of treatments such as educational programmes, behavioural therapy, acupuncture, medication, electrophysical agents, manual therapy and exercise therapy. Although the above therapies are widely used, they show limited effect at best, with frequent recurrences of LBP. There is insufficient data to prove that one type of exercise is superior to another. Manual therapy is a common therapeutic method used in the treatment of LBP. Therefore, we hypothesised that manual therapy combined with therapeutic exercises would lead to a greater reduction in back pain and improvement in functional status. The aim of the study was to evaluate the effect of 6 weeks of manual therapy combined with therapeutic exercise on pain and functional status in subjects with chronic non-specific low back pain.

Detailed description: The individuals with chronic non-specific low back pain participated in the study. Subjects were randomly divided into two groups: physiotherapy and manual therapy. All the participants received 12 intervention sessions. In addition, all subjects exercised at home 5 days a week. Subjects' back static strength endurance was assessed by the ITO test, abdominal muscle static strength endurance was assessed by the Kraus-Webber test, fear of movement by the TAMPA kinesiophobia test, torso mobility by the Schober test, pain by the numerical analogy scale. Functional status was assessed by Oswestry and Roland-Morris questionnaires.

Eligibility criteria: Inclusion Criteria:

* Non-specific low back pain (\>8 weeks);
* Persons of working age;
* Must be able to perform therapeutic exercises.

Exclusion Criteria:

* Severe cardiovascular disease;
* Oncological disorders;
* Neurological symptoms of disorders;
* Osteoarthritis;
* Spondylolisthesis and spondylosis;
* Radiculopathy;
* Myelopathy;
* Spinal fracture.
* Pregnancy or lactation.

Primary outcomes:
measure: Change from baseline Pain at 6 weeks
timeFrame: Baseline and after 6 weeks
measure: Change from baseline Oswestry Disability Index for functional status at 6 weeks
timeFrame: Baseline and after 6 weeks
measure: Change from baseline Roland Morris Disability Questionnaire at 6 weeks
timeFrame: Baseline and after 6 weeks
measure: Change from baseline Mobility of the lumbar spine at 6 weeks
timeFrame: Baseline and after 6 weeks
measure: Change from baseline Abdominal muscle static endurance at 6 weeks
timeFrame: Baseline and after 6 weeks
measure: Change from baseline Back muscle static endurance at 6 weeks
timeFrame: Baseline and after 6 weeks
measure: Change from baseline Kinesiophobia at 6 weeks
timeFrame: Baseline and after 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian Sports University
Study officials:
affiliation: Lithuanian Sports University
name: Vytautas Pilelis, Master
role: PRINCIPAL_INVESTIGATOR
References: