The Effect of Manual Therapy and Therapeutic Exercises on Pain and Functional Status in Persons With Low Back Pain

NCT ID: NCT05784168

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2022-12-01

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual therapy

6 weeks, 12 sessions in total, 2 times a week of manual therapy: spinal manipulation, specific mobilisations and stretches. Manual therapy treatments are carried out by a physiotherapist with more than 10 years of experience.

In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.

Group Type: EXPERIMENTAL

Manual therapy

Intervention Type: OTHER

6 weeks, 12 sessions in total, 2 times a week of manual therapy: spinal manipulation, specific mobilisations and stretches. Manual therapy treatments are carried out by a physiotherapist with more than 10 years of experience.

In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.

Exercise therapy

6 weeks, 12 sessions in total, 2 times a week therapeutic exercise programme under the supervision of a physiotherapist. The exercise programme consisted of muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.

In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.

Group Type: EXPERIMENTAL

Exercise therapy

Intervention Type: OTHER

6 weeks, 12 sessions in total, 2 times a week therapeutic exercise programme under the supervision of a physiotherapist. The exercise programme consisted of muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.

In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.

Interventions

Manual therapy

6 weeks, 12 sessions in total, 2 times a week of manual therapy: spinal manipulation, specific mobilisations and stretches. Manual therapy treatments are carried out by a physiotherapist with more than 10 years of experience.

In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.

Intervention Type: OTHER

Exercise therapy

6 weeks, 12 sessions in total, 2 times a week therapeutic exercise programme under the supervision of a physiotherapist. The exercise programme consisted of muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.

In addition, 6 weeks, 5 times a week, a programme of therapeutic exercises at home: muscle strengthening and stretching, balance and coordination training, spinal stabilisation exercises.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lithuanian Sports University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vytautas Pilelis, Master

Role: PRINCIPAL_INVESTIGATOR

Lithuanian Sports University

Locations

Lithuanian Sports University

Kaunas, , Lithuania

Countries

Lithuania

Other Identifiers

LithuanianSportsU12

Identifier Type: -

Identifier Source: org_study_id