Combined Treatment of Manual Therapy and Therapeutic Exercise in Patients With Low Back Pain

NCT ID: NCT04384185

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-04-15

Brief Summary

MAIN OBJECTIVE: to assess whether an exercise protocol on the lumbar musculature by adding manual therapy techniques on the diaphragm muscle has the same or greater effect on chronic non-specific lumbar pain than an isolated exercise protocol.

SECONDARY OBJECTIVES: to evaluate the effectiveness of a lumbar exercise protocol in chronic non-specific low back pain in isolation; To evaluate the effectiveness of both therapies in improving joint range in patients with chronic non-specific low back pain and, finally, to assess catastrophism and the avoidance of lumbar mobility when carrying out loaded movements.

HYPOTHESIS: that a lumbar exercise protocol combined with manual therapy treatment on the diaphragm is equal or more effective on pain in patients with chronic nonspecific low back pain than treatment with the same lumbar exercise protocol in isolation.

Detailed Description

METHODOLOGY: A prospective randomized clinical trial with two types of intervention (lumbar exercise protocol and manual diaphragm therapy) will be carried out. The variables to be measured are pain, disability, mobility and kinesiophobia. It will be performed in two groups of 21 people who are of legal age, who have low back pain of more than 3 months duration and which is of non-specific origin.

The patients will be randomized and divided into two groups A (control) and B (experimental).

Group A will undergo an exercise protocol.

Group B will undergo the same protocol plus manual therapy techniques on diaphragm muscle. Study participants will have treatment twice a week for 8 weeks, the first information session and the second measurement-evaluation session in the first week of treatment. In the following 3 weeks the session will last 40 minutes for both groups. In the 4th week the established measurements will be carried out again.

Conditions

Low Back Pain, Mechanical; Musculoskeletal Manipulations; Exercise Training

Study Design

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

Study Groups

Group A: Exercise therapy

Group A: will perform an exercise protocol to improve the stability of the spine muscle of low-back

Group Type: EXPERIMENTAL

Exercise protocol

Intervention Type: OTHER

Exercises:

• Pelvic tilt.
• brinding.
• cuadruped arm/leg raise.
• Abdominal strengthening exercises.
• Low-back muscles stretching.
• The side bridge.
• Side leg separation

Group B. Manual therapy and exercises

Group B: Will be treated with manual therapy in the diaphragm muscle and the same protocol of therapeutic exercise applied in group A

Group Type: EXPERIMENTAL

Exercise protocol

Intervention Type: OTHER

Exercises:

• Pelvic tilt.
• brinding.
• cuadruped arm/leg raise.
• Abdominal strengthening exercises.
• Low-back muscles stretching.
• The side bridge.
• Side leg separation

Manual therapy

Intervention Type: OTHER

1. Functional diaphragm balancing technique: gentle vertical pressure was applied for 5 minutes at the diaphragm level.

2. Muscle fiber stretching technique: a cranial traction was performed from the lower edge of the costal arches during the inspiratory breathing phase, for more than 10 respiratory cycles.

3. Phrenic-center inhibition technique (Figure 3C): the soft tissue was pumped during the expiratory phase by gently and simultaneously using both hands to create pressure in cranial and caudal direction, for more than 10 respiratory cycles.

Interventions

Exercise protocol

Exercises:

• Pelvic tilt.
• brinding.
• cuadruped arm/leg raise.
• Abdominal strengthening exercises.
• Low-back muscles stretching.
• The side bridge.
• Side leg separation

Intervention Type: OTHER

Manual therapy

1. Functional diaphragm balancing technique: gentle vertical pressure was applied for 5 minutes at the diaphragm level.

2. Muscle fiber stretching technique: a cranial traction was performed from the lower edge of the costal arches during the inspiratory breathing phase, for more than 10 respiratory cycles.

3. Phrenic-center inhibition technique (Figure 3C): the soft tissue was pumped during the expiratory phase by gently and simultaneously using both hands to create pressure in cranial and caudal direction, for more than 10 respiratory cycles.

Intervention Type: OTHER

Other Intervention Names

Myofascial manipulation

Eligibility Criteria

Inclusion Criteria

• Legal age
• Non-specific Low-Back pain
• Pain more 3 months

Exclusion Criteria

• subjects with lumbar herniation.
• Spine canal stenosis
• Subjects with neurological disease.
• Lumbar surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alcala

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Daniel Pecos Martín

PhD. Daniel Pecos Martín

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomas Gallego Izquierdo, PhD

Role: STUDY_CHAIR

Alcala University

Locations

Grupo Fisioterapia y Dolor

Alcalá de Henares, Madrid, Spain

Countries

Spain

Other Identifiers

CEIM/HU/2020/12

Identifier Type: -

Identifier Source: org_study_id