NCT04384185

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

Effectiveness of a Therapeutic Exercise Protocol Combined With Manual Therapy Techniques on the Diaphragm Muscle in Patients With Low Back Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Alcala · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Exercise protocol	Exercises: * Pelvic tilt. * brinding. * cuadruped arm/leg raise. * Abdominal strengthening exercises. * Low-back muscles stretching. * The side bridge. * Side leg separation
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.

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-01-30
• Completion: 2021-04-15
• First posted: 2020-05-12
• Last updated: 2021-09-28

Locations

1 site across 1 country: Spain