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

University of Alcala

Status: Completed

Conditions: Exercise Training; Low Back Pain, Mechanical; Musculoskeletal Manipulations

Treatments: Other: Manual therapy; Other: Exercise protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT04384185

CEIM/HU/2020/12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

Group A: Exercise therapy

Experimental group

Description:

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

Treatment:

Other: Exercise protocol

Group B. Manual therapy and exercises

Experimental group

Description:

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

Treatment:

Other: Manual therapy

Other: Exercise protocol