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

NCT04384185 | Completed DMC

• 1 other identifier: CEIM/HU/2020/12
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain, Mechanical; Musculoskeletal Manipulations; Exercise Training

Outcome Measures

Primary Outcomes (1)

• Low-back pain

  The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient with lowback pain.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and ten the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.

  Change from Baseline disability at 3 months

Secondary Outcomes (3)

• Disability with Oswestry Disability Index

  Change from Baseline disability at 3 months

• Lumbar range of motion

  Change from Baseline disability at 3 months

• Kinesiophobia

  Change from Baseline disability at 3 months

Study Arms (2)

Group A: Exercise therapy

EXPERIMENTAL

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

Other: Exercise protocol

Group B. Manual therapy and exercises

EXPERIMENTAL

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

Other: Exercise protocol; Other: Manual therapy

Interventions

Exercise protocol OTHER

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

Group A: Exercise therapy; Group B. Manual therapy and exercises

Manual therapy 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.

Also known as: Myofascial manipulation

Group B. Manual therapy and exercises

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Grupo Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28871, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Tomas Gallego Izquierdo, PhD

  Alcala University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Daniel Pecos Martín

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: May 12, 2020
• Study Start: September 1, 2020
• Primary Completion: January 30, 2021
• Study Completion: April 15, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

ES (1)