Immediate Changes After Manual Therapy in Patients With Non-specific Back Pain

NCT02520648 | Completed

• 1 other identifier: ID009
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to investigate the immediate effects of neuro-lymphatic treatment, thoracic vertebral and costal articulatory in terms of back pain levels, cervical and dorsal flexibility, sense of body comfort and satisfaction with the treatment received.

Conditions

Back Pain

Keywords

Back pain; Manual therapy

Outcome Measures

Primary Outcomes (5)

• Cervical flexion

  Cervical movement was evaluated with cervical goniometer. The Cervical Range of Motion (CROM) system combines inclinometers and magnets arranged on a head support and also supported on the nose bone.

  15 minutes after treatment

• Cervical extension

  Global cervical movement was evaluated with cervical goniometer. The Cervical Range of Motion (CROM) system combines inclinometers and magnets arranged on a head support and also supported on the nose bone.

  15 minutes after treatment

• Cervical inclination

  Global cervical movement on both sides was evaluated with cervical goniometer. The Cervical Range of Motion (CROM) system combines inclinometers and magnets arranged on a head support and also supported on the nose bone.

  15 minutes after treatment

• Cervical rotation

  Global cervical movement on both sides was evaluated with cervical goniometer. The Cervical Range of Motion (CROM) system combines inclinometers and magnets arranged on a head support and also supported on the nose bone.

  15 minutes after treatment

• Test sit-and-reach

  Test sit-and-reach or finger-floor distance. The subject remains standing on a box designed for this purpose, leaving the arms and trunk relaxed. In this position the subject flexes the trunk forward and maintains its maximum flexion for 3 seconds. This is repeated and the most favorable is measured. There is a vertical scale with a range of 50 cm (25 cm negative and 25cm positive). The evaluator is placed next to the scale and records the furthest measure touched by the fingertips of both hands. If the hands reach different measures, the shortest is recorded.

  15 minutes after treatment

Secondary Outcomes (3)

• Satisfaction / comfort

  15 minutes after treatment

• McGill pain perception

  15 minutes after treatment

• Patient global impression of change scale

  15 minutes after treatment

Study Arms (3)

Neuro-lymphatic treatment

ACTIVE COMPARATOR

Participants were positioned in prone, with the head in neutral position and the arms beside the body. They were asked to perform conscious breathing. The physical therapist applied direct firm rotary pressure, via thumb or tip finger, for 1 minute, from the transverse processes of T1 to the transverse processes of T12. To finish the intervention, hands were placed on the skull and sacrum during 2 minutes without movement. Neuro-lymphatic reflexes as referred to applied kinesiology, are locations on the body that are believed to affect a specific muscle and organ. Duration of the treatment is 15 minutes.

Other: Neuro-lymphatic treatment

Articulatory spinal manual therapy.

EXPERIMENTAL

Then the therapist performs pressures in the transverse apophysis from D1 to D12 (level of the paravertebral muscles, at a distance of 2 fingers of the spinous apophysis), applying sustained pressure during expiratory time until the articulatory barrier is reached. Three repetitions are performed at each vertebral level. It is done bilaterally, then longitudinal pressures are applied on dorsal vertebrae during expiratory time, 3 repetitions. It ends like treatment 1. This technique aims to normalize possible slight dysfunctions of the spine, enhance the feeling of comfort and pain, and relax the spine. Duration of the treatment is 15 minutes.

Other: Articulatory spinal manual therapy

Articulatory costal Manual therapy.

EXPERIMENTAL

The therapist performs costal-vertebral articulatory movement, from 1st to 12th rib (level of the outside paravertebral muscles, at a distance of 4 fingers from the spinous apophysis on the back of the costal body) applying a sustained pressure during expiratory time and promoting its biomechanics, up to the articulatory barrier. Three repetitions are performed at each costal level. It is done bilaterally, then longitudinal pressures are applied on dorsal vertebrae during expiratory time, 3 repetitions. It ends like treatment 1. This technique aims to normalize the mobility of the ribs, enhance the feeling of comfort and pain, and relax the spine. Duration of the treatment is 15 minutes.

Other: Articulatory costal Manual therapy

Interventions

Neuro-lymphatic treatment OTHER

The physical therapist applied direct firm rotary pressure, via thumb or tip finger, for 1 minute, from the transverse processes of T1 to the transverse processes of T12. To finish the intervention, hands were placed on the skull and sacrum during 2 minutes without movement.

Neuro-lymphatic treatment

Articulatory spinal manual therapy OTHER

Then the therapist performs pressures in the transverse apophysis from D1 to D12 (level of the paravertebral muscles, at a distance of 2 fingers of the spinous apophysis), applying sustained pressure during expiratory time until the articulatory barrier is reached.

Articulatory spinal manual therapy.

Articulatory costal Manual therapy OTHER

The therapist performs costal-vertebral articulatory movement, from 1st to 12th rib (level of the outside paravertebral muscles, at a distance of 4 fingers from the spinous apophysis on the back of the costal body) applying a sustained pressure during expiratory time and promoting its biomechanics, up to the articulatory barrier.

Articulatory costal Manual therapy.

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Non-specific Back Pain subjects between 20 and 30 years old were recruited and voluntarily participated in the study.

You may not qualify if:

• Excluded subjects with musculoskeletal injuries such as spine or balance disorders
• Those which were recovering from an injury of the locomotor or neurological system, or
• Those who had sequelae from any trauma suffered in the past six months that could affect the results of the study.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Gemma V. Espí López

Valencia, 46010, Spain

Location

Related Publications (2)

• Martinez-Segura R, Fernandez-de-las-Penas C, Ruiz-Saez M, Lopez-Jimenez C, Rodriguez-Blanco C. Immediate effects on neck pain and active range of motion after a single cervical high-velocity low-amplitude manipulation in subjects presenting with mechanical neck pain: a randomized controlled trial. J Manipulative Physiol Ther. 2006 Sep;29(7):511-7. doi: 10.1016/j.jmpt.2006.06.022.

  PMID: 16949939 RESULT

• Bicalho E, Setti JA, Macagnan J, Cano JL, Manffra EF. Immediate effects of a high-velocity spine manipulation in paraspinal muscles activity of nonspecific chronic low-back pain subjects. Man Ther. 2010 Oct;15(5):469-75. doi: 10.1016/j.math.2010.03.012. Epub 2010 May 5.

  PMID: 20447857 RESULT

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• G V Espí-López, P

  Department of Physiotherapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: August 13, 2015
• Study Start: July 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 3, 2016

Record last verified: 2016-04

Locations

ES (1)