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

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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Other: Neuro-lymphatic treatment; Other: Articulatory spinal manual therapy; Other: Articulatory costal Manual therapy

Detailed Description

Subjects:

The study was conducted at the Faculty of Physiotherapy of the University of Valencia (Spain). Persistent non-specific back pain subjects between 20 and 30 years old were recruited and voluntarily participated in the study. 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.

Study design:

The conducted study was an experimental, longitudinal and prospective, controlled, randomized and single-blind design (subjects and therapists didn't know the objectives of the treatment nor how many treatments were offered, evaluators were unaware of the treatments applied). There were 3 groups: a) neuro-lymphatic treatment; b) vertebral articulatory treatment; c) proximal costal articulatory treatment.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46010
    • Gemma v. Espí López

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Neuro-lymphatic treatment; 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; 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.
EXPERIMENTAL: Articulatory spinal manual therapy.; 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; 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.
EXPERIMENTAL: Articulatory costal Manual therapy.; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction / comfort	Two questionnaires were used. They were designed for this purpose and adapted. They included assessment of sense of wellbeing and comfort on 7 different body areas through a 10 cm scale where 0 is absolute discomfort and 10 full comfort. Subsequently, 16 affirmations were included (to be confirmed), of which 4 are inverted which are scored with a Likert scale of 1 to 5.	15 minutes after treatment
McGill pain perception	The McGill Pain Questionnaire (MPQ) evaluates quantitatively three dimensions of pain. This questionnaire evaluates quantitative and qualitative aspects of pain, such as location, quality, intensity and temporal characteristics. They are gathered into several categories which in turn form four large groups: sensory, emotional, evaluative and miscellaneous.	15 minutes after treatment
Patient global impression of change scale	the Patient global impression of change scale, it has 7 affirmations to choose from and a pain analogue scale of 10 cm. (Hurst H and J Bolton). This questionnaire was passed only after treatment.	15 minutes after treatment

Collaborators and Investigators

• Sponsor: University of Valencia
• Investigators: Study Director: G V Espí-López, P, Department of Physiotherapy

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: August 4, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (ESTIMATE): August 13, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): May 3, 2016
• Last Update Submitted That Met QC Criteria: April 29, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Back pain; Manual therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: ID009