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Completed

NCT Number: NCT02520648

Immediate Changes After Manual Therapy in Patients With 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.

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Key information

Conditions

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

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gemma V. Espí López

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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 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.

Primary outcomes

  1. Cervical flexion

    Time frame: 15 minutes after treatment

    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.

  2. Cervical extension

    Time frame: 15 minutes after treatment

    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.

  3. Cervical inclination

    Time frame: 15 minutes after treatment

    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.

  4. Cervical rotation

    Time frame: 15 minutes after treatment

    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.

  5. Test sit-and-reach

    Time frame: 15 minutes after treatment

    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.

Secondary outcomes

  1. Satisfaction / comfort

    Time frame: 15 minutes after treatment

    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.

  2. McGill pain perception

    Time frame: 15 minutes after treatment

    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.

  3. Patient global impression of change scale

    Time frame: 15 minutes after treatment

    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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Acronym: EffDorsMan

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 13, 2015
Registry last updated
May 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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