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

Back Pain Clinical Trial

— EffDorsMan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02520648
• Other study ID #: ID009
• Status: Completed
• Phase: N/A
• First received: August 4, 2015
• Last updated: April 29, 2016
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Gemma V. Espí López	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. E — View Citation

Martínez-Segura R, Fernández-de-las-Peñas C, Ruiz-Sáez M, López-Jiménez C, Rodríguez-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 mechanica — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes