Clinical trial NCT02520648: Immediate Changes After Manual Therapy in Patients With Non-specific Back Pain
Official title: Immediate Changes After Manual Therapy Techniques in Patients With Persistent Non-specific Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Back Pain
Keywords: Back pain
Manual therapy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 125
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cervical flexion
timeFrame: 15 minutes after treatment
measure: Cervical extension
timeFrame: 15 minutes after treatment
measure: Cervical inclination
timeFrame: 15 minutes after treatment
measure: Cervical rotation
timeFrame: 15 minutes after treatment
measure: Test sit-and-reach
timeFrame: 15 minutes after treatment
Secondary outcomes:
measure: Satisfaction / comfort
timeFrame: 15 minutes after treatment
measure: McGill pain perception
timeFrame: 15 minutes after treatment
measure: Patient global impression of change scale
timeFrame: 15 minutes after treatment
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma V. Espí López
Study officials:
affiliation: Department of Physiotherapy
name: G V Espí-López, P
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.