Clinical trial NCT04444414: Manual Therapy on Balance and Mood States
Official title: Effect of a Manual Therapy Protocol on Balance and Mood States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Young Adult
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial with 2 groups (experimental and control)
Primary purpose: TREATMENT

Brief summary: The aims of this study was to compare the effectiveness of a protocol of manual therapy on the static balance, dynamic balance and mood states in health participants. This study will consist of a randomized controlled trial. Participants will be healthy subjects divided into 2 groups, being an experimental group that will receive a manual therapy session and a control group without treatment. It will be evaluated at the start of the study, after treatment and one week later.

Detailed description: Background

Evidence suggest that the application of manual therapy could be effective in multiple pathologies, but there are few studies which have investigated the effectiveness of manual therapy in to balance and mood states.

Objective To compare the effectiveness of a protocol of manual therapy on the static balance, dynamic balance and mood states in health participants.

Metods

This is a randomized controlled trial which will be carried out with young adults. The sample will be divided into 2 groups: a) experimental group that will receive a manual therapy session; b) a control group without treatment. All subjects signed the informed consent and confidentiality of the data was reserved according to the Helsinki declaration. The treatments were carried out in the laboratories of the University of Valencia and the project was approved by the institution's ethics committee.

The experimental group to receive manual therapy (Bilateral manipulation lumbosacral, hip joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping, decompression of connective tissue of the patellofemoral region, internal and external joint line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus gapping, and muscle strengthening). The control group will not receive treatment and only evaluations will be performed.

Outcomes

The evaluations will consist of the following variables: Star Excursion Balance Test (SEBT), Unipedal Stance Test (UPST), Patient Global Impression of Change (PGIC) and POMS (Profile Of Mood States). Evaluations will be carried out at three times: at the beginning of the study, after treatment and one week later.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 30 years
* That they can take all the tests from the study evaluations.

Exclusion Criteria:

* Those who are doing some balance training program.
* Individuals who have some deterioration in balance, regardless of whether the cause is the vestibular system, the visual, proprioceptive, any surgery.
* Participants suffering from tingling or numbness.
* Those who have pain in the lower limbs greater than 3 on the Visual Analog Scale.
* That the lower limbs or in the lumbosacral region have orthopedic problems or traumatic injuries, they will not be able to participate either, including as such scoliosis, ligament pathologies, osteoarthritis, prostheses.
* Pregnancy.

Primary outcomes:
measure: Star Excursion Balance Test (SEBT)
timeFrame: 1-week
Secondary outcomes:
measure: Unipedal Stance Test (UPST)
timeFrame: 1-week
measure: Patient Global Impression of Change (PGIC)
timeFrame: 1-week
measure: POMS (Profile Of Mood States)
timeFrame: 1-week
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Gemma Espí
Study officials:
References:
citation: Espi-Lopez GV, Serra-Ano P, Vicent-Ferrando J, Sanchez-Moreno-Giner M, Arias-Buria JL, Cleland J, Fernandez-de-Las-Penas C. Effectiveness of Inclusion of Dry Needling in a Multimodal Therapy Program for Patellofemoral Pain: A Randomized Parallel-Group Trial. J Orthop Sports Phys Ther. 2017 Jun;47(6):392-401. doi: 10.2519/jospt.2017.7389. Epub 2017 May 13.
citation: Espi-Lopez GV, Lopez-Martinez S, Ingles M, Serra-Ano P, Aguilar-Rodriguez M. Effect of manual therapy versus proprioceptive neuromuscular facilitation in dynamic balance, mobility and flexibility in field hockey players. A randomized controlled trial. Phys Ther Sport. 2018 Jul;32:173-179. doi: 10.1016/j.ptsp.2018.04.017. Epub 2018 Apr 22.