Clinical trial NCT04955314: Value of Manual Therapy Specificity Referred to Pain Intensity in Patients With Subacute and Unspecified Low Back Pain
Official title: The Importance of Manual Therapy Specificity Referred to Pain Intensity in Patients With Subacute and Unspecified Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
subacute
manual therapy
PA
mobilization
manipulation
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be divided into two groups and a different physiotherapist from the one who will subsequently perform the intervention will assess and determine which is the most painful segment in each of them.

In the first of the groups, the intervention to be carried out will be through posteroanterior vertebral mobilizations in the most painful lumbar segment. The members of the second group will undergo this same technique on a painful segment of the region adjacent to the one they have referred as the main source of pain.
Primary purpose: TREATMENT

Brief summary: This study proves the specificity of manual therapy in unspecified an subacute low back pain

Detailed description: The purpose of the study is to determine the importance of manual therapy specificity in relation to subacute low back pain.

In order to do this, it will be selected a sample of at least 48 people who suffer low back pain whose duration has not exceeded 12 weeks. Patients will be divided into two groups and a different physiotherapist from the one who will subsequently perform the intervention, will assess and determine which is the most painful segment in each of them.

In the first group, the intervention to be carried out will be through posteroanterior (PA) vertebral mobilizations in the most painful lumbar segment. The members of the second group will undergo this same technique on a painful segment of the region adjacent to the one they have referred as the main source of pain.

Each of these sessions will continue until the patient's symptoms have decreased two points on the numerical scale of pain. There will be one session per week, for six weeks.

To determine the differences between the two groups, there will be carried out 4 measurements of pain, functional disability, quality of life and kinesiophobia, and 3 measurements of pressure pain threshold were performed. Each one of them will be carried out in the first session, in the third week of treatment, in the last session of the treatment and one month after the end of the treatment. The last measeurement will be executed online and that is why the pressure pain threshold will be measured three times while the rest will be do it.

The hypothesis is that it won´t be differences in the amount of pain between the tratment on the main painful segment and the treatment on his adyacent segment.

Eligibility criteria: Inclusion Criteria:

* People aged between 18 and 65 years old with unspecific and subacute low back pain.
* Participants must be capable of walking twice a week 20 minutes per day.

Exclusion Criteria:

* People with history of spinal surgeries, osteoporosis and tumor.
* Pregnant and people with severe respiratory and cardiac illness.

Primary outcomes:
measure: Change in Pain intensity
timeFrame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Secondary outcomes:
measure: Change in Health related quality of life
timeFrame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
measure: Change in Kinesiophobia
timeFrame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
measure: Change in Disability
timeFrame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
measure: Change in Pressure Pain Threshold
timeFrame: Baseline, 3 weeks and 6 weeks after intervention beginning.
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad de Alcalá
Study officials:
affiliation: University of Jaen
name: Alexander Achalandabaso
role: STUDY_DIRECTOR
References: