Clinical trial NCT04664348: Does Low Back Position Matters in Manual Therapy Treatment
Official title: Is the Positioning of the Lumbar Spine Relevant to the Manual Treatment of the Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. A total of 46 subjects of legal age with non-specific chronic low back pain will be selected and randomized into two interventions.

The first group will receive lumbar posteroanterior mobilizations with the lumbar spine in extension and the second group will receive lumbar mobilizations with neutral position of the spine. Both groups will also receive a home exercise program for the lumbar spine.

The total duration of the treatments will be 6 weeks, with pre-treatment, at 3 weeks of the treatment, post-treatment evaluations at 6 weeks, with a follow-up after 1 month and with a follow-up after 3 months.

The objective will be to evaluate which of the two interventions is more effective in addressing disability variables (main variable), pressure pain threshold, pain location, pain intensity, quality of life, quality of sleep, depression and kinesiophobia.


Eligibility criteria: Inclusion Criteria:

* subjects with unspecific low back pain of 3 or more months of evolution prior commencement of the intervention

Exclusion Criteria:

* lumbar pain related to infectious diseases
* fractures
* oncological processes
* women in gestation period.

Primary outcomes:
measure: Changes in Disability
timeFrame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Secondary outcomes:
measure: Changes in Pressure pain threshold
timeFrame: Baseline, 3 weeks and 6 weeks after intervention commencement
measure: Changes in Site of pain
timeFrame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
measure: Pain measured with visual analogic scale
timeFrame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
measure: Health measured with the short form health survey version II
timeFrame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
measure: Quality of sleep measured with the Pittsburgh Sleep Quality Index
timeFrame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
measure: Depression measured with Beck's Depression Inventory
timeFrame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
measure: Kinesiophobia measured with the TAMPA scale of kinesiophobia
timeFrame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
measure: Changes in Medication
timeFrame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Adrián Cabañas
state: Madrid
Study officials:
References: