Value of Manual Therapy Specificity Referred to Pain Intensity in Patients With Subacute and Unspecified Low Back Pain

NCT04955314 | Completed

• 1 other identifier: CEIM/HU/2020/6/56
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Low Back Pain

Keywords

low back pain; subacute; manual therapy; PA; mobilization; manipulation

Outcome Measures

Primary Outcomes (1)

• Change in Pain intensity

  Using Numeric Pain Rating Scale (NPRS). In this scale patients rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)

  Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.

Secondary Outcomes (4)

• Change in Health related quality of life

  Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.

• Change in Kinesiophobia

  Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.

• Change in Disability

  Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.

• Change in Pressure Pain Threshold

  Baseline, 3 weeks and 6 weeks after intervention beginning.

Study Arms (2)

PA mobilizations on their main painfull vertebral segment

EXPERIMENTAL

Patients who will be treated with PA mobilizations on their main painfull vertebral segment.

Other: PA vertebral mobilization

PA mobilizations on an adjacent vertebral segment from the most painful

EXPERIMENTAL

Patients who will be treated with PA mobilizations on an adjacent vertebral segment from the most painful.

Other: PA vertebral mobilization

Interventions

PA vertebral mobilization OTHER

A PA mobilization is a technique in which one vertebra slides over another due to a force applied with the hands of the physiotherapist

PA mobilizations on an adjacent vertebral segment from the most painful; PA mobilizations on their main painfull vertebral segment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

Universidad de Alcalá

Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexander Achalandabaso

  University of Jaen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Model Details: 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.

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: July 8, 2021
• Study Start: May 11, 2021
• Primary Completion: August 25, 2021
• Study Completion: September 25, 2021
• Last Updated: January 3, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)