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

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

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

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: PA vertebral mobilization

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.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28805
    • Universidad de Alcala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PA mobilizations on their main painfull vertebral segment; Patients who will be treated with PA mobilizations on their main painfull vertebral segment.	Other: PA vertebral mobilization; A PA mobilization is a technique in which one vertebra slides over another due to a force applied with the hands of the physiotherapist
Experimental: PA mobilizations on an adjacent vertebral segment from the most painful; Patients who will be treated with PA mobilizations on an adjacent vertebral segment from the most painful.	Other: PA vertebral mobilization; A PA mobilization is a technique in which one vertebra slides over another due to a force applied with the hands of the physiotherapist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Health related quality of life	Using SF-36.This scale is made up of 36 items divided into 8 sections. The result can range from 0 to 100, where 0 is the worst possible health condition and 100 is the best one.	Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Change in Kinesiophobia	Using the tampa scale for kinesiophobia-11 (TSK-11) to measure fear of movement, pain and injury relapse. The result can range from 11-44 points where higher scores indicate greater fear of pain, movement, and injury.	Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Change in Disability	Using Oswestry Disability Index (ODI).The final score of this scale ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound	Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Change in Pressure Pain Threshold	Using an Algometer. This is an instrument for measuring sensitivity to pressure or to pain	Baseline, 3 weeks and 6 weeks after intervention beginning.

Collaborators and Investigators

• Sponsor: University of Jaén

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): August 25, 2021
• Study Completion (Actual): September 25, 2021

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: July 5, 2021
• First Posted (Actual): July 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: low back pain; subacute; manual therapy; mobilization; manipulation; PA
• Additional Relevant MeSH Terms: Neurologic Manifestations; Back Pain; Low Back Pain; Pain
• Other Study ID Numbers: CEIM/HU/2020/6/56

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No