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Completed

NCT Number: NCT04955314

Value 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

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Alcalá

Madrid, 28805, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change in Pain intensity

    Time frame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.

    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)

Secondary outcomes

  1. Change in Health related quality of life

    Time frame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.

    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.

  2. Change in Kinesiophobia

    Time frame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.

    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.

  3. Change in Disability

    Time frame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.

    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

  4. Change in Pressure Pain Threshold

    Time frame: Baseline, 3 weeks and 6 weeks after intervention beginning.

    Using an Algometer. This is an instrument for measuring sensitivity to pressure or to pain

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 8, 2021
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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