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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PA vertebral mobilization
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, subacute, manual therapy, PA, mobilization, manipulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad de Alcalá

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

PA mobilizations on their main painfull vertebral segment

PA mobilizations on an adjacent vertebral segment from the most painful

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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.
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
Change in Pressure Pain Threshold
Using an Algometer. This is an instrument for measuring sensitivity to pressure or to pain

Full Information

First Posted
June 2, 2021
Last Updated
December 10, 2021
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT04955314
Brief Title
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

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
August 25, 2021 (Actual)
Study Completion Date
September 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Jaén

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, subacute, manual therapy, PA, mobilization, manipulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Care Provider
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PA mobilizations on their main painfull vertebral segment
Arm Type
Experimental
Arm Description
Patients who will be treated with PA mobilizations on their main painfull vertebral segment.
Arm Title
PA mobilizations on an adjacent vertebral segment from the most painful
Arm Type
Experimental
Arm Description
Patients who will be treated with PA mobilizations on an adjacent vertebral segment from the most painful.
Intervention Type
Other
Intervention Name(s)
PA vertebral mobilization
Intervention Description
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 Outcome Measure Information:
Title
Change in Pain intensity
Description
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)
Time Frame
Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Secondary Outcome Measure Information:
Title
Change in Health related quality of life
Description
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.
Time Frame
Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Title
Change in Kinesiophobia
Description
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.
Time Frame
Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Title
Change in Disability
Description
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
Time Frame
Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Title
Change in Pressure Pain Threshold
Description
Using an Algometer. This is an instrument for measuring sensitivity to pressure or to pain
Time Frame
Baseline, 3 weeks and 6 weeks after intervention beginning.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Achalandabaso
Organizational Affiliation
University of Jaen
Official's Role
Study Director
Facility Information:
Facility Name
Universidad de Alcalá
City
Madrid
ZIP/Postal Code
28805
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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