Effectiveness Comparison of Thoracic Thrust Manipulation in People With Neck or Low Back Pain

October 27, 2021 updated by: Alexander Achalandabaso, University of Jaén

Comparison of the Effectiveness of the Thoracic Thrust Manipulation in People With Neck or Low Back Pain

Objective:

To compare the effectiveness of thoracic thrust manipulation, together with massages techniques and stretching, between people with neck pain versus people with low back pain.

Methods:

The research will be performed from August 2021 to October 2021 at the University of Alcala de Henares. (Madrid)

A minimum of forty-six (46) volunteers will participate in this research, and they will be divided in two groups of twenty-three (23). One group will be formed by candidates suffering from neck pain (group A) and the other one by candidate with low back pain (group B).

Both groups will receive the same treatment and specific stretching exercises as applicable in accordance to the pain area, e.g.: group A will get the massage and the stretching exercises more suitable for the neck pain and group B the same but for the low back pain. Nevertheless both groups will receive the same technical thrust manipulation in thoracic area.

All these treatments will be applied of the volunteers at the University of Alcalá.

The treatment includes the following activities:

  1. Twenty (20) minutes massage in the pain area, as applicable.
  2. Technical thrust manipulation in thoracic area.
  3. Ten (10) minutes stretching in accordance to the pain area treated. The stretching shall be repeated twice a week by each volunteer.

A total of six (6) sessions will be carried out during six (6) weeks, one session per week.

Pain, disability, kinesiophobia, HRQoL will be assessed as follow:

  1. Before first session. (In this evaluation will be also analyzed demographic variables i.e.: height, weight, age, gender, academic level, smoker/no smoker)
  2. Between third and fourth session.
  3. After sixth session.
  4. Four weeks after sixth session.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Alcalá De Henares, Madrid, Spain, 28801
        • Alicia Masip

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Age between 18 and 65 years
  • Non-specific neck/low back pain for the last three (3) months before the first session.

Exclusion Criteria:

  • Previous surgery in the areas covered by this research (neck and/or low back)
  • Red flags: Cancer or tumor, fracture...
  • Scoliosis or osteoporosis
  • Neck or low back pain with radiculopathy symptoms
  • Central nervous system involvement
  • Fear to manipulation
  • Neck pain associated with whiplash injuries on the last six (6) months
  • Pregnant women
  • Not understand, write and speak Spanish fluently

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A group: neck pain
Other: Massage and stretching on neck area and thoracic thrust manipulation
  1. Twenty (20) minutes massage in the neck area. The volunteer will be in prone position during the massage.
  2. Technical thrust manipulation in thoracic area. For this technique the volunteer will be in supine position with their arms folded on the chest (making a "V"). The therapist will locate one hand on the spinous processes to be treated, and the other one on the arms of the patient to make easier the manipulation.
  3. Ten (10) minutes specific stretching for the neck area. These stretching exercises shall be repeated twice a week by each volunteer. Stretching will be made on the trapezius superior, musculus levator scapulae and sternocleidomastoideus holding the position thirty (30) seconds. Each muscle stretch shall be repeated three times.
Experimental: B group: low back pain
Other: Massage and stretching on low back area and thoracic thrust manipulation
  1. Twenty (20) minutes massage in the low back area. The volunteer will be in prone position during the massage.
  2. Technical thrust manipulation in thoracic area. For this technique the volunteer will be in supine position with their arms folded on the chest (making a "V"). The therapist will locate one hand on the spinous processes to be treated, and the other one on the arms of the patient to make easier the manipulation.
  3. Ten (10) minutes specific stretching for the low back area. These stretching exercises shall be repeated twice a week by each volunteer. Stretching activities will be: cat-cow pose, lower back stretches and knee twist holding the position thirty (30) seconds. Each muscle stretch shall be repeated three times.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neck and Low Back Pain
Time Frame: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
using a Visual Analogue Scale (VAS) from 0 to 10
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neck Pain related disability
Time Frame: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Using the Neck Disability Index (NID) Questionnaire
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Change in Health related quality of life (HRQoL)
Time Frame: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Using the SF-12 Quality of Life Questionnaire
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Change in kinesiophobia
Time Frame: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Using the fear avoidance beliefs (FAB) questionnaire
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Change in Low Back Pain related disability
Time Frame: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Using the Oswestry Disability Index (ODI) Questionnaire
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jaén

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2021

Primary Completion (Actual)

September 29, 2021

Study Completion (Actual)

October 27, 2021

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

July 29, 2021

Study Record Updates

Last Update Posted (Actual)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alcalá

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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