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

Sponsor
University of Jaén (Other)
Overall Status
Completed
CT.gov ID
NCT04981574
Collaborator
(none)
60
1
2
2.8
21.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Massage and stretching on neck area and thoracic thrust manipulation
  • Other: Massage and stretching on low back area and thoracic thrust manipulation
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
It is a controlled clinical trial with parallel groupsIt is a controlled clinical trial with parallel groups
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effectiveness of the Thoracic Thrust Manipulation in People With Neck or Low Back Pain
Actual Study Start Date :
Aug 4, 2021
Actual Primary Completion Date :
Sep 29, 2021
Actual Study Completion Date :
Oct 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: A group: neck pain

Other: Massage and stretching on neck area and thoracic thrust manipulation
Twenty (20) minutes massage in the neck area. The volunteer will be in prone position during the massage. 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. 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
Twenty (20) minutes massage in the low back area. The volunteer will be in prone position during the massage. 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. 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.

Outcome Measures

Primary Outcome Measures

  1. Change in Neck and Low Back Pain [Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement]

    using a Visual Analogue Scale (VAS) from 0 to 10

Secondary Outcome Measures

  1. Change in Neck Pain related disability [Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement]

    Using the Neck Disability Index (NID) Questionnaire

  2. Change in Health related quality of life (HRQoL) [Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement]

    Using the SF-12 Quality of Life Questionnaire

  3. Change in kinesiophobia [Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement]

    Using the fear avoidance beliefs (FAB) questionnaire

  4. Change in Low Back Pain related disability [Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement]

    Using the Oswestry Disability Index (ODI) Questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alicia Masip Alcalá De Henares Madrid Spain 28801

Sponsors and Collaborators

  • University of Jaén

Investigators

  • Study Director: Alexander Achalandabaso, University of Jaén

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexander Achalandabaso, Principal investigator, University of Jaén
ClinicalTrials.gov Identifier:
NCT04981574
Other Study ID Numbers:
  • Alcalá
First Posted:
Jul 29, 2021
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alexander Achalandabaso, Principal investigator, University of Jaén
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 28, 2021