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

Primary Purpose

Neck Pain, Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Massage and stretching on neck area and thoracic thrust manipulation
Massage and stretching on low back area and thoracic thrust manipulation
Sponsored by
University of Jaén
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring neck pain, low back pain, spinal manipulation, acute pain

Eligibility Criteria

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

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

Sites / Locations

  • Alicia Masip

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A group: neck pain

B group: low back pain

Arm Description

Outcomes

Primary Outcome Measures

Change in Neck and Low Back Pain
using a Visual Analogue Scale (VAS) from 0 to 10

Secondary Outcome Measures

Change in Neck Pain related disability
Using the Neck Disability Index (NID) Questionnaire
Change in Health related quality of life (HRQoL)
Using the SF-12 Quality of Life Questionnaire
Change in kinesiophobia
Using the fear avoidance beliefs (FAB) questionnaire
Change in Low Back Pain related disability
Using the Oswestry Disability Index (ODI) Questionnaire

Full Information

First Posted
July 7, 2021
Last Updated
October 27, 2021
Sponsor
University of Jaén
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1. Study Identification

Unique Protocol Identification Number
NCT04981574
Brief Title
Effectiveness Comparison of Thoracic Thrust Manipulation in People With Neck or Low Back Pain
Official Title
Comparison of the Effectiveness of the Thoracic Thrust Manipulation in People With Neck or Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 4, 2021 (Actual)
Primary Completion Date
September 29, 2021 (Actual)
Study Completion Date
October 27, 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
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: Twenty (20) minutes massage in the pain area, as applicable. Technical thrust manipulation in thoracic area. 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: Before first session. (In this evaluation will be also analyzed demographic variables i.e.: height, weight, age, gender, academic level, smoker/no smoker) Between third and fourth session. After sixth session. Four weeks after sixth session.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Low Back Pain
Keywords
neck pain, low back pain, spinal manipulation, acute pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
It is a controlled clinical trial with parallel groups
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A group: neck pain
Arm Type
Experimental
Arm Title
B group: low back pain
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Massage and stretching on neck area and thoracic thrust manipulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Massage and stretching on low back area and thoracic thrust manipulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Neck and Low Back Pain
Description
using a Visual Analogue Scale (VAS) from 0 to 10
Time Frame
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Secondary Outcome Measure Information:
Title
Change in Neck Pain related disability
Description
Using the Neck Disability Index (NID) Questionnaire
Time Frame
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Title
Change in Health related quality of life (HRQoL)
Description
Using the SF-12 Quality of Life Questionnaire
Time Frame
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Title
Change in kinesiophobia
Description
Using the fear avoidance beliefs (FAB) questionnaire
Time Frame
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Title
Change in Low Back Pain related disability
Description
Using the Oswestry Disability Index (ODI) Questionnaire
Time Frame
Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Achalandabaso
Organizational Affiliation
University of Jaén
Official's Role
Study Director
Facility Information:
Facility Name
Alicia Masip
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28801
Country
Spain

12. IPD Sharing Statement

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

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