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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neck Pain, Low Back Pain

Intervention / Treatment
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* Other: Massage and stretching on neck area and thoracic thrust manipulation
* Other: Massage and stretching on low back area and thoracic thrust manipulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a controlled clinical trial with parallel groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A group: neck pain<br> | Other: Massage and stretching on neck area and thoracic thrust manipulation<br>* 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.<br>|
| Experimental: B group: low back pain<br> | Other: Massage and stretching on low back area and thoracic thrust manipulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Neck and Low Back Pain | 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 | 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) | Using the SF-12 Quality of Life Questionnaire | Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement | 
| Change in kinesiophobia | 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 | Using the Oswestry Disability Index (ODI) Questionnaire | Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neck pain, low back pain, spinal manipulation, acute pain