Clinical trial NCT04981574: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Low Back Pain
Keywords: neck pain
low back pain
spinal manipulation
acute pain
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a controlled clinical trial with parallel groups
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Neck and Low Back Pain
timeFrame: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Secondary outcomes:
measure: Change in Neck Pain related disability
timeFrame: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
measure: Change in Health related quality of life (HRQoL)
timeFrame: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
measure: Change in kinesiophobia
timeFrame: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
measure: Change in Low Back Pain related disability
timeFrame: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Alicia Masip
state: Madrid
Study officials:
affiliation: University of Jaén
name: Alexander Achalandabaso
role: STUDY_DIRECTOR
References: