Neck PainNCT04981574
Effectiveness Comparison of Thoracic Thrust Manipulation in People With Neck or Low Back Pain
A study testing Massage and stretching on neck area and thoracic thrust manipulation and Massage and stretching on low back area and thoracic thrust manipulation in people with Neck Pain and Low Back Pain, run by University of Jaén at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neck Pain, Low Back Pain
- What is being tested?
- Massage and stretching on neck area and thoracic thrust manipulation and Massage and stretching on low back area and thoracic thrust manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 4 Aug 2021to 27 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years
- Non-specific neck/low back pain for the last three (3) months before the first session.
Who cannot join
- 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
Show all 9Show fewer
- Neck pain associated with whiplash injuries on the last six (6) months
- Pregnant women
- Not understand, write and speak Spanish fluently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Neck Pain, Low Back Pain
- Being tested
- Massage and stretching on neck area and thoracic thrust manipulation, Massage and stretching on low back area and thoracic thrust manipulation
- Keywords
- neck pain, low back pain, spinal manipulation, acute pain
- Medical subject headings
- Neck Pain, Low Back Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage and stretching on neck area and thoracic thrust manipulationOther
- 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.
Massage and stretching on low back area and thoracic thrust manipulationOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| A group: neck pain | Experimental | Not described Receives: Other: Massage and stretching on neck area and thoracic thrust manipulation |
| B group: low back pain | Experimental | Not described Receives: Other: Massage and stretching on low back area and thoracic thrust manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Neck and Low Back Pain
using a Visual Analogue Scale (VAS) from 0 to 10
Measured: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Secondary outcomes (4)
Change in Neck Pain related disability
Using the Neck Disability Index (NID) Questionnaire
Measured: 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
Measured: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Change in kinesiophobia
Using the fear avoidance beliefs (FAB) questionnaire
Measured: 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
Measured: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start4 Aug 2021
- Primary completion29 Sep 2021
- Study completion27 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- It is a controlled clinical trial with parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Achalandabaso, University of Jaén
- Investigators
- Alexander Achalandabaso, Study director, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981574
- Sponsor's protocol ID
- Alcalá
- Status last verified
- Oct 2021
- First submitted
- 7 Jul 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of the Thoracic Thrust Manipulation in People With Neck or Low Back Pain
- ClinicalTrials.gov ID
- NCT04981574
- Acronym / sponsor ID
- Alcalá
- Conditions
- Neck Pain, Low Back Pain
- Keywords
- neck pain, low back pain, spinal manipulation, acute pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 27 Oct 2021 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It is a controlled clinical trial with parallel groups
| Arm | Type | Receives |
|---|---|---|
| A group: neck pain | Experimental | Other: Massage and stretching on neck area and thoracic thrust manipulation |
| B group: low back pain | Experimental | Other: Massage and stretching on low back area and thoracic thrust manipulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 65 years
- Non-specific neck/low back pain for the last three (3) months before the first session.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage and stretching on neck area and thoracic thrust manipulation1. 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. | Other | A group: neck pain |
| Massage and stretching on low back area and thoracic thrust manipulation1. 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. | Other | B group: low back pain |
Primary outcome
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
4 secondary outcomes
Change in Neck Pain related disability
Time frame: 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
Change in kinesiophobia
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Achalandabaso study director
University of Jaén
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage and stretching on neck area and thoracic thrust manipulation and Massage and stretching on low back area and thoracic thrust manipulation in people with Neck Pain and Low Back Pain, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neck and Low Back Pain (time frame: Baseline, 3 weeks, 6 weeks, and 10 weeks after intervention commencement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2021; AzTrials last refreshed its copy on 6 Nov 2026.