Low Back PainNCT04955314
Value of Manual Therapy Specificity Referred to Pain Intensity in Patients With Subacute and Unspecified Low Back Pain
A study testing PA vertebral mobilization in people with Low Back Pain, run by University of Jaén at 1 site in Spain.
Trial summary
This study proves the specificity of manual therapy in unspecified an subacute low back pain Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- PA vertebral mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- 11 May 2021to 25 Sep 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
- People aged between 18 and 65 years old with unspecific and subacute low back pain.
- Participants must be capable of walking twice a week 20 minutes per day.
Who cannot join
- People with history of spinal surgeries, osteoporosis and tumor.
- Pregnant and people with severe respiratory and cardiac illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Importance of Manual Therapy Specificity Referred to Pain Intensity in Patients With Subacute and Unspecified Low Back Pain
This study proves the specificity of manual therapy in unspecified an subacute low back pain
Read the detailed description
The purpose of the study is to determine the importance of manual therapy specificity in relation to subacute low back pain.
In order to do this, it will be selected a sample of at least 48 people who suffer low back pain whose duration has not exceeded 12 weeks. Patients will be divided into two groups and a different physiotherapist from the one who will subsequently perform the intervention, will assess and determine which is the most painful segment in each of them.
In the first group, the intervention to be carried out will be through posteroanterior (PA) vertebral mobilizations in the most painful lumbar segment. The members of the second group will undergo this same technique on a painful segment of the region adjacent to the one they have referred as the main source of pain.
Each of these sessions will continue until the patient's symptoms have decreased two points on the numerical scale of pain. There will be one session per week, for six weeks.
To determine the differences between the two groups, there will be carried out 4 measurements of pain, functional disability, quality of life and kinesiophobia, and 3 measurements of pressure pain threshold were performed. Each one of them will be carried out in the first session, in the third week of treatment, in the last session of the treatment and one month after the end of the treatment. The last measeurement will be executed online and that is why the pressure pain threshold will be measured three times while the rest will be do it.
The hypothesis is that it won´t be differences in the amount of pain between the tratment on the main painful segment and the treatment on his adyacent segment.
- Conditions
- Low Back Pain
- Being tested
- PA vertebral mobilization
- Keywords
- low back pain, subacute, manual therapy, PA, mobilization, manipulation
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PA vertebral mobilizationOther
A PA mobilization is a technique in which one vertebra slides over another due to a force applied with the hands of the physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| PA mobilizations on their main painfull vertebral segment | Experimental | Patients who will be treated with PA mobilizations on their main painfull vertebral segment. Receives: Other: PA vertebral mobilization |
| PA mobilizations on an adjacent vertebral segment from the most painful | Experimental | Patients who will be treated with PA mobilizations on an adjacent vertebral segment from the most painful. Receives: Other: PA vertebral mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity
Using Numeric Pain Rating Scale (NPRS). In this scale patients rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)
Measured: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Secondary outcomes (4)
Change in Health related quality of life
Using SF-36.This scale is made up of 36 items divided into 8 sections. The result can range from 0 to 100, where 0 is the worst possible health condition and 100 is the best one.
Measured: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Change in Kinesiophobia
Using the tampa scale for kinesiophobia-11 (TSK-11) to measure fear of movement, pain and injury relapse. The result can range from 11-44 points where higher scores indicate greater fear of pain, movement, and injury.
Measured: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Change in Disability
Using Oswestry Disability Index (ODI).The final score of this scale ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound
Measured: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Change in Pressure Pain Threshold
Using an Algometer. This is an instrument for measuring sensitivity to pressure or to pain
Measured: Baseline, 3 weeks and 6 weeks after intervention beginning.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start11 May 2021
- Primary completion25 Aug 2021
- Study completion25 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be divided into two groups and a different physiotherapist from the one who will subsequently perform the intervention will assess and determine which is the most painful segment in each of them. In the first of the groups, the intervention to be carried out will be through posteroanterior vertebral mobilizations in the most painful lumbar segment. The members of the second group will undergo this same technique on a painful segment of the region adjacent to the one they have referred as the main source of pain.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 48 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 Jaen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955314
- Sponsor's protocol ID
- CEIM/HU/2020/6/56
- Status last verified
- Dec 2021
- First submitted
- 2 Jun 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Manual Therapy Specificity Referred to Pain Intensity in Patients With Subacute and Unspecified Low Back Pain
- ClinicalTrials.gov ID
- NCT04955314
- Acronym / sponsor ID
- CEIM/HU/2020/6/56
- Conditions
- Low Back Pain
- Keywords
- low back pain, subacute, manual therapy, PA, mobilization, manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Sep 2021 (actual)
- First posted
- 8 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.
This study proves the specificity of manual therapy in unspecified an subacute low back pain
Detailed description
The purpose of the study is to determine the importance of manual therapy specificity in relation to subacute low back pain.
In order to do this, it will be selected a sample of at least 48 people who suffer low back pain whose duration has not exceeded 12 weeks. Patients will be divided into two groups and a different physiotherapist from the one who will subsequently perform the intervention, will assess and determine which is the most painful segment in each of them.
In the first group, the intervention to be carried out will be through posteroanterior (PA) vertebral mobilizations in the most painful lumbar segment. The members of the second group will undergo this same technique on a painful segment of the region adjacent to the one they have referred as the main source of pain.
Each of these sessions will continue until the patient's symptoms have decreased two points on the numerical scale of pain. There will be one session per week, for six weeks.
To determine the differences between the two groups, there will be carried out 4 measurements of pain, functional disability, quality of life and kinesiophobia, and 3 measurements of pressure pain threshold were performed. Each one of them will be carried out in the first session, in the third week of treatment, in the last session of the treatment and one month after the end of the treatment. The last measeurement will be executed online and that is why the pressure pain threshold will be measured three times while the rest will be do it.
The hypothesis is that it won´t be differences in the amount of pain between the tratment on the main painful segment and the treatment on his adyacent segment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- The patients will be divided into two groups and a different physiotherapist from the one who will subsequently perform the intervention will assess and determine which is the most painful segment in each of them. In the first of the groups, the intervention to be carried out will be through posteroanterior vertebral mobilizations in the most painful lumbar segment. The members of the second group will undergo this same technique on a painful segment of the region adjacent to the one they have referred as the main source of pain.
| Arm | Type | Receives |
|---|---|---|
| PA mobilizations on their main painfull vertebral segment | Experimental | Other: PA vertebral mobilizationPatients who will be treated with PA mobilizations on their main painfull vertebral segment. |
| PA mobilizations on an adjacent vertebral segment from the most painful | Experimental | Other: PA vertebral mobilizationPatients who will be treated with PA mobilizations on an adjacent vertebral segment from the most painful. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People aged between 18 and 65 years old with unspecific and subacute low back pain.
- Participants must be capable of walking twice a week 20 minutes per day.
Key exclusion criteria (2 listed)
- People with history of spinal surgeries, osteoporosis and tumor.
- Pregnant and people with severe respiratory and cardiac illness.
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 |
|---|---|---|
| PA vertebral mobilizationA PA mobilization is a technique in which one vertebra slides over another due to a force applied with the hands of the physiotherapist | Other | PA mobilizations on an adjacent vertebral segment from the most painful, PA mobilizations on their main painfull vertebral segment |
Primary outcome
Change in Pain intensity
Time frame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Using Numeric Pain Rating Scale (NPRS). In this scale patients rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)
4 secondary outcomes
Change in Health related quality of life
Time frame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Change in Kinesiophobia
Time frame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Change in Disability
Time frame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.
Change in Pressure Pain Threshold
Time frame: Baseline, 3 weeks and 6 weeks after intervention beginning.
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 3 Jan 2022.
- Individual participant dataSharing planned: No
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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 Jaen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PA vertebral mobilization in people with 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 2 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 3 Jan 2022. 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 Pain intensity (time frame: Baseline, 3 weeks, 6 weeks and 10 weeks after intervention beginning.). 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 3 Jan 2022.