Chronic Low-back PainNCT04664348
Does Low Back Position Matters in Manual Therapy Treatment
A study testing Posteroanterior mobilization (neutral) and Posteroanterior mobilization (extension) in people with Chronic Low-back Pain, run by University of Jaén at 1 site in Spain.
Trial summary
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Posteroanterior mobilization (neutral) and Posteroanterior mobilization (extension)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSpain
- Study dates
- 9 Dec 2020to 30 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects with unspecific low back pain of 3 or more months of evolution prior commencement of the intervention
Who cannot join
- lumbar pain related to infectious diseases
- fractures
- oncological processes
- women in gestation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is the Positioning of the Lumbar Spine Relevant to the Manual Treatment of the Chronic Low Back Pain
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. A total of 46 subjects of legal age with non-specific chronic low back pain will be selected and randomized into two interventions.
The first group will receive lumbar posteroanterior mobilizations with the lumbar spine in extension and the second group will receive lumbar mobilizations with neutral position of the spine. Both groups will also receive a home exercise program for the lumbar spine.
Read more
The total duration of the treatments will be 6 weeks, with pre-treatment, at 3 weeks of the treatment, post-treatment evaluations at 6 weeks, with a follow-up after 1 month and with a follow-up after 3 months.
The objective will be to evaluate which of the two interventions is more effective in addressing disability variables (main variable), pressure pain threshold, pain location, pain intensity, quality of life, quality of sleep, depression and kinesiophobia.
- Conditions
- Chronic Low-back Pain
- Being tested
- Posteroanterior mobilization (neutral), Posteroanterior mobilization (extension)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posteroanterior mobilization (neutral)Other
Positioning of the patient: Prone position with the lumbar area uncovered.
Positioning of the therapist: Stand to one side of the table at the pelvis of the patient.
Explanation of the technique: The contact will be made with the hypothenar eminence on the spinous processes to be treated. The other hand of the physiotherapist will reinforce the grip to obtain greater stability and precision. It will proceed to carry out some posteroanterior pushes of the target vertebrae, in order to desensitize the chosen area. The force exerted and the speed of the technique will be controlled by the therapist. The technique will be finished when the participant let the therapist know when the pain is gone or when the patient no longer refer a decrease on its pain.
Both groups: The patient will be provided with a list of exercises focused on improving resistance to mechanical load in the lumbar region. The completion of the exercise will be in the 6 weeks of the duration of the treatment.
Posteroanterior mobilization (extension)Other
Positioning of the patient: Prone position with the lumbar area uncovered. The head of the stretcher will be raised upwards, placing progressively to extend the lumbar region, until the patient communicates the reproduction of its symptoms.
Positioning of the therapist: Stand to one side of the table at the pelvis of the patient.
Explanation of the technique: The contact will be made with the hypothenar eminence on the spinous processes to be treated. The other hand of the physiotherapist will reinforce the grip to obtain greater stability and precision. It will proceed to carry out some posteroanterior pushes of the target vertebrae, in order to desensitize the chosen area. The force exerted and the speed of the technique will be controlled by the therapist. The technique will be finished when the participant let the therapist know when the pain is gone or when the patient no longer refer a decrease on its pain.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Posteroanterior lumbar mobilization (extension of the lumbar spine) | Experimental | Not described Receives: Other: Posteroanterior mobilization (extension) |
| Experimental: Posteroanterior lumbar mobilization (lumbar spine in neutral positioning) | Experimental | Not described Receives: Other: Posteroanterior mobilization (neutral) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Disability
measured with the Oswestry Low Back Pain Disability Questionnaire. The interpretation of the scores of this scale varies from 0% to 100%.
0% to 20%: minimal disability: The patient can cope with most living activities.
21%-40%: moderate disability 41%-60%: severe disability 61%-80%: crippled 81%-100%: These patients are either bed-bound or exaggerating their symptoms.
Measured: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Secondary outcomes (8)
Changes in Pressure pain threshold
measured with a Wagner brand Force Dial with a 1 cm2 rubber disc at the end of the device.
Measured: Baseline, 3 weeks and 6 weeks after intervention commencement
Changes in Site of pain
measured with the body pain map
Measured: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Pain measured with visual analogic scale
A straight horizontal line of fixed length, usually 100 mm is drawn. The ends are defined as the extreme limits of the parameter to be measured (pain) orientated from the left (worst) to the right (best).
Measured: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Health measured with the short form health survey version II
It consists of 12 items from the 8 dimensions of the short form health survey 36: Physical Function, Function Social, Physical role, Emotional role, Mental health, Vitality, Body pain , General Health. For each of the 8 dimensions, the items are coded, aggregated and transformed into a scale that ranges from 0 (the worst state of health for that dimension) to 100 (the best state of health).
Measured: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Quality of sleep measured with the Pittsburgh Sleep Quality Index
In scoring the Pittsburgh Sleep Quality Index, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Depression measured with Beck's Depression Inventory
When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is compared to a key to determine the depression's severity. The standard cut-off scores were as follows:
0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.
Higher total scores indicate more severe depressive symptoms.
Measured: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Kinesiophobia measured with the TAMPA scale of kinesiophobia
The total score ranges between 17 and 68. A high value on the TAMPA scale of kinesiophobia indicates a high degree of kinesiophobia.
Cutoff score developed by Vlaeyen:
- score of 37 or over is considered as high
- scores below 37 is considered as low)
Measured: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Changes in Medication
The patient will be asked about how many days a week they have needed to take medication
Measured: Baseline, 3 weeks, 6 weeks, 1 month and 3 months 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 posted11 Dec 2020
- Study start9 Dec 2020
- Primary completion31 Jan 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664348
- Sponsor's protocol ID
- CEIM/HU/2020/42
- Status last verified
- Jun 2021
- First submitted
- 5 Dec 2020
- Last updated
- 10 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the Positioning of the Lumbar Spine Relevant to the Manual Treatment of the Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT04664348
- Acronym / sponsor ID
- CEIM/HU/2020/42
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 11 Dec 2020 (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.
The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcalá. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. A total of 46 subjects of legal age with non-specific chronic low back pain will be selected and randomized into two interventions.
The first group will receive lumbar posteroanterior mobilizations with the lumbar spine in extension and the second group will receive lumbar mobilizations with neutral position of the spine. Both groups will also receive a home exercise program for the lumbar spine.
The total duration of the treatments will be 6 weeks, with pre-treatment, at 3 weeks of the treatment, post-treatment evaluations at 6 weeks, with a follow-up after 1 month and with a follow-up after 3 months.
The objective will be to evaluate which of the two interventions is more effective in addressing disability variables (main variable), pressure pain threshold, pain location, pain intensity, quality of life, quality of sleep, depression and kinesiophobia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Posteroanterior lumbar mobilization (extension of the lumbar spine) | Experimental | Other: Posteroanterior mobilization (extension) |
| Experimental: Posteroanterior lumbar mobilization (lumbar spine in neutral positioning) | Experimental | Other: Posteroanterior mobilization (neutral) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects with unspecific low back pain of 3 or more months of evolution prior commencement of the intervention
Key exclusion criteria (4 listed)
- lumbar pain related to infectious diseases
- fractures
- oncological processes
- women in gestation period.
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 |
|---|---|---|
| Posteroanterior mobilization (neutral)Positioning of the patient: Prone position with the lumbar area uncovered. Positioning of the therapist: Stand to one side of the table at the pelvis of the patient. Explanation of the technique: The contact will be made with the hypothenar eminence on the spinous processes to be treated. The other hand of the physiotherapist will reinforce the grip to obtain greater stability and precision. It will proceed to carry out some posteroanterior pushes of the target vertebrae, in order to desensitize the chosen area. The force exerted and the speed of the technique will be controlled by the therapist. The technique will be finished when the participant let the therapist know when the pain is gone or when the patient no longer refer a decrease on its pain. Both groups: The patient will be provided with a list of exercises focused on improving resistance to mechanical load in the lumbar region. The completion of the exercise will be in the 6 weeks of the duration of the treatment. | Other | Experimental: Posteroanterior lumbar mobilization (lumbar spine in neutral positioning) |
| Posteroanterior mobilization (extension)Positioning of the patient: Prone position with the lumbar area uncovered. The head of the stretcher will be raised upwards, placing progressively to extend the lumbar region, until the patient communicates the reproduction of its symptoms. Positioning of the therapist: Stand to one side of the table at the pelvis of the patient. Explanation of the technique: The contact will be made with the hypothenar eminence on the spinous processes to be treated. The other hand of the physiotherapist will reinforce the grip to obtain greater stability and precision. It will proceed to carry out some posteroanterior pushes of the target vertebrae, in order to desensitize the chosen area. The force exerted and the speed of the technique will be controlled by the therapist. The technique will be finished when the participant let the therapist know when the pain is gone or when the patient no longer refer a decrease on its pain. | Other | Experimental: Posteroanterior lumbar mobilization (extension of the lumbar spine) |
Primary outcome
Changes in Disability
Time frame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
measured with the Oswestry Low Back Pain Disability Questionnaire. The interpretation of the scores of this scale varies from 0% to 100%. 0% to 20%: minimal disability: The patient can cope with most living activities. 21%-40%: moderate disability 41%-60%: severe disability 61%-80%: crippled 81%-100%: These patients are either bed-bound or exaggerating their symptoms.
8 secondary outcomes
Changes in Pressure pain threshold
Time frame: Baseline, 3 weeks and 6 weeks after intervention commencement
Changes in Site of pain
Time frame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Pain measured with visual analogic scale
Time frame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Health measured with the short form health survey version II
Time frame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Quality of sleep measured with the Pittsburgh Sleep Quality Index
Time frame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Depression measured with Beck's Depression Inventory
Time frame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Kinesiophobia measured with the TAMPA scale of kinesiophobia
Time frame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months after intervention commencement
Changes in Medication
Time frame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months 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 10 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posteroanterior mobilization (neutral) and Posteroanterior mobilization (extension) in people with Chronic 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 1 inclusion and 4 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 10 Jun 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?
Changes in Disability (time frame: Baseline, 3 weeks, 6 weeks, 1 month and 3 months 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 10 Jun 2021.