Low Back Pain, MechanicalNCT04384185
Combined Treatment of Manual Therapy and Therapeutic Exercise in Patients With Low Back Pain
A study testing Exercise protocol and Manual therapy in people with Low Back Pain, Mechanical and Musculoskeletal Manipulations, run by University of Alcala at 1 site in Spain.
Trial summary
MAIN OBJECTIVE: to assess whether an exercise protocol on the lumbar musculature by adding manual therapy techniques on the diaphragm muscle has the same or greater effect on chronic non-specific lumbar pain than an isolated exercise protocol. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Low Back Pain, Mechanical, Musculoskeletal Manipulations, Exercise Training
- What is being tested?
- Exercise protocol and Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 15 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Legal age
- Non-specific Low-Back pain
- Pain more 3 months
Who cannot join
- subjects with lumbar herniation.
- Spine canal stenosis
- Subjects with neurological disease.
- Lumbar surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Therapeutic Exercise Protocol Combined With Manual Therapy Techniques on the Diaphragm Muscle in Patients With Low Back Pain
MAIN OBJECTIVE: to assess whether an exercise protocol on the lumbar musculature by adding manual therapy techniques on the diaphragm muscle has the same or greater effect on chronic non-specific lumbar pain than an isolated exercise protocol.
SECONDARY OBJECTIVES: to evaluate the effectiveness of a lumbar exercise protocol in chronic non-specific low back pain in isolation; To evaluate the effectiveness of both therapies in improving joint range in patients with chronic non-specific low back pain and, finally, to assess catastrophism and the avoidance of lumbar mobility when carrying out loaded movements.
HYPOTHESIS: that a lumbar exercise protocol combined with manual therapy treatment on the diaphragm is equal or more effective on pain in patients with chronic nonspecific low back pain than treatment with the same lumbar exercise protocol in isolation.
Read the detailed description
METHODOLOGY: A prospective randomized clinical trial with two types of intervention (lumbar exercise protocol and manual diaphragm therapy) will be carried out. The variables to be measured are pain, disability, mobility and kinesiophobia. It will be performed in two groups of 21 people who are of legal age, who have low back pain of more than 3 months duration and which is of non-specific origin.
The patients will be randomized and divided into two groups A (control) and B (experimental).
Group A will undergo an exercise protocol.
Group B will undergo the same protocol plus manual therapy techniques on diaphragm muscle. Study participants will have treatment twice a week for 8 weeks, the first information session and the second measurement-evaluation session in the first week of treatment. In the following 3 weeks the session will last 40 minutes for both groups. In the 4th week the established measurements will be carried out again.
- Being tested
- Exercise protocol, Manual therapy
- 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.
Exercise protocolOther
Exercises:
- Pelvic tilt.
- brinding.
- cuadruped arm/leg raise.
- Abdominal strengthening exercises.
- Low-back muscles stretching.
- The side bridge.
- Side leg separation
Manual therapyOther
Also called Myofascial manipulation
- Functional diaphragm balancing technique: gentle vertical pressure was applied for 5 minutes at the diaphragm level.
- Muscle fiber stretching technique: a cranial traction was performed from the lower edge of the costal arches during the inspiratory breathing phase, for more than 10 respiratory cycles.
- Phrenic-center inhibition technique (Figure 3C): the soft tissue was pumped during the expiratory phase by gently and simultaneously using both hands to create pressure in cranial and caudal direction, for more than 10 respiratory cycles.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Exercise therapy | Experimental | Group A: will perform an exercise protocol to improve the stability of the spine muscle of low-back Receives: Other: Exercise protocol |
| Group B. Manual therapy and exercises | Experimental | Group B: Will be treated with manual therapy in the diaphragm muscle and the same protocol of therapeutic exercise applied in group A Receives: Other: Exercise protocol; Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Low-back pain
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient with lowback pain.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and ten the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.
Measured: Change from Baseline disability at 3 months
Secondary outcomes (3)
Disability with Oswestry Disability Index
The Oswestry Disability Index (ODI) is a questionnaire used by clinicians and researchers to quantify disability for low back pain.The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible
Measured: Change from Baseline disability at 3 months
Lumbar range of motion
Mobility. It will be measured using an electronic inclinometer.The TiltMeter© -advanced level and inclinometer app is an inclinometer app of iPhone®. The investigation has demonstrated that the app possesses good to excellent reliability (ICC ≥ 0.77) and concurrent validity with a gravity-based inclinometer (r ≥ 0.86) for measuring standing isolated lumbar flexion and extension range of movement
Measured: Change from Baseline disability at 3 months
Kinesiophobia
Kinesiophobia was measured by an 11-item version of the Tampa Scale of Kinesiophobia (TSK-11). The 11 items of the scale each have 4 response options; all anchored with the answers "strongly disagree", which scores 1 point, and "strongly agree", which scores 4 points. The total sum score is calculated and can range between 11 and 44 points. A high score indicates strong fear of movement/(re)injury, i.e. high kinesiophobia. TSK-11 has been psychometrically evaluated and has shown good construct validity and reliability among older people (i.e. internal consistency (Cronbach alpha, 0.74-0.87) and test-retest reliability (ICC r = 0.747)
Measured: Change from Baseline disability at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start1 Sep 2020
- Primary completion30 Jan 2021
- Study completion15 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back Pain, MechanicalStudies 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
- Randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Daniel Pecos Martín, University of Alcala
- Investigators
- Tomas Gallego Izquierdo, PhD, Study chair, Alcala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384185
- Sponsor's protocol ID
- CEIM/HU/2020/12
- Status last verified
- Sep 2021
- First submitted
- 7 May 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Therapeutic Exercise Protocol Combined With Manual Therapy Techniques on the Diaphragm Muscle in Patients With Low Back Pain
- ClinicalTrials.gov ID
- NCT04384185
- Acronym / sponsor ID
- CEIM/HU/2020/12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 12 May 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.
MAIN OBJECTIVE: to assess whether an exercise protocol on the lumbar musculature by adding manual therapy techniques on the diaphragm muscle has the same or greater effect on chronic non-specific lumbar pain than an isolated exercise protocol.
SECONDARY OBJECTIVES: to evaluate the effectiveness of a lumbar exercise protocol in chronic non-specific low back pain in isolation; To evaluate the effectiveness of both therapies in improving joint range in patients with chronic non-specific low back pain and, finally, to assess catastrophism and the avoidance of lumbar mobility when carrying out loaded movements.
HYPOTHESIS: that a lumbar exercise protocol combined with manual therapy treatment on the diaphragm is equal or more effective on pain in patients with chronic nonspecific low back pain than treatment with the same lumbar exercise protocol in isolation.
Detailed description
METHODOLOGY: A prospective randomized clinical trial with two types of intervention (lumbar exercise protocol and manual diaphragm therapy) will be carried out. The variables to be measured are pain, disability, mobility and kinesiophobia. It will be performed in two groups of 21 people who are of legal age, who have low back pain of more than 3 months duration and which is of non-specific origin.
The patients will be randomized and divided into two groups A (control) and B (experimental).
Group A will undergo an exercise protocol.
Group B will undergo the same protocol plus manual therapy techniques on diaphragm muscle. Study participants will have treatment twice a week for 8 weeks, the first information session and the second measurement-evaluation session in the first week of treatment. In the following 3 weeks the session will last 40 minutes for both groups. In the 4th week the established measurements will be carried out again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group A: Exercise therapy | Experimental | Other: Exercise protocolGroup A: will perform an exercise protocol to improve the stability of the spine muscle of low-back |
| Group B. Manual therapy and exercises | Experimental | Other: Exercise protocol, Other: Manual therapyGroup B: Will be treated with manual therapy in the diaphragm muscle and the same protocol of therapeutic exercise applied in group A |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Legal age
- Non-specific Low-Back pain
- Pain more 3 months
Key exclusion criteria (4 listed)
- subjects with lumbar herniation.
- Spine canal stenosis
- Subjects with neurological disease.
- Lumbar surgery
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 |
|---|---|---|
| Exercise protocolExercises: * Pelvic tilt. * brinding. * cuadruped arm/leg raise. * Abdominal strengthening exercises. * Low-back muscles stretching. * The side bridge. * Side leg separation | Other | Group A: Exercise therapy, Group B. Manual therapy and exercises |
| Manual therapyAlso: Myofascial manipulation1. Functional diaphragm balancing technique: gentle vertical pressure was applied for 5 minutes at the diaphragm level. 2. Muscle fiber stretching technique: a cranial traction was performed from the lower edge of the costal arches during the inspiratory breathing phase, for more than 10 respiratory cycles. 3. Phrenic-center inhibition technique (Figure 3C): the soft tissue was pumped during the expiratory phase by gently and simultaneously using both hands to create pressure in cranial and caudal direction, for more than 10 respiratory cycles. | Other | Group B. Manual therapy and exercises |
Primary outcome
Low-back pain
Time frame: Change from Baseline disability at 3 months
The investigators use a Visual Analog Scale (VAS) to determine the intensity of the patient with lowback pain.The VAS is a 100-mm line, oriented horizontally, with one end representing "no pain" and ten the other end representing "worst pain." Subjects will be asked to rate their current pain with a mark on the scale.
3 secondary outcomes
Disability with Oswestry Disability Index
Time frame: Change from Baseline disability at 3 months
Lumbar range of motion
Time frame: Change from Baseline disability at 3 months
Kinesiophobia
Time frame: Change from Baseline disability at 3 months
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 Sep 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.
Tomas Gallego Izquierdo, PhD study chair
Alcala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise protocol and Manual therapy in people with Low Back Pain, Mechanical and Musculoskeletal Manipulations, run by University of Alcala 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 3 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 28 Sep 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?
Low-back pain (time frame: Change from Baseline disability at 3 months). 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 Sep 2021.