Back PainEffDorsManNCT02520648
Immediate Changes After Manual Therapy in Patients With Non-specific Back Pain
A study testing Neuro-lymphatic treatment, Articulatory spinal manual therapy and Articulatory costal Manual therapy in people with Back Pain, run by University of Valencia at 1 site in Spain.
Trial summary
The purpose of this trial is to investigate the immediate effects of neuro-lymphatic treatment, thoracic vertebral and costal articulatory in terms of back pain levels, cervical and dorsal flexibility, sense of body comfort and satisfaction with the treatment received. Read more about this study
- Who is it for?
- Ages 20 to 30 years
- Conditions the study is for
- Back Pain
- What is being tested?
- Neuro-lymphatic treatment, Articulatory spinal manual therapy and Articulatory costal Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2015to Apr 2016
- 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 20 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-specific Back Pain subjects between 20 and 30 years old were recruited and voluntarily participated in the study.
Who cannot join
- Excluded subjects with musculoskeletal injuries such as spine or balance disorders
- Those which were recovering from an injury of the locomotor or neurological system, or
- Those who had sequelae from any trauma suffered in the past six months that could affect the results of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Changes After Manual Therapy Techniques in Patients With Persistent Non-specific Back Pain
The purpose of this trial is to investigate the immediate effects of neuro-lymphatic treatment, thoracic vertebral and costal articulatory in terms of back pain levels, cervical and dorsal flexibility, sense of body comfort and satisfaction with the treatment received.
Read the detailed description
Subjects:
The study was conducted at the Faculty of Physiotherapy of the University of Valencia (Spain). Persistent non-specific back pain subjects between 20 and 30 years old were recruited and voluntarily participated in the study. Excluded subjects with musculoskeletal injuries such as spine or balance disorders, those which were recovering from an injury of the locomotor or neurological system, or those who had sequelae from any trauma suffered in the past six months that could affect the results of the study.
Study design:
The conducted study was an experimental, longitudinal and prospective, controlled, randomized and single-blind design (subjects and therapists didn't know the objectives of the treatment nor how many treatments were offered, evaluators were unaware of the treatments applied). There were 3 groups: a) neuro-lymphatic treatment; b) vertebral articulatory treatment; c) proximal costal articulatory treatment.
- Conditions
- Back Pain
- Being tested
- Neuro-lymphatic treatment, Articulatory spinal manual therapy, Articulatory costal Manual therapy
- Keywords
- Back pain, Manual therapy
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro-lymphatic treatmentOther
The physical therapist applied direct firm rotary pressure, via thumb or tip finger, for 1 minute, from the transverse processes of T1 to the transverse processes of T12. To finish the intervention, hands were placed on the skull and sacrum during 2 minutes without movement.
Articulatory spinal manual therapyOther
Then the therapist performs pressures in the transverse apophysis from D1 to D12 (level of the paravertebral muscles, at a distance of 2 fingers of the spinous apophysis), applying sustained pressure during expiratory time until the articulatory barrier is reached.
Articulatory costal Manual therapyOther
The therapist performs costal-vertebral articulatory movement, from 1st to 12th rib (level of the outside paravertebral muscles, at a distance of 4 fingers from the spinous apophysis on the back of the costal body) applying a sustained pressure during expiratory time and promoting its biomechanics, up to the articulatory barrier.
| Study group | Role | What they receive |
|---|---|---|
| Neuro-lymphatic treatment | Active comparator | Participants were positioned in prone, with the head in neutral position and the arms beside the body. They were asked to perform conscious breathing. The physical therapist applied direct firm rotary pressure, via thumb or tip finger, for 1 minute, from the transverse processes of T1 to the transverse processes of T12. To finish the intervention, hands were placed on the skull and sacrum during 2 minutes without movement. Neuro-lymphatic reflexes as referred to applied kinesiology, are locations on the body that are believed to affect a specific muscle and organ. Duration of the treatment is 15 minutes. Receives: Other: Neuro-lymphatic treatment |
| Articulatory spinal manual therapy. | Experimental | Then the therapist performs pressures in the transverse apophysis from D1 to D12 (level of the paravertebral muscles, at a distance of 2 fingers of the spinous apophysis), applying sustained pressure during expiratory time until the articulatory barrier is reached. Three repetitions are performed at each vertebral level. It is done bilaterally, then longitudinal pressures are applied on dorsal vertebrae during expiratory time, 3 repetitions. It ends like treatment 1. This technique aims to normalize possible slight dysfunctions of the spine, enhance the feeling of comfort and pain, and relax the spine. Duration of the treatment is 15 minutes. Receives: Other: Articulatory spinal manual therapy |
| Articulatory costal Manual therapy. | Experimental | The therapist performs costal-vertebral articulatory movement, from 1st to 12th rib (level of the outside paravertebral muscles, at a distance of 4 fingers from the spinous apophysis on the back of the costal body) applying a sustained pressure during expiratory time and promoting its biomechanics, up to the articulatory barrier. Three repetitions are performed at each costal level. It is done bilaterally, then longitudinal pressures are applied on dorsal vertebrae during expiratory time, 3 repetitions. It ends like treatment 1. This technique aims to normalize the mobility of the ribs, enhance the feeling of comfort and pain, and relax the spine. Duration of the treatment is 15 minutes. Receives: Other: Articulatory costal Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical flexion
Cervical movement was evaluated with cervical goniometer. The Cervical Range of Motion (CROM) system combines inclinometers and magnets arranged on a head support and also supported on the nose bone.
Measured: 15 minutes after treatment
Cervical extension
Global cervical movement was evaluated with cervical goniometer. The Cervical Range of Motion (CROM) system combines inclinometers and magnets arranged on a head support and also supported on the nose bone.
Measured: 15 minutes after treatment
Cervical inclination
Global cervical movement on both sides was evaluated with cervical goniometer. The Cervical Range of Motion (CROM) system combines inclinometers and magnets arranged on a head support and also supported on the nose bone.
Measured: 15 minutes after treatment
Cervical rotation
Global cervical movement on both sides was evaluated with cervical goniometer. The Cervical Range of Motion (CROM) system combines inclinometers and magnets arranged on a head support and also supported on the nose bone.
Measured: 15 minutes after treatment
Test sit-and-reach
Test sit-and-reach or finger-floor distance. The subject remains standing on a box designed for this purpose, leaving the arms and trunk relaxed. In this position the subject flexes the trunk forward and maintains its maximum flexion for 3 seconds. This is repeated and the most favorable is measured. There is a vertical scale with a range of 50 cm (25 cm negative and 25cm positive). The evaluator is placed next to the scale and records the furthest measure touched by the fingertips of both hands. If the hands reach different measures, the shortest is recorded.
Measured: 15 minutes after treatment
Secondary outcomes (3)
Satisfaction / comfort
Two questionnaires were used. They were designed for this purpose and adapted. They included assessment of sense of wellbeing and comfort on 7 different body areas through a 10 cm scale where 0 is absolute discomfort and 10 full comfort. Subsequently, 16 affirmations were included (to be confirmed), of which 4 are inverted which are scored with a Likert scale of 1 to 5.
Measured: 15 minutes after treatment
McGill pain perception
The McGill Pain Questionnaire (MPQ) evaluates quantitatively three dimensions of pain. This questionnaire evaluates quantitative and qualitative aspects of pain, such as location, quality, intensity and temporal characteristics. They are gathered into several categories which in turn form four large groups: sensory, emotional, evaluative and miscellaneous.
Measured: 15 minutes after treatment
Patient global impression of change scale
the Patient global impression of change scale, it has 7 affirmations to choose from and a pain analogue scale of 10 cm. (Hurst H and J Bolton). This questionnaire was passed only after treatment.
Measured: 15 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
- Investigators
- G V Espí-López, P, Study director, Department of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520648
- Sponsor's protocol ID
- ID009
- Acronym
- EffDorsMan
- Status last verified
- Apr 2016
- First submitted
- 4 Aug 2015
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Martinez-Segura R, Fernandez-de-las-Penas C, Ruiz-Saez M, Lopez-Jimenez C, Rodriguez-Blanco C. Immediate effects on neck pain and active range of motion after a single cervical high-velocity low-amplitude manipulation in subjects presenting with mechanical neck pain: a randomized controlled trial. J Manipulative Physiol Ther. 2006 Sep;29(7):511-7. doi: 10.1016/j.jmpt.2006.06.022.
PubMed 16949939Bicalho E, Setti JA, Macagnan J, Cano JL, Manffra EF. Immediate effects of a high-velocity spine manipulation in paraspinal muscles activity of nonspecific chronic low-back pain subjects. Man Ther. 2010 Oct;15(5):469-75. doi: 10.1016/j.math.2010.03.012. Epub 2010 May 5.
PubMed 20447857
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Changes After Manual Therapy Techniques in Patients With Persistent Non-specific Back Pain
- ClinicalTrials.gov ID
- NCT02520648
- Acronym / sponsor ID
- EffDorsMan / ID009
- Conditions
- Back Pain
- Keywords
- Back pain, Manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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 purpose of this trial is to investigate the immediate effects of neuro-lymphatic treatment, thoracic vertebral and costal articulatory in terms of back pain levels, cervical and dorsal flexibility, sense of body comfort and satisfaction with the treatment received.
Detailed description
Subjects:
The study was conducted at the Faculty of Physiotherapy of the University of Valencia (Spain). Persistent non-specific back pain subjects between 20 and 30 years old were recruited and voluntarily participated in the study. Excluded subjects with musculoskeletal injuries such as spine or balance disorders, those which were recovering from an injury of the locomotor or neurological system, or those who had sequelae from any trauma suffered in the past six months that could affect the results of the study.
Study design:
The conducted study was an experimental, longitudinal and prospective, controlled, randomized and single-blind design (subjects and therapists didn't know the objectives of the treatment nor how many treatments were offered, evaluators were unaware of the treatments applied). There were 3 groups: a) neuro-lymphatic treatment; b) vertebral articulatory treatment; c) proximal costal articulatory treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuro-lymphatic treatment | Active comparator | Other: Neuro-lymphatic treatmentParticipants were positioned in prone, with the head in neutral position and the arms beside the body. They were asked to perform conscious breathing. The physical therapist applied direct firm rotary pressure, via thumb or tip finger, for 1 minute, from the transverse processes of T1 to the transverse processes of T12. To finish the intervention, hands were placed on the skull and sacrum during 2 minutes without movement. Neuro-lymphatic reflexes as referred to applied kinesiology, are locations on the body that are believed to affect a specific muscle and organ. Duration of the treatment is 15 minutes. |
| Articulatory spinal manual therapy. | Experimental | Other: Articulatory spinal manual therapyThen the therapist performs pressures in the transverse apophysis from D1 to D12 (level of the paravertebral muscles, at a distance of 2 fingers of the spinous apophysis), applying sustained pressure during expiratory time until the articulatory barrier is reached. Three repetitions are performed at each vertebral level. It is done bilaterally, then longitudinal pressures are applied on dorsal vertebrae during expiratory time, 3 repetitions. It ends like treatment 1. This technique aims to normalize possible slight dysfunctions of the spine, enhance the feeling of comfort and pain, and relax the spine. Duration of the treatment is 15 minutes. |
| Articulatory costal Manual therapy. | Experimental | Other: Articulatory costal Manual therapyThe therapist performs costal-vertebral articulatory movement, from 1st to 12th rib (level of the outside paravertebral muscles, at a distance of 4 fingers from the spinous apophysis on the back of the costal body) applying a sustained pressure during expiratory time and promoting its biomechanics, up to the articulatory barrier. Three repetitions are performed at each costal level. It is done bilaterally, then longitudinal pressures are applied on dorsal vertebrae during expiratory time, 3 repetitions. It ends like treatment 1. This technique aims to normalize the mobility of the ribs, enhance the feeling of comfort and pain, and relax the spine. Duration of the treatment is 15 minutes. |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Non-specific Back Pain subjects between 20 and 30 years old were recruited and voluntarily participated in the study.
Key exclusion criteria (3 listed)
- Excluded subjects with musculoskeletal injuries such as spine or balance disorders
- Those which were recovering from an injury of the locomotor or neurological system, or
- Those who had sequelae from any trauma suffered in the past six months that could affect the results of the study.
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 |
|---|---|---|
| Neuro-lymphatic treatmentThe physical therapist applied direct firm rotary pressure, via thumb or tip finger, for 1 minute, from the transverse processes of T1 to the transverse processes of T12. To finish the intervention, hands were placed on the skull and sacrum during 2 minutes without movement. | Other | Neuro-lymphatic treatment |
| Articulatory spinal manual therapyThen the therapist performs pressures in the transverse apophysis from D1 to D12 (level of the paravertebral muscles, at a distance of 2 fingers of the spinous apophysis), applying sustained pressure during expiratory time until the articulatory barrier is reached. | Other | Articulatory spinal manual therapy. |
| Articulatory costal Manual therapyThe therapist performs costal-vertebral articulatory movement, from 1st to 12th rib (level of the outside paravertebral muscles, at a distance of 4 fingers from the spinous apophysis on the back of the costal body) applying a sustained pressure during expiratory time and promoting its biomechanics, up to the articulatory barrier. | Other | Articulatory costal Manual therapy. |
Primary outcome
Cervical flexion
Time frame: 15 minutes after treatment
Cervical movement was evaluated with cervical goniometer. The Cervical Range of Motion (CROM) system combines inclinometers and magnets arranged on a head support and also supported on the nose bone.
Cervical extension
Time frame: 15 minutes after treatment
Global cervical movement was evaluated with cervical goniometer. The Cervical Range of Motion (CROM) system combines inclinometers and magnets arranged on a head support and also supported on the nose bone.
Cervical inclination
Time frame: 15 minutes after treatment
Global cervical movement on both sides was evaluated with cervical goniometer. The Cervical Range of Motion (CROM) system combines inclinometers and magnets arranged on a head support and also supported on the nose bone.
Cervical rotation
Time frame: 15 minutes after treatment
Global cervical movement on both sides was evaluated with cervical goniometer. The Cervical Range of Motion (CROM) system combines inclinometers and magnets arranged on a head support and also supported on the nose bone.
Test sit-and-reach
Time frame: 15 minutes after treatment
Test sit-and-reach or finger-floor distance. The subject remains standing on a box designed for this purpose, leaving the arms and trunk relaxed. In this position the subject flexes the trunk forward and maintains its maximum flexion for 3 seconds. This is repeated and the most favorable is measured. There is a vertical scale with a range of 50 cm (25 cm negative and 25cm positive). The evaluator is placed next to the scale and records the furthest measure touched by the fingertips of both hands. If the hands reach different measures, the shortest is recorded.
3 secondary outcomes
Satisfaction / comfort
Time frame: 15 minutes after treatment
McGill pain perception
Time frame: 15 minutes after treatment
Patient global impression of change scale
Time frame: 15 minutes after treatment
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 May 2016.
- Results publication: PubMed 16949939Martinez-Segura R, Fernandez-de-las-Penas C, Ruiz-Saez M, Lopez-Jimenez C, Rodriguez-Blanco C. Immediate effects on neck pain and active range of motion after a single cervical high-velocity low-amplitude manipulation in subjects presenting with mechanical neck pain: a randomized controlled trial. J Manipulative Physiol Ther. 2006 Sep;29(7):511-7. doi: 10.1016/j.jmpt.2006.06.022.
- Results publication: PubMed 20447857Bicalho E, Setti JA, Macagnan J, Cano JL, Manffra EF. Immediate effects of a high-velocity spine manipulation in paraspinal muscles activity of nonspecific chronic low-back pain subjects. Man Ther. 2010 Oct;15(5):469-75. doi: 10.1016/j.math.2010.03.012. Epub 2010 May 5.
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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.
G V Espí-López, P study director
Department of Physiotherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro-lymphatic treatment, Articulatory spinal manual therapy and Articulatory costal Manual therapy in people with Back Pain, run by University of Valencia 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 3 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 May 2016. 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?
Cervical flexion (time frame: 15 minutes after treatment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02520648, which also lists 2 linked publications.
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 May 2016.