Neck PainNCT05085600
Effects of a Single Manual Therapy-Exercise Versus Exercise Session in Patients With Chronic Neck Pain
A study testing Exercise and Manual Therapy + Exercise in people with Neck Pain, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Chronic neck pain is described as pain located between the occiput and the third thoracic vertebra that persists for more than 3 months. Chronic neck pain is one of the biggest musculoskeletal health problem in industrialized countries, representing 14.6% of all such problems today. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Exercise and Manual Therapy + Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 20 Oct 2021to 1 Dec 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 diagnosed with chronic neck pain
- More than 18 years old
- Loss of mobility in one or more upper cervical spine segments found through manual assessment according to Zito et al. (2006) and Kaltenborn (2012).
- A positive result in the Flexion rotation-test in the upper cervical spine (less than 32º or a difference of 10º or more between the two rotations.
- Not being able to exceed 24 mmHg in the cranio-cervical flexion test.
- Signing the informed consent.
Who cannot join
- Contraindication to manual therapy or exercise (pathological changes due to neoplasm, inflammation infections, osteopenia, congenital collagenous compromise syndromes "Down´s, Ehlers-Danlos, Grisel, Morquio"
- Marked degeneration of the cervical spine that may affect cervical spine ligament integrity.
- History of trauma to cervical vessels.
- Anticoagulant therapy or blood clotting disorders or to have participated in any program of exercises or manual therapy treatments designed to improve the performance of the cervical region in the previous 3 months.
- Post-traumatic neck pain or red flags according to Rushton et al.
- Inability to maintain the supine position, use of pacemakers, an inability to perform the flexion rotation-test
- Language difficulties that hinder understanding of informed consent or completion of the questionnaires necessary for this study.
- Subjects with litigation or lawsuits pending
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
Official title: Effects of a Single Manual Therapy-Exercise Versus Exercise Session in Patients With Chronic Neck Pain and Upper Cervical Spine Dysfunction. Randomized Controlled Trial
Chronic neck pain is described as pain located between the occiput and the third thoracic vertebra that persists for more than 3 months. Chronic neck pain is one of the biggest musculoskeletal health problem in industrialized countries, representing 14.6% of all such problems today. 50% of the adult population will experience cervical pain at some point during the year.
The objective of this study is to compare the effectiveness of a single exercise session with manual therapy techniques of the upper cervical spine against a single exercise session in patients with chronic neck pain and upper cervical spine dysfunction.
Read more
The treatment will be applied by 1 therapist with orthopedic manual therapist (MT)-specialist training and more than 10 years of MT experience.
The primary outcome measurements will be cervical mobility and cervical pressure pain threshold. Intensity of pain will be also used as secondary outcome measure. These measurements shall be taken before and immediately after the relevant intervention.
Exercise Group After the baseline assessments, patients will performed the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine.
In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions.
The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will be mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side. Also, no pain will be allowed in the positions. Exercises were always carried out without pain, because pain can be an inhibitor of muscle contraction.
The Exercise (E) group will carried out one 20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks.
Manual Therapy + Exercise Group The MT + E group will carried out 20-minute sessions led by an experienced physical therapist. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation (high velocity low amplitude) and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise. The MT techniques were applied depending on the clinical findings in each patient.
Read the detailed description
Chronic neck pain is described as pain located between the occiput and the third thoracic vertebra that persists for more than 3 months. Chronic neck pain is one of the biggest musculoskeletal health problem in industrialized countries, representing 14.6% of all such problems today. 50% of the adult population will experience cervical pain at some point during the year.
The objective of this study is to compare the effectiveness of a single exercise session with manual therapy techniques of the upper cervical spine against a single exercise session in patients with chronic neck pain and upper cervical spine dysfunction.
The treatment will be applied by 1 therapist with orthopedic manual therapist (MT)-specialist training and more than 10 years of MT experience.
The primary outcome measurements will be cervical mobility and cervical pressure pain threshold. Intensity of pain will be also used as secondary outcome measure. These measurements shall be taken before and immediately after the relevant intervention.
Exercise Group After the baseline assessments, patients will performed the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine.
In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions.
The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will be mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side. Also, no pain will be allowed in the positions. Exercises were always carried out without pain, because pain can be an inhibitor of muscle contraction.
The Exercise (E) group will carried out one 20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks.
Manual Therapy + Exercise Group The MT + E group will carried out 20-minute sessions led by an experienced physical therapist. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation (high velocity low amplitude) and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise. The MT techniques were applied depending on the clinical findings in each patient.
- Conditions
- Neck Pain
- Being tested
- Exercise, Manual Therapy + Exercise
- Keywords
- spine, manual therapy, exercise, chronic neck pain
- Medical subject headings
- Neck Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Patients will begin performing the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine.
In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions.
The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side.
Manual Therapy + ExerciseOther
20-minute session. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group | Active comparator | 20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks. Receives: Other: Exercise |
| Exercise + Manual Therapy Group | Experimental | 20-minute session. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise Receives: Other: Manual Therapy + Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active range of motion mobility in the inferior cervical region (º)
Mobility in the inferior cervical region will be evaluated in a sitting position with the back vertical and resting on the backrest of the chair with a CROM device (floating compass; Plastimo Airguide, Inc, Buffalo Groove,IL). Flexion, extension, right and left side-bending and right and left rotation will be measured. Three measurements will be made for each movement, and the result will be the mean of the three measurements.
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Active range of motion mobility in the upper cervical region (º)
Flexion rotation-test will be used to measure the upper rotation, predominantly at C1-2. To perform this test, the subjects position themselves in the supine position and the evaluator passively will take the patients cervical spine to its maximum flexion and then will rotated the head to the right and left side with the occiput resting against the evaluator's abdomen. The movement will stopped at whichever situation occurs first, either the subject presents symptoms, or the evaluator reaches the end of the range of motion and finds a firm end feel. A CROM device will be used too, and three measurements will be performed for each movement, with the result being the mean of the three measurements
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Pressure Pain Threshold (Kpa)
Cervical pressure pain threshold (PPT) will be measured using a digital algometer (Somedic AB Farsta, Somedic SenseLab AB, Sweden) with a round surface area of 1 cm2, and pressure will be applied at the rate of 1 kg/cm2/s perpendicular to the skin. With the subject supine, PPT will be assessed over 6 points bilaterally with a 10-second rest between each measurement: first metacarpal joint, upper trapezius muscle, elevator of scapula, C5-6 zygapophyseal joint, C2-3 zygapophyseal joint, and suboccipital muscles. Patients will be instructed to press the button of the digital algometer at the precise moment that pressure sensation changed to pain. The mean of 3 trials will be calculated over each point and used for analysis.
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary outcomes (1)
Pain Intensity (Visual analogue scale 0-100 mm)
Intensity of pain in the cervical region will be measured with VAS from 0 to 100 mm in length, with the extremes defined as "no pain" (0) and "the worst pain imaginable" (100) and without any intermediate points.
Measured: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start20 Oct 2021 (estimated)
- Primary completion20 Nov 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacobo Rodríguez Sanz, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085600
- Sponsor's protocol ID
- CER-2021-A2
- Status last verified
- Oct 2021
- First submitted
- 7 Oct 2021
- Last updated
- 28 Oct 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 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Single Manual Therapy-Exercise Versus Exercise Session in Patients With Chronic Neck Pain and Upper Cervical Spine Dysfunction. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05085600
- Acronym / sponsor ID
- CER-2021-A2
- Conditions
- Neck Pain
- Keywords
- spine, manual therapy, exercise, chronic neck pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 20 Oct 2021 (estimated)
- Primary completion
- 20 Nov 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 20 Oct 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.
Chronic neck pain is described as pain located between the occiput and the third thoracic vertebra that persists for more than 3 months. Chronic neck pain is one of the biggest musculoskeletal health problem in industrialized countries, representing 14.6% of all such problems today. 50% of the adult population will experience cervical pain at some point during the year.
The objective of this study is to compare the effectiveness of a single exercise session with manual therapy techniques of the upper cervical spine against a single exercise session in patients with chronic neck pain and upper cervical spine dysfunction.
The treatment will be applied by 1 therapist with orthopedic manual therapist (MT)-specialist training and more than 10 years of MT experience.
The primary outcome measurements will be cervical mobility and cervical pressure pain threshold. Intensity of pain will be also used as secondary outcome measure. These measurements shall be taken before and immediately after the relevant intervention.
Exercise Group After the baseline assessments, patients will performed the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine.
In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions.
The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will be mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side. Also, no pain will be allowed in the positions. Exercises were always carried out without pain, because pain can be an inhibitor of muscle contraction.
The Exercise (E) group will carried out one 20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks.
Manual Therapy + Exercise Group The MT + E group will carried out 20-minute sessions led by an experienced physical therapist. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation (high velocity low amplitude) and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise. The MT techniques were applied depending on the clinical findings in each patient.
Detailed description
Chronic neck pain is described as pain located between the occiput and the third thoracic vertebra that persists for more than 3 months. Chronic neck pain is one of the biggest musculoskeletal health problem in industrialized countries, representing 14.6% of all such problems today. 50% of the adult population will experience cervical pain at some point during the year.
The objective of this study is to compare the effectiveness of a single exercise session with manual therapy techniques of the upper cervical spine against a single exercise session in patients with chronic neck pain and upper cervical spine dysfunction.
The treatment will be applied by 1 therapist with orthopedic manual therapist (MT)-specialist training and more than 10 years of MT experience.
The primary outcome measurements will be cervical mobility and cervical pressure pain threshold. Intensity of pain will be also used as secondary outcome measure. These measurements shall be taken before and immediately after the relevant intervention.
Exercise Group After the baseline assessments, patients will performed the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine.
In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions.
The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will be mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side. Also, no pain will be allowed in the positions. Exercises were always carried out without pain, because pain can be an inhibitor of muscle contraction.
The Exercise (E) group will carried out one 20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks.
Manual Therapy + Exercise Group The MT + E group will carried out 20-minute sessions led by an experienced physical therapist. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation (high velocity low amplitude) and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise. The MT techniques were applied depending on the clinical findings in each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Active comparator | Other: Exercise20-minute session, composed of 2 blocks of 10 repetitions, holding each exercise for 10 seconds, a 40-second rest between each repetition and 2 minutes between blocks. |
| Exercise + Manual Therapy Group | Experimental | Other: Manual Therapy + Exercise20-minute session. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects diagnosed with chronic neck pain
- More than 18 years old
- Loss of mobility in one or more upper cervical spine segments found through manual assessment according to Zito et al. (2006) and Kaltenborn (2012).
- A positive result in the Flexion rotation-test in the upper cervical spine (less than 32º or a difference of 10º or more between the two rotations.
- Not being able to exceed 24 mmHg in the cranio-cervical flexion test.
Key exclusion criteria (8 listed)
- Contraindication to manual therapy or exercise (pathological changes due to neoplasm, inflammation infections, osteopenia, congenital collagenous compromise syndromes "Down´s, Ehlers-Danlos, Grisel, Morquio"
- Marked degeneration of the cervical spine that may affect cervical spine ligament integrity.
- History of trauma to cervical vessels.
- Anticoagulant therapy or blood clotting disorders or to have participated in any program of exercises or manual therapy treatments designed to improve the performance of the cervical region in the previous 3 months.
- Post-traumatic neck pain or red flags according to Rushton et al.
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 |
|---|---|---|
| ExercisePatients will begin performing the cervical stabilization exercise, and will taught to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine. In addition, progress will continued in the exercise of the contraction of deep neck flexor muscles in other positions. The progression of the exercises will be adapted to each patient, depending on their evolution. Firstly, exercises will undertaken in the supine and standing positions; once these positions will mastered, the exercises progressed to asymmetric positions with cervical bending and/or rotation toward each patient's most symptomatic side. | Other | Exercise Group |
| Manual Therapy + Exercise20-minute session. In the first 5 minutes, muscle techniques will be performed to prepare the tissue of the upper cervical spine before applying joint techniques. In the next 15 minutes, manipulation and / or mobilization techniques of the upper cervical spine, including the C2-3 segment, will be combined with cervical exercise | Other | Exercise + Manual Therapy Group |
Primary outcome
Active range of motion mobility in the inferior cervical region (º)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Mobility in the inferior cervical region will be evaluated in a sitting position with the back vertical and resting on the backrest of the chair with a CROM device (floating compass; Plastimo Airguide, Inc, Buffalo Groove,IL). Flexion, extension, right and left side-bending and right and left rotation will be measured. Three measurements will be made for each movement, and the result will be the mean of the three measurements.
Active range of motion mobility in the upper cervical region (º)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Flexion rotation-test will be used to measure the upper rotation, predominantly at C1-2. To perform this test, the subjects position themselves in the supine position and the evaluator passively will take the patients cervical spine to its maximum flexion and then will rotated the head to the right and left side with the occiput resting against the evaluator's abdomen. The movement will stopped at whichever situation occurs first, either the subject presents symptoms, or the evaluator reaches the end of the range of motion and finds a firm end feel. A CROM device will be used too, and three measurements will be performed for each movement, with the result being the mean of the three measurements
Pressure Pain Threshold (Kpa)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Cervical pressure pain threshold (PPT) will be measured using a digital algometer (Somedic AB Farsta, Somedic SenseLab AB, Sweden) with a round surface area of 1 cm2, and pressure will be applied at the rate of 1 kg/cm2/s perpendicular to the skin. With the subject supine, PPT will be assessed over 6 points bilaterally with a 10-second rest between each measurement: first metacarpal joint, upper trapezius muscle, elevator of scapula, C5-6 zygapophyseal joint, C2-3 zygapophyseal joint, and suboccipital muscles. Patients will be instructed to press the button of the digital algometer at the precise moment that pressure sensation changed to pain. The mean of 3 trials will be calculated over each point and used for analysis.
1 secondary outcome
Pain Intensity (Visual analogue scale 0-100 mm)
Time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Results and safety
Results are not available in the source record.
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.
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 and Manual Therapy + Exercise in people with Neck Pain, run by Universitat Internacional de Catalunya 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 6 inclusion and 8 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacobo Rodríguez-Sanz, PhD (+34636136789, jrodriguezs@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active range of motion mobility in the inferior cervical region (º) (time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)). The study lists 3 primary outcomes in all. 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.