Subacromial Impingement SyndromeNCT04102397
Subacromial Impingement Syndrome: Vojta Therapy vs Standard Treatment
A study testing Vojta therapy after standard therapy and Standard therapy in people with Subacromial Impingement Syndrome and Vojta Therapy, run by Castilla-La Mancha Health Service at 1 site in Spain.
Trial summary
Impingement Syndrome (IS) is the most common alteration of the shoulder's articular complex of diverse etiology. Forty to 50% of those affected seek medical attention due to the pain; in half of these cases, the pain persists a year after the first medical appointment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subacromial Impingement Syndrome, Vojta Therapy
- What is being tested?
- Vojta therapy after standard therapy and Standard therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2013to Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients had to fulfill at least three of the following criteria:
- Pain in active Abd (70-120º), considered impingement +.
- Pain on palpation of any of the following osteotendinous insertions: infraspinatus, teres minor, supraspinatus, subscapularis, and biceps.
- Pain in any of the following isometric contractions: Abd (first 10º), internal rotation (in the anatomical position and with 90º elbow flexion), and shoulder flexion.
- Positive on the Neer test.
- Positive on Hawkins test.
- Nighttime shoulder pain.
- Exclusion Criteria: Signs of a full thickness rotator cuff tear, acute inflammation or cervical radicular pain, calcification of the cuff tendons, glenohumeral instability, previous shoulder surgery, limited passive joint balance, pain due to suspected visceral or infectious process, shoulder pain of neurological origins, bilateral involvement, physiotherapeutic treatment in the past 6 months, aged <18, refusal to participate in the study, and physical and/or psychological dependence.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Subacromial Impingement Syndrome: Efficacy of Vojta Therapy Compared to Standard Physiotherapy Treatment
Impingement Syndrome (IS) is the most common alteration of the shoulder's articular complex of diverse etiology. Forty to 50% of those affected seek medical attention due to the pain; in half of these cases, the pain persists a year after the first medical appointment. It represents a sizeable drain on healthcare resources and a loss of productivity. Initial treatment of IS is generally conservative and includes a wide range of procedures and educational protocols. If conservative treatment fails, arthroscopy may be recommended for decompression. The standard treatment (ST) applied in the Quintanar de la Orden Physiotherapy Unit (UFQO), located within the healthcare area of Toledo, Spain, is prescribed by a rehabilitation specialist. It consists of one or more of the following procedures: transcutaneous electrical nerve stimulation (TENS), ultrasound therapy, kinesiotherapy, and cryotherapy.
Reflex Locomotion - or Vojta - Therapy, is a physiotherapeutic procedure that entails all the components of human locomotion. It consists of applying stimuli to certain areas of the body with the patient in various positions in order to produce a neurophysiological facilitation of both the central nervous system and the neuromuscular system, activating global and innate locomotive patterns or complexes, namely the Creeping Reflex and the Rolling Reflex. Both complexes provoke a certain coordination of striated muscle throughout the entire body. This enables a change from pathological patterns to alternative physiological patterns that are painless, efficient, and functional, by means of generating significant global effects, including the axial extension of the spine, correct positioning of the shoulder girdle, and activation of the abdominal musculature, all of which are altered by shoulder pathologies. Therefore, because of the high prevalence of IS and the lack of scientific studies on physiotherapeutic interventions on the shoulder, the investigators decided to conduct a clinical trial on the utility of Vojta Therapy in the treatment of IS. The investigators hoped to improve on the studies published to date, which vary greatly in methodological quality and use small sample sizes and heterogeneous populations. Moreover, no published studies have examined the use of Vojta Therapy in relation to shoulder pathologies in general, or to IS in particular.
Read the detailed description
Sample size: The necessary sample size was calculated taking into account that for the main result indicator (level of pain), the investigators expected to find an improvement of at least 2 points with the implementation of Vojta. The investigators therefore assumed a variability of 2.5 points (standard deviation) on the pain scale, a value previously estimated in patients suffering shoulder pain in the same healthcare area. In order to detect this difference with a power of 80% (β error=20%) and a 95% confidence interval (α error=5%), it was necessary to recruit 25 patients per group. Assuming an attrition rate no higher than 20%, the final sample size required was 60 patients (30 per group).
Explanatory variables
- Sociodemographic: Gender, age, employment status, and type of work.
- Anthropometric: Weight, height, and body mass index (BMI) (kg/m2).
- Anamnesis: Dominant upper limb affected, tobacco use, current and/or previously suffered illnesses, surgical history of the shoulder, previous treatments of the shoulder and diagnostic tests conducted, analgesic use.
- Experimental treatment: Standard Therapy (ST) vs. Standard plus Vojta Therapy (SVT).
Administration and evaluation of therapy
- Initial evaluation: First, the evaluating physiotherapist took down the patient's medical history on an evaluation sheet; they then proceeded to administer the CMS and gave the patient the self-administered VAS and DAS scales, along with the SF-12 survey. Finally, a physiotherapist from the health clinic applied the assigned treatment (15 sessions for 3 weeks, independent of therapy type).
- Therapeutic intervention: experimental group vs active compared group.
- Second evaluation: After 15 sessions, carried out by the evaluating physiotherapist. Identical to the baseline evaluation.
- Third evaluation: Three months after the initial evaluation.
Validated measurement scales to evaluate results:
- VAS Scale: A universal method for evaluating pain, with maximum reproducibility among observers, a good relation to descriptive scales, and high sensitivity and reliability. The patient marks the pain intensity on a scale graded from 0 ("no pain") to 10 cm ("unbearable pain").
- DASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire: The most commonly used questionnaire to globally evaluate the functionality of the upper limbs from the patient's perspective. It consists of 30 objective questions, has excellent reproducibility, high sensibility, good internal consistency, and a high sensitivity to changes. It is graded from 0 to 100 (with a higher score indicating greater disability).
- Constant-Murley Scale (CMS): An evaluation system of shoulder functionality more commonly used in Europe and the United States. It assesses pain, functionality, strength, and joint range of motion. The subjective assessment section evaluates pain, daily activities, and sleep disturbances (maximum score=35) while the objective assessment section measures joint range of motion (with a goniometer) and shoulder strength (with a dynamometer).
- SF-12 Health Survey: A shortened version of the SF-36, this survey has a high internal consistency, validity, and reliability. It is the most widely used health measurement in the medical field. Using 12 categories, it evaluates 8 positive and negative dimensions of physical and mental health, and, by extension, of quality of life: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The scale goes from 0 to 100 (the higher the score, the better the quality of life).
VAS, DASH, and SF-12 are all self-administered tests. They were given to each patient three times: after signing the informed consent form, at the end of the 15 therapy sessions, and 12 weeks after the start of the therapy. The CMS was likewise administered to each patient three times - the day of the initial evaluation, after 15 treatment sessions, and 12 weeks after the start of treatment - by 3 evaluating physiotherapists who had no knowledge of the assigned groups and who had not been involved with the patients' treatment. The evaluating therapists all had previous experience administering the CMS, thus guaranteeing interobserver validity.
- Conditions
- Subacromial Impingement Syndrome, Vojta Therapy
- Being tested
- Vojta therapy after standard therapy, Standard therapy
- Keywords
- Subacromial Impingement Syndrome; Vojta therapy; pain
- Medical subject headings
- Shoulder Impingement Syndrome, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta therapy after standard therapyProcedure or surgery
Vojta Therapy ~20 minutes/session: Application of the Reflex Creeping complex, activating several stimulus points on the facial and the nuchal sides (Figure 3a), and then the activation of the Reflex Rolling complex in both the supine position and with the patient lying on his or her side, alternating between nuchal and facial stimulation and guiding from the head.
Standard therapyProcedure or surgery
~50 minutes/session:
- TENS Current (20 minutes, phase duration=0.10 microseconds, frequency=50 Hz). The intensity applied depended on the patient's tolerance for the treatment (Figure 2a).
- Pulsating ultrasound (5 minutes around the shoulder, frequency=1MHz, intensity=1 W/cm2) (Figure 2b).
- Kinesiotherapy. In stages: at first assisted (with isometric exercises), then free, and finally, with resistance, usually with elastic bands (Figure 2c).
- Cryotherapy (5 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Standard plus Vojta therapy (SVT) | Experimental | The physiotherapist's hands produce the activation with no need for medication or external equipment, thus guaranteeing the patient's safety.this therapy is able to change pathological patterns to painless patterns that reduce the use of energy caused by movement difficulty. The end result is to facilitate movement without strain. Receives: Procedure: Vojta therapy after standard therapy |
| Standard therapy (ST) | Active comparator | It consists of one or more of the following procedures: transcutaneous electrical nerve stimulation (TENS), ultrasound therapy, kinesiotherapy, and cryotherapy. Receives: Procedure: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain by VAS. Main result indicator. "Change" is being assessed
Pain is measured with VAS Scale (a self-administered test). Pain graduation by VAS scale: intensity is graded from 0 ("no pain") to 10 cm ("unbearable pain").
VAS scale was given to each patient three times: after signing the informed consent form, at the end of the 15 therapy sessions, and 12 weeks after the start of the therapy.
Measured: Through study completion, an average of 1 year and a half
Pain by CMS. Main result indicator. "Change" is being assessed
Pain is also measured with and Constant-Murley Scale (CMS). Maximum score for CSM measurement=35 The CMS was administered three times: the day of the initial evaluation, after 15 treatment sessions, and 12 weeks after the start of treatment - by 3 evaluating physiotherapists who had no knowledge of the assigned groups and who had not been involved with the patients' treatment.
Measured: Through study completion, an average of 1 year and a half
Secondary outcomes (5)
Joint range of motion. "Change" is being assessed
Joint of range was determined with CMS, which CMS was administered three times: the day of the initial evaluation, after 15 treatment sessions, and 12 weeks after the start of treatment - by 3 evaluating physiotherapists who had no knowledge of the assigned groups and who had not been involved with the patients' treatment.
Maximum score for CSM measurement=35
Measured: Through study completion, an average of 1 year and a half
Strength. "Change" is being assessed
Strength was also measured with CMS. Again, CMS was administered the day of the initial evaluation, after 15 treatment sessions, and 12 weeks after the start of treatment - by 3 evaluating physiotherapists who had no knowledge of the assigned groups and who had not been involved with the patients' treatment.
Maximum score for CSM measurement=35
Measured: Through study completion, an average of 1 year and a half
Functionality by DASH. "Change" is being assessed
Functionality was determined by means of DASH questionaire (Disabilities of the Arm, Shoulder, and Hand).
DASH was given to each patient three times: after signing the informed consent form, at the end of the 15 therapy sessions, and 12 weeks after the start of the therapy.
DASH is graded from 0 to 100 (with a higher score indicating greater disability)
Measured: Through study completion, an average of 1 year and a half
Functionality by CMS. "Change" is being assessed
Functionality was also determined by means of Constant-Murley Scale (CMS). Anew, CMS was administered: the day of the initial evaluation, after 15 treatment sessions, and 12 weeks after the start of treatment - by 3 evaluating physiotherapists who had no knowledge of the assigned groups and who had not been involved with the patients' treatment.
Maximum score for CSM measurement=35
Measured: Through study completion, an average of 1 year and a half
Quality of life. "Change" is being assessed
Quality of life was evaluated with SF-12 Health Survey (the shortened version of the SF-36).
SF-12 was also given three times: after signing the informed consent form, at the end of the 15 therapy sessions, and 12 weeks after the start of the therapy.
It goes from 0 to 100 (the higher the score, the better the quality of life)
Measured: Through study completion, an average of 1 year and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study startAug 2013
- Primary completionFeb 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial Impingement SyndromeStudies 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
- This is an analytical experimental study conducted as a randomized clinical trial with two parallel intervention levels: a control group and an experimental group. All patients diagnosed with IS by a rehabilitation specialist from the La Mancha Central Hospital were referred to the UFCO, where the study was duly explained to them. The final sample consisted of those patients who fulfilled the inclusion criteria and gave their informed consent in writing.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Castilla-La Mancha Health Service
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario La Mancha Centro
- Responsible party
- Sponsor
- Investigators
- Inmaculada Tello Díaz-Maroto, Study chair, Universidad Autonoma de MadridJorge Lucas Torres de la Guía, Study chair, Centro de Salud Quintanar de la OrdenCarmen Jiménez-Antona, Study chair, Universidad Rey Juan Carlos de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04102397
- Sponsor's protocol ID
- SIS-VT
- Status last verified
- Sep 2019
- First submitted
- 12 May 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subacromial Impingement Syndrome: Efficacy of Vojta Therapy Compared to Standard Physiotherapy Treatment
- ClinicalTrials.gov ID
- NCT04102397
- Acronym / sponsor ID
- SIS-VT
- Conditions
- Subacromial Impingement Syndrome, Vojta Therapy
- Keywords
- Subacromial Impingement Syndrome; Vojta therapy; pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Castilla-La Mancha Health ServiceUniversity, hospital or other
- Collaborators
- Complejo Hospitalario La Mancha Centro
- Study start
- Aug 2013 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Sep 2019 (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.
Impingement Syndrome (IS) is the most common alteration of the shoulder's articular complex of diverse etiology. Forty to 50% of those affected seek medical attention due to the pain; in half of these cases, the pain persists a year after the first medical appointment. It represents a sizeable drain on healthcare resources and a loss of productivity. Initial treatment of IS is generally conservative and includes a wide range of procedures and educational protocols. If conservative treatment fails, arthroscopy may be recommended for decompression. The standard treatment (ST) applied in the Quintanar de la Orden Physiotherapy Unit (UFQO), located within the healthcare area of Toledo, Spain, is prescribed by a rehabilitation specialist. It consists of one or more of the following procedures: transcutaneous electrical nerve stimulation (TENS), ultrasound therapy, kinesiotherapy, and cryotherapy.
Reflex Locomotion - or Vojta - Therapy, is a physiotherapeutic procedure that entails all the components of human locomotion. It consists of applying stimuli to certain areas of the body with the patient in various positions in order to produce a neurophysiological facilitation of both the central nervous system and the neuromuscular system, activating global and innate locomotive patterns or complexes, namely the Creeping Reflex and the Rolling Reflex. Both complexes provoke a certain coordination of striated muscle throughout the entire body. This enables a change from pathological patterns to alternative physiological patterns that are painless, efficient, and functional, by means of generating significant global effects, including the axial extension of the spine, correct positioning of the shoulder girdle, and activation of the abdominal musculature, all of which are altered by shoulder pathologies. Therefore, because of the high prevalence of IS and the lack of scientific studies on physiotherapeutic interventions on the shoulder, the investigators decided to conduct a clinical trial on the utility of Vojta Therapy in the treatment of IS. The investigators hoped to improve on the studies published to date, which vary greatly in methodological quality and use small sample sizes and heterogeneous populations. Moreover, no published studies have examined the use of Vojta Therapy in relation to shoulder pathologies in general, or to IS in particular.
Detailed description
Sample size: The necessary sample size was calculated taking into account that for the main result indicator (level of pain), the investigators expected to find an improvement of at least 2 points with the implementation of Vojta. The investigators therefore assumed a variability of 2.5 points (standard deviation) on the pain scale, a value previously estimated in patients suffering shoulder pain in the same healthcare area. In order to detect this difference with a power of 80% (β error=20%) and a 95% confidence interval (α error=5%), it was necessary to recruit 25 patients per group. Assuming an attrition rate no higher than 20%, the final sample size required was 60 patients (30 per group).
Explanatory variables
- Sociodemographic: Gender, age, employment status, and type of work.
- Anthropometric: Weight, height, and body mass index (BMI) (kg/m2).
- Anamnesis: Dominant upper limb affected, tobacco use, current and/or previously suffered illnesses, surgical history of the shoulder, previous treatments of the shoulder and diagnostic tests conducted, analgesic use.
- Experimental treatment: Standard Therapy (ST) vs. Standard plus Vojta Therapy (SVT).
Administration and evaluation of therapy
- Initial evaluation: First, the evaluating physiotherapist took down the patient's medical history on an evaluation sheet; they then proceeded to administer the CMS and gave the patient the self-administered VAS and DAS scales, along with the SF-12 survey. Finally, a physiotherapist from the health clinic applied the assigned treatment (15 sessions for 3 weeks, independent of therapy type).
- Therapeutic intervention: experimental group vs active compared group.
- Second evaluation: After 15 sessions, carried out by the evaluating physiotherapist. Identical to the baseline evaluation.
- Third evaluation: Three months after the initial evaluation.
Validated measurement scales to evaluate results:
- VAS Scale: A universal method for evaluating pain, with maximum reproducibility among observers, a good relation to descriptive scales, and high sensitivity and reliability. The patient marks the pain intensity on a scale graded from 0 ("no pain") to 10 cm ("unbearable pain").
- DASH (Disabilities of the Arm, Shoulder, and Hand) Questionnaire: The most commonly used questionnaire to globally evaluate the functionality of the upper limbs from the patient's perspective. It consists of 30 objective questions, has excellent reproducibility, high sensibility, good internal consistency, and a high sensitivity to changes. It is graded from 0 to 100 (with a higher score indicating greater disability).
- Constant-Murley Scale (CMS): An evaluation system of shoulder functionality more commonly used in Europe and the United States. It assesses pain, functionality, strength, and joint range of motion. The subjective assessment section evaluates pain, daily activities, and sleep disturbances (maximum score=35) while the objective assessment section measures joint range of motion (with a goniometer) and shoulder strength (with a dynamometer).
- SF-12 Health Survey: A shortened version of the SF-36, this survey has a high internal consistency, validity, and reliability. It is the most widely used health measurement in the medical field. Using 12 categories, it evaluates 8 positive and negative dimensions of physical and mental health, and, by extension, of quality of life: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The scale goes from 0 to 100 (the higher the score, the better the quality of life).
VAS, DASH, and SF-12 are all self-administered tests. They were given to each patient three times: after signing the informed consent form, at the end of the 15 therapy sessions, and 12 weeks after the start of the therapy. The CMS was likewise administered to each patient three times - the day of the initial evaluation, after 15 treatment sessions, and 12 weeks after the start of treatment - by 3 evaluating physiotherapists who had no knowledge of the assigned groups and who had not been involved with the patients' treatment. The evaluating therapists all had previous experience administering the CMS, thus guaranteeing interobserver validity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is an analytical experimental study conducted as a randomized clinical trial with two parallel intervention levels: a control group and an experimental group. All patients diagnosed with IS by a rehabilitation specialist from the La Mancha Central Hospital were referred to the UFCO, where the study was duly explained to them. The final sample consisted of those patients who fulfilled the inclusion criteria and gave their informed consent in writing.
| Arm | Type | Receives |
|---|---|---|
| Standard plus Vojta therapy (SVT) | Experimental | Procedure: Vojta therapy after standard therapyThe physiotherapist's hands produce the activation with no need for medication or external equipment, thus guaranteeing the patient's safety.this therapy is able to change pathological patterns to painless patterns that reduce the use of energy caused by movement difficulty. The end result is to facilitate movement without strain. |
| Standard therapy (ST) | Active comparator | Procedure: Standard therapyIt consists of one or more of the following procedures: transcutaneous electrical nerve stimulation (TENS), ultrasound therapy, kinesiotherapy, and cryotherapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Pain in active Abd (70-120º), considered impingement +.
- Pain on palpation of any of the following osteotendinous insertions: infraspinatus, teres minor, supraspinatus, subscapularis, and biceps.
- Pain in any of the following isometric contractions: Abd (first 10º), internal rotation (in the anatomical position and with 90º elbow flexion), and shoulder flexion.
- Positive on the Neer test.
- Positive on Hawkins test.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Vojta therapy after standard therapyVojta Therapy ~20 minutes/session: Application of the Reflex Creeping complex, activating several stimulus points on the facial and the nuchal sides (Figure 3a), and then the activation of the Reflex Rolling complex in both the supine position and with the patient lying on his or her side, alternating between nuchal and facial stimulation and guiding from the head. | Procedure or surgery | Standard plus Vojta therapy (SVT) |
| Standard therapy~50 minutes/session: * TENS Current (20 minutes, phase duration=0.10 microseconds, frequency=50 Hz). The intensity applied depended on the patient's tolerance for the treatment (Figure 2a). * Pulsating ultrasound (5 minutes around the shoulder, frequency=1MHz, intensity=1 W/cm2) (Figure 2b). * Kinesiotherapy. In stages: at first assisted (with isometric exercises), then free, and finally, with resistance, usually with elastic bands (Figure 2c). * Cryotherapy (5 minutes). | Procedure or surgery | Standard therapy (ST) |
Primary outcome
Pain by VAS. Main result indicator. "Change" is being assessed
Time frame: Through study completion, an average of 1 year and a half
Pain is measured with VAS Scale (a self-administered test). Pain graduation by VAS scale: intensity is graded from 0 ("no pain") to 10 cm ("unbearable pain"). VAS scale was given to each patient three times: after signing the informed consent form, at the end of the 15 therapy sessions, and 12 weeks after the start of the therapy.
Pain by CMS. Main result indicator. "Change" is being assessed
Time frame: Through study completion, an average of 1 year and a half
Pain is also measured with and Constant-Murley Scale (CMS). Maximum score for CSM measurement=35 The CMS was administered three times: the day of the initial evaluation, after 15 treatment sessions, and 12 weeks after the start of treatment - by 3 evaluating physiotherapists who had no knowledge of the assigned groups and who had not been involved with the patients' treatment.
5 secondary outcomes
Joint range of motion. "Change" is being assessed
Time frame: Through study completion, an average of 1 year and a half
Strength. "Change" is being assessed
Time frame: Through study completion, an average of 1 year and a half
Functionality by DASH. "Change" is being assessed
Time frame: Through study completion, an average of 1 year and a half
Functionality by CMS. "Change" is being assessed
Time frame: Through study completion, an average of 1 year and a half
Quality of life. "Change" is being assessed
Time frame: Through study completion, an average of 1 year and a half
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 25 Sep 2019.
- 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.
Inmaculada Tello Díaz-Maroto study chair
Universidad Autonoma de Madrid
Jorge Lucas Torres de la Guía study chair
Centro de Salud Quintanar de la Orden
Carmen Jiménez-Antona study chair
Universidad Rey Juan Carlos de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vojta therapy after standard therapy and Standard therapy in people with Subacromial Impingement Syndrome and Vojta Therapy, run by Castilla-La Mancha Health Service 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 8 inclusion and 0 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 25 Sep 2019. 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?
Pain by VAS. Main result indicator. "Change" is being assessed (time frame: Through study completion, an average of 1 year and a half). The study lists 2 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 25 Sep 2019.