Ankle StiffnessNCT02653807
Comparison of Two Manual Therapy Techniques on Ankle Dorsiflexion
A study testing mobilization with movement and osteopathic mobilization in people with Ankle Stiffness, run by Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Ankle rigidity is a common musculoskeletal disorder affecting the talocrural joint, which can impair weight-bearing ankle dorsiflexion (WBADF). The objective was to compare the efficacy of Mulligan Mobilization with Movement (MWM) and Osteopathic Mobilization (OM) for improving ankle dorsiflexion range of motion (ROM)… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ankle Stiffness
- What is being tested?
- mobilization with movement and osteopathic mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2015to Mar 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male gender, aged between 18 to 40 years, with a chronic unilateral mobility deficit of the talocrural joint; i.e. subjective blocking sensation and/or feeling of ankle stiffness together with the presence of ankle region pain/tenderness, during active WBADF while squatting. Subjects were recruited with chronic unilateral mobility deficit of the talocrural joint, which could be following a previous history of ankle injury or without previous history of ankle injury.
Who cannot join
- a history of ankle joint surgery or injury to the foot, ankle, knee or hip in the previous one-year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Immediate Effects of Two Manual Therapy Techniques on Ankle Musculoarticular Stiffness and Dorsiflexion Range of Motion in People With Chronic Ankle Rigidity: A Randomized Clinical Trial
Ankle rigidity is a common musculoskeletal disorder affecting the talocrural joint, which can impair weight-bearing ankle dorsiflexion (WBADF). The objective was to compare the efficacy of Mulligan Mobilization with Movement (MWM) and Osteopathic Mobilization (OM) for improving ankle dorsiflexion range of motion (ROM) and musculoarticular stiffness (MAS).
Read the detailed description
Increased musculoarticular stiffness (MAS) of the talocrural joint is a frequently encountered problem, identified during evaluation of weight bearing ankle dorsiflexion (WBADF). Such stiffness may follow ankle injury such as ankle sprain. In such a situation, MAS could be increased and might leads to a lack of joint flexibility as well as decreased dorsiflexion range-of-motion (ROM), however asymmetric rigidity does not necessarily always follow ankle sprain. Nevertheless, MAS is an important and necessary component of normal stability of the talocrural joint and could help to prevent abnormal ankle joint movement and ankle sprains.
Measurement of MAS can be determined by a technique known as free-oscillation, which is a comprehensive measure of joint stiffness comprising the stiffness of the muscle-tendon unit, skin, ligaments and joint capsule, along with a number of other mechanical and neuromuscular factors. The assessment of MAS is important when evaluating muscular performance, injury prevention and gender differences in flexibility. For example, men, as well as older people, are known to present with greater MAS than women and young people.
MAS of the talocrural joint can be objectively measured using an electromechanical device that imparts a passive oscillatory dorsiflexion movement, but also by means of clinical tests such as toe-wall distance and angular goniometric measurement during the weight bearing lunge test. Electromechanical measurement of ankle MAS has been used in several previous studies of asymptomatic participants and in patients with fibromyalgia syndrome, and spasticity after a stroke.
In orthopaedic manual therapy, different methods have been proposed to treat MAS associated with loss of dorsiflexion ROM at the talocrural joint. These include single session of Mulligan's Mobilization with Movement (MWM), anteroposterior mobilization of the talus, high velocity thrust, and Osteopathic Mobilization (OM). These methods have been described in clinical practice manuals, with greater proportion of studies reporting on the effects of MWM in comparison to high velocity thrust for improving ankle dorsiflexion ROM in chronic ankle instability or to study MWM efficacy in isolation for subacute or recurrent ankle sprains and for chronic ankle instability. With the exception of one study the results are generally in favor of MWM.
Generally MWM is an increasingly popular form of manual therapy for musculoskeletal disorders, concerning the ankle MWM try to improve talocrural ROM. MWM is a combination of accessory joint glide of the talus combined with active ankle dorsiflexion movement. The patient performs active WBADF while the therapist simultaneously applies an anteroposterior glide of the talus with respective posteroanterior tibial glide with the aid of a manual therapy belt. OM is a purely passive anteroposterior mobilization of the talus with respect to tibia, performed in a non weight-bearing position. To date, there have been no studies comparing the effectiveness of each technique with respect to electromechanically determined ankle MAS or ankle joint ROM determined by the WBADF lunge test.
Therefore, the aim of the study was to investigate the relative efficacy of MWM and OM on MAS as the primary outcome measurement and joint ROM during the WBADF lunge test as the secondary outcome measurement. The hypothesis was that MWM would produce significantly greater reduction in MAS and increased ankle joint ROM when compared to OM.
- Conditions
- Ankle Stiffness
- Being tested
- mobilization with movement, osteopathic mobilization
- Keywords
- manual therapy, osteopathy, mobilization with movement, ankle, stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobilization with movementOther
manual therapy intervention
osteopathic mobilizationOther
manual therapy intervention
| Study group | Role | What they receive |
|---|---|---|
| mobilization with movement | Experimental | MWM at the talocrural joint during active weight bearing ankle dorsiflexion with the belt Receives: Other: mobilization with movement |
| osteopathic mobilization | Active comparator | passive mobilization of the talo-crural joint Receives: Other: osteopathic mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromechanical device measurement of MAS (Lehmann device, 1989)
The electromechanical device used to quantify musculoarticular stiffness had been used in previous research studies and has ben shown to have high precision, reliability and accuracy. An oscillating footplate produces passive ankle joint dorsiflexion with 5° amplitude sinusoidal rotary displacements. Thirty trials of 10 different oscillation frequencies, varying from 3 to 12 Hz, were applied on each subject during each session. See Detrembleur and Plaghki (2000) for more details of the process.
Measured: Change from baseline until discharge of treatment (same day, single session)
Secondary outcomes (1)
WBAD lunge test
the weight bearing ankle dorsiflexion lunge test a common clinical test used to evaluate ankle dorsiflexion ROM (Powden et al., 2015) which has been shown to have moderate to excellent intra-rater reliability (ICC = 0,65-0,99) with a minimal detectable change of 1,9 cm and 4,7°. A graduated tape measure was placed on the floor, perpendicular to the wall. The investigator demonstrated the measurement procedure test to the subject providing standardized instructions. The subject placed his symptomatic foot with the big toe aligned on the tape measure and performed ankle dorsiflexion until his knee touched the wall. An iPhone was used to measure the degree of tibial inclination.
Measured: Change from baseline until discharge of treatment (same day, single session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Ankle StiffnessStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Hidalgo, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653807
- Sponsor's protocol ID
- IREC/CARS-UCL-Hidalgo
- Status last verified
- Mar 2016
- First submitted
- 5 Jan 2016
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bleyenheuft C, Detrembleur C, Deltombe T, Fomekong E, Lejeune TM. Quantitative assessment of anaesthetic nerve block and neurotomy in spastic equinus foot: a review of two cases. J Rehabil Med. 2008 Nov;40(10):879-81. doi: 10.2340/16501977-0263.
PubMed 19242629Dierick F, Detrembleur C, Trintignac G, Masquelier E. Nature of passive musculoarticular stiffness increase of ankle in female subjects with fibromyalgia syndrome. Eur J Appl Physiol. 2011 Sep;111(9):2163-71. doi: 10.1007/s00421-011-1850-2. Epub 2011 Feb 6.
PubMed 21298443Gilbreath JP, Gaven SL, Van Lunen L, Hoch MC. The effects of mobilization with movement on dorsiflexion range of motion, dynamic balance, and self-reported function in individuals with chronic ankle instability. Man Ther. 2014 Apr;19(2):152-7. doi: 10.1016/j.math.2013.10.001.
PubMed 24834500Hidalgo B, Pitance L, Hall T, Detrembleur C, Nielens H. Short-term effects of Mulligan mobilization with movement on pain, disability, and kinematic spinal movements in patients with nonspecific low back pain: a randomized placebo-controlled trial. J Manipulative Physiol Ther. 2015 Jul-Aug;38(6):365-74. doi: 10.1016/j.jmpt.2015.06.013. Epub 2015 Jul 26.
PubMed 26215900Lehmann JF, Price R, deLateur BJ, Hinderer S, Traynor C. Spasticity: quantitative measurements as a basis for assessing effectiveness of therapeutic intervention. Arch Phys Med Rehabil. 1989 Jan;70(1):6-15.
PubMed 2916921Marron-Gomez D, Rodriguez-Fernandez AL, Martin-Urrialde JA. The effect of two mobilization techniques on dorsiflexion in people with chronic ankle instability. Phys Ther Sport. 2015 Feb;16(1):10-5. doi: 10.1016/j.ptsp.2014.02.001. Epub 2014 Feb 14.
PubMed 24679362Powden CJ, Hoch JM, Hoch MC. Reliability and minimal detectable change of the weight-bearing lunge test: A systematic review. Man Ther. 2015 Aug;20(4):524-32. doi: 10.1016/j.math.2015.01.004. Epub 2015 Jan 29.
PubMed 25704110Suydam SM, Soulas EM, Elliott DM, Silbernagel KG, Buchanan TS, Cortes DH. Viscoelastic properties of healthy achilles tendon are independent of isometric plantar flexion strength and cross-sectional area. J Orthop Res. 2015 Jun;33(6):926-31. doi: 10.1002/jor.22878. Epub 2015 Apr 27.
PubMed 25882209Vicenzino B, Branjerdporn M, Teys P, Jordan K. Initial changes in posterior talar glide and dorsiflexion of the ankle after mobilization with movement in individuals with recurrent ankle sprain. J Orthop Sports Phys Ther. 2006 Jul;36(7):464-71. doi: 10.2519/jospt.2006.2265.
PubMed 16881463Ditroilo M, Watsford M, Murphy A, De Vito G. Assessing musculo-articular stiffness using free oscillations: theory, measurement and analysis. Sports Med. 2011 Dec 1;41(12):1019-32. doi: 10.2165/11591470-000000000-00000.
PubMed 22060176Collins N, Teys P, Vicenzino B. The initial effects of a Mulligan's mobilization with movement technique on dorsiflexion and pain in subacute ankle sprains. Man Ther. 2004 May;9(2):77-82. doi: 10.1016/S1356-689X(03)00101-2.
PubMed 15040966Teixeira LM, Pires T, Silva RD, de Resende MA. Immediate effect of a single anteroposterior talus mobilization on dorsiflexion range of motion in participants with orthopedic dysfunction of the ankle and foot. J Manipulative Physiol Ther. 2013 Jul-Aug;36(6):369-75. doi: 10.1016/j.jmpt.2013.06.003. Epub 2013 Jul 11.
PubMed 23850371Cejudo A, Sainz de Baranda P, Ayala F, Santonja F. A simplified version of the weight-bearing ankle lunge test: description and test-retest reliability. Man Ther. 2014 Aug;19(4):355-9. doi: 10.1016/j.math.2014.03.008. Epub 2014 Apr 2.
PubMed 24746162Bennell KL, Talbot RC, Wajswelner H, Techovanich W, Kelly DH, Hall AJ. Intra-rater and inter-rater reliability of a weight-bearing lunge measure of ankle dorsiflexion. Aust J Physiother. 1998;44(3):175-180. doi: 10.1016/s0004-9514(14)60377-9.
PubMed 11676731
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effects of Two Manual Therapy Techniques on Ankle Musculoarticular Stiffness and Dorsiflexion Range of Motion in People With Chronic Ankle Rigidity: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02653807
- Acronym / sponsor ID
- IREC/CARS-UCL-Hidalgo
- Conditions
- Ankle Stiffness
- Keywords
- manual therapy, osteopathy, mobilization with movement, ankle, stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Jan 2016 (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.
Ankle rigidity is a common musculoskeletal disorder affecting the talocrural joint, which can impair weight-bearing ankle dorsiflexion (WBADF). The objective was to compare the efficacy of Mulligan Mobilization with Movement (MWM) and Osteopathic Mobilization (OM) for improving ankle dorsiflexion range of motion (ROM) and musculoarticular stiffness (MAS).
Detailed description
Increased musculoarticular stiffness (MAS) of the talocrural joint is a frequently encountered problem, identified during evaluation of weight bearing ankle dorsiflexion (WBADF). Such stiffness may follow ankle injury such as ankle sprain. In such a situation, MAS could be increased and might leads to a lack of joint flexibility as well as decreased dorsiflexion range-of-motion (ROM), however asymmetric rigidity does not necessarily always follow ankle sprain. Nevertheless, MAS is an important and necessary component of normal stability of the talocrural joint and could help to prevent abnormal ankle joint movement and ankle sprains.
Measurement of MAS can be determined by a technique known as free-oscillation, which is a comprehensive measure of joint stiffness comprising the stiffness of the muscle-tendon unit, skin, ligaments and joint capsule, along with a number of other mechanical and neuromuscular factors. The assessment of MAS is important when evaluating muscular performance, injury prevention and gender differences in flexibility. For example, men, as well as older people, are known to present with greater MAS than women and young people.
MAS of the talocrural joint can be objectively measured using an electromechanical device that imparts a passive oscillatory dorsiflexion movement, but also by means of clinical tests such as toe-wall distance and angular goniometric measurement during the weight bearing lunge test. Electromechanical measurement of ankle MAS has been used in several previous studies of asymptomatic participants and in patients with fibromyalgia syndrome, and spasticity after a stroke.
In orthopaedic manual therapy, different methods have been proposed to treat MAS associated with loss of dorsiflexion ROM at the talocrural joint. These include single session of Mulligan's Mobilization with Movement (MWM), anteroposterior mobilization of the talus, high velocity thrust, and Osteopathic Mobilization (OM). These methods have been described in clinical practice manuals, with greater proportion of studies reporting on the effects of MWM in comparison to high velocity thrust for improving ankle dorsiflexion ROM in chronic ankle instability or to study MWM efficacy in isolation for subacute or recurrent ankle sprains and for chronic ankle instability. With the exception of one study the results are generally in favor of MWM.
Generally MWM is an increasingly popular form of manual therapy for musculoskeletal disorders, concerning the ankle MWM try to improve talocrural ROM. MWM is a combination of accessory joint glide of the talus combined with active ankle dorsiflexion movement. The patient performs active WBADF while the therapist simultaneously applies an anteroposterior glide of the talus with respective posteroanterior tibial glide with the aid of a manual therapy belt. OM is a purely passive anteroposterior mobilization of the talus with respect to tibia, performed in a non weight-bearing position. To date, there have been no studies comparing the effectiveness of each technique with respect to electromechanically determined ankle MAS or ankle joint ROM determined by the WBADF lunge test.
Therefore, the aim of the study was to investigate the relative efficacy of MWM and OM on MAS as the primary outcome measurement and joint ROM during the WBADF lunge test as the secondary outcome measurement. The hypothesis was that MWM would produce significantly greater reduction in MAS and increased ankle joint ROM when compared to OM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mobilization with movement | Experimental | Other: mobilization with movementMWM at the talocrural joint during active weight bearing ankle dorsiflexion with the belt |
| osteopathic mobilization | Active comparator | Other: osteopathic mobilizationpassive mobilization of the talo-crural joint |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- male gender, aged between 18 to 40 years, with a chronic unilateral mobility deficit of the talocrural joint; i.e. subjective blocking sensation and/or feeling of ankle stiffness together with the presence of ankle region pain/tenderness, during active WBADF while squatting. Subjects were recruited with chronic unilateral mobility deficit of the talocrural joint, which could be following a previous history of ankle injury or without previous history of ankle injury.
Key exclusion criteria (1 listed)
- a history of ankle joint surgery or injury to the foot, ankle, knee or hip in the previous one-year.
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 |
|---|---|---|
| mobilization with movementmanual therapy intervention | Other | mobilization with movement |
| osteopathic mobilizationmanual therapy intervention | Other | osteopathic mobilization |
Primary outcome
Electromechanical device measurement of MAS (Lehmann device, 1989)
Time frame: Change from baseline until discharge of treatment (same day, single session)
The electromechanical device used to quantify musculoarticular stiffness had been used in previous research studies and has ben shown to have high precision, reliability and accuracy. An oscillating footplate produces passive ankle joint dorsiflexion with 5° amplitude sinusoidal rotary displacements. Thirty trials of 10 different oscillation frequencies, varying from 3 to 12 Hz, were applied on each subject during each session. See Detrembleur and Plaghki (2000) for more details of the process.
1 secondary outcome
WBAD lunge test
Time frame: Change from baseline until discharge of treatment (same day, single session)
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 18 Mar 2016.
- Background: PubMed 19242629Bleyenheuft C, Detrembleur C, Deltombe T, Fomekong E, Lejeune TM. Quantitative assessment of anaesthetic nerve block and neurotomy in spastic equinus foot: a review of two cases. J Rehabil Med. 2008 Nov;40(10):879-81. doi: 10.2340/16501977-0263.
- Background: PubMed 21298443Dierick F, Detrembleur C, Trintignac G, Masquelier E. Nature of passive musculoarticular stiffness increase of ankle in female subjects with fibromyalgia syndrome. Eur J Appl Physiol. 2011 Sep;111(9):2163-71. doi: 10.1007/s00421-011-1850-2. Epub 2011 Feb 6.
- Background: PubMed 24834500Gilbreath JP, Gaven SL, Van Lunen L, Hoch MC. The effects of mobilization with movement on dorsiflexion range of motion, dynamic balance, and self-reported function in individuals with chronic ankle instability. Man Ther. 2014 Apr;19(2):152-7. doi: 10.1016/j.math.2013.10.001.
- Background: PubMed 26215900Hidalgo B, Pitance L, Hall T, Detrembleur C, Nielens H. Short-term effects of Mulligan mobilization with movement on pain, disability, and kinematic spinal movements in patients with nonspecific low back pain: a randomized placebo-controlled trial. J Manipulative Physiol Ther. 2015 Jul-Aug;38(6):365-74. doi: 10.1016/j.jmpt.2015.06.013. Epub 2015 Jul 26.
- Background: PubMed 2916921Lehmann JF, Price R, deLateur BJ, Hinderer S, Traynor C. Spasticity: quantitative measurements as a basis for assessing effectiveness of therapeutic intervention. Arch Phys Med Rehabil. 1989 Jan;70(1):6-15.
- Background: PubMed 24679362Marron-Gomez D, Rodriguez-Fernandez AL, Martin-Urrialde JA. The effect of two mobilization techniques on dorsiflexion in people with chronic ankle instability. Phys Ther Sport. 2015 Feb;16(1):10-5. doi: 10.1016/j.ptsp.2014.02.001. Epub 2014 Feb 14.
- Background: PubMed 25704110Powden CJ, Hoch JM, Hoch MC. Reliability and minimal detectable change of the weight-bearing lunge test: A systematic review. Man Ther. 2015 Aug;20(4):524-32. doi: 10.1016/j.math.2015.01.004. Epub 2015 Jan 29.
- Background: PubMed 25882209Suydam SM, Soulas EM, Elliott DM, Silbernagel KG, Buchanan TS, Cortes DH. Viscoelastic properties of healthy achilles tendon are independent of isometric plantar flexion strength and cross-sectional area. J Orthop Res. 2015 Jun;33(6):926-31. doi: 10.1002/jor.22878. Epub 2015 Apr 27.
- Background: PubMed 16881463Vicenzino B, Branjerdporn M, Teys P, Jordan K. Initial changes in posterior talar glide and dorsiflexion of the ankle after mobilization with movement in individuals with recurrent ankle sprain. J Orthop Sports Phys Ther. 2006 Jul;36(7):464-71. doi: 10.2519/jospt.2006.2265.
- Background: PubMed 22060176Ditroilo M, Watsford M, Murphy A, De Vito G. Assessing musculo-articular stiffness using free oscillations: theory, measurement and analysis. Sports Med. 2011 Dec 1;41(12):1019-32. doi: 10.2165/11591470-000000000-00000.
- Background: PubMed 15040966Collins N, Teys P, Vicenzino B. The initial effects of a Mulligan's mobilization with movement technique on dorsiflexion and pain in subacute ankle sprains. Man Ther. 2004 May;9(2):77-82. doi: 10.1016/S1356-689X(03)00101-2.
- Background: PubMed 23850371Teixeira LM, Pires T, Silva RD, de Resende MA. Immediate effect of a single anteroposterior talus mobilization on dorsiflexion range of motion in participants with orthopedic dysfunction of the ankle and foot. J Manipulative Physiol Ther. 2013 Jul-Aug;36(6):369-75. doi: 10.1016/j.jmpt.2013.06.003. Epub 2013 Jul 11.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobilization with movement and osteopathic mobilization in people with Ankle Stiffness, run by Université Catholique de Louvain at 1 site in Belgium.
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 1 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 18 Mar 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 Belgium. 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?
Electromechanical device measurement of MAS (Lehmann device, 1989) (time frame: Change from baseline until discharge of treatment (same day, single session)). 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 NCT02653807, which also lists 14 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 18 Mar 2016.