Osteoarthritis, HipNCT04771936
Relationship of Core Stability on Pain and Functional Levels in Patients Diagnosed With Hip Osteoarthritis
A study testing Physiotherapy Exercises in people with Osteoarthritis, Hip, run by University of Malta at 1 site in Malta.
Trial summary
Osteoarthritis (OA) is a common disease that occurs more commonly amongst the elderly and is caused by the destruction of the joint cartilage. It is considered to be one of the most common joint disorders worldwide and a main cause of disability amongst older adults. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Physiotherapy Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteMalta
- Study dates
- 28 Jun 2021to 30 Jun 2022
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients awaiting a total hip replacement
- Anyone above the age of 40 years
Who cannot join
- Patients with neurologic conditions affecting mobility
- Patients with cognitive impairments
- Patients not willing to comply
Trial locations and contacts
1 site in 1 country.
About this study
Osteoarthritis (OA) is a common disease that occurs more commonly amongst the elderly and is caused by the destruction of the joint cartilage. It is considered to be one of the most common joint disorders worldwide and a main cause of disability amongst older adults. After the knee, the hip is considered to be the second most commonly affected joint by OA. One of the functional capacities affected by OA is muscle strength with studies looking into knee OA documenting a decrement of this measure. It is reported that the muscle strength of the quadriceps, hamstrings and other musculature around the hip is significantly impaired in patients with knee OA compared to age-matched controls.
Evidence for quadriceps muscle weakness in knee OA is consistent and programs based on quadriceps strengthening exercises as a core component in the management of knee OA are now evidence-based. Lower extremity muscle weakness is also apparent in hip OA. However, compared to the knee, there is less literature on muscle strength in hip OA with guidelines for therapeutic exercise prescription being more expert rather than evidence-based. Therefore, one of the major questions that arises here is whether muscle weakness as observed in knee OA is evident in hip OA, and if so, which muscles are most affected.
Read more
A concept which has been found to help diminish the effect of decreased muscle strength in the above mentioned muscle groups is optimal core stability. Core stability contributes to strength, endurance, flexibility and motor control all of which optimise the stability of the spine during both dynamic and static tasks in daily normal biomechanical function in patients with a diagnosis of OA knees. Despite such evidence, no studies to the knowledge of the researcher have looked into the effects of core stability on pain and functional levels in patients with a diagnosis of OA hip. A lack of literature in relation to this aspect is due to the unavailability of a gold standard for measuring core stability.
Therefore, the objective of this study will be multifold with an investigation into which muscles in the lower limb are predominantly weaker, whether there is core muscle weakness in patients with hip OA, looking for any correlation between both these factors and whether an exercise programme leads to changes on functional activity and pain levels.
Read the detailed description
Osteoarthritis (OA) is a common disease that occurs more commonly amongst the elderly and is caused by the destruction of the joint cartilage. It is considered to be one of the most common joint disorders worldwide and a main cause of disability amongst older adults. After the knee, the hip is considered to be the second most commonly affected joint by OA.
One of the functional capacities affected by OA is muscle strength with studies looking into knee OA documenting a decrement of this measure. The muscle strength of the quadriceps, hamstrings and other musculature around the hip is significantly impaired in patients with knee OA compared to age-matched controls.
Evidence for quadriceps muscle weakness in knee OA is consistent and programs based on quadriceps strengthening exercises as a core component in the management of knee OA are now evidence-based. Lower extremity muscle weakness is also apparent in hip OA. However, compared to the knee, there is less literature on muscle strength in hip OA with guidelines for therapeutic exercise prescription being more expert rather than evidence-based. Therefore, one of the major questions that arises here is whether muscle weakness as observed in knee OA is evident in hip OA, and if so, which muscles are most affected.
A concept which has been found to help diminish the effect of decreased muscle strength in the above mentioned muscle groups is optimal core stability. Core stability contributes to strength, endurance, flexibility and motor control all of which optimise the stability of the spine during both dynamic and static tasks in daily normal biomechanical function in patients with a diagnosis of OA knees. Despite such evidence, no studies to the knowledge of the researcher have looked into the effects of core stability on pain and functional levels in patients with a diagnosis of OA hip. Lack of literature in relation to this aspect is due to the unavailability of a gold standard for measuring core stability.
Therefore, the objective of this study will be multifold with an investigation into which muscles in the lower limb are predominantly weaker, whether there is core muscle weakness in patients with hip OA, looking for any correlation between both these factors and whether an exercise programme leads to changes on functional activity and pain levels.
All the patients who give consent to participate shall be randomly assigned to three groups being the control group who shall be awaiting surgery and not receiving a regular physiotherapy exercise intervention, the exercise group who shall be subject to a set of conventional exercises based and a core exercise group who shall be performing the conventional exercises plus exercises aimed at the activation of the core muscles. These exercises shall be carried out three times weekly for a period of three months. During the first four weeks, all sessions shall be supervised by a physiotherapist who shall monitor and increase the duration or difficulty of exercises according to patients' progression. From the 5th to the 8th week, patients shall attend two supervised sessions and complete the third one at home. Between the 9th and the 12th week, patients shall then attend one supervised intervention and complete two exercise sessions at home. All patients shall be given a copy of the exercise sheet with instructions for use at home. Anonymisation shall be ensured with every patient through assignment of a random code for every individual. Patients assigned to the control group shall be given a chance to enrol into the program upon completion of the study if they wish to do so.
- Conditions
- Osteoarthritis, Hip
- Being tested
- Physiotherapy Exercises
- Keywords
- Hip, Osteoarthritis, Exercise, Core Stability
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy ExercisesOther
All patients shall be randomly assigned to 3 groups: the control group who shall be awaiting surgery and not receiving a regular physiotherapy, the exercise group who shall be subject to a set of conventional exercises and a core exercise group who shall be performing the conventional exercises plus exercises aimed at the activation of core muscles. These exercises shall be carried out 3 times weekly for a period of 3 months. During the first 4 weeks, all sessions shall be supervised by a physiotherapist. From the 5th to the 8th week, patients shall attend 2 supervised sessions and complete the 3rd one at home. Between the 9th and the 12th week, patients shall then attend 1 supervised intervention and complete 2 sessions at home.Patients assigned to the control group shall be given a chance to enrol into the program upon completion of the study if they wish to do so.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group who shall be awaiting surgery and not receiving a regular physiotherapy exercise intervention |
| Conventional Exercise Group | Active comparator | The conventional exercise group shall be subject to a set of conventional exercises based on a program described by Deyle et al (2000). Receives: Other: Physiotherapy Exercises |
| Conventional Exercise Group with added core exercises | Experimental | This exercise group shall be subject to a set of conventional exercises based on a program described by Deyle et al (2000) and core exercises aimed at the activation of the core muscles as adapted from Imai et al (2010). Receives: Other: Physiotherapy Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain levels assessed using the Numerical Pain Rating Scale (NPRS)
The NPRS is a type of pain scale widely used in the clinical setting aswell as in research. The research found that the NPRS is a simple and valid tool to use with Cleland et al (2008) reporting acceptable construct validity for this tool (p < 0.001). It is usually presented on a horizontal line on which the patient's pain intensity is represented by a point between the marks of 0 (no pain) to 10 (extreme pain). The NPRS is a segmented, numerical version of the Visual Analogue Scale (VAS), as shown in the image below. Its simplicity, reliability, and validity make the NPRS the optimal tool for describing pain severity or intensity (The British Pain Society, 2019).
Measured: Week 0 and week 12
Change in functional Levels assessed using the WOMAC Scale
The Western Ontario and McMaster Universities (WOMAC) is a widely used instrument which is specific to assessing patients with hip and knee OA. This assessment tool is self- administered and is multidimensional (Bellamy, 2008). It consists of 33 items which evaluate the health and function of the patient from various aspects including clinical symptoms (5 questions), severity of joint stiffness (2 questions), degree of pain (9 questions), and activity of daily living (17 questions). Each question has five subscales were the subject score between situations of never or none to situations of extreme or always. A higher score is a representation of a better situation and less pain. Different validation studies of WOMAC make this clinical instrument usable for knee and hip OA and enable clinical investigators to assess those clinical outcome reports using this index from different parts of the world collectively (Ebrahimzadeh et al, 2014).
Measured: Week 0 and week 12
Change in functional Levels assessed using the 6 MWT
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. Such a test has been reported to be a valid and reliable indicator of aerobic fitness (ATS guidelines, 2002). It is considered to be a useful objective baseline measure and has normative results and minimal clinically important differences established for a range of older individuals. The subjects will be instructed that they may stop and rest during the test, but the time will keep running. At the end of the six minutes, the time walked and distance will be noted and recorded. Standardised encouragement is provided at 1-minute intervals, and the person should not be paced. Individuals may use assistive devices during the test (ATS guidelines, 2002).
Measured: Week 0 and week 12
Change in lower limb muscle strength
All subjects will undergo peak isometric lower limb muscle torque testing for the following muscle groups: Quadriceps, Hamstrings, Adductors and Abductors using a dynamometer. A demonstration on how to carry out the test correctly will be done together with a single trial to familiarise with the participants with the technique and procedure. A maximum of three attempts will be performed with the average result taken. Participants will be instructed to exert maximal effort and will be verbally coached to push as hard as they can for each recorded trial.
Measured: Week 0 and week 12
Change in core Muscle Strength using a pressure biofeedback unit (PBU)
Participants will be placed in a supine position with the pelvis over the pressure biofeedback unit (PBU) and their hands resting over their chest. The PBU will be placed under the lumbar spine at the level of L3, with a pressure of 40 mm Hg. The participants will be asked to place their hip in flexion or their knee in flexion/extension while in the supine position. They will be asked to 'Take a deep breath in and draw their navel in toward their spine as they exhale'. Each participant will be asked to hold the contraction for as long as they can while maintaining the contraction at 40mmHg on the PBU gauge. Those able to maintain the abdominal contraction for at least 10 seconds at 40 mmHg will be considered as having good core strength. Those unable to hold the contraction for 10 seconds at the mentioned pressure will be considered as having a weak core (Rajan Bhore et al, 2019).
Measured: Week 0 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start28 Jun 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies 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
- Patients with a diagnosis of OA hip who are awaiting a total hip replacement will be recruited in this study. Both male and female subjects age 40 years and over will be included in the study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilona Dalmas, University of Malta
- Investigators
- Tonio Agius, PhD, Study director, Lecturer at University of Malta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771936
- Sponsor's protocol ID
- 2395
- Status last verified
- Nov 2022
- First submitted
- 20 Feb 2021
- Last updated
- 23 Nov 2022
- 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 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Core Stability on Pain and Functional Levels in Patients Diagnosed With Hip Osteoarthritis
- ClinicalTrials.gov ID
- NCT04771936
- Acronym / sponsor ID
- 2395
- Conditions
- Osteoarthritis, Hip
- Keywords
- Hip, Osteoarthritis, Exercise, Core Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of MaltaUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 Feb 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.
Osteoarthritis (OA) is a common disease that occurs more commonly amongst the elderly and is caused by the destruction of the joint cartilage. It is considered to be one of the most common joint disorders worldwide and a main cause of disability amongst older adults. After the knee, the hip is considered to be the second most commonly affected joint by OA. One of the functional capacities affected by OA is muscle strength with studies looking into knee OA documenting a decrement of this measure. It is reported that the muscle strength of the quadriceps, hamstrings and other musculature around the hip is significantly impaired in patients with knee OA compared to age-matched controls.
Evidence for quadriceps muscle weakness in knee OA is consistent and programs based on quadriceps strengthening exercises as a core component in the management of knee OA are now evidence-based. Lower extremity muscle weakness is also apparent in hip OA. However, compared to the knee, there is less literature on muscle strength in hip OA with guidelines for therapeutic exercise prescription being more expert rather than evidence-based. Therefore, one of the major questions that arises here is whether muscle weakness as observed in knee OA is evident in hip OA, and if so, which muscles are most affected.
A concept which has been found to help diminish the effect of decreased muscle strength in the above mentioned muscle groups is optimal core stability. Core stability contributes to strength, endurance, flexibility and motor control all of which optimise the stability of the spine during both dynamic and static tasks in daily normal biomechanical function in patients with a diagnosis of OA knees. Despite such evidence, no studies to the knowledge of the researcher have looked into the effects of core stability on pain and functional levels in patients with a diagnosis of OA hip. A lack of literature in relation to this aspect is due to the unavailability of a gold standard for measuring core stability.
Therefore, the objective of this study will be multifold with an investigation into which muscles in the lower limb are predominantly weaker, whether there is core muscle weakness in patients with hip OA, looking for any correlation between both these factors and whether an exercise programme leads to changes on functional activity and pain levels.
Detailed description
Osteoarthritis (OA) is a common disease that occurs more commonly amongst the elderly and is caused by the destruction of the joint cartilage. It is considered to be one of the most common joint disorders worldwide and a main cause of disability amongst older adults. After the knee, the hip is considered to be the second most commonly affected joint by OA.
One of the functional capacities affected by OA is muscle strength with studies looking into knee OA documenting a decrement of this measure. The muscle strength of the quadriceps, hamstrings and other musculature around the hip is significantly impaired in patients with knee OA compared to age-matched controls.
Evidence for quadriceps muscle weakness in knee OA is consistent and programs based on quadriceps strengthening exercises as a core component in the management of knee OA are now evidence-based. Lower extremity muscle weakness is also apparent in hip OA. However, compared to the knee, there is less literature on muscle strength in hip OA with guidelines for therapeutic exercise prescription being more expert rather than evidence-based. Therefore, one of the major questions that arises here is whether muscle weakness as observed in knee OA is evident in hip OA, and if so, which muscles are most affected.
A concept which has been found to help diminish the effect of decreased muscle strength in the above mentioned muscle groups is optimal core stability. Core stability contributes to strength, endurance, flexibility and motor control all of which optimise the stability of the spine during both dynamic and static tasks in daily normal biomechanical function in patients with a diagnosis of OA knees. Despite such evidence, no studies to the knowledge of the researcher have looked into the effects of core stability on pain and functional levels in patients with a diagnosis of OA hip. Lack of literature in relation to this aspect is due to the unavailability of a gold standard for measuring core stability.
Therefore, the objective of this study will be multifold with an investigation into which muscles in the lower limb are predominantly weaker, whether there is core muscle weakness in patients with hip OA, looking for any correlation between both these factors and whether an exercise programme leads to changes on functional activity and pain levels.
All the patients who give consent to participate shall be randomly assigned to three groups being the control group who shall be awaiting surgery and not receiving a regular physiotherapy exercise intervention, the exercise group who shall be subject to a set of conventional exercises based and a core exercise group who shall be performing the conventional exercises plus exercises aimed at the activation of the core muscles. These exercises shall be carried out three times weekly for a period of three months. During the first four weeks, all sessions shall be supervised by a physiotherapist who shall monitor and increase the duration or difficulty of exercises according to patients' progression. From the 5th to the 8th week, patients shall attend two supervised sessions and complete the third one at home. Between the 9th and the 12th week, patients shall then attend one supervised intervention and complete two exercise sessions at home. All patients shall be given a copy of the exercise sheet with instructions for use at home. Anonymisation shall be ensured with every patient through assignment of a random code for every individual. Patients assigned to the control group shall be given a chance to enrol into the program upon completion of the study if they wish to do so.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Patients with a diagnosis of OA hip who are awaiting a total hip replacement will be recruited in this study. Both male and female subjects age 40 years and over will be included in the study.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group who shall be awaiting surgery and not receiving a regular physiotherapy exercise intervention |
| Conventional Exercise Group | Active comparator | Other: Physiotherapy ExercisesThe conventional exercise group shall be subject to a set of conventional exercises based on a program described by Deyle et al (2000). |
| Conventional Exercise Group with added core exercises | Experimental | Other: Physiotherapy ExercisesThis exercise group shall be subject to a set of conventional exercises based on a program described by Deyle et al (2000) and core exercises aimed at the activation of the core muscles as adapted from Imai et al (2010). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients awaiting a total hip replacement
- Anyone above the age of 40 years
Key exclusion criteria (3 listed)
- Patients with neurologic conditions affecting mobility
- Patients with cognitive impairments
- Patients not willing to comply
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 |
|---|---|---|
| Physiotherapy ExercisesAll patients shall be randomly assigned to 3 groups: the control group who shall be awaiting surgery and not receiving a regular physiotherapy, the exercise group who shall be subject to a set of conventional exercises and a core exercise group who shall be performing the conventional exercises plus exercises aimed at the activation of core muscles. These exercises shall be carried out 3 times weekly for a period of 3 months. During the first 4 weeks, all sessions shall be supervised by a physiotherapist. From the 5th to the 8th week, patients shall attend 2 supervised sessions and complete the 3rd one at home. Between the 9th and the 12th week, patients shall then attend 1 supervised intervention and complete 2 sessions at home.Patients assigned to the control group shall be given a chance to enrol into the program upon completion of the study if they wish to do so. | Other | Conventional Exercise Group, Conventional Exercise Group with added core exercises |
Primary outcome
Change in pain levels assessed using the Numerical Pain Rating Scale (NPRS)
Time frame: Week 0 and week 12
The NPRS is a type of pain scale widely used in the clinical setting aswell as in research. The research found that the NPRS is a simple and valid tool to use with Cleland et al (2008) reporting acceptable construct validity for this tool (p < 0.001). It is usually presented on a horizontal line on which the patient's pain intensity is represented by a point between the marks of 0 (no pain) to 10 (extreme pain). The NPRS is a segmented, numerical version of the Visual Analogue Scale (VAS), as shown in the image below. Its simplicity, reliability, and validity make the NPRS the optimal tool for describing pain severity or intensity (The British Pain Society, 2019).
Change in functional Levels assessed using the WOMAC Scale
Time frame: Week 0 and week 12
The Western Ontario and McMaster Universities (WOMAC) is a widely used instrument which is specific to assessing patients with hip and knee OA. This assessment tool is self- administered and is multidimensional (Bellamy, 2008). It consists of 33 items which evaluate the health and function of the patient from various aspects including clinical symptoms (5 questions), severity of joint stiffness (2 questions), degree of pain (9 questions), and activity of daily living (17 questions). Each question has five subscales were the subject score between situations of never or none to situations of extreme or always. A higher score is a representation of a better situation and less pain. Different validation studies of WOMAC make this clinical instrument usable for knee and hip OA and enable clinical investigators to assess those clinical outcome reports using this index from different parts of the world collectively (Ebrahimzadeh et al, 2014).
Change in functional Levels assessed using the 6 MWT
Time frame: Week 0 and week 12
The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. Such a test has been reported to be a valid and reliable indicator of aerobic fitness (ATS guidelines, 2002). It is considered to be a useful objective baseline measure and has normative results and minimal clinically important differences established for a range of older individuals. The subjects will be instructed that they may stop and rest during the test, but the time will keep running. At the end of the six minutes, the time walked and distance will be noted and recorded. Standardised encouragement is provided at 1-minute intervals, and the person should not be paced. Individuals may use assistive devices during the test (ATS guidelines, 2002).
Change in lower limb muscle strength
Time frame: Week 0 and week 12
All subjects will undergo peak isometric lower limb muscle torque testing for the following muscle groups: Quadriceps, Hamstrings, Adductors and Abductors using a dynamometer. A demonstration on how to carry out the test correctly will be done together with a single trial to familiarise with the participants with the technique and procedure. A maximum of three attempts will be performed with the average result taken. Participants will be instructed to exert maximal effort and will be verbally coached to push as hard as they can for each recorded trial.
Change in core Muscle Strength using a pressure biofeedback unit (PBU)
Time frame: Week 0 and week 12
Participants will be placed in a supine position with the pelvis over the pressure biofeedback unit (PBU) and their hands resting over their chest. The PBU will be placed under the lumbar spine at the level of L3, with a pressure of 40 mm Hg. The participants will be asked to place their hip in flexion or their knee in flexion/extension while in the supine position. They will be asked to 'Take a deep breath in and draw their navel in toward their spine as they exhale'. Each participant will be asked to hold the contraction for as long as they can while maintaining the contraction at 40mmHg on the PBU gauge. Those able to maintain the abdominal contraction for at least 10 seconds at 40 mmHg will be considered as having good core strength. Those unable to hold the contraction for 10 seconds at the mentioned pressure will be considered as having a weak core (Rajan Bhore et al, 2019).
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 23 Nov 2022.
- 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.
Tonio Agius, PhD study director
Lecturer at University of Malta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy Exercises in people with Osteoarthritis, Hip, run by University of Malta at 1 site in Malta.
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 2 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 23 Nov 2022. 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 Malta. 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?
Change in pain levels assessed using the Numerical Pain Rating Scale (NPRS) (time frame: Week 0 and week 12). 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?
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 23 Nov 2022.