StrainsNCT02104258
Rehabilitation of Acute Hamstring Injuries in Male Athletes
A study testing Physiotherapy ASPETAR and Physiotherapy ASPETAR+ in people with Strains, run by Aspetar at 1 site in Qatar.
Trial summary
The purpose of the study is to compare the effect of two rehabilitation protocols with different emphasis on eccentric exercises after acute hamstring muscle strain injuries on the time to return to sports (RTS) and the rate of re-injuries in male athletes. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Strains
- What is being tested?
- Physiotherapy ASPETAR and Physiotherapy ASPETAR+
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteQatar
- Study dates
- Mar 2014to 20 Feb 2020
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male athletes
- Age 18-50 years
- Acute onset posterior thigh pain when training or competing, identified as:
- Patient reported sudden event
- Patient reported pain in posterior thigh
- Clinical diagnosis of an acute hamstring muscle strain injury, defined as:
Show all 13Show fewer
- Localised pain during palpation of hamstring muscle
- Increasing pain during isometric contraction
- Localised pain when performing a passive straight leg raise test
- MRI confirmed isolated hamstring lesion (increased high signal intensity on fat saturated sequences)
- MRI performed ≤5 days from injury
- Available for ≥3 physiotherapy sessions per week at Aspetar
- Available for follow-up
Who cannot join
- Patients with verified or suspected previous hamstring injury within the last 6 months in the same leg
- Chronic hamstring complaints >2 months
- Grade III injury including complete hamstring disruption or avulsion of all tendons
- Contraindications to MRI
- Patients that do not have an intention to return to full sport activity
- Patients that do not want to receive one of the two therapies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rehabilitation of Acute Hamstring Injuries in Male Athletes: A Prospective Single-site Randomized Controlled Clinical Trial Comparing Two Rehabilitation Protocols With Different Emphasis on Eccentric Exercises
The purpose of the study is to compare the effect of two rehabilitation protocols with different emphasis on eccentric exercises after acute hamstring muscle strain injuries on the time to return to sports (RTS) and the rate of re-injuries in male athletes.
The hypothesis is that the addition of early eccentric hamstring exercises being performed at longer muscle-tendon length towards end range of motion alter the outcomes RTS and re-injuries in a rehabilitation protocol after acute hamstring muscle strain injuries.
Read the detailed description
Background and rationale:
Acute hamstring muscle strain injuries represent the most prevalent non-contact muscle injury reported in sports. Despite the high prevalence and a rapidly expanding body of literature investigating hamstring muscle strain injuries, [1] occurrence and re-injury rates have not improved over the last three decades [2]. Therefore, rehabilitation and secondary prevention are of particular concern, and the primary objective of all rehabilitation protocols is to return an athlete to pre-injury level as soon as possible with a minimal risk of injury recurrence.There is still a lack of consensus and clinical research regarding the effectiveness of various rehabilitation protocols for acute hamstring injuries in athletes participating in sports with high sprinting demands [3,4]. To our knowledge, there are no prospective, randomised trials investigating the effect of different rehabilitation protocols in a Middle-Eastern athletic population. Eccentric strength training has shown to reduce the risk of both new acute hamstring injuries as well as re-injuries [5,6], whereas hamstring exercises being performed at longer muscle-tendon length, preferentially mimicking movements occuring simultaneously at both the knee and hip are reported to be more effective than a protocol containing conventional exercises [7], and are suggested to be a key strategy in the management of hamstring injuries. However, the preventive effect related to the eccentric training remains unclear and is still debated and the optimal intensity of eccentric training in rehabilitation of acute hamstring strain injuries and prevention of re-injuries is yet unknown [8].
The primary objective in this study is therefore to compare the effect of two rehabilitation protocols after acute hamstring muscle strain injuries on the time to return to sports (RTS) and the rate of re-injuries in male athletes in a prospective single-site randomized controlled trial.
The investigators aim to include 90 male athletes with clinical signs and MRI abnormalities consistent with an acute hamstring muscle strain injury. The injured athletes will be randomised into one of two different rehabilitation protocols with unlike emphasis on eccentric exercises.
- Conditions
- Strains
- Being tested
- Physiotherapy ASPETAR, Physiotherapy ASPETAR+
- Keywords
- Hamstring, Muscle, Injury, Treatment, Rehabilitation
- Medical subject headings
- Sprains and Strains, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy ASPETAROther
Standardized physiotherapy protocol
Physiotherapy ASPETAR+Other
Standardized physiotherapy protocol including early lengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy ASPETAR | Active comparator | The patients will follow the ASPETAR Hamstring Rehabilitation Protocol, which is a standardised physiotherapy protocol, including range of motion exercises, progressive strengthening exercises, core stability training and agility exercises [10].
The ASPETAR protocol consist of predefined rehabilitation stages including sports specific stages. Specific functional based criteria for progression will be utilized for each of the six rehabilitation stages. No pain provocation when performing the exercises will be allowed.
The rehabilitation will be initiated as soon as possible after inclusion and the patients will be supervised by experienced physiotherapists in the Rehabilitation Department at Aspetar 3 to 5 days per week. Receives: Other: Physiotherapy ASPETAR |
| Physiotherapy ASPETAR+ | Active comparator | The patients will follow the ASPETAR+ Hamstring Rehabilitation Protocol. ASPETAR+ is similar to ASPETAR, but consists of additional lengthening exercises which will be initiated early in the rehabilitation phase.
ASPETAR+ consist of predefined rehabilitation stages including sports specific stages. Specific functional based criteria for progression will be utilized for each of the six rehabilitation stages. No pain provocation when performing the exercises will be allowed.
The rehabilitation will be initiated as soon as possible after inclusion and the patients will be supervised by experienced physiotherapists in the Rehabilitation Department at Aspetar 3 to 5 days per week. Receives: Other: Physiotherapy ASPETAR+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Return to Sport (RTS)
Number of days between initial injury and return to full unrestricted training and/or match play
Measured: After the initial injury, patients will be followed daily during working days for the duration of time until they return to RTS, with an expected average of 25 days up to 1 year
Secondary outcomes (1)
Re-injury within 2 months, 6 months and 12 months after RTS
In the event of a clinical suspicion of re-injury, the player will be advised to immediately call the primary investigator and consult a physician
Measured: The patients will be monitored by phone 2 months, 6 months and 12 months after RTS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2014 (estimated)
- Study startMar 2014
- Primary completion20 Feb 2019
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for StrainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspetar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodney Whiteley, PhD, PT, Principal investigator, Aspetar Orthopaedic and Sports Medicine HospitalArnlaug Wangensteen, MSc, Study director, Aspetar Orthopaedic and Sports Medicine Hospital, Norwegian School for Sports ScienceRoald Bahr, Prof. PhD MD, Study director, Aspetar Orthopaedic and Sports Medicine HospitalErik Witvrouw, Prof. PhD PT, Study director, Aspetar Orthopaedic and Sports Medicine HoslpitalJohannes Tol, PhD MD, Study director, Aspetar Orthopaedic and Sports Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02104258
- Sponsor's protocol ID
- HAR47
- Other IDs
- CMO/000047/fj
- Status last verified
- Feb 2020
- First submitted
- 22 Mar 2014
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Hamilton B. Hamstring muscle strain injuries: what can we learn from history? Br J Sports Med. 2012 Oct;46(13):900-3. doi: 10.1136/bjsports-2012-090931. Epub 2012 Mar 29. No abstract available.
PubMed 22460740Kerkhoffs GM, van Es N, Wieldraaijer T, Sierevelt IN, Ekstrand J, van Dijk CN. Diagnosis and prognosis of acute hamstring injuries in athletes. Knee Surg Sports Traumatol Arthrosc. 2013 Feb;21(2):500-9. doi: 10.1007/s00167-012-2055-x. Epub 2012 May 24.
PubMed 22622781Reurink G, Goudswaard GJ, Tol JL, Verhaar JA, Weir A, Moen MH. Therapeutic interventions for acute hamstring injuries: a systematic review. Br J Sports Med. 2012 Feb;46(2):103-9. doi: 10.1136/bjsports-2011-090447. Epub 2011 Oct 28.
PubMed 22039218Mason DL, Dickens VA, Vail A. Rehabilitation for hamstring injuries. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004575. doi: 10.1002/14651858.CD004575.pub3.
PubMed 23235611Arnason A, Andersen TE, Holme I, Engebretsen L, Bahr R. Prevention of hamstring strains in elite soccer: an intervention study. Scand J Med Sci Sports. 2008 Feb;18(1):40-8. doi: 10.1111/j.1600-0838.2006.00634.x. Epub 2007 Mar 12.
PubMed 17355322Petersen J, Thorborg K, Nielsen MB, Budtz-Jorgensen E, Holmich P. Preventive effect of eccentric training on acute hamstring injuries in men's soccer: a cluster-randomized controlled trial. Am J Sports Med. 2011 Nov;39(11):2296-303. doi: 10.1177/0363546511419277. Epub 2011 Aug 8.
PubMed 21825112Askling CM, Tengvar M, Thorstensson A. Acute hamstring injuries in Swedish elite football: a prospective randomised controlled clinical trial comparing two rehabilitation protocols. Br J Sports Med. 2013 Oct;47(15):953-9. doi: 10.1136/bjsports-2013-092165. Epub 2013 Mar 27.
PubMed 23536466Malliaropoulos N, Mendiguchia J, Pehlivanidis H, Papadopoulou S, Valle X, Malliaras P, Maffulli N. Hamstring exercises for track and field athletes: injury and exercise biomechanics, and possible implications for exercise selection and primary prevention. Br J Sports Med. 2012 Sep;46(12):846-51. doi: 10.1136/bjsports-2011-090474. Epub 2012 Jun 9.
PubMed 22685125Whiteley R, Jacobsen P, Prior S, Skazalski C, Otten R, Johnson A. Correlation of isokinetic and novel hand-held dynamometry measures of knee flexion and extension strength testing. J Sci Med Sport. 2012 Sep;15(5):444-50. doi: 10.1016/j.jsams.2012.01.003. Epub 2012 Mar 15.
PubMed 22424705Askling CM, Nilsson J, Thorstensson A. A new hamstring test to complement the common clinical examination before return to sport after injury. Knee Surg Sports Traumatol Arthrosc. 2010 Dec;18(12):1798-803. doi: 10.1007/s00167-010-1265-3. Epub 2010 Sep 18.
PubMed 20852842Tol JL, Hamilton B, Eirale C, Muxart P, Jacobsen P, Whiteley R. At return to play following hamstring injury the majority of professional football players have residual isokinetic deficits. Br J Sports Med. 2014 Sep;48(18):1364-9. doi: 10.1136/bjsports-2013-093016. Epub 2014 Feb 3.
PubMed 24493666Zein MI, Mokkenstorm MJK, Cardinale M, Holtzhausen L, Whiteley R, Moen MH, Reurink G, Tol JL; Qatari and Dutch Hamstring Study Group. Baseline clinical and MRI risk factors for hamstring reinjury showing the value of performing baseline MRI and delaying return to play: a multicentre, prospective cohort of 330 acute hamstring injuries. Br J Sports Med. 2024 Jul 1;58(14):766-776. doi: 10.1136/bjsports-2023-107878.
PubMed 38729628Whiteley R, van Dyk N, Wangensteen A, Hansen C. Clinical implications from daily physiotherapy examination of 131 acute hamstring injuries and their association with running speed and rehabilitation progression. Br J Sports Med. 2018 Mar;52(5):303-310. doi: 10.1136/bjsports-2017-097616. Epub 2017 Oct 30.
PubMed 29084725
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Acute Hamstring Injuries in Male Athletes: A Prospective Single-site Randomized Controlled Clinical Trial Comparing Two Rehabilitation Protocols With Different Emphasis on Eccentric Exercises
- ClinicalTrials.gov ID
- NCT02104258
- Acronym / sponsor ID
- HAR47
- Conditions
- Strains
- Keywords
- Hamstring, Muscle, Injury, Treatment, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- AspetarUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- 20 Feb 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 4 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the effect of two rehabilitation protocols with different emphasis on eccentric exercises after acute hamstring muscle strain injuries on the time to return to sports (RTS) and the rate of re-injuries in male athletes.
The hypothesis is that the addition of early eccentric hamstring exercises being performed at longer muscle-tendon length towards end range of motion alter the outcomes RTS and re-injuries in a rehabilitation protocol after acute hamstring muscle strain injuries.
Detailed description
Background and rationale:
Acute hamstring muscle strain injuries represent the most prevalent non-contact muscle injury reported in sports. Despite the high prevalence and a rapidly expanding body of literature investigating hamstring muscle strain injuries, [1] occurrence and re-injury rates have not improved over the last three decades [2]. Therefore, rehabilitation and secondary prevention are of particular concern, and the primary objective of all rehabilitation protocols is to return an athlete to pre-injury level as soon as possible with a minimal risk of injury recurrence.There is still a lack of consensus and clinical research regarding the effectiveness of various rehabilitation protocols for acute hamstring injuries in athletes participating in sports with high sprinting demands [3,4]. To our knowledge, there are no prospective, randomised trials investigating the effect of different rehabilitation protocols in a Middle-Eastern athletic population. Eccentric strength training has shown to reduce the risk of both new acute hamstring injuries as well as re-injuries [5,6], whereas hamstring exercises being performed at longer muscle-tendon length, preferentially mimicking movements occuring simultaneously at both the knee and hip are reported to be more effective than a protocol containing conventional exercises [7], and are suggested to be a key strategy in the management of hamstring injuries. However, the preventive effect related to the eccentric training remains unclear and is still debated and the optimal intensity of eccentric training in rehabilitation of acute hamstring strain injuries and prevention of re-injuries is yet unknown [8].
The primary objective in this study is therefore to compare the effect of two rehabilitation protocols after acute hamstring muscle strain injuries on the time to return to sports (RTS) and the rate of re-injuries in male athletes in a prospective single-site randomized controlled trial.
The investigators aim to include 90 male athletes with clinical signs and MRI abnormalities consistent with an acute hamstring muscle strain injury. The injured athletes will be randomised into one of two different rehabilitation protocols with unlike emphasis on eccentric exercises.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy ASPETAR | Active comparator | Other: Physiotherapy ASPETARThe patients will follow the ASPETAR Hamstring Rehabilitation Protocol, which is a standardised physiotherapy protocol, including range of motion exercises, progressive strengthening exercises, core stability training and agility exercises [10]. The ASPETAR protocol consist of predefined rehabilitation stages including sports specific stages. Specific functional based criteria for progression will be utilized for each of the six rehabilitation stages. No pain provocation when performing the exercises will be allowed. The rehabilitation will be initiated as soon as possible after inclusion and the patients will be supervised by experienced physiotherapists in the Rehabilitation Department at Aspetar 3 to 5 days per week. |
| Physiotherapy ASPETAR+ | Active comparator | Other: Physiotherapy ASPETAR+The patients will follow the ASPETAR+ Hamstring Rehabilitation Protocol. ASPETAR+ is similar to ASPETAR, but consists of additional lengthening exercises which will be initiated early in the rehabilitation phase. ASPETAR+ consist of predefined rehabilitation stages including sports specific stages. Specific functional based criteria for progression will be utilized for each of the six rehabilitation stages. No pain provocation when performing the exercises will be allowed. The rehabilitation will be initiated as soon as possible after inclusion and the patients will be supervised by experienced physiotherapists in the Rehabilitation Department at Aspetar 3 to 5 days per week. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male athletes
- Age 18-50 years
- Acute onset posterior thigh pain when training or competing, identified as:
- Clinical diagnosis of an acute hamstring muscle strain injury, defined as:
- MRI confirmed isolated hamstring lesion (increased high signal intensity on fat saturated sequences)
Key exclusion criteria (6 listed)
- Patients with verified or suspected previous hamstring injury within the last 6 months in the same leg
- Chronic hamstring complaints >2 months
- Grade III injury including complete hamstring disruption or avulsion of all tendons
- Contraindications to MRI
- Patients that do not have an intention to return to full sport activity
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 ASPETARStandardized physiotherapy protocol | Other | Physiotherapy ASPETAR |
| Physiotherapy ASPETAR+Standardized physiotherapy protocol including early lengthening exercises | Other | Physiotherapy ASPETAR+ |
Primary outcome
Time to Return to Sport (RTS)
Time frame: After the initial injury, patients will be followed daily during working days for the duration of time until they return to RTS, with an expected average of 25 days up to 1 year
Number of days between initial injury and return to full unrestricted training and/or match play
1 secondary outcome
Re-injury within 2 months, 6 months and 12 months after RTS
Time frame: The patients will be monitored by phone 2 months, 6 months and 12 months after RTS
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 Feb 2020.
- Background: PubMed 22460740Hamilton B. Hamstring muscle strain injuries: what can we learn from history? Br J Sports Med. 2012 Oct;46(13):900-3. doi: 10.1136/bjsports-2012-090931. Epub 2012 Mar 29. No abstract available.
- Background: PubMed 22622781Kerkhoffs GM, van Es N, Wieldraaijer T, Sierevelt IN, Ekstrand J, van Dijk CN. Diagnosis and prognosis of acute hamstring injuries in athletes. Knee Surg Sports Traumatol Arthrosc. 2013 Feb;21(2):500-9. doi: 10.1007/s00167-012-2055-x. Epub 2012 May 24.
- Background: PubMed 22039218Reurink G, Goudswaard GJ, Tol JL, Verhaar JA, Weir A, Moen MH. Therapeutic interventions for acute hamstring injuries: a systematic review. Br J Sports Med. 2012 Feb;46(2):103-9. doi: 10.1136/bjsports-2011-090447. Epub 2011 Oct 28.
- Background: PubMed 23235611Mason DL, Dickens VA, Vail A. Rehabilitation for hamstring injuries. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD004575. doi: 10.1002/14651858.CD004575.pub3.
- Background: PubMed 17355322Arnason A, Andersen TE, Holme I, Engebretsen L, Bahr R. Prevention of hamstring strains in elite soccer: an intervention study. Scand J Med Sci Sports. 2008 Feb;18(1):40-8. doi: 10.1111/j.1600-0838.2006.00634.x. Epub 2007 Mar 12.
- Background: PubMed 21825112Petersen J, Thorborg K, Nielsen MB, Budtz-Jorgensen E, Holmich P. Preventive effect of eccentric training on acute hamstring injuries in men's soccer: a cluster-randomized controlled trial. Am J Sports Med. 2011 Nov;39(11):2296-303. doi: 10.1177/0363546511419277. Epub 2011 Aug 8.
- Background: PubMed 23536466Askling CM, Tengvar M, Thorstensson A. Acute hamstring injuries in Swedish elite football: a prospective randomised controlled clinical trial comparing two rehabilitation protocols. Br J Sports Med. 2013 Oct;47(15):953-9. doi: 10.1136/bjsports-2013-092165. Epub 2013 Mar 27.
- Background: PubMed 22685125Malliaropoulos N, Mendiguchia J, Pehlivanidis H, Papadopoulou S, Valle X, Malliaras P, Maffulli N. Hamstring exercises for track and field athletes: injury and exercise biomechanics, and possible implications for exercise selection and primary prevention. Br J Sports Med. 2012 Sep;46(12):846-51. doi: 10.1136/bjsports-2011-090474. Epub 2012 Jun 9.
- Background: PubMed 22424705Whiteley R, Jacobsen P, Prior S, Skazalski C, Otten R, Johnson A. Correlation of isokinetic and novel hand-held dynamometry measures of knee flexion and extension strength testing. J Sci Med Sport. 2012 Sep;15(5):444-50. doi: 10.1016/j.jsams.2012.01.003. Epub 2012 Mar 15.
- Background: PubMed 20852842Askling CM, Nilsson J, Thorstensson A. A new hamstring test to complement the common clinical examination before return to sport after injury. Knee Surg Sports Traumatol Arthrosc. 2010 Dec;18(12):1798-803. doi: 10.1007/s00167-010-1265-3. Epub 2010 Sep 18.
- Background: PubMed 24493666Tol JL, Hamilton B, Eirale C, Muxart P, Jacobsen P, Whiteley R. At return to play following hamstring injury the majority of professional football players have residual isokinetic deficits. Br J Sports Med. 2014 Sep;48(18):1364-9. doi: 10.1136/bjsports-2013-093016. Epub 2014 Feb 3.
- Derived from this study: PubMed 38729628Zein MI, Mokkenstorm MJK, Cardinale M, Holtzhausen L, Whiteley R, Moen MH, Reurink G, Tol JL; Qatari and Dutch Hamstring Study Group. Baseline clinical and MRI risk factors for hamstring reinjury showing the value of performing baseline MRI and delaying return to play: a multicentre, prospective cohort of 330 acute hamstring injuries. Br J Sports Med. 2024 Jul 1;58(14):766-776. doi: 10.1136/bjsports-2023-107878.
- Individual participant dataSharing planned: Undecided
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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.
Rodney Whiteley, PhD, PT principal investigator
Aspetar Orthopaedic and Sports Medicine Hospital
Arnlaug Wangensteen, MSc study director
Aspetar Orthopaedic and Sports Medicine Hospital, Norwegian School for Sports Science
Roald Bahr, Prof. PhD MD study director
Aspetar Orthopaedic and Sports Medicine Hospital
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 ASPETAR and Physiotherapy ASPETAR+ in people with Strains, run by Aspetar at 1 site in Qatar.
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 13 inclusion and 6 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 Feb 2020. 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 Qatar. 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?
Time to Return to Sport (RTS) (time frame: After the initial injury, patients will be followed daily during working days for the duration of time until they return to RTS, with an expected average of 25 days up to 1 year). 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 NCT02104258, which also lists 13 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 25 Feb 2020.