Sports Physical TherapyNCT06943079
PNF and BFR Affect on Pain, ROM & Functional Outcome in Post-op ACL
A study testing Effect of Hold Relax technique with Blood Flow Restriction technique on functional outcome and Effect of Hold Relax technique without Blood Flow Restriction technique on functional outcomes in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
Trial summary
A randomized controlled trial investigated the effects of Hold Relax Technique (HRT) with and without Blood Flow Restriction (BFR) on pain, range of motion (ROM), and functional disability in patients with post-operative ACL rehabilitation. This study includes all types of genders with age limit is 25-45 years. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Sports Physical Therapy
- What is being tested?
- Effect of Hold Relax technique with Blood Flow Restriction technique on functional outcome and Effect of Hold Relax technique without Blood Flow Restriction technique on functional outcomes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Feb 2024to 10 Jan 2025
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group 25-45 years.
- Both gender male and female.
- Patient underwent arthroscopic ACL repair procedure.
- Patients in 6 weeks of rehabilitation phase.
- Grafts of hamstring muscle were used in repair.
- Max range achieved after post-op day 1.
- Low- moderate pain intensity.
Who cannot join
- Any form of bone carcinoma.
- Any Post-OP active infectionous Patients.
- Any circulatory effects.
- DVT and pulmonary embolism.
- Loose Implant placement.
- Non co-operative Patient.
- Hyperasthetic Patient.
- Polytraumatic Post-OP Patient.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ghurki Trust and Teaching Hospital
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Hold-relax Technique With or Without Blood Flow Restriction on Pain, Range of Motion and Functional Disability in Patients With Post Operative ACL Rehabilitation.
A randomized controlled trial investigated the effects of Hold Relax Technique (HRT) with and without Blood Flow Restriction (BFR) on pain, range of motion (ROM), and functional disability in patients with post-operative ACL rehabilitation. This study includes all types of genders with age limit is 25-45 years. But the aim is to infer the answers to the following questions; Does HRT has better effects than HRT with BFR? How much effect should be noted ? The research will show that if both HRT and HRT with BFR groups had significant pain reduction, the HRT with BFR group demonstrated greater ROM improvement and significant enhancement in functional ability compared to the HRT and control groups.
Read the detailed description
A randomized clinical trial will be conducted under Riphah International University guidelines and nonprobability convenient sampling will be used to collect data from the 48 participants from the Ghurki trust and teaching hospital setting. Participants will go through ACL reconstruction specifically the usage of a hamstring graft. The participants were allocated into two groups by using randomization through computer-generated software A and B. In A group only HRT will be applied to check the effects on pain, ROM, and functional disability. In the B group HRT with BFR will be utilized to note the effects on pain, ROM, and functional disability.
- Conditions
- Sports Physical Therapy
- Being tested
- Effect of Hold Relax technique with Blood Flow Restriction technique on functional outcome, Effect of Hold Relax technique without Blood Flow Restriction technique on functional outcomes
- Keywords
- ACL reconstruction, Hamstring graft, Hold relax technique, Blood flow restriction, Knee joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effect of Hold Relax technique with Blood Flow Restriction technique on functional outcomeDevice
Also called Hold Relax teachnique, Blood Flow Restriction technique
Participants are randomly allocated to group A through computerised generated method. The both combine intervention is divided into 3 intervals and their results will be calculated on 0 week, 3rd, and 6th week. On every interval, pain through numeric pain rating scale, range of motion through goniometer, and functional disability through lower extremity functional scale will be measured. 2-3/week frequency of intervention will be applied on the participant.
Effect of Hold Relax technique without Blood Flow Restriction technique on functional outcomesOther
Also called Hold Relax technique
Participants are randomly allocated to group B through computerised generated method. The intervention is divided into 3 intervals and their results will be calculated on 0 week, 3rd, and 6th week. On every interval, pain through numeric pain rating scale, range of motion through goniometer, and functional disability through lower extremity functional scale will be measured. 2-3/week frequency of intervention will be applied on the participant.
| Study group | Role | What they receive |
|---|---|---|
| A - Hold Relax technique with Blood Flow Restriction technique | Experimental | Effects of Hold Relax technique with Blood Flow Restriction on functional outcome Receives: Device: Effect of Hold Relax technique with Blood Flow Restriction technique on functional outcome |
| B - Hold relax technique without blood Flow Restriction technique | Active comparator | Effect of Hold Relax technique without Blood flow restriction on functional outcomes Receives: Other: Effect of Hold Relax technique without Blood Flow Restriction technique on functional outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
1- BFR Cuff
BFR requires a tourniquet to be placed on a limb. The cuff needs to be tightened to a specific pressure that occludes venous flow while still allowing arterial flow whilst exercises are being performed. Simple pieces of equipment such as surgical tubing or elastic straps have been used in gym settings to achieve this result. These are not advisable as you are unable to monitor the amount of blood flow occlusion. A thin diameter may also cause too much local pressure and result in tissue damage.(29)
Measured: 6 weeks
2- UNIVERSAL GONIOMETER
The measurement of joint range of motion (ROM), also referred to as goniometry, is a crucial physical therapy practice.(30) Goniometry, the measuring of joint angles, is a frequently used assessment tool in the tracking of rehabilitation interventions as well as issues with the musculoskeletal system. It is generally performed with a universal goniometer (UG).(31) Inter-tester reliability for universal goniometers is mediocre.(32)
Measured: 6 weeks
3- NUMERIC PAIN RATING SCALE (NPRS)
The Numeric Pain Rating Scale (NRS-11) is an eleven-point rating system with a score of 0 representing no pain at all and a score of 10 representing the greatest agony the patient has ever had. In this context, the NPRS-11 pain severity score of "4" is usually given particular weight, indicating that it may serve as a threshold value for pain severity in clinical practice.(33) Its dependability coefficient is high (0.95-0.96).(34)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start11 Feb 2024
- Primary completion2 Dec 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Sports Physical TherapyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Model description
- 2 groups; A for the application of HRT B includes HRT and BFR Their effects will be noted on 0 week, 3rd week and 6th week to conclude its result.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Humera Mubashar Senior Lecturer, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943079
- Sponsor's protocol ID
- REC/RCR & AHS/24/0120
- Status last verified
- Apr 2025
- First submitted
- 17 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
PubMed 10201543Chesworth BM, Culham E, Tata GE, Peat M. Validation of outcome measures in patients with patellofemoral syndrome. J Orthop Sports Phys Ther. 1989;10(8):302-8. doi: 10.2519/jospt.1989.10.8.302.
PubMed 18796951Kujala UM, Jaakkola LH, Koskinen SK, Taimela S, Hurme M, Nelimarkka O. Scoring of patellofemoral disorders. Arthroscopy. 1993;9(2):159-63. doi: 10.1016/s0749-8063(05)80366-4.
PubMed 8461073Irrgang JJ, Snyder-Mackler L, Wainner RS, Fu FH, Harner CD. Development of a patient-reported measure of function of the knee. J Bone Joint Surg Am. 1998 Aug;80(8):1132-45. doi: 10.2106/00004623-199808000-00006.
PubMed 9730122Martin DP, Engelberg R, Agel J, Swiontkowski MF. Comparison of the Musculoskeletal Function Assessment questionnaire with the Short Form-36, the Western Ontario and McMaster Universities Osteoarthritis Index, and the Sickness Impact Profile health-status measures. J Bone Joint Surg Am. 1997 Sep;79(9):1323-35. doi: 10.2106/00004623-199709000-00006.
PubMed 9314394McHorney CA, Tarlov AR. Individual-patient monitoring in clinical practice: are available health status surveys adequate? Qual Life Res. 1995 Aug;4(4):293-307. doi: 10.1007/BF01593882.
PubMed 7550178Nelson EC, Berwick DM. The measurement of health status in clinical practice. Med Care. 1989 Mar;27(3 Suppl):S77-90. doi: 10.1097/00005650-198903001-00007.
PubMed 2646493Al-Hadidi F, Bsisu I, AlRyalat SA, Al-Zu'bi B, Bsisu R, Hamdan M, Kanaan T, Yasin M, Samarah O. Association between mobile phone use and neck pain in university students: A cross-sectional study using numeric rating scale for evaluation of neck pain. PLoS One. 2019 May 20;14(5):e0217231. doi: 10.1371/journal.pone.0217231. eCollection 2019.
PubMed 31107910Bergh A, Lauridsen NG, Hesbach AL. Concurrent Validity of Equine Joint Range of Motion Measurement: A Novel Digital Goniometer versus Universal Goniometer. Animals (Basel). 2020 Dec 19;10(12):2436. doi: 10.3390/ani10122436.
PubMed 33352686Perez-de la Cruz S, de Leon OA, Mallada NP, Rodriguez AV. Validity and intra-examiner reliability of the Hawk goniometer versus the universal goniometer for the measurement of range of motion of the glenohumeral joint. Med Eng Phys. 2021 Mar;89:7-11. doi: 10.1016/j.medengphy.2021.01.005. Epub 2021 Jan 27.
PubMed 33608127Keil H, Beisemann N, Swartman B, Schnetzke M, Vetter SY, Grutzner PA, Franke J. Intraoperative revision rates due to three-dimensional imaging in orthopedic trauma surgery: results of a case series of 4721 patients. Eur J Trauma Emerg Surg. 2023 Feb;49(1):373-381. doi: 10.1007/s00068-022-02083-x. Epub 2022 Sep 1.
PubMed 36048181Dong HY, Tong MS, Wang J, Liu Y, Tao GY, Petersen RH, Jara-Palomares L, Wang Y, Sun YB, Chen J. Risk factors for pulmonary embolism in lung cancer patients with lower limb deep venous thrombosis: a case-control study. Transl Lung Cancer Res. 2023 Jul 31;12(7):1539-1548. doi: 10.21037/tlcr-23-346. Epub 2023 Jul 19.
PubMed 37577319Muller S, Buhl L, Nuesch C, Pagenstert G, Mundermann A, Egloff C. Favorable Patient-Reported, Clinical, and Functional Outcomes 2 Years After ACL Repair and InternalBrace Augmentation Compared With ACL Reconstruction and Healthy Controls. Am J Sports Med. 2023 Oct;51(12):3131-3141. doi: 10.1177/03635465231194784. Epub 2023 Sep 7.
PubMed 37675973Barman SR, Chan SW, Kao FC, Ho HY, Khan I, Pal A, Huang CC, Lin ZH. A self-powered multifunctional dressing for active infection prevention and accelerated wound healing. Sci Adv. 2023 Jan 25;9(4):eadc8758. doi: 10.1126/sciadv.adc8758. Epub 2023 Jan 25.
PubMed 36696504Rim CH, Park S, Yoon WS, Shin IS, Park HC. Radiotherapy for bone metastases of hepatocellular carcinoma: a hybrid systematic review with meta-analyses. Int J Radiat Biol. 2023;99(3):419-430. doi: 10.1080/09553002.2022.2094020. Epub 2022 Aug 8.
PubMed 35758976
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hold-relax Technique With or Without Blood Flow Restriction on Pain, Range of Motion and Functional Disability in Patients With Post Operative ACL Rehabilitation.
- ClinicalTrials.gov ID
- NCT06943079
- Acronym / sponsor ID
- REC/RCR & AHS/24/0120
- Conditions
- Sports Physical Therapy
- Keywords
- ACL reconstruction, Hamstring graft, Hold relax technique, Blood flow restriction, Knee joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 11 Feb 2024 (actual)
- Primary completion
- 2 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 24 Apr 2025 (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.
A randomized controlled trial investigated the effects of Hold Relax Technique (HRT) with and without Blood Flow Restriction (BFR) on pain, range of motion (ROM), and functional disability in patients with post-operative ACL rehabilitation. This study includes all types of genders with age limit is 25-45 years. But the aim is to infer the answers to the following questions; Does HRT has better effects than HRT with BFR? How much effect should be noted ? The research will show that if both HRT and HRT with BFR groups had significant pain reduction, the HRT with BFR group demonstrated greater ROM improvement and significant enhancement in functional ability compared to the HRT and control groups.
Detailed description
A randomized clinical trial will be conducted under Riphah International University guidelines and nonprobability convenient sampling will be used to collect data from the 48 participants from the Ghurki trust and teaching hospital setting. Participants will go through ACL reconstruction specifically the usage of a hamstring graft. The participants were allocated into two groups by using randomization through computer-generated software A and B. In A group only HRT will be applied to check the effects on pain, ROM, and functional disability. In the B group HRT with BFR will be utilized to note the effects on pain, ROM, and functional disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups; A for the application of HRT B includes HRT and BFR Their effects will be noted on 0 week, 3rd week and 6th week to conclude its result.
| Arm | Type | Receives |
|---|---|---|
| A - Hold Relax technique with Blood Flow Restriction technique | Experimental | Device: Effect of Hold Relax technique with Blood Flow Restriction technique on functional outcomeEffects of Hold Relax technique with Blood Flow Restriction on functional outcome |
| B - Hold relax technique without blood Flow Restriction technique | Active comparator | Other: Effect of Hold Relax technique without Blood Flow Restriction technique on functional outcomesEffect of Hold Relax technique without Blood flow restriction on functional outcomes |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age group 25-45 years.
- Both gender male and female.
- Patient underwent arthroscopic ACL repair procedure.
- Patients in 6 weeks of rehabilitation phase.
- Grafts of hamstring muscle were used in repair.
Key exclusion criteria (8 listed)
- Any form of bone carcinoma.
- Any Post-OP active infectionous Patients.
- Any circulatory effects.
- DVT and pulmonary embolism.
- Loose Implant placement.
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 |
|---|---|---|
| Effect of Hold Relax technique with Blood Flow Restriction technique on functional outcomeAlso: Hold Relax teachnique, Blood Flow Restriction techniqueParticipants are randomly allocated to group A through computerised generated method. The both combine intervention is divided into 3 intervals and their results will be calculated on 0 week, 3rd, and 6th week. On every interval, pain through numeric pain rating scale, range of motion through goniometer, and functional disability through lower extremity functional scale will be measured. 2-3/week frequency of intervention will be applied on the participant. | Device | A - Hold Relax technique with Blood Flow Restriction technique |
| Effect of Hold Relax technique without Blood Flow Restriction technique on functional outcomesAlso: Hold Relax techniqueParticipants are randomly allocated to group B through computerised generated method. The intervention is divided into 3 intervals and their results will be calculated on 0 week, 3rd, and 6th week. On every interval, pain through numeric pain rating scale, range of motion through goniometer, and functional disability through lower extremity functional scale will be measured. 2-3/week frequency of intervention will be applied on the participant. | Other | B - Hold relax technique without blood Flow Restriction technique |
Primary outcome
1- BFR Cuff
Time frame: 6 weeks
BFR requires a tourniquet to be placed on a limb. The cuff needs to be tightened to a specific pressure that occludes venous flow while still allowing arterial flow whilst exercises are being performed. Simple pieces of equipment such as surgical tubing or elastic straps have been used in gym settings to achieve this result. These are not advisable as you are unable to monitor the amount of blood flow occlusion. A thin diameter may also cause too much local pressure and result in tissue damage.(29)
2- UNIVERSAL GONIOMETER
Time frame: 6 weeks
The measurement of joint range of motion (ROM), also referred to as goniometry, is a crucial physical therapy practice.(30) Goniometry, the measuring of joint angles, is a frequently used assessment tool in the tracking of rehabilitation interventions as well as issues with the musculoskeletal system. It is generally performed with a universal goniometer (UG).(31) Inter-tester reliability for universal goniometers is mediocre.(32)
3- NUMERIC PAIN RATING SCALE (NPRS)
Time frame: 6 weeks
The Numeric Pain Rating Scale (NRS-11) is an eleven-point rating system with a score of 0 representing no pain at all and a score of 10 representing the greatest agony the patient has ever had. In this context, the NPRS-11 pain severity score of "4" is usually given particular weight, indicating that it may serve as a threshold value for pain severity in clinical practice.(33) Its dependability coefficient is high (0.95-0.96).(34)
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 24 Apr 2025.
- Background: PubMed 10201543Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
- Background: PubMed 18796951Chesworth BM, Culham E, Tata GE, Peat M. Validation of outcome measures in patients with patellofemoral syndrome. J Orthop Sports Phys Ther. 1989;10(8):302-8. doi: 10.2519/jospt.1989.10.8.302.
- Background: PubMed 8461073Kujala UM, Jaakkola LH, Koskinen SK, Taimela S, Hurme M, Nelimarkka O. Scoring of patellofemoral disorders. Arthroscopy. 1993;9(2):159-63. doi: 10.1016/s0749-8063(05)80366-4.
- Background: PubMed 9730122Irrgang JJ, Snyder-Mackler L, Wainner RS, Fu FH, Harner CD. Development of a patient-reported measure of function of the knee. J Bone Joint Surg Am. 1998 Aug;80(8):1132-45. doi: 10.2106/00004623-199808000-00006.
- Background: PubMed 9314394Martin DP, Engelberg R, Agel J, Swiontkowski MF. Comparison of the Musculoskeletal Function Assessment questionnaire with the Short Form-36, the Western Ontario and McMaster Universities Osteoarthritis Index, and the Sickness Impact Profile health-status measures. J Bone Joint Surg Am. 1997 Sep;79(9):1323-35. doi: 10.2106/00004623-199709000-00006.
- Background: PubMed 7550178McHorney CA, Tarlov AR. Individual-patient monitoring in clinical practice: are available health status surveys adequate? Qual Life Res. 1995 Aug;4(4):293-307. doi: 10.1007/BF01593882.
- Background: PubMed 2646493Nelson EC, Berwick DM. The measurement of health status in clinical practice. Med Care. 1989 Mar;27(3 Suppl):S77-90. doi: 10.1097/00005650-198903001-00007.
- Background: PubMed 31107910Al-Hadidi F, Bsisu I, AlRyalat SA, Al-Zu'bi B, Bsisu R, Hamdan M, Kanaan T, Yasin M, Samarah O. Association between mobile phone use and neck pain in university students: A cross-sectional study using numeric rating scale for evaluation of neck pain. PLoS One. 2019 May 20;14(5):e0217231. doi: 10.1371/journal.pone.0217231. eCollection 2019.
- Background: PubMed 33352686Bergh A, Lauridsen NG, Hesbach AL. Concurrent Validity of Equine Joint Range of Motion Measurement: A Novel Digital Goniometer versus Universal Goniometer. Animals (Basel). 2020 Dec 19;10(12):2436. doi: 10.3390/ani10122436.
- Background: PubMed 33608127Perez-de la Cruz S, de Leon OA, Mallada NP, Rodriguez AV. Validity and intra-examiner reliability of the Hawk goniometer versus the universal goniometer for the measurement of range of motion of the glenohumeral joint. Med Eng Phys. 2021 Mar;89:7-11. doi: 10.1016/j.medengphy.2021.01.005. Epub 2021 Jan 27.
- Background: PubMed 36048181Keil H, Beisemann N, Swartman B, Schnetzke M, Vetter SY, Grutzner PA, Franke J. Intraoperative revision rates due to three-dimensional imaging in orthopedic trauma surgery: results of a case series of 4721 patients. Eur J Trauma Emerg Surg. 2023 Feb;49(1):373-381. doi: 10.1007/s00068-022-02083-x. Epub 2022 Sep 1.
- Background: PubMed 37577319Dong HY, Tong MS, Wang J, Liu Y, Tao GY, Petersen RH, Jara-Palomares L, Wang Y, Sun YB, Chen J. Risk factors for pulmonary embolism in lung cancer patients with lower limb deep venous thrombosis: a case-control study. Transl Lung Cancer Res. 2023 Jul 31;12(7):1539-1548. doi: 10.21037/tlcr-23-346. Epub 2023 Jul 19.
- 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.
Humera Mubashar Senior Lecturer, MS-OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effect of Hold Relax technique with Blood Flow Restriction technique on functional outcome and Effect of Hold Relax technique without Blood Flow Restriction technique on functional outcomes in people with Sports Physical Therapy, run by Riphah International University at 1 site in Pakistan.
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 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. 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 Pakistan. 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?
1- BFR Cuff (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06943079, which also lists 34 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 24 Apr 2025.