Shoulder PainNCT03437239
BFR After Bicep Tenodesis
A study testing Delfi PTS II Portable Tourniquet System in people with Shoulder Pain and Bone Mineral Density, run by Brooke Army Medical Center.
Trial summary
A randomized controlled pilot study evaluating the effect of occlusion training on bone density and function of the upper extremity following a biceps tenodesis. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain, Bone Mineral Density, Muscle Strength
- What is being tested?
- Delfi PTS II Portable Tourniquet System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Feb 2018to Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Selected to undergo a unilateral bicep tenodesis
- Males and females age 18-65
- DoD beneficiaries
- Must be able to read and write in English in order to consent
Who cannot join
- Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10.
- Rehabilitation protocol with prohibited muscle strengthening greater than 6 weeks post-operation.
- Current metallic implants that contraindicate or significantly affect the sensitivity of DEXA scan
- Current implanted defibrillator or pacemaker
- Pregnancy - per patient self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, these patients will not be included in this study.
- Recent history of deep vein thrombosis within the 12 months or on active treatment with anticoagulants
Show all 13Show fewer
- Currently taking medications that are known to affect bone density to include heparin, warfarin, glucocorticoids, medroxyprogesterone acetate, cancer treatment medications, bisphosphonates or other osteoporosis treatment medications, and thyroid hormone.
- History of hyperparathyroidism
- History of upper quadrant lymph node dissection
- Patient endorsement of easy bruising
- History of an upper extremity amputation
- Active infection in the operative extremity
- Cancer (current diagnosis per medical record)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Blood Flow Restriction Training After Bicep Tenodesis: A Pilot Study
A randomized controlled pilot study evaluating the effect of occlusion training on bone density and function of the upper extremity following a biceps tenodesis.
Read the detailed description
Blood flow restriction training, resistance exercise performed with a specialized venous tourniquet, leads to beneficial changes in muscle strength at low resistance and minimal stress on the nearby joint. Early research further indicates that it improves systemic bone mineral density with change in bone turnover markers. This novel resistance training has the potential to improve muscle strength and bone density in individuals who are medically unable to perform high resistance exercises typically required to improve these attributes. Our study will examine the effect of occlusion training on bone density and function of the upper extremity following a bicep tenodesis. The primary objective of the intervention is to achieve improved bone density and accelerated recovery of upper extremity function as assessed using measures such as validated questionnaires, functional outcome testing, strength testing, and dual energy x-ray absorptiometry.
- Conditions
- Shoulder Pain, Bone Mineral Density, Muscle Strength
- Being tested
- Delfi PTS II Portable Tourniquet System
- Keywords
- Bicep tenodesis
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delfi PTS II Portable Tourniquet SystemDevice
This is a portable tourniquet system that allows for occlusion of venous outflow without inhibiting arterial blood flow. This portable tourniquet system allows for rapid cuff inflation and deflation with a battery. The Delfi PTS is a purpose-built system that allows for precise control of pressure throughout training, despite the natural changes in muscle shape and length. The device has advanced pressure leak detection that monitors the tourniquet cuff, tubing, and connectors for air leaks and safely alerts staff to hazards or follow-up actions required. The device has visual and audio alarms for over and under pressure and elapsed time as well as a large, easily visible display of tourniquet pressure and elapsed time. The Delfi PTS II calibrates and self-tests on startup. It has a safety interlock that limits the normal maximum pressure and integrated tourniquet cuff testing as recommended in current AORN Standards and Recommended Practices
| Study group | Role | What they receive |
|---|---|---|
| Occlusion Training | Experimental | Patients undergoing a biceps tenodesis that are expected to begin a rehabilitation protocol with strength training by 6 weeks postoperatively for a continued 12 weeks course of 2-3 times per week of occupational therapy to include occlusion training. Receives: Device: Delfi PTS II Portable Tourniquet System |
| Non-occlusion Training | No intervention | Patients undergoing a biceps tenodesis that are expected to begin a rehabilitation protocol with strength training by 6 weeks postoperatively for a continued 12 weeks course of 2-3 times per week of occupational therapy without occlusion training (standard of care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative Forearm Bone Density
Bone Density will be measured using the GE Lunar Dual Energy X-ray Absorptiometry (iDXA) device maintained and operated by the Nuclear Medicine clinic at SAMMC in accordance with the International Society for Clinical Densitometry (ISCD) Best Practices for dual energy x-ray absorptiometry guidance
Measured: 24 weeks
Total Body Bone Density
Bone Density will be measured using the GE Lunar Dual Energy X-ray Absorptiometry (iDXA) device maintained and operated by the Nuclear Medicine clinic at SAMMC in accordance with the International Society for Clinical Densitometry (ISCD) Best Practices for dual energy x-ray absorptiometry guidance
Measured: 24 weeks
Elbow Flexion Strength
Elbow Flexion Strength will be assessed using the BTE PrimusRS dynamometer after the completion of the rehabilitation protocol, approximately 18 weeks postoperative. The patient will be seated with a lap belt to perform testing, to include isokinetic measurements of elbow flexion and forearm supination. The patient will perform 3 trials of one repetition on both the operative forearm and the contralateral arm of both elbow flexion and supination. The PrimusRS will generate a number of pounds of force used, which will be averaged for each side and used for analysis to represent strength. The BTE PrimusRS has been validated for measuring strength and used in numerous studies for various joints and movements to include elbow flexion and forearm supination
Measured: 18 weeks
Forearm Supination Strength
Forearm Supination Strength will be assessed using the BTE PrimusRS dynamometer after the completion of the rehabilitation protocol, approximately 18 weeks postoperative. The patient will be seated with a lap belt to perform testing, to include isokinetic measurements of elbow flexion and forearm supination. The patient will perform 3 trials of one repetition on both the operative forearm and the contralateral arm of both elbow flexion and supination. The PrimusRS will generate a number of pounds of force used, which will be averaged for each side and used for analysis to represent strength. The BTE PrimusRS has been validated for measuring strength and used in numerous studies for various joints and movements to include elbow flexion and forearm supination
Measured: 18 weeks
Grip Strength
Grip strength will be assessed using the JAMAR Hand Dynamometer. It has been selected for use in this study as per the recommendation by the American Society for the Surgery of the Hand and American Society of Hand Therapists ASHT) as the tool of choice to measure grip strength. Studies have shown that the JAMAR dynamometer has high instrument and test-retest reliability. Grip strength will be tested according to the testing position and procedure recommended by the ASHT. The mean of three successive trials will be recorded. There are established normative data for grip strength by both age and hand dominance.
Measured: 18 weeks.
Secondary outcomes (5)
Femoral Neck Bone Density
Bone Density will be measured using the GE Lunar Dual Energy X-ray Absorptiometry (iDXA) device maintained and operated by the Nuclear Medicine clinic at SAMMC in accordance with the International Society for Clinical Densitometry (ISCD) Best Practices for dual energy x-ray absorptiometry guidance
Measured: 24 weeks
Lumbar Spine Bone Density
Bone Density will be measured using the GE Lunar Dual Energy X-ray Absorptiometry (iDXA) device maintained and operated by the Nuclear Medicine clinic at SAMMC in accordance with the International Society for Clinical Densitometry (ISCD) Best Practices for dual energy x-ray absorptiometry guidance
Measured: 24 weeks
Pain
An 11-point verbal Numerical Rating Scale (NRS) (Appendix F) will be used to assess the subject's upper extremity pain the day of each assessment as well as during therapy sessions. The 0 to 10 NRS has been found to be valid and reliable in many patient populations including the musculoskeletal population [64] and has been recommended for inclusion in the core NIH Toolbox for use with adults
Measured: 24 weeks
Disability of the Arm, Shoulder, and Hand
The QuickDASH consists of 11 items that measure physical function and symptoms in musculoskeletal disorders of the upper limb. The QuickDASH includes two optional scales to assess a patient's function with work activities as well as sports or playing an instrument. The QuickDASH is scored in two components: the 11-item disability section where each item is scored 1-5, and the optional work and sport/music modules. This study will only use the disability section. Respondents indicate the amount of difficulty they have performing the items (1=no difficulty, 6=unable). Scores are summed and averaged and the value is transformed to a score out of 100 by subtracting one and multiplying by 25. A higher score indicates greater disability. The QuickDASH has been validated and shown to be reliable when compared to the Disabilities of the Arm, Shoulder, and Hand
Measured: 24 weeks
Functional Scale
The Patient Specific Functional Scale is a patient-specific outcome measure to assess functional status. The patient is asked to identify three to five activities that he or she has difficulty performing due to his or her condition. The patient then rates the amount of limitation he or she has in performing each of these activities on an 11-point scale with 0 being unable to perform the activity and 10 being able to perform the activity with no problem. An average score for the activities gives an ability score out of 10. The PSFS has been shown to be valid and responsive in the upper extremity musculoskeletal patient population
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study startFeb 2018 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Griffin Holauchock, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437239
- Sponsor's protocol ID
- C.2018.019
- Status last verified
- Feb 2018
- First submitted
- 13 Feb 2018
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training After Bicep Tenodesis: A Pilot Study
- ClinicalTrials.gov ID
- NCT03437239
- Acronym / sponsor ID
- C.2018.019
- Conditions
- Shoulder Pain, Bone Mineral Density, Muscle Strength
- Keywords
- Bicep tenodesis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Feb 2018 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 19 Feb 2018 (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 pilot study evaluating the effect of occlusion training on bone density and function of the upper extremity following a biceps tenodesis.
Detailed description
Blood flow restriction training, resistance exercise performed with a specialized venous tourniquet, leads to beneficial changes in muscle strength at low resistance and minimal stress on the nearby joint. Early research further indicates that it improves systemic bone mineral density with change in bone turnover markers. This novel resistance training has the potential to improve muscle strength and bone density in individuals who are medically unable to perform high resistance exercises typically required to improve these attributes. Our study will examine the effect of occlusion training on bone density and function of the upper extremity following a bicep tenodesis. The primary objective of the intervention is to achieve improved bone density and accelerated recovery of upper extremity function as assessed using measures such as validated questionnaires, functional outcome testing, strength testing, and dual energy x-ray absorptiometry.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Occlusion Training | Experimental | Device: Delfi PTS II Portable Tourniquet SystemPatients undergoing a biceps tenodesis that are expected to begin a rehabilitation protocol with strength training by 6 weeks postoperatively for a continued 12 weeks course of 2-3 times per week of occupational therapy to include occlusion training. |
| Non-occlusion Training | No intervention | –Patients undergoing a biceps tenodesis that are expected to begin a rehabilitation protocol with strength training by 6 weeks postoperatively for a continued 12 weeks course of 2-3 times per week of occupational therapy without occlusion training (standard of care). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Selected to undergo a unilateral bicep tenodesis
- Males and females age 18-65
- DoD beneficiaries
- Must be able to read and write in English in order to consent
Key exclusion criteria (13 listed)
- Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10.
- Rehabilitation protocol with prohibited muscle strengthening greater than 6 weeks post-operation.
- Current metallic implants that contraindicate or significantly affect the sensitivity of DEXA scan
- Current implanted defibrillator or pacemaker
- Pregnancy - per patient self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, these patients will not be included in this study.
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 |
|---|---|---|
| Delfi PTS II Portable Tourniquet SystemThis is a portable tourniquet system that allows for occlusion of venous outflow without inhibiting arterial blood flow. This portable tourniquet system allows for rapid cuff inflation and deflation with a battery. The Delfi PTS is a purpose-built system that allows for precise control of pressure throughout training, despite the natural changes in muscle shape and length. The device has advanced pressure leak detection that monitors the tourniquet cuff, tubing, and connectors for air leaks and safely alerts staff to hazards or follow-up actions required. The device has visual and audio alarms for over and under pressure and elapsed time as well as a large, easily visible display of tourniquet pressure and elapsed time. The Delfi PTS II calibrates and self-tests on startup. It has a safety interlock that limits the normal maximum pressure and integrated tourniquet cuff testing as recommended in current AORN Standards and Recommended Practices | Device | Occlusion Training |
Primary outcome
Operative Forearm Bone Density
Time frame: 24 weeks
Bone Density will be measured using the GE Lunar Dual Energy X-ray Absorptiometry (iDXA) device maintained and operated by the Nuclear Medicine clinic at SAMMC in accordance with the International Society for Clinical Densitometry (ISCD) Best Practices for dual energy x-ray absorptiometry guidance
Total Body Bone Density
Time frame: 24 weeks
Bone Density will be measured using the GE Lunar Dual Energy X-ray Absorptiometry (iDXA) device maintained and operated by the Nuclear Medicine clinic at SAMMC in accordance with the International Society for Clinical Densitometry (ISCD) Best Practices for dual energy x-ray absorptiometry guidance
Elbow Flexion Strength
Time frame: 18 weeks
Elbow Flexion Strength will be assessed using the BTE PrimusRS dynamometer after the completion of the rehabilitation protocol, approximately 18 weeks postoperative. The patient will be seated with a lap belt to perform testing, to include isokinetic measurements of elbow flexion and forearm supination. The patient will perform 3 trials of one repetition on both the operative forearm and the contralateral arm of both elbow flexion and supination. The PrimusRS will generate a number of pounds of force used, which will be averaged for each side and used for analysis to represent strength. The BTE PrimusRS has been validated for measuring strength and used in numerous studies for various joints and movements to include elbow flexion and forearm supination
Forearm Supination Strength
Time frame: 18 weeks
Forearm Supination Strength will be assessed using the BTE PrimusRS dynamometer after the completion of the rehabilitation protocol, approximately 18 weeks postoperative. The patient will be seated with a lap belt to perform testing, to include isokinetic measurements of elbow flexion and forearm supination. The patient will perform 3 trials of one repetition on both the operative forearm and the contralateral arm of both elbow flexion and supination. The PrimusRS will generate a number of pounds of force used, which will be averaged for each side and used for analysis to represent strength. The BTE PrimusRS has been validated for measuring strength and used in numerous studies for various joints and movements to include elbow flexion and forearm supination
Grip Strength
Time frame: 18 weeks.
Grip strength will be assessed using the JAMAR Hand Dynamometer. It has been selected for use in this study as per the recommendation by the American Society for the Surgery of the Hand and American Society of Hand Therapists ASHT) as the tool of choice to measure grip strength. Studies have shown that the JAMAR dynamometer has high instrument and test-retest reliability. Grip strength will be tested according to the testing position and procedure recommended by the ASHT. The mean of three successive trials will be recorded. There are established normative data for grip strength by both age and hand dominance.
5 secondary outcomes
Femoral Neck Bone Density
Time frame: 24 weeks
Lumbar Spine Bone Density
Time frame: 24 weeks
Pain
Time frame: 24 weeks
Disability of the Arm, Shoulder, and Hand
Time frame: 24 weeks
Functional Scale
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Delfi PTS II Portable Tourniquet System in people with Shoulder Pain and Bone Mineral Density, run by Brooke Army Medical Center.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Griffin M Holauchock, M.S. (210-916-2270, griffin.m.holauchock.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative Forearm Bone Density (time frame: 24 weeks). 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 19 Feb 2018.