Muscle; Injury, Quadriceps (Thigh)NCT05809947
Mechanisms of Tissue Repair After Muscle Injury and Tendon Strain
A study testing Neuromuscular electrical stimulation in people with Muscle; Injury, Quadriceps (Thigh) and Tendon Strain, run by Bispebjerg Hospital at 1 site in Denmark.
Trial summary
The study is a 5-week human study including 24 18-35 year old healthy men. Each participant will have muscle injury and tendon strain induced in one leg using neuromuscular electrical stimulation in conjunction with forced lengthening contractions. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle; Injury, Quadriceps (Thigh), Tendon Strain
- What is being tested?
- Neuromuscular electrical stimulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Apr 2023to 3 Jan 2024
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men
- BMI between 18.5-30 kg/m^2
Who cannot join
- Smoking
- Regular strength training within the last 3 months
- Current or former use of anabolic steroids or growth hormone
- Use of corticosteroids in the last 3 months
- Use of blood thinning medication
- Use of medication which can affect muscle protein synthesis
Show all 9Show fewer
- Current or former drug og alcohol abuse
- Knee pain
- Previous participation in studies using deuterated water or alanine tracers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Regulation of Human Tendon and Skeletal Muscle Protein Turnover Following Tissue Injury: Mechanisms Behind Regeneration and Injury Preventive Adaptations
The study is a 5-week human study including 24 18-35 year old healthy men. Each participant will have muscle injury and tendon strain induced in one leg using neuromuscular electrical stimulation in conjunction with forced lengthening contractions. The investigators will monitor the recovery from injury/strain over a 4 week period, in which half of the subjects will receive growth hormone (somatropin) to stimulate the connective tissue synthesis.
- Conditions
- Muscle; Injury, Quadriceps (Thigh), Tendon Strain
- Being tested
- Neuromuscular electrical stimulation
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular electrical stimulationOther
Also called Neuromuscular electrical stimulation using Theta 4 channel stimulator from Chattanooga. Coupled with forced eccentric contractions.
One bout of neuromuscular electrical stimulation in conjunction with forced lengthening contractions on one leg
| Study group | Role | What they receive |
|---|---|---|
| Growth hormone/somatropin | Experimental | Somatropin over two weeks (33.3 ug/kg/day in the first week, 50 ug/kg/day in the second week) Receives: Other: Neuromuscular electrical stimulation |
| Placebo | Placebo comparator | Injections of placebo/saline over two weeks Receives: Other: Neuromuscular electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of somatropin on muscle protein synthesis 14 days after injury
The difference in fractional synthesis rate in muscle proteins 14 days after injury with or without 14 days treatment with somatropin. Measured using deuterated water
Measured: 14 days
Secondary outcomes (14)
Muscle protein synthesis 7 days after injury
The difference in fractional synthesis rate in muscle proteins 7 days after injury vs control (no injury) with or without 7 days treatment with somatropin. Measured using deuterated water
Measured: 7 days
Muscle protein synthesis 14 days after injury
The difference in fractional synthesis rate in muscle proteins 14 days after injury compared to control leg (no injury). Measured using deuterated water.
Measured: 14 days
Muscle protein breakdown 14 days after injury
The difference in fractional synthesis rate in muscle proteins 14 days after injury vs. control (no injury) with or without 14 days treatment with somatropin. Measured using stable isotop labelled alanine.
Measured: 14 days
Muscle protein breakdown 7 days after injury
The difference in fractional synthesis rate in muscle proteins 7 days after injury vs. control (no injury) with or without 7 days treatment with somatropin. Measured using stable isotop labelled alanine.
Measured: 7 days
Muscle protein breakdown 28 days after injury
The difference in fractional synthesis rate in muscle proteins 28 days after injury vs. control (no injury) with or without 14 days treatment with somatropin. Measured using stable isotop labelled alanine.
Measured: 28 days
Histochemical staining of muscle cross sections 7 days after injury
Number of satellite cells, fibroblasts and immune cells in injured vs. control tissue (no injury), with and without growth hormone. Measured using histochemical staining of muscle cross sections
Measured: 7 days
Histochemical staining of muscle cross sections 14 days after injury
Number of satellite cells, fibroblasts and immune cells in injured vs. control tissue (no injury), with and without growth hormone. Measured using histochemical staining of muscle cross sections
Measured: 14 days
Histochemical staining of muscle cross sections 28 days after injury
Number of satellite cells, fibroblasts and immune cells in injured vs. control tissue (no injury), with and without growth hormone. Measured using histochemical staining of muscle cross sections
Measured: 28 days
The effect of somatropin on tendon tissue synthesis
The difference in fractional synthesis rate in tendon proteins after 7 days placebo/treatment with somatropin. Measured using deuterated water
Measured: 7 days
Tendon tissue synthesis 7 days after strain
The difference in fractional synthesis rate in tendon proteins 7 days after strain compared to control leg (no strain). Measured using deuterated water
Measured: 7 days
Tendon tissue synthesis 7 days after strain with/without somatropin
The difference in fractional synthesis rate in tendon proteins 7 days after strain compared to control leg (no strain) with or without somatropin. Measured using deuterated water
Measured: 7 days
Isometric muscle force output 7 days following injury
The difference in isometric muscle force output 7 days after injury vs. control (no injury) with or without 7 days treatment with somatropin.
Measured: 7 days
Isometric muscle force output 14 days following injury
The difference in isometric muscle force output 14 days after injury vs. control (no injury) with or without 14 days treatment with somatropin.
Measured: 14 days
Isometric muscle force output 28 days following injury
The difference in isometric muscle force output 28 days after injury vs. control (no injury) with or without 14 days treatment with somatropin.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start11 Apr 2023
- Primary completion3 Jan 2024
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle; Injury, Quadriceps (Thigh)Studies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grith Højfeldt, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809947
- Sponsor's protocol ID
- BBH150
- Status last verified
- Jan 2024
- First submitted
- 17 Mar 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will be made available upon individual request once the study is finalised and published.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Human Tendon and Skeletal Muscle Protein Turnover Following Tissue Injury: Mechanisms Behind Regeneration and Injury Preventive Adaptations
- ClinicalTrials.gov ID
- NCT05809947
- Acronym / sponsor ID
- BBH150
- Conditions
- Muscle; Injury, Quadriceps (Thigh), Tendon Strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 12 Apr 2023 (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.
The study is a 5-week human study including 24 18-35 year old healthy men. Each participant will have muscle injury and tendon strain induced in one leg using neuromuscular electrical stimulation in conjunction with forced lengthening contractions. The investigators will monitor the recovery from injury/strain over a 4 week period, in which half of the subjects will receive growth hormone (somatropin) to stimulate the connective tissue synthesis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth hormone/somatropin | Experimental | Other: Neuromuscular electrical stimulationSomatropin over two weeks (33.3 ug/kg/day in the first week, 50 ug/kg/day in the second week) |
| Placebo | Placebo comparator | Other: Neuromuscular electrical stimulationInjections of placebo/saline over two weeks |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy men
- BMI between 18.5-30 kg/m^2
Key exclusion criteria (9 listed)
- Smoking
- Regular strength training within the last 3 months
- Current or former use of anabolic steroids or growth hormone
- Use of corticosteroids in the last 3 months
- Use of blood thinning medication
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 |
|---|---|---|
| Neuromuscular electrical stimulationAlso: Neuromuscular electrical stimulation using Theta 4 channel stimulator from Chattanooga. Coupled with forced eccentric contractions.One bout of neuromuscular electrical stimulation in conjunction with forced lengthening contractions on one leg | Other | Growth hormone/somatropin, Placebo |
Primary outcome
Effect of somatropin on muscle protein synthesis 14 days after injury
Time frame: 14 days
The difference in fractional synthesis rate in muscle proteins 14 days after injury with or without 14 days treatment with somatropin. Measured using deuterated water
14 secondary outcomes
Muscle protein synthesis 7 days after injury
Time frame: 7 days
Muscle protein synthesis 14 days after injury
Time frame: 14 days
Muscle protein breakdown 14 days after injury
Time frame: 14 days
Muscle protein breakdown 7 days after injury
Time frame: 7 days
Muscle protein breakdown 28 days after injury
Time frame: 28 days
Histochemical staining of muscle cross sections 7 days after injury
Time frame: 7 days
Histochemical staining of muscle cross sections 14 days after injury
Time frame: 14 days
Histochemical staining of muscle cross sections 28 days after injury
Time frame: 28 days
The effect of somatropin on tendon tissue synthesis
Time frame: 7 days
Tendon tissue synthesis 7 days after strain
Time frame: 7 days
Tendon tissue synthesis 7 days after strain with/without somatropin
Time frame: 7 days
Isometric muscle force output 7 days following injury
Time frame: 7 days
Isometric muscle force output 14 days following injury
Time frame: 14 days
Isometric muscle force output 28 days following injury
Time frame: 28 days
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 9 Jan 2024.
- Individual participant dataSharing planned: No. The IPD will be made available upon individual request once the study is finalised and published.
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Recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation in people with Muscle; Injury, Quadriceps (Thigh) and Tendon Strain, run by Bispebjerg Hospital at 1 site in Denmark.
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 9 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 9 Jan 2024. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Effect of somatropin on muscle protein synthesis 14 days after injury (time frame: 14 days). 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 9 Jan 2024.