CounterstrainNCT05226611
The Effect of Counterstrain Technique on Muscle Stiffness and Pain on Trapezius Tender Points in Medical Students
A study testing Counterstrain in people with Counterstrain and MyotonPRO, run by New York Institute of Technology at 1 site in United States.
Trial summary
Medical students are prone to developing neck pain due to prolonged studying and poor posture. This can manifest as tender points in the upper trapezius region. Counterstrain (CS) is an osteopathic manipulative technique that has shown efficacy in previous studies in treating tender points. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Counterstrain, MyotonPRO, Tender Points
- What is being tested?
- Counterstrain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 14 Apr 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subject is at least 18 years of age
Who cannot join
- Traumatized (sprained or strained) tissues, which would be negatively affected by the positioning of the patient
- Illness or other conditions in which strict positional restrictions preclude treatment
- Instability of the area being positioned that has the potential to produce unwanted neurologic or vascular side effects
- Vascular or neurologic syndromes, such as basilar insufficiency or neural foraminal compromise whereby the position of treatment has the potential to exacerbate the condition
- Severe degenerative spondylosis with local fusion and no motion at the level where treatment positioning would normally take place
- Pregnancy
- Positive for COVID-19 as well as symptoms indicating a SARS-CoV-2 infection
Trial locations and contacts
1 site in 1 country.
United States1 site
NYIT College of Osteopathic Medicine
Glen Head, New York, 11545
About this study
Medical students are prone to developing neck pain due to prolonged studying and poor posture. This can manifest as tender points in the upper trapezius region. Counterstrain (CS) is an osteopathic manipulative technique that has shown efficacy in previous studies in treating tender points. The MyotonPRO is a myotonometric device that can be used to measure various muscle parameters such as muscle stiffness. There is limited research regarding the use of osteopathic manipulative medicine to produce measurable changes in muscle stiffness by the MyotonPRO. This educational study aims to establish the efficacy of CS technique in decreasing the pain level of upper trapezius tender points in medical students as well as determining if CS causes a significant decrease in muscle stiffness in treated tender points as measured by the MyotonPRO. The investigators hope this educational study will encourage further studies on how osteopathic manipulative techniques affects the physiologic parameters of muscles.
- Conditions
- Counterstrain, MyotonPRO, Tender Points
- Being tested
- Counterstrain
- Keywords
- Counterstrain, MyotonPRO, Tender points, Medical Students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CounterstrainOther
Counterstrain is a hands-on OMM technique that involves shortening the muscle to resolve the dysfunctional muscle stretch reflex and holding it for 90 seconds. The patient is then brought back to a neutral position and reassessed.
| Study group | Role | What they receive |
|---|---|---|
| Tender point treatment with Counterstrain | Experimental | A tender point was located in the upper trapezius region of the test subject and treated with counterstrain. The side with the highest initial pain level was used as the treatment side. Pain level was measured before and after treatment. The MyotonPRO was also used to measure physiologic parameters of the muscle before and after treatment. Receives: Other: Counterstrain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Pain level of the tender point as rated by the test subject out of a scale of 1 to 10, 1 being very little pain and 10 being the most pain the test subject has ever felt.
Measured: This was done immediately before and immediately after counterstrain treatment. Counterstrain treatment is a hands-on osteopathic manipulative technique that involves shortening the muscle belly of the painful region.
Secondary outcomes (1)
Muscle Stiffness
Muscle stiffness measured by the MyotonPRO, a myotonometric device that applies a brief mechanical impulse to the targeted muscle, used to measure physiologic parameters such as muscle stiffness.
Measured: This was done immediately before and immediately after counterstrain treatment. Counterstrain treatment is a hands-on osteopathic manipulative technique that involves shortening the muscle belly of the painful region.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start10 Mar 2021
- Primary completion14 Apr 2021
- Study completion14 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CounterstrainStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226611
- Sponsor's protocol ID
- #BHS-1561
- Status last verified
- Jan 2022
- First submitted
- 12 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- 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 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Counterstrain Technique on Muscle Stiffness and Pain on Trapezius Tender Points in Medical Students
- ClinicalTrials.gov ID
- NCT05226611
- Acronym / sponsor ID
- #BHS-1561
- Conditions
- Counterstrain, MyotonPRO, Tender Points
- Keywords
- Counterstrain, MyotonPRO, Tender points, Medical Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- New York Institute of TechnologyUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 7 Feb 2022 (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.
Medical students are prone to developing neck pain due to prolonged studying and poor posture. This can manifest as tender points in the upper trapezius region. Counterstrain (CS) is an osteopathic manipulative technique that has shown efficacy in previous studies in treating tender points. The MyotonPRO is a myotonometric device that can be used to measure various muscle parameters such as muscle stiffness. There is limited research regarding the use of osteopathic manipulative medicine to produce measurable changes in muscle stiffness by the MyotonPRO. This educational study aims to establish the efficacy of CS technique in decreasing the pain level of upper trapezius tender points in medical students as well as determining if CS causes a significant decrease in muscle stiffness in treated tender points as measured by the MyotonPRO. The investigators hope this educational study will encourage further studies on how osteopathic manipulative techniques affects the physiologic parameters of muscles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tender point treatment with Counterstrain | Experimental | Other: CounterstrainA tender point was located in the upper trapezius region of the test subject and treated with counterstrain. The side with the highest initial pain level was used as the treatment side. Pain level was measured before and after treatment. The MyotonPRO was also used to measure physiologic parameters of the muscle before and after treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subject is at least 18 years of age
Key exclusion criteria (7 listed)
- Traumatized (sprained or strained) tissues, which would be negatively affected by the positioning of the patient
- Illness or other conditions in which strict positional restrictions preclude treatment
- Instability of the area being positioned that has the potential to produce unwanted neurologic or vascular side effects
- Vascular or neurologic syndromes, such as basilar insufficiency or neural foraminal compromise whereby the position of treatment has the potential to exacerbate the condition
- Severe degenerative spondylosis with local fusion and no motion at the level where treatment positioning would normally take place
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 |
|---|---|---|
| CounterstrainCounterstrain is a hands-on OMM technique that involves shortening the muscle to resolve the dysfunctional muscle stretch reflex and holding it for 90 seconds. The patient is then brought back to a neutral position and reassessed. | Other | Tender point treatment with Counterstrain |
Primary outcome
Pain level
Time frame: This was done immediately before and immediately after counterstrain treatment. Counterstrain treatment is a hands-on osteopathic manipulative technique that involves shortening the muscle belly of the painful region.
Pain level of the tender point as rated by the test subject out of a scale of 1 to 10, 1 being very little pain and 10 being the most pain the test subject has ever felt.
1 secondary outcome
Muscle Stiffness
Time frame: This was done immediately before and immediately after counterstrain treatment. Counterstrain treatment is a hands-on osteopathic manipulative technique that involves shortening the muscle belly of the painful region.
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 7 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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 Counterstrain in people with Counterstrain and MyotonPRO, run by New York Institute of Technology at 1 site in United States.
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 1 inclusion and 7 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 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Pain level (time frame: This was done immediately before and immediately after counterstrain treatment. Counterstrain treatment is a hands-on osteopathic manipulative technique that involves shortening the muscle belly of the painful region.). 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 7 Feb 2022.