PainNCT02812381
Efficacy of Neuromuscular Bandage Technique Against Jones Technique After the Supraespinatus Muscle Tendon Suture
A study testing KT and SCS in people with Pain, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal.
Trial summary
The suture of the supraspinatus tendon is a common surgery that requires physical therapy for back pain and functional impairment to such surgery. Kinesiotaping technique (KT) is being used to treat myofascial trigger points that appear after surgery and for the treatment of physiotherapy in the supraspinatus muscle… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- KT and SCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Aug 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Among patients attending the 1st and 5th week after Intervention.
- Patients with age above 18 years.
- Patients of both sexes.
- Patients with a detectable with algometer trigger point in the supraspinatus and / or deltoid .
Who cannot join
- Patient with Impaired Communication .
- Patients with signs of infection .
- Patients with previous surgery on the shoulder or shoulder capsulitis submit .
- Patient scammers cervical herniated discs or brachial neuropathy .
- Patients with tumor pathology.
- Patients with fibromyalgia,
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- Pregnant patients.
- Patients with central pain .
- Patients conducted simultaneously treatments .
About this study
Official title: Efficacy of Neuromuscular Bandage Technique Against Jones Technique After the Supraespinatus Muscle Tendon Suture: a Prospective Randomized Clinical Trial
The suture of the supraspinatus tendon is a common surgery that requires physical therapy for back pain and functional impairment to such surgery. Kinesiotaping technique (KT) is being used to treat myofascial trigger points that appear after surgery and for the treatment of physiotherapy in the supraspinatus muscle and deltoid.
To evaluate the effectiveness of KT technique over the technique of Jones (Straincounterstrain or SCS) in patients undergoing suture the tendon of the supraspinatus muscle.
Read the detailed description
Objective: To evaluate the effectiveness of the KT technique against Jones (Strain-Counterstrain or SCS) technique in patients with the suture of the tendon of the supraspinatus muscle.
Design: Test clinically controlled, randomized, masking of intervention by double placebo and blind to the subject of the essay and the Studio analyst.
METHOD: Patients with supraspinatus tendon suture are randomly divided into two groups: a group treated with KT (n = 18) and other treated with SCS (n = 18). The treatment was applied the 1st, 4th and 8th day of physical therapy session. All patients were evaluated the 1st and the 12th day of the session with the visual analog scale of pain (VAS), with the scale of Disabilities of the arm, shoulder and hand (DASH) to assess the functionality and active direction-finding (ROM) to assess travel articulate.
- Conditions
- Pain
- Being tested
- KT, SCS
- Keywords
- Trigger Points, movement
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KTProcedure or surgery
to aplicate neuromuscular bandage technique(KT)
SCSProcedure or surgery
To aplicate strain-counterstrain above trigger point
| Study group | Role | What they receive |
|---|---|---|
| SCS (Jones tecnique) | Active comparator | 18 patients were treatment with straincounterstrain Receives: Procedure: SCS |
| KT Kinesiotaping | Sham comparator | 18 patients were treatment with neuromuscular bandage Receives: Procedure: KT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the DASH between sixth and eighth week , in patients with supraespinatus muscle tendon suture.
All participants (36) has been mesured:
- First day of the sixth week after surgery with DASH,
- Four days later of the first medition , it repeated the technique asigned but it hasn´t been mesured.
- Eight days later or the first meditión, it repeated the technique asigned but it hasn´t been mesured.
- Twelve days later of the first medition , it repeated the mesured with DASH,
Measured: From first day of the sixth week after surgery to twelve days after of the first medition.
Secondary outcomes (1)
Change in the VAS between sixth and eighth week , in patients with supraespinatus muscle tendon suture.
All participants (36) has been mesured:
- First day of the sixth week after surgery with VAS scale.
- Four days later of the first medition , it repeated the technique asigned but it hasn´t been mesured.
- Eight days later or the first meditión, it repeated the technique asigned but it hasn´t been mesured.
- Twelve days later of the first medition , it repeated the mesured with VAS
Measured: From first day of the sixth week after surgery to twelve days after of the first medition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ANA ROMOJARO, THERAPIST, Principal investigator, UNIVERSIDAD DE ALCALA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812381
- Sponsor's protocol ID
- BC-2013
- Status last verified
- Mar 2016
- First submitted
- 29 Mar 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The investigators would like to share in the magazine "Manual Therapy"
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Neuromuscular Bandage Technique Against Jones Technique After the Supraespinatus Muscle Tendon Suture: a Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02812381
- Acronym / sponsor ID
- BC-2013
- Conditions
- Pain
- Keywords
- Trigger Points, movement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 24 Jun 2016 (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 suture of the supraspinatus tendon is a common surgery that requires physical therapy for back pain and functional impairment to such surgery. Kinesiotaping technique (KT) is being used to treat myofascial trigger points that appear after surgery and for the treatment of physiotherapy in the supraspinatus muscle and deltoid.
To evaluate the effectiveness of KT technique over the technique of Jones (Straincounterstrain or SCS) in patients undergoing suture the tendon of the supraspinatus muscle.
Detailed description
Objective: To evaluate the effectiveness of the KT technique against Jones (Strain-Counterstrain or SCS) technique in patients with the suture of the tendon of the supraspinatus muscle.
Design: Test clinically controlled, randomized, masking of intervention by double placebo and blind to the subject of the essay and the Studio analyst.
METHOD: Patients with supraspinatus tendon suture are randomly divided into two groups: a group treated with KT (n = 18) and other treated with SCS (n = 18). The treatment was applied the 1st, 4th and 8th day of physical therapy session. All patients were evaluated the 1st and the 12th day of the session with the visual analog scale of pain (VAS), with the scale of Disabilities of the arm, shoulder and hand (DASH) to assess the functionality and active direction-finding (ROM) to assess travel articulate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCS (Jones tecnique) | Active comparator | Procedure: SCS18 patients were treatment with straincounterstrain |
| KT Kinesiotaping | Sham comparator | Procedure: KT18 patients were treatment with neuromuscular bandage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Among patients attending the 1st and 5th week after Intervention.
- Patients with age above 18 years.
- Patients of both sexes.
- Patients with a detectable with algometer trigger point in the supraspinatus and / or deltoid .
Key exclusion criteria (9 listed)
- Patient with Impaired Communication .
- Patients with signs of infection .
- Patients with previous surgery on the shoulder or shoulder capsulitis submit .
- Patient scammers cervical herniated discs or brachial neuropathy .
- Patients with tumor pathology.
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 |
|---|---|---|
| KTto aplicate neuromuscular bandage technique(KT) | Procedure or surgery | KT Kinesiotaping |
| SCSTo aplicate strain-counterstrain above trigger point | Procedure or surgery | SCS (Jones tecnique) |
Primary outcome
Change in the DASH between sixth and eighth week , in patients with supraespinatus muscle tendon suture.
Time frame: From first day of the sixth week after surgery to twelve days after of the first medition.
All participants (36) has been mesured: * First day of the sixth week after surgery with DASH, * Four days later of the first medition , it repeated the technique asigned but it hasn´t been mesured. * Eight days later or the first meditión, it repeated the technique asigned but it hasn´t been mesured. * Twelve days later of the first medition , it repeated the mesured with DASH,
1 secondary outcome
Change in the VAS between sixth and eighth week , in patients with supraespinatus muscle tendon suture.
Time frame: From first day of the sixth week after surgery to twelve days after of the first medition.
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 31 Aug 2016.
- Individual participant dataSharing planned: Yes. The investigators would like to share in the magazine "Manual Therapy"
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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.
ANA ROMOJARO, THERAPIST principal investigator
UNIVERSIDAD DE ALCALA
Questions about this trial
What is this clinical trial studying?
A study testing KT and SCS in people with Pain, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal.
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 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 31 Aug 2016. 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. 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?
Change in the DASH between sixth and eighth week , in patients with supraespinatus muscle tendon suture. (time frame: From first day of the sixth week after surgery to twelve days after of the first medition.). 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 31 Aug 2016.