Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001141538
Ethics application status
Approved
Date submitted
12/06/2024
Date registered
20/09/2024
Date last updated
20/09/2024
Date data sharing statement initially provided
20/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Immediate Effects of Blood Flow Restriction Compared to Isometrics on Pain Threshold and Strength in individuals with forearm myofascial trigger points
Scientific title
Immediate Effects of Blood Flow Restriction Compared to Isometrics on Pain Threshold and Strength in individuals with forearm myofascial trigger points
Secondary ID [1] 312331 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
myofascial trigger points 334097 0
Condition category
Condition code
Musculoskeletal 330771 330771 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 330905 330905 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effect on pain threshold to pressure and strength will be compared in 3 arms of treatment with individuals with trigger points in the epicondyle area.

A single intervention will be performed on all arms. This session will be done on an individual basis. The application of the technique will be performed by a physiotherapist researcher with more than 5 years of clinical experience. We will monitor adherence with a pulse oximeter.

The first arm (intervention) will receive 50% blood restriction flow therapy with a SAGA FITNESS BFR cuff, and will perform 4 sets of 30 x 15 x 15 x 15 repetitions of epicondyle musculature eccentric exercises at 20% of 1 one-repetition maximum test (RM), with a rest time of 60 seconds between sets. The total duration of the intervention will be around 20 minutes.

The second arm (intervention) will perform isometric exercises at 80% of 1RM through a wrist extension with half of the forearm supported. 5 sets of 45 seconds, with 1 minute of rest between sets. We will monitor the adherence by direct observation.

All treatments will be delivered at the University Clinic of the Faculty of Nursing and Physiotherapy of the Universidad Pontificia de Salamanca, Madrid campus.
Intervention code [1] 328814 0
Rehabilitation
Intervention code [2] 328932 0
Prevention
Intervention code [3] 328933 0
Treatment: Other
Comparator / control treatment
In arm 3 (control) participants will receive high power superinductive therapy equipment (Zimmer emField pro) will be used. The device generates a magnetic field of up to 3 Tesla with frequencies ranging from 1-100 Hz. The participant will remain seated with his/her arm resting on the table.The movable arm of the device will be placed 10 centimetres above the epicondyle area of the forearm, and set the prearranged program “pain in the lateral aspect of the elbow” for 15 min.
Control group
Active

Outcomes
Primary outcome [1] 338531 0
pain pressure threshold
Timepoint [1] 338531 0
immediately after the intervention
Secondary outcome [1] 436291 0
arm extension strength
Timepoint [1] 436291 0
immediately after the intervention
Secondary outcome [2] 436292 0
pressure pain threshold
Timepoint [2] 436292 0
24 h after the intervention
Secondary outcome [3] 436293 0
arm extension strength
Timepoint [3] 436293 0
24h after the intervention

Eligibility
Key inclusion criteria
-Who have forearm pain or who feel overloaded
-Who have active or latent myofascial trigger points.
-Signed informed consent form
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- No recognized upper limb pathology, such as previous surgeries or diagnosed injuries.
- Language or cognitive barriers that affect the ability to understand all aspects of the study.
- Pregnancy or planned pregnancy during the study period.
- Cardiovascular disease
- Persons diagnosed with and/or pharmacologically treated for:
- Diabetes mellitus
- Edema
- Open fractures
- Soft tissue injuries
- Skin grafting
- Anemia
- Cancer
- Neurological or neurovegetative alterations.
- People with shift work schedule with night shifts.
- Ingestion of analgesic in the previous 24 hours.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque envelopes to be opened at the time of treatment by the investigator performing the intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The online program randomizer.org will be used. The sample will be divided into 18 blocks of 6
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/06/2024
Date of last participant enrolment
Anticipated
6/10/2024
Actual
Date of last data collection
Anticipated
10/10/2024
Actual
Sample size
Target
108
Accrual to date
10
Final
Recruitment outside Australia
Country [1] 26375 0
Spain
State/province [1] 26375 0
Madrid

Funding & Sponsors
Funding source category [1] 316728 0
University
Name [1] 316728 0
Nursing and Physiotherapy Faculty Salus Infirmorum. Pontifical University of Salamanca
Country [1] 316728 0
Spain
Primary sponsor type
University
Name
Nursing and Physiotherapy Faculty Salus Infirmorum, Pontifical University of Salamanca
Address
Country
Spain
Secondary sponsor category [1] 318935 0
None
Name [1] 318935 0
Address [1] 318935 0
Country [1] 318935 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315502 0
Ethics committee of Pontifical University of Salamanca
Ethics committee address [1] 315502 0
Ethics committee country [1] 315502 0
Spain
Date submitted for ethics approval [1] 315502 0
12/02/2024
Approval date [1] 315502 0
19/04/2024
Ethics approval number [1] 315502 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134902 0
Prof Pablo Leardy
Address 134902 0
Faculty of Nursing and Physiotherapy Salus Infirmorum. Gaztambide street. Number 12. Postcode: 28015, Madrid. Spain
Country 134902 0
Spain
Phone 134902 0
+34923277134 1041
Fax 134902 0
Email 134902 0
[email protected]
Contact person for public queries
Name 134903 0
Sara Perpiña-Martinez
Address 134903 0
Faculty of Nursing and Physiotherapy Salus Infirmorum. Gaztambide street. Number 12. Postcode: 28015, Madrid. Spain
Country 134903 0
Spain
Phone 134903 0
+34923277134
Fax 134903 0
Email 134903 0
[email protected]
Contact person for scientific queries
Name 134904 0
Sara Perpiña-Martinez
Address 134904 0
Faculty of Nursing and Physiotherapy Salus Infirmorum. Gaztambide street. Number 12. Postcode: 28015, Madrid. Spain
Country 134904 0
Spain
Phone 134904 0
+34923277134
Fax 134904 0
Email 134904 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.