NCT04073199

Brief Summary

The shoulder stability has always been related to the rotator cuff complex, although more and more is contemplated the Teres Major muscle and its affectation in the shape of the trigger points within this pathology. As non-invasive measures for the deactivation of these myofascial points, Travell and Simons recommended the pressure maintained along with muscular stretch. Stretching are usually a technique widely used in our practice as physiotherapists and it is necessary to study its effects in the clinic. As an objective we plan to compare the effect of passive stretching in short lever according to the Orthopaedic Manual Therapy concept if it produces better result in the pain, the rank of movement and in the Function, with the effect of stretching by means of a long lever in affected patients of subacromial syndrome. This is a randomized controlled study with blind evaluator approved by the Ethical Committee of the Institut d'Investigació en atenció Primaria Jordi Gol. After checking the inclusion and exclusion criteria, you will be asked, voluntarily, that the patient sign informed consent. The variables will then be valued independent and dependent on the study. It will randomly be assigned to one of the three groups in the study. The 3 groups receive the protocolized treatment for the service they consist of In superficial thermotherapy, an educational talk and kinesitherapy. The intervention groups will receive alternate days, with a total of six sessions, the stretch corresponding to the group to which they have been assigned. In the case of the Long Lever Group, the intervention consists in a rotary stretch through the humerus as a mobile point. And in the case of the Short Lever Group a stretch of translocation through the scapula as a mobile point. The main variables used will be: age, side effects, habits involving the shoulder, pain intensity, pain threshold at pressure and function, among others. The dependent variables will be measured: pain intensity by means of Analogue Scale Visual, the function through the Constant-Murley test, the Movement Range with Goniometer and the Pressure Threshold Pain with a pressure gauge brand Stech.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2017

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2020

Completed
Last Updated

August 29, 2019

Status Verified

August 1, 2019

Enrollment Period

3.2 years

First QC Date

August 27, 2019

Last Update Submit

August 27, 2019

Conditions

Keywords

stretching,teres major, subacromial syndrome, manual therapy

Outcome Measures

Primary Outcomes (4)

  • Pain Intensity

    It will be measured using an Analog Visual Scale. The scale to be used, always the same in each measurement.

    2 minutes needed for the explanation and the realization of the measure.

  • Threshold Pressure Pain

    The patient will be placed in a chair with a table in front, where can support the elbow and forearm in shape comfortable. The physiotherapist takes a clamp without pushing the Teres Major muscle and will perform progressive pressure with the algometer until the patient refers pain sensation. The subjects who perceive pain with a threshold of pressure below 2kg / cm2 will be included in the study according to Andersen et al

    5 minutes needed for explain the technique and realise it.

  • Active Mobility

    The measurement of active mobility (active flexion, active extension, active abduction, active external rotation, active internal rotation) will be done in standing position with the back supported in the framework of a door (to unify positions and allow us to carry out the extension) with a goniometer for flexion, extension, abduction and external rotation, and with a tape metric for internal rotation (measurement from the thumb to the spinous process of C7)

    10 minutes needed for explain the movements required and make de measurements.

  • Function

    The assessment of the function will be performed through the constant Constant-Murley test. The Constant-Murley test abbreviated is a scale that measures the function of the shoulder on the basis of three components: pain, mobility and activities of daily life, resulting in a value maximum of 75 points, in the case that there is no limitation.

    10 minutes needed for the realization of the test

Study Arms (3)

Long Lever Group

ACTIVE COMPARATOR

This arm receive the protocolized treatment along with the long passive stretch of the Teres Major in Long Lever with the patient in supine position.

Procedure: Long Lever Group

Short Lever Group

ACTIVE COMPARATOR

This arm receive the protocolized treatment along with the short lever stretch according to the Orthopaedic Manual Therapy of the Teres Major.

Procedure: Short Lever Group

Control Group

NO INTERVENTION

only receive the protocolized physiotherapy treatment for the Subacromial syndrome that is applied in the Rehabilitation Service, without the addition of any additional stretch technique.

Interventions

the physiotherapist wears the limb passively towards flexion, external rotation and abduction until the physiotherapist has perception of stretch of the tissues (sensation terminal elastic firm according to the concept of Orthopaedic Manual Therapy for the soft tissue treatment) The patient's own weight stabilizes the proximal segment, in case that the scapula is not stable, the physiotherapist fixes with his free hand the scapula. The technique will be performed two days a week, at intervals of 20 seconds of technique and 20 rest periods for ten reps (estimated time per session is 7 minutes approximate).

Long Lever Group

It consists of a stretch made by the physiotherapist, with the patient in supine position, with the extremity to be treated in a submaximal position of flexion and external rotation (fixed by the arm and body of the physiotherapist) and realizing the stretch a through the scapula in the medial and caudal dorsal direction. The technique will be performed two days per week, at intervals of 20 seconds of technique and 20 rest periods for ten reps (estimated time per session is 7 minutes approximate)

Short Lever Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • More than 18 years.
  • Present clinical diagnosis of Subacromial Impingement Syndrome
  • Threshold of pain in the Teres Major muscle pressure less than 2 Kg / cm2.
  • Signature of informed consent.

You may not qualify if:

  • Pre-shoulder surgery (\<1 year).
  • Inability to keep supine position.
  • Contraindications for stretching: (collagen / tissue diseases connective: Ehlers-Danlos, Morquio, Grisel), scars in the healing process or pathological in the area like keloids, acute inflammatory process on the shoulder (\<7 days), severe limitation of the range of movement towards flexion (\<90º passive).
  • Infiltrations (the last 3 months) or during treatment.
  • Be pending litigation or legal claim.
  • Cognitive problems or idiomatic barrier.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Rehabilitació en Atenció Primària (Institut Català de la Salut)

Cornellà de Llobregat, Barcelona, 08940, Spain

Location

Related Publications (5)

  • van der Heijden GJ. Shoulder disorders: a state-of-the-art review. Baillieres Best Pract Res Clin Rheumatol. 1999 Jun;13(2):287-309. doi: 10.1053/berh.1999.0021.

    PMID: 10952865BACKGROUND
  • Page MJ, Green S, Mrocki MA, Surace SJ, Deitch J, McBain B, Lyttle N, Buchbinder R. Electrotherapy modalities for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012225. doi: 10.1002/14651858.CD012225.

    PMID: 27283591BACKGROUND
  • Yu H, Cote P, Shearer HM, Wong JJ, Sutton DA, Randhawa KA, Varatharajan S, Southerst D, Mior SA, Ameis A, Stupar M, Nordin M, van der Velde GM, Carroll L, Jacobs CL, Taylor-Vaisey AL, Abdulla S, Shergill Y. Effectiveness of passive physical modalities for shoulder pain: systematic review by the Ontario protocol for traffic injury management collaboration. Phys Ther. 2015 Mar;95(3):306-18. doi: 10.2522/ptj.20140361. Epub 2014 Nov 13.

    PMID: 25394425BACKGROUND
  • van den Dolder PA, Roberts DL. A trial into the effectiveness of soft tissue massage in the treatment of shoulder pain. Aust J Physiother. 2003;49(3):183-8. doi: 10.1016/s0004-9514(14)60238-5.

    PMID: 12952518BACKGROUND
  • Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.

    PMID: 3791738BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Gemma G Nin, Ms

    Institut Català de la Salut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2019

First Posted

August 29, 2019

Study Start

March 20, 2017

Primary Completion

May 20, 2020

Study Completion

May 20, 2020

Last Updated

August 29, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will share

Individual Participant Data can be shared once the study has finished and its subsequent publication with anyone who requires it formally in writing to the Main Investigator

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Individual Participant Data will be available after its publication. Please contact the Main Investigator

Locations