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Comparison of Two Stretching Techniques in Patients Suffering From Subacromial Syndrome

Primary Purpose

Subacromial Impingement Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Long Lever Group
Short Lever Group
Sponsored by
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subacromial Impingement Syndrome focused on measuring stretching,teres major, subacromial syndrome, manual therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Long Lever Group

Short Lever Group

Control Group

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 27, 2019
Last Updated
August 27, 2019
Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
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1. Study Identification

Unique Protocol Identification Number
NCT04073199
Brief Title
Comparison of Two Stretching Techniques in Patients Suffering From Subacromial Syndrome
Official Title
Effectiveness of the Stretching of the Teres Major in Patients Suffering From Subacromial Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
May 20, 2020 (Anticipated)
Study Completion Date
May 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome
Keywords
stretching,teres major, subacromial syndrome, manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long Lever Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Short Lever Group
Arm Type
Active Comparator
Arm Description
This arm receive the protocolized treatment along with the short lever stretch according to the Orthopaedic Manual Therapy of the Teres Major.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Long Lever Group
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Short Lever Group
Intervention Description
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)
Primary Outcome Measure Information:
Title
Pain Intensity
Description
It will be measured using an Analog Visual Scale. The scale to be used, always the same in each measurement.
Time Frame
2 minutes needed for the explanation and the realization of the measure.
Title
Threshold Pressure Pain
Description
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
Time Frame
5 minutes needed for explain the technique and realise it.
Title
Active Mobility
Description
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)
Time Frame
10 minutes needed for explain the movements required and make de measurements.
Title
Function
Description
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.
Time Frame
10 minutes needed for the realization of the test

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gemma G Nin, Ms
Organizational Affiliation
Institut Català de la Salut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Rehabilitació en Atenció Primària (Institut Català de la Salut)
City
Cornellà De Llobregat
State/Province
Barcelona
ZIP/Postal Code
08940
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
Individual Participant Data will be available after its publication. Please contact the Main Investigator
Citations:
PubMed Identifier
10952865
Citation
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.
Results Reference
background
PubMed Identifier
27283591
Citation
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.
Results Reference
background
PubMed Identifier
25394425
Citation
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.
Results Reference
background
PubMed Identifier
12952518
Citation
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.
Results Reference
background
PubMed Identifier
3791738
Citation
Constant CR, Murley AH. A clinical method of functional assessment of the shoulder. Clin Orthop Relat Res. 1987 Jan;(214):160-4.
Results Reference
background

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Comparison of Two Stretching Techniques in Patients Suffering From Subacromial Syndrome

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