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Inclusion of Mobilisation With Movement to an Exercise Programme in Rotator Cuff Related Pain

Primary Purpose

Rotator Cuff Injuries, Shoulder Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Mobilisation with Movement
Sham Mobilisation with Movement
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries focused on measuring rotator cuff pain, mobilisation with movement, exercises

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Unilateral shoulder pain of atraumatic origin.
  • Complaining of shoulder pain for at least six weeks.
  • Scoring at least 3 out 10 on a numeric pain rating scale (0- no pain; 10- worst pain imaginable).
  • Pain on active shoulder movement
  • Pain provoked by at least three of the following tests: Hawkins-Kennedy, Neer, painful arc, resisted external rotation, empty or full can.
  • Participants referred by a specialist under the diagnosis of subacromial impingement syndrome, rotator cuff tendinopathy, partial rotator cuff tears, subacromial pain, bursitis.

Exclusion Criteria:

  • Shoulder pain following a traumatic event.
  • History compatible with complete rotator cuff and biceps rupture.
  • Adhesive capsulitis.
  • History of dislocation.
  • Glenohumeral osteoarthritis.
  • Cancer
  • Systemic, local or self-immune inflammatory conditions.
  • Previous shoulder or neck surgery.
  • Familiar pain provoked by neck movements.
  • Presence of radicular signs.
  • Use of corticosteroids over the past six months.
  • Diagnosis of fibromyalgia.
  • Participants with clinical depression
  • Participants under treatment for her/his shoulder condition.

Sites / Locations

  • Albrecht - Clínica Integrada de ReabilitaçãoRecruiting
  • Faculdades Integradas de Taquara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental group

Placebo group

Arm Description

Exercise programme: 2-3 sets of 10-15 repetitions of shoulder girdle and glenohumeral strengthening exercises performed in different positions in addition to three stretching exercises. Mobilisation with movement (MWM): the participant and physiotherapist will decide one movement more functionally relevant to the patient. Afterwards, attempts of MWM will be applied to different joints in order to identify one particular MWM that improves significantly the movement previously selected. Then, one set of six to ten repetitions will be applied. This process of pragmatically using MWM will be conducted in every session, but from the second session onwards, two to three sets of ten repetitions will be applied, with an interval of sixty seconds between sets. In case of failure to identify an MWM that improves the movement significantly, the patient decides which one seemed to be best and one set of six repetitions will be applied to the onset of discomfort.

The exercise programme is exactly the same as the experimental group. Sham MWM: the participant and physiotherapist will decide together one movement that is more functionally relevant to the patient. Afterwards, a sham MWM (Delgado-Gil et al 2015) will be applied and the movement previously selected will be repeated six times in the first consultation. The participant will be informed that he/she should move to the onset of symptoms, if they occur.This process will be conducted in every session, but from the second session onwards, two to three sets of 10 repetitions will be applied, with an interval of sixty seconds between sets. In case the sham MWM failed to improve the movement significantly, one set of six repetitions will be applied only.

Outcomes

Primary Outcome Measures

Shoulder Pain Disability Index (SPADI).
SPADI is a self-reported questionnaire that contains thirteen different items. There are two domains: pain (5 items) and functional activity (8 items). Each item ranges from 0 (no pain / no difficulty) to 10 (worst imaginable pain / so difficult that requires help).
Visual Analogue Scale (VAS) for pain.
VAS for pain, is a scale that measures pain level. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).

Secondary Outcome Measures

Active pain-free range of motion.
Active pain-free range of motion will be assessed for flexion, abduction (Kolber et al, 2011), external rotation (Cools et al, 2014) and hand behind back (Satpute et al, 2016). An inclinometer (Baseline, Enterprises Inc) will be used to measure the ranges of motion. All measurements will be conducted to the onset of pain.
Pain pressure threshold
Measurements will be collected at three different sides: 5 cm distal to the lateral border of the acromion on both sides over the deltoid muscle, and 10 cm distal to the tibiofemoral joint line, over the tibialis anterior muscle on the unaffected side (Paul et al, 2012). A calibrated digital algometer (Wagner instruments, model FPX 25) will be used to assess the pain pressure threshold. An interval of 30 seconds will be respected between measurements.
Global rating scale of change (GROC)
GROC is designed to measure a patient's improvement or deterioration over time as a result of an intervention.The amplitude of this difference is scored on a numerical or visual analogue scale. In this research a 15 point scale will be used (Kamper et al, 2009).
Expectations of physiotherapy
The scale to be used in this study to assess expectation has been previously used in patients with shoulder disorders (Chester et al, 2018). Participants will answer the following question: "How much do you expect your shoulder problem to change as a result of physiotherapy treatment?. Please circle one box only". Possible answers are: Completely recover, Much improve, Slightly improve, No change, Slightly worse, Much worse, Worse than ever.

Full Information

First Posted
November 15, 2019
Last Updated
October 17, 2021
Sponsor
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT04175184
Brief Title
Inclusion of Mobilisation With Movement to an Exercise Programme in Rotator Cuff Related Pain
Official Title
The Effects of the Inclusion of Mobilisation With Movement to an Exercise Programme in Patients With Rotator Cuff Related Pain.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rotator cuff related pain is considered the main source of musculoskeletal shoulder pain that affects function and produces pain on movement. Amongst the existing physiotherapeutic management approaches, exercise therapy has been recognized as the first line approach. The use of manual therapy in the management of this condition has been debated and studies have shown contradictory results. A specific manual therapy approach, mobilisation with movement (MWM), seems promising in this population as it aims to improve pain-free range of motion and includes active engagement of the participant.
Detailed Description
Rotator cuff related pain is a term that includes a diversity of shoulder conditions known as: subacromial impingement syndrome, rotator cuff tendinitis/tendinopathy, rotator cuff tear, bursitis. The use of a broader term is useful as the diagnostic accuracy of special orthopaedic tests have been widely criticised and are unable to identify pathognomonic sources of symptoms in people presenting with shoulder pain. Additionally, even though diagnostic imaging is capable of identifying pathology in patients with rotator cuff related pain, studies demonstrate that their correlation with clinical presentation is questionable. Shoulder pain is one of the most common sources of musculoskeletal pain that might affect up to 20% of the population. Additional important epidemiological data concerning shoulder pain is the fact that approximately 40% of people complaining of shoulder pain will still be symptomatic after six months. Physiotherapy has an important role in the management of rotator cuff related pain and exercise is the main therapeutic approach when considering pain and functional restriction, Mobilisation with movement (MWM) is one alternative musculoskeletal approach that focuses on improving active pain-free range of motion. This concept of treatment incorporates a passive accessory glide produced by the clinician, followed by an active movement executed by the patient. Different studies have suggested positive effects of MWM in patients complaining of shoulder pain. On the other hand, other studies reported no superior effects when using MWM in their studies. Several methodological aspects might have influenced this discrepancy in results, such as population, dosage and type of MWM utilized, follow-up period and outcome measures. Due to this uncertainty, the current research aims to further explore the inclusion of MWM to an exercise programme in patients with rotator cuff related pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries, Shoulder Pain
Keywords
rotator cuff pain, mobilisation with movement, exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial, placebo-controlled, with a parallel group design
Masking
ParticipantOutcomes Assessor
Masking Description
Blinding of participants: participants will be unaware about the specificities of the group allocation. The inclusion of a sham mobilisation with movement (MWM) procedure has the aim to mask the manual therapy procedure. For a naive participant, it is unlikely that he/she might be able to discern the real MWM from the sham MWM. In addition, participants will be requested to avoid discussing the interventions received with the outcome assessor. A scale ranging from "treatment under investigation" to "I don´t know" will be used to assess blinding of participants. Blinding of outcome assessor: this research assistant will only be responsible for conducting the outcome assessments. He/she will be unaware of group allocation and will also be requested not to discuss any specifics about the treatment programmes with the participants
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Exercise programme: 2-3 sets of 10-15 repetitions of shoulder girdle and glenohumeral strengthening exercises performed in different positions in addition to three stretching exercises. Mobilisation with movement (MWM): the participant and physiotherapist will decide one movement more functionally relevant to the patient. Afterwards, attempts of MWM will be applied to different joints in order to identify one particular MWM that improves significantly the movement previously selected. Then, one set of six to ten repetitions will be applied. This process of pragmatically using MWM will be conducted in every session, but from the second session onwards, two to three sets of ten repetitions will be applied, with an interval of sixty seconds between sets. In case of failure to identify an MWM that improves the movement significantly, the patient decides which one seemed to be best and one set of six repetitions will be applied to the onset of discomfort.
Arm Title
Placebo group
Arm Type
Sham Comparator
Arm Description
The exercise programme is exactly the same as the experimental group. Sham MWM: the participant and physiotherapist will decide together one movement that is more functionally relevant to the patient. Afterwards, a sham MWM (Delgado-Gil et al 2015) will be applied and the movement previously selected will be repeated six times in the first consultation. The participant will be informed that he/she should move to the onset of symptoms, if they occur.This process will be conducted in every session, but from the second session onwards, two to three sets of 10 repetitions will be applied, with an interval of sixty seconds between sets. In case the sham MWM failed to improve the movement significantly, one set of six repetitions will be applied only.
Intervention Type
Other
Intervention Name(s)
Mobilisation with Movement
Other Intervention Name(s)
MWM, Mobilization with movement
Intervention Description
MWM is a pain-free manual therapy procedure that aims to restore full active pain-free range of motion. It consists of an accessory movement performed by the therapist followed by an active movement executed by the patient. The accessory glide might be produced by the therapist´s hands or by a belt. Minor changes in the amount of force or direction of the glide are common to produce better results. The MWM procedures will be used pragmatically in this study. Therefore, several attempts might be needed to produce the outcome desired. In the case of the shoulder, they can be applied to the glenohumeral joint, scapulothoracic joint, acromioclavicular joint, cervical and thoracic spines and the rib cage. The decision making process in this study will be based on the outcome observed. The procedure that produced the greatest improvement in active pain-free range of motion will be the one used on that occasion.
Intervention Type
Other
Intervention Name(s)
Sham Mobilisation with Movement
Other Intervention Name(s)
sham MWM, sham Mobilization with movement
Intervention Description
Sham MWM is a comparator procedure used in this research to control for placebo related mechanisms of action. This procedure has already been used in previous research (Delgado-Gil et al 2015). Briefly, the therapist will stand opposite to the affected shoulder, he/she will place the thenar eminence of the anterior hand on the skin in front of the humeral head, while the posterior hand will rest on the scapula. Both hands will just lightly rest on the skin, no accessory glide will be performed to the humeral head. Then, the participant will move his/her shoulder in the direction previously selected. Shall the procedure elicit pain-free full range of motion, the participant will move their shoulder ten times. Otherwise, the movement should be performed up to the onset of symptoms.
Primary Outcome Measure Information:
Title
Shoulder Pain Disability Index (SPADI).
Description
SPADI is a self-reported questionnaire that contains thirteen different items. There are two domains: pain (5 items) and functional activity (8 items). Each item ranges from 0 (no pain / no difficulty) to 10 (worst imaginable pain / so difficult that requires help).
Time Frame
Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.
Title
Visual Analogue Scale (VAS) for pain.
Description
VAS for pain, is a scale that measures pain level. The scale ranges from 0 (no pain) to 10 (worst imaginable pain).
Time Frame
Changes from baseline and study completion (5 weeks) and 4 weeks follow-up.
Secondary Outcome Measure Information:
Title
Active pain-free range of motion.
Description
Active pain-free range of motion will be assessed for flexion, abduction (Kolber et al, 2011), external rotation (Cools et al, 2014) and hand behind back (Satpute et al, 2016). An inclinometer (Baseline, Enterprises Inc) will be used to measure the ranges of motion. All measurements will be conducted to the onset of pain.
Time Frame
Changes from baseline and study completion (5 weeks).
Title
Pain pressure threshold
Description
Measurements will be collected at three different sides: 5 cm distal to the lateral border of the acromion on both sides over the deltoid muscle, and 10 cm distal to the tibiofemoral joint line, over the tibialis anterior muscle on the unaffected side (Paul et al, 2012). A calibrated digital algometer (Wagner instruments, model FPX 25) will be used to assess the pain pressure threshold. An interval of 30 seconds will be respected between measurements.
Time Frame
Changes from baseline and study completion (5 weeks).
Title
Global rating scale of change (GROC)
Description
GROC is designed to measure a patient's improvement or deterioration over time as a result of an intervention.The amplitude of this difference is scored on a numerical or visual analogue scale. In this research a 15 point scale will be used (Kamper et al, 2009).
Time Frame
Through study completion and 4 weeks follow-up.
Title
Expectations of physiotherapy
Description
The scale to be used in this study to assess expectation has been previously used in patients with shoulder disorders (Chester et al, 2018). Participants will answer the following question: "How much do you expect your shoulder problem to change as a result of physiotherapy treatment?. Please circle one box only". Possible answers are: Completely recover, Much improve, Slightly improve, No change, Slightly worse, Much worse, Worse than ever.
Time Frame
Change at 3 weeks of treatment from baseline
Other Pre-specified Outcome Measures:
Title
Chronic Pain Self-Efficacy Scale
Description
Self-efficacy is considered an important predictor of patients with shoulder pain (Chester et al, 2018). The domains of pain (5 questions) and function (9 questions) of the chronic pain self-efficacy scale will be used in this study (Salvetti & Pimenta, 2005). Values range from 10 to 100, higher values indicate greater self-efficacy.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral shoulder pain of atraumatic origin. Complaining of shoulder pain for at least six weeks. Scoring at least 3 out 10 on a numeric pain rating scale (0- no pain; 10- worst pain imaginable). Pain on active shoulder movement Pain provoked by at least three of the following tests: Hawkins-Kennedy, Neer, painful arc, resisted external rotation, empty or full can. Participants referred by a specialist under the diagnosis of subacromial impingement syndrome, rotator cuff tendinopathy, partial rotator cuff tears, subacromial pain, bursitis. Exclusion Criteria: Shoulder pain following a traumatic event. History compatible with complete rotator cuff and biceps rupture. Adhesive capsulitis. History of dislocation. Glenohumeral osteoarthritis. Cancer Systemic, local or self-immune inflammatory conditions. Previous shoulder or neck surgery. Familiar pain provoked by neck movements. Presence of radicular signs. Use of corticosteroids over the past six months. Diagnosis of fibromyalgia. Participants with clinical depression Participants under treatment for her/his shoulder condition.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafael Baeske, PhD student
Phone
+55 51 981702422
Email
rbaeske@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo Faria, PhD
Phone
+55 51 999798728
Email
marcelofsilva@ufcspa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Faria, PhD
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albrecht - Clínica Integrada de Reabilitação
City
São Leopoldo
State/Province
Rio Grande Do Sul
ZIP/Postal Code
93020-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Baeske, PhD
Phone
+55 51 981702422
Email
rbaeske@yahoo.com
First Name & Middle Initial & Last Name & Degree
Selma Albrecht
Phone
+55 51 30372720
Email
selma@clinicaalbrecht.com.br
Facility Name
Faculdades Integradas de Taquara
City
Taquara
State/Province
Rio Grande Do Sul
ZIP/Postal Code
95612-150
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Baeske, PhD student
Phone
+55 51 981702422
Email
rbaeske@yahoo.com
First Name & Middle Initial & Last Name & Degree
Selma Albrecht
Phone
+55 51 30372720
Email
selma@clinicaalbrecht.com.br

12. IPD Sharing Statement

Plan to Share IPD
No
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Inclusion of Mobilisation With Movement to an Exercise Programme in Rotator Cuff Related Pain

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