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Trial record 1 of 1 for:    NCT04175184
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Inclusion of Mobilisation With Movement to an Exercise Programme in Rotator Cuff Related Pain

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ClinicalTrials.gov Identifier: NCT04175184
Recruitment Status : Unknown
Verified November 2020 by Rafael Baeske, Federal University of Health Science of Porto Alegre.
Recruitment status was:  Recruiting
First Posted : November 22, 2019
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Rafael Baeske, Federal University of Health Science of Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Injuries Shoulder Pain Other: Mobilisation with Movement Other: Sham Mobilisation with Movement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial, placebo-controlled, with a parallel group design
Masking: Double (Participant, Outcomes 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

Primary Purpose: Treatment
Official Title: The Effects of the Inclusion of Mobilisation With Movement to an Exercise Programme in Patients With Rotator Cuff Related Pain.
Actual Study Start Date : November 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 1, 2022

Arm Intervention/treatment
Experimental: Experimental group
  1. 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.
  2. 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.
Other: Mobilisation with Movement

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.

Other Names:
  • MWM
  • Mobilization with movement

Sham Comparator: Placebo group
  1. The exercise programme is exactly the same as the experimental group.
  2. 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.
Other: Sham Mobilisation with Movement
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.
Other Names:
  • sham MWM
  • sham Mobilization with movement




Primary Outcome Measures :
  1. Shoulder Pain Disability Index (SPADI). [ Time Frame: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up. ]
    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).

  2. Visual Analogue Scale (VAS) for pain. [ Time Frame: Changes from baseline and study completion (5 weeks) and 4 weeks follow-up. ]
    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 :
  1. Active pain-free range of motion. [ Time Frame: Changes from baseline and study completion (5 weeks). ]

    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.


  2. Pain pressure threshold [ Time Frame: Changes from baseline and study completion (5 weeks). ]

    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.


  3. Global rating scale of change (GROC) [ Time Frame: Through study completion and 4 weeks follow-up. ]
    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).

  4. Expectations of physiotherapy [ Time Frame: Change at 3 weeks of treatment from baseline ]

    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.



Other Outcome Measures:
  1. Chronic Pain Self-Efficacy Scale [ Time Frame: Baseline ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04175184


Contacts
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Contact: Rafael Baeske, PhD student +55 51 981702422 rbaeske@yahoo.com
Contact: Marcelo Faria, PhD +55 51 999798728 marcelofsilva@ufcspa.edu.br

Locations
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Brazil
Albrecht - Clínica Integrada de Reabilitação Recruiting
São Leopoldo, Rio Grande Do Sul, Brazil, 93020-080
Contact: Rafael Baeske, PhD    +55 51 981702422    rbaeske@yahoo.com   
Contact: Selma Albrecht    +55 51 30372720    selma@clinicaalbrecht.com.br   
Faculdades Integradas de Taquara Not yet recruiting
Taquara, Rio Grande Do Sul, Brazil, 95612-150
Contact: Rafael Baeske, PhD student    +55 51 981702422    rbaeske@yahoo.com   
Contact: Selma Albrecht    +55 51 30372720    selma@clinicaalbrecht.com.br   
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
Investigators
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Principal Investigator: Marcelo Faria, PhD Federal University of Health Science of Porto Alegre
Publications:
SALVETTI, M. G.; PIMENTA, C. A. M. Validação da Chronic Pain Self-Efficacy Scale para a Língua Portuguesa. Rev Psiq Clín, v. 32, n. 4, p. 202, 2005

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rafael Baeske, Principal investigator, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT04175184    
Other Study ID Numbers: 10534119.5.0000.5345
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: October 19, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rafael Baeske, Federal University of Health Science of Porto Alegre:
rotator cuff pain
mobilisation with movement
exercises
Additional relevant MeSH terms:
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Shoulder Pain
Rotator Cuff Injuries
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries