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Completed

NCT Number: NCT04175184

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

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.

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Key information

Conditions

Rotator Cuff Injuries Arthralgia Behavior Joint Diseases Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Rupture Shoulder Injuries Shoulder Pain Signs and Symptoms Tendon Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albrecht - Clínica Integrada de Reabilitação, São Leopoldo, Rio Grande do Sul, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mobilisation with movement

Other

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 Mobilisation with Movement

Other

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 outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Registry information

Official study title

The Effects of the Inclusion of Mobilisation With Movement to an Exercise Programme in Patients With Rotator Cuff Related Pain.

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Nov 22, 2019
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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