Clinical trial NCT02217540: Mulligan Concept Mobilisation With Movement for Shoulder Dysfunction in Older Adults
Official title: Mulligan Concept Mobilisation With Movement for Shoulder Dysfunction in Older Adults- A Pilot Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disorder of Shoulder
Keywords: Shoulder, disability evaluation, physiotherapy modalities
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 44
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To pilot the methods proposed for conducting a full randomised clinical trial to evaluate the effect of Mulligan concept mobilization with movement on shoulder functionality in older adults with shoulder dysfunction.

Design: Pilot randomised, single-blinded clinical trial. Setting: Three nursing homes, Toledo, Spain. Participants: 44 older adults with shoulder dysfunction. Interventions: Participants will be randomly allocated into control group (n=22) treated with a physiotherapy standard protocol proposed by the Spanish Rheumatology Society; and experimental group (n=22) treated with the same physical therapy standard protocol and Mulligan concept mobilisation with movement. Both interventions will take place three times a week for 2 consecutive weeks.

Main outcomes: Primary outcome is shoulder functionality measured with Shoulder Disability Questionnaire (S-SDQ) Spanish version, and secondary outcomes are active glenohumeral range of motion and pain intensity. Data will be collected at baseline, after each group intervention, and 1 and 3 months after finishing interventions.

Detailed description: Shoulder dysfunction is a common problem in older adults reaching up to 21% of prevalence. Shoulder symptoms, such as pain and reduced shoulder active range of motion (AROM) and function, might be associated to chronic pain, disability and decline in physical performance over time. Upper limbs and shoulder joint proper functionality leads to an adequate independence in activities of daily living (ADL) and functional performance. Therefore, maintaining independence in ADL and functional well-being in older adults should be a priority target for health care. A successful therapeutic approach depends on the understanding that the aging process is the responsible of major changes involving muscle disorders and joint stiffness.

Among the most common approaches to treating in¬dividuals with shoulder dysfunction, physiotherapy interven¬tion is often recommended as the first choice for a conservative treatment. Physiotherapy treatment usually includes therapeutic exercises, manual therapy, and various modalities and there are controversies about the most effective approach for pain reduc¬tion, increase in AROM and function, and decrease in disability in people with shoulder dysfunction. There is evidence about the effectiveness of thera¬peutic exercise, and the benefit of manual therapy for improvements in mobility and a trend in improving pain measures, while increases in function and quality of life are still questionable.

Some evidence was found about the effects of therapeutic exercise programs for overall performance improvement in older adults, but not specifically shoulder dysfunction. Regarding manual therapy in elderly, Knebl et al. developed a study about the effectiveness of Spencer manipulative technique in shoulder pain and found an improvement in functionality, shoulder AROM and pain intensity. Van den Dolder et al. investigated the effect of soft tissue massage on shoulder ROM, pain and dysfunction in patients with a mean age of 64 years old and found statistically significant results. Therefore, manual therapy techniques may be an option for correcting joint mechanics, promoting adhesion removal and restoring passive shoulder mobility in older adults.

Mobilisation with movement (MWM) is a manual therapy technique based on the analysis and correction of any minor positional fault in a joint. According to Mulligan, positional faults are due to various soft tissue and/or bone lesions in/around the joint and were explained in patients with shoulder pain by a kinematic study. This technique aims to realign joints positional faults by applying a manually specific oriented glide to a painful joint, assessing and adjusting force intensity, while the patient actively performs joint movement, so that patient's symptoms are immediately relieved and the maneuvers improve pain and movement. Therefore, when a correction mobilization is sustained, pain-free movement is restored and several repetitions are performed in order to get an improvement that lasts over time. The initial effects of MWM were assessed by Teys et al. in adults; who proved its effectiveness in increasing shoulder AROM and decreasing positional faults. Therefore, MWM may be an effective technique in physiotherapy treatment for shoulder dysfunction, as this it addresses passive and active shoulder structures. However, no studies about MWM effectiveness for shoulder dysfunction in older adults have been found.

The purpose of this pilot clinical trial is to pilot the methods proposed to conduct a full randomised controlled clinical trial to determine the effect of Mulligan concept MWM for shoulder dysfunction in older adults. The primary objectives are to evaluate the feasibility of recruitment, randomisation, retention, assessment procedures, and implementation of Mulligan concept MWM intervention. A secondary aim is to undertake a preliminary comparison of patient reported-outcomes and to estimate the variability of these outcomes in older adults with shoulder dysfunction.

Eligibility criteria: Inclusion Criteria:

* to be over 65 years old
* diagnosed with shoulder dysfunction (shoulder pain and/or limited AROM in the last 4 weeks) by their physician
* dependent on at least 1 ADL
* with a limited glenohumeral AROM of 25% - 75%
* resident in the nursing homes where the study took place.

Exclusion Criteria:

* subjects with moderate or severe cognitive impairment
* specific rheumatic diseases, osteoarthritis, neoplasms
* shoulder joint instability
* circulatory disorders (hemophilia, clotting problems)
* skin problems aggravated by contact with the skin
* traumas in the past month
* bilateral shoulder disorders

Primary outcomes:
measure: Spanish-Shoulder Disability Questionnaire
timeFrame: baseline and 3 times after interventions
Secondary outcomes:
measure: Range of motion and pain
timeFrame: baseline and 3 times after intervention
Other outcomes:
Locations:
city: Villarrubia de Santiago
country: Spain
facility: Mensajeros de la Paz
state: Toledo
Study officials:
affiliation: University of Alcala
name: Cristina Lirio Romero, MsC
role: PRINCIPAL_INVESTIGATOR
References:
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