Efficacy of Manual Therapy and Exercise in Patients With Shoulder Adhesive Capsulitis. A Randomized Clinical Trial. (MTEAC)

Efficacy of Manual Therapy and Therapeutic Exercise in Patients With Shoulder Adhesive Capsulitis. Which Factors Are More Correlated With?

The efficacy of manual therapy and therapeutic exercise in patients suffering from adhesive capsulitis of the shoulder will be studied. Furthermore, different biomechanic and psychosocial factors will be measured with a nine month follow-up

Study Overview

• Status: Unknown
• Conditions: Shoulder Pain
• Intervention / Treatment: Other: Manual therapy; Other: Therapeutic exercise

Detailed Description

Adhesive capsulitis of the shoulder is a painful entity characterized by stiffness in the shoulder joint. There exist different clinical trial related to this pathology, however a lack of information of both efficacy and methodology used in manual therapy treatment remains unclear, as well as therapeutic exercise treatment. Furthermore, the duration of the improvement after different conservative treatments is also unknown. Besides, little is known about which factors are more correlated with pain and function.Thus, biomechanic and psychosocial factors together with ultrasound measurements and blood glucose concentration (see "outcome and secondary measures" section ) will be analyzed before and after the treatment, with a nine months follow up. Results will be spread showing short term effects and long term effects in different publications.

Hence, the aim of this study is twofold: i)To analyze the efficacy of manual therapy and therapeutic exercise in patients with shoulder adhesive capsulitis; ii) To correlate pain and function with ultrasonography, biomechanic and psychosocial factors, as well as blood glucose concentration, before and after the treatments proposed with a nine months follow up.

Method

This study is designed as a clinical trial, with two randomised parallel groups comparing two different conservative intervention (MT vs MT+E) (See "Arms and Interventions" section). It will be carried out in different Hospital and primary care centers where patients suffering from adhesive capsulitis of the shoulder will be asked to participate in the project. If participants are eligible then they will be include in the study. All participants will have to sign informed consent after be shown about the whole project as by written (informative sheet) as by speech from the physiotherapist in charge.

Once include in the study definitely, all factors detailed (see "outcome measures" section) will be measured. Also, every factor will be correlated with shoulder pain and function. This way, the investigators could predict which factor are more correlated with. Furthermore, if significant correlations are found, such factors could be used as predictors or monitoring tool when patients with shoulder adhesive capsulitis are treated

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ANTONIO RONDON-RAMOS, PT; Phone Number: 0034 610566313; Email: antonio.rondon.sspa@juntadeandalucia.es

Study Locations

• Spain
  • Malaga
    • Fuengirola, Malaga, Spain, 29603
      • Recruiting
      • Las Albarizas primary care centre
      • Contact: Juan Luis Díaz Cerrillo, PT; Phone Number: +34627911441; Email: juanlu1x2@hotmail.com
      • Contact: Susana Clavero Cano, PT; Phone Number: +34600142510; Email: susclavero@gmail.com
    • Fuengirola, Malaga, Spain, 29651
      • Recruiting
      • Las Lagunas Care Centre
      • Contact: Antonio Rondón Ramos, PT; Phone Number: +34600142611; Email: antonio.rondon.sspa@juntadeandalucia.es
    • Marbella, Malaga, Spain, 29670
      • Recruiting
      • San Pedro primary care centre
      • Contact: Gina Rocío Ariza Hurtado, PT; Email: ginarizado@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• People suffering from adhesive capsulitis as indicated by passive range of motion loss >25% in at least 2 movement planes, together with at least 50% loss of passive external rotation in comparison with the uninvolved shoulder.

Exclusion Criteria:

• Shoulder pain that was deemed to be originating from any passive and/or neck movement or if there was a neurological impairment, osteoporosis, haemophilia and/or malignancies
• Corticoid injections during the six months prior to the study
• Analgesic-antiinflammatory medication intake during the intervention phase of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manual therapy (MT); MT: Manual Therapy. Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done.	Other: Manual therapy; Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done.
Experimental: Therapeutic exercise (E); E: Therapeutic Exercise. Shoulder extension: Elastic bands. Shoulder flexion: Elastic bands Shoulder external rotation: Elastic bands. Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing "push up" on the wall. Thoracic column movements: Flexion-extension	Other: Manual therapy; Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done.; Other: Therapeutic exercise; Shoulder extension: Elastic bands.; Shoulder flexion: Elastic bands; Shoulder external rotation: Elastic bands.; Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing "push up" on the wall.; Thoracic column movements: Flexion-extension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at nine months	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline pressure algometry at nine months	Assessment of central sensitization: It will be carried out on the affected and unaffected shoulder (mid belly of medium deltoid muscle: 2 cm under acromion). Also, the quadriceps rectus femoris (ipsilateral to frozen shoulder, middle spine iliac antero-superior (SIAS) and top patella) will be assessed.	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline ultrasonography at nine months	Different structures will be measured by ultrasonography such as tendons (supraspinatus, infraspinatus, subscapularis and long head biceps tendon) and ligaments (coracohumeral and upper glenohumeral ligaments). Furthermore, acromiohumeral distance and coracohumeral distance will be analyzed. In addition, presence of neovascularization will be studied.	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline electromyography at nine months	It will be investigated the surface electromyographic (EMG) relative muscle activity of the upper (UT) and lower trapezius (LT) as well as serratus anterior (SA) muscles during both ascending and descending phases of arm elevation in participants with adhesive capsulitis of the shoulder	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline dynamometry at nine months	Assessment of shoulder force (unit of measure: kilograms) in seated position (handheld dynamometer) : Elevation in the scapular plane at 90°; Outer rotation with flexion elbow at 90°; Inner rotation with flexion elbow at 90°; Lift off position: Patient places arm behind the back, 90° flexion elbow. Three measurements will be carried out in each position. The mean will be the final value.	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline blood glucose concentration at nine months	To assess metabolic factors venous blood samples will be collected.Information about a person's average levels of blood glucose, over the past 3 months (A1C) will be obtained with the "A1C" test or glycohemoglobin test.	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline range of movement (ROM) at nine months	Measurement of mobility in different planes: Active shoulder flexion and abduction will be measured with the patient seated, in the scapular plane and relative to the thorax. In addition, active external and internal rotation will be measured in neutral (shoulder in adduction), 30°, 60° and 90° of abducted position.	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline heart rate variability (HRV) at nine months	Measurement of Autonomic nervous system activity: Resting HRV provides quantitative information regarding cardiac autonomic tone.	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline CSI questionnaire at nine months	Measurement of central sensitization (CS): The Central Sensitization Inventory (CSI) was developed to assess the overlapping health-related symptom dimensions of CS	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline "pain vigilance and awareness" questionnaire at nine months	The Pain Vigilance and Awareness Questionnaire(PVAQ) is a 16-item measure of pain-related awareness and vigilance. It shows predicted relations with measures of attention-related pain coping strategies, supporting the validity of the total score as a measure of attention to pain	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline pain Catastrophizing Scale questionnaire at nine months	Assessment of the mechanisms by which catastrophizing impacts on pain experience.	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline short form-36 (SF-36) at nine months	Measurement of Quality of life: The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline McGill questionnaire at nine months	Measurement of pain: The McGill Pain Questionnaire can be used to evaluate a person experiencing significant pain. It can be used to monitor the pain over time and to determine the effectiveness of any intervention.	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at nine months	Assessment of quality of life.: This questionnaire measure upper limb symptoms as well as patient ability to do certain activities.	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Change from baseline Autonomic Symptom Profile questionnaire (ASP) at nine months	Measurement of Autonomic nervous system activity: The Autonomic Symptom Profile (ASP) is a validated self-report questionnaire that comprehensively assesses autonomic symptoms across 11 subscales and yields a composite autonomic symptom score	time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)

Collaborators and Investigators

• Sponsor: University of Malaga
• Investigators: Principal Investigator: ALEJANDRO LUQUE-SUAREZ, PT, PhD, UNIVERSITY OF MALAGA, SPAIN

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2016
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 26, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): October 24, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: chronic pain; function; ultrasonography; central sensitization; force
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain; Bursitis
• Other Study ID Numbers: UMA MTEAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The results obtained in this project will be disseminated to the research community through different vias such as publications and oral/poster presentations

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No