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

Primary Purpose

Shoulder Pain

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual therapy
Therapeutic exercise
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring chronic pain, central sensitization, function, force, ultrasonography

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Las Albarizas primary care centreRecruiting
  • Las Lagunas Care CentreRecruiting
  • San Pedro primary care centreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Manual therapy (MT)

Therapeutic exercise (E)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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.
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.
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.
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.
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
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
Change from baseline pain Catastrophizing Scale questionnaire at nine months
Assessment of the mechanisms by which catastrophizing impacts on pain experience.
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.
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.
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.
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

Full Information

First Posted
November 22, 2016
Last Updated
October 22, 2018
Sponsor
University of Malaga
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1. Study Identification

Unique Protocol Identification Number
NCT02976974
Brief Title
Efficacy of Manual Therapy and Exercise in Patients With Shoulder Adhesive Capsulitis. A Randomized Clinical Trial.
Acronym
MTEAC
Official Title
Efficacy of Manual Therapy and Therapeutic Exercise in Patients With Shoulder Adhesive Capsulitis. Which Factors Are More Correlated With?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 30, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga

4. Oversight

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

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
chronic pain, central sensitization, function, force, ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Manual therapy (MT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Therapeutic exercise (E)
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Manual therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at nine months
Description
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 Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Secondary Outcome Measure Information:
Title
Change from baseline pressure algometry at nine months
Description
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 Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline ultrasonography at nine months
Description
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 Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline electromyography at nine months
Description
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 Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline dynamometry at nine months
Description
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 Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline blood glucose concentration at nine months
Description
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 Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline range of movement (ROM) at nine months
Description
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 Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline heart rate variability (HRV) at nine months
Description
Measurement of Autonomic nervous system activity: Resting HRV provides quantitative information regarding cardiac autonomic tone.
Time Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline CSI questionnaire at nine months
Description
Measurement of central sensitization (CS): The Central Sensitization Inventory (CSI) was developed to assess the overlapping health-related symptom dimensions of CS
Time Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline "pain vigilance and awareness" questionnaire at nine months
Description
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 Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline pain Catastrophizing Scale questionnaire at nine months
Description
Assessment of the mechanisms by which catastrophizing impacts on pain experience.
Time Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline short form-36 (SF-36) at nine months
Description
Measurement of Quality of life: The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.
Time Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline McGill questionnaire at nine months
Description
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 Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at nine months
Description
Assessment of quality of life.: This questionnaire measure upper limb symptoms as well as patient ability to do certain activities.
Time Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)
Title
Change from baseline Autonomic Symptom Profile questionnaire (ASP) at nine months
Description
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 Frame
time (t) 1(prior to treatment), t2 (just received treatment), t3 (3 months later), t4 (6 months later), t5 (9 months later)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ANTONIO RONDON-RAMOS, PT
Phone
0034 610566313
Email
antonio.rondon.sspa@juntadeandalucia.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALEJANDRO LUQUE-SUAREZ, PT, PhD
Organizational Affiliation
UNIVERSITY OF MALAGA, SPAIN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Las Albarizas primary care centre
City
Fuengirola
State/Province
Malaga
ZIP/Postal Code
29603
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Luis Díaz Cerrillo, PT
Phone
+34627911441
Email
juanlu1x2@hotmail.com
First Name & Middle Initial & Last Name & Degree
Susana Clavero Cano, PT
Phone
+34600142510
Email
susclavero@gmail.com
Facility Name
Las Lagunas Care Centre
City
Fuengirola
State/Province
Malaga
ZIP/Postal Code
29651
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Rondón Ramos, PT
Phone
+34600142611
Email
antonio.rondon.sspa@juntadeandalucia.es
Facility Name
San Pedro primary care centre
City
Marbella
State/Province
Malaga
ZIP/Postal Code
29670
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gina Rocío Ariza Hurtado, PT
Email
ginarizado@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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

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